imt busplan_l-terry-copyright

1 Innova Medical Technologies, Inc. Copyright 2012. Confidential and Proprietary. All Rights Reserved. No duplication or transmission of this information without written permission of Innova Medical Principal.

Business Plan 2012

i n n o v a m e d e c p . c o m

Quality Investment. Quality Life.


Business Plan 2012

Quality Investment Quality Life

CONFIDENTIAL. No offering is made or intended by this document. Any offering of interest in Innova Medical Technologies, Inc. (IMT) will be made only in compliance with Federal and State securities laws. This document includes confidential and proprietary information of and regarding IMT. This document is provided for informational purposes only. You may not use this document except for informational purposes, and you may not reproduce this document in whole or in part, or divulge any of its contents without the prior written consent of an IMT Principal or Partner. By accepting this document, you agree to be bound by these restrictions and limitations.


bad | IDEA

Listening to anyone

who tells you where to get a really great real estate deal


good | IDEA

Listening to Innova Med

Teach you how to profit from an investment in healthcare

Finally…Freedom to be a dancing fool!


Contents

1. Executive Summary 7 1.1 Mission 8 1.2 Business Overview 9 1.3 Company Overview 12 1.4 Success Factors 19 1.5 Investment Structure 22 1.7 Investor Capacity 24

2. Company Overview 25 2.1 Ownership 26 2.2 Experience 27 2.3 Executable Strategy 28 2.4 Manufacturing Experience 29

3. Operations 30 3.1 Milestones 31 3.2 Key Services 32 3.3 Personal Letter From The CEO 33 3.3 Founders Bio | Lisa Terry 34 3.3 Founders Bio | George Nelson 35 3.3 Management Bio | John McCallum 36 3.3 Management Bio | Irwin Zucker 37 3.3 Management Bio | David Gregory 38 3.3 Management Bio | Steve Porter 39 3.3 Management Bio | Peter Helander 40 3.4 Hiring Plan 41

4. Industry Analysis 44 4.1 Critical Questions 45 4.2 Medical Device Industry Snapshot 46 4.3 Medical Device Industry Forecast 47

5. Customer Analysis 48 5.1 Our Customers 49

6. Core Business Model 51 6.1 Problems We Solve 52 6.2 Solutions We Provide 54 6.3 Implementation Snapshot 57 6.4 Stakeholder Snapshot 58 6.5 Stakeholder Benefits 59 6.6 Civic Impact 60

7. Marketing Plan 61 7.1 Core Approach 62 7.2 Core Focus 63 7.3 Core Offerings 64 7.4 Core Marketing Competencies 66 7.5 Core Selling Competencies 67 7.6 USP 69 7.7 Core Income Model 71 7.8 Promotions Strategy 72


8. Products 738.1 Core Medical Device 748.2 Supporting Devices 75

9. Competitive Analysis 769.1 Industry Competitors 779.2 Competitive Advantage 79

10. Financial Highlights 8010.1 Financial Snapshot 8110.2 Cost Assumptions 8210.3 Income Projections 8310.4 Quarterly Balance Sheet 5 Year Projected 8410.5 Expenses Summary 85

11. Reimbersement 8611.1 Important Clinical Studies 87 12. Reference Sources 9312.1 ECP Overview 9412.2 ECP Treatment Overview 9512.3 ECP Critical Component 9612.4 How ECP Works 9712.5 Beneficial Mechanisms of ECP 9812.6 Reimbursement 9912.7 Patient Criteria 10012.8 Important Clinical Studies 10112.9 ECP Clinicals 102 13. Disclaimer 105 14 Contact InnovaMed 106


1. Executive Summary

“ ““I have found no greater satisfaction than

achieving success through honest dealing and

strict adherence to the view that, for you to gain,

those you deal with should gain as well.”

Alan Greenspan


1.1 Mission

ECP GaveUs Our

Lives Back!

Where does a better quality of life begin?

70 million people know

the answer.

Facts:

According to the World Health Organization (WHO), Cardiovascular Diseases (CVD’s) affect over 70 million people, and represents 60% of all deaths worldwide. More people die annually from CVDs than from any other cause.

CVD’s are recognized as the #1 Global Economic Risk to our worldwide economic stability. The recognized #2 killer is Hypertension, and # 3 is Diabetes. ECP is recognized as the only single medical therapy that effectively treats and/or cures all three.

In the U.S., CVD’s are responsible for one in every three deaths, equal to 2,200 deaths per day, or one person every 34 seconds.

Innova Medical Technologies is about to change all that.

FOR QUALITY OF LIFE IT’S THE BIG ISSUE!Our Mission: Our mission is to improve the health of all CVD sufferers, and others benefitted through our non-invasive,

life-saving, FDA approved treatment options via primary and specialty care providers around the world. Innova Med plans to

be an instrument of global change through education, patient advocacy and subsidized patient care to the indigent through

our non-profit organization, the Quality of Life Advocacy (QOLA). Innova Medical shall effectively serve our employees,

investors, and local community by thoughtful implementation of its integrity and leadership based business practices, which

outcomes shall provide a sustainable, profitable and long-term model of success and service in pursuit of our highest goal…

providing all of our stakeholders the opportunity to achieve a greater quality of life.


1.2 Business Overview

Innova Medical Technologies, Inc. (IMT or Innova) was established in November, 2011 by its

Founders, George Nelson and Lisa Terry. After months of research, due diligence, focus studies and

successful pilot trials, Innova Medical officially incorporated in March, 2012. Beyond its Founders

contribution of capital necessary to support its pre-development efforts, Innova Medical successfully

acquired the longest-standing 30 year durable medical equipment manufacturing industry leader,

Cardiomedics, Inc. in September, 2012 for $15M.

Its Founders head executive, marketing, sales and distribution operations. John McCallum,

Cardiomedics past President & CEO, shall continue as President & COO from its Irvine, CA

location to ensure a streamlined manufacturing integration and expand into PR, Regulatory

markets, International Partner & Clinical funding development, and Irwin Zucker shall head R&D

and logistics operations.

IMT is a designated S-Corporation with a formation date of March 15. 2012.

Innovative Market Approach

Innova Medical’s Founder’s share a prior 10 year track record as a market maker responsible for

expanding dental services into the cosmetic sector via execution of its innovative and multi-market

development strategies within B2B, B2C, retail and vending distribution channels, being first to

market in what is now a $119 Billion per year industry.

Innova Med’s similarly unique ‘Medical Vending’ model shall trend away from the long-held

conservative capital equipment direct-sales only model, and ‘Cardiology only’ ECP market focus,

into a pay-as-you-go services model, called The Pulse Program, which will not require a physician

to layout capital of $65-85,000 in advance. As part of its Pulse Program, Innova’s corporate account

managers will be involved in marketing ECP to current patients, implementing and supporting

patient loyalty and retention programs, and work as an advocate between the physician and

Company, when patients are in need of the Company’s non-profit scholarship fund to assist in paying

co-pays or out-of-pocket expenses of private indemnity plans. Innova’s local market representatives

will also create brand awareness and create PR programs through civic and community involvement

in the local markets.

Innova Med offers a full-turn key business and marketing solution providing a synergistic and

innovative approach to exponential sales expansion of proven medical therapies. IMT provides

opportunities for med-tech investors and other stakeholders, and established, innovative solutions

for physicians, patients and payors.


Innova Med offers a full-turn key business and marketing solution providing a synergistic and innovative approach

to exponential sales expansion of proven medical therapies. IMT provides opportunities for med-tech investors and

other stakeholders, and established, innovative solutions for physicians, patients and payors.

Its alliance with the World Health Organization (WHO) will assist the U.S. in complying with 2010-2012 mandates

for member Nations to offer more affordable, accessible, patient-focused, primary healthcare alternatives over

speciality care with implementation of same beginning January, 2013.

Sales Forecasts

Forecasts place more than 200 new units into the Top 20 medical markets in the U.S. through Its Pulse Program

model within its first 12 months. Innova’s expanded marketplace of over 400,000 General Practitioners, D.O.’s,

Internists, D.O.’s, Urologists, Specialty Clinics, Sports Therapy Centers, and Medi-Spas, among others creates

expansive growth opportunities beyond the 14,000+/- cardiologists targeted to date by industry players.

The most profitable aspect of Innova’s Pulse Program is its ability to create and sustain residual income from

treatments performed by it’s in place unit’s year-to-year.

As a result of Innova’s recent acquisition of Cardiomedics, direct sales from existing exclusive international markets

including Mexico, Taiwan and Germany represent more than 200 additional device installations in a standard direct

sales fashion to hospitals and specialty clinics in those markets in the next 18 months.

Innova Medical is poised for global expansion as a result of the relationships being further developed through the

WHO, and jointly through the United Nations (UN) Medical Device Buying office, which preliminary discussions

forecast a deployment plan which includes introduction of our External Counter Pulsation (ECP) devices into 300 of

the 600 UN’s owned hospitals located in 39 countries around the world over the next 5 years.

Details of Innova’s strategic, marketing, sales, and financial plan can be found in detail within this plan.




Corporate Structure:

Capital Request

Innova Med is seeking $2.75M in Expansion Capital, via Preferred Series B Equity, Convertible Debt or other hybrid

structure to reach its expansion goals in support of its recent acquisition.

Upon Issuance of Shares in the event the $2,750,000 capitalization sought is received in the form of equity, the company’s

equity structure fully diluted, inclusive of this projected round of financing is reflected below:

•Founders Shares represent 65%

•DirectorsandEmployeeTrustsrepresent5%

•Currentequityinvestorsrepresent2%

•Projectedequityinvestorsshallcontrol28%

•TheCompanyhasAuthorized20,000,000shares

Notes: This projection shows the effect of the next round of financing.


IMT’s Executive, Sales and Administrative office is located at 1005 Alderman Drive, Alpharetta,

Georgia 30005, and is headed by Managing Partners, George Nelson and Lisa Terry.

IMT’s R&D and Logistics Operations office is located at 19186 East Prentice

Circle, Centennial, CO 80015 and is heading by CLO, Irwin Zucker.

Innova Med’s logistic office is in a thriving business and residential area within minutes of Denver, CO.

CARDIOMEDICS Manufacturing office currently operates from a single location at 7 Whatney,

Irvine, California 92618-2849.

1.3 Company Overview

Innova Medical Building(10,000 sf of office and 3,000 sf warehouse

IMT Currently Operates from Three Locations:

Innova Med’s offices are located within the Metro Atlanta area, in an upscale business community which is shared by #261 on the Top Fortune 500 list, Newell-Rubbermaid, UPS and Metropolitan Life. Lexis-Nexis, AT&T, and Verizon Wireless are located in nearby office complexes.

Atlanta ranks fourth in the nation among cities with the most FORTUNE 500 Headquarters, boasting 25 companies such as Coca-Cola, BellSouth, and Home Depot located within minutes from its corporate office.

Innova Med is surrounded by dynamism and enjoys the stability of a strong regional economy, with an emphasis on the attractiveness of the local busi-ness climate.

Home to 4 of the Top 10 Medical Specialty hospitals in the U.S. according to U.S. News Reports4, such as Emory University Hospital, Piedmont Hospital, The Shepard Center and Wesley Woods, Innova Med shall seek medical af-filiate, advocacy and program partnerships to expand its brand.

Innova Med is Located 38 miles from Atlanta Hartsfield Airport, with ease of access via Atlanta’s MARTA (mass rapid commuter train) and minutes from Midtown and Buckhead, thriving financial and commercial centers.


Planned Manufacturing Facility Move:

The Company has just negotiated a successful contract manufacturing agreement with Spectrum Assembly, Inc.,

located in San Diego County, CA, which manufacturing will be transferred at significant cost savings and recognize

speed to market advantages over its current structure by November 8, 2012.

Spectrum Assembly has the certifications necessary to manufacture per specification, including ISO 9001:2008 and

ISO 13485:2003. The facilities are FDA registered and 21CFR 820 compliant, are compliant with GMP/QSR require-

ments, and routinely pass standard audits by UL, CE, and ETL.

IMT and newly acquired CARDIOMEDICS are now conducting business as Innova Medical Technologies, but

will retain the Cardiomedics name under a DBA to allow a smooth transition with its component suppliers and

regulatory agencies. Combined, Innova shall now act exclusively to manufacture, and operate its sales, marketing and

distribution programs.

Together they shall be known as the “Company” when references throughout this Plan are necessary.

http://www.saicorp.com/industries-served/medical/



In 2001, the FDA provided 510(K) clearance, and in 2002 the U.S. Health & Human Services approved this durable medical

device to deliver ECP therapy, which addresses unmet clinical needs in the management of individuals with various forms of

Cardiovascular Disease (CVD), the #1 killer of the human race. ECP is a non-surgical, non-invasive therapy offered through

healthcare professionals.

30 years ago, Cardiomedics was the first company to fund clinical trials and to achieve a FDA 510(k) certification. Since incep-

tion, its ECP device has been the only device with a historically recognized - ZERO adverse effect rate -and beneficial treatment

factor of over 87%...unmatched by any other medical device or surgical intervention.

In March, 2012, after 2 years and an additional $3M in R&D to develop the most advanced ECP hardware and software

technology in the market today, Cardiomedics launched the CardioAssist 4500gs, which showcased Its proprietary offerings

including the only iPad app based, Wi-Fi, remote viewing technology. It is also the only portable unit available today, having

moved away from the standard exam bed sized unit, which does not require a separate exam room to facilitate, thus removing

one of the top two barriers to sale.

The number one barrier to sale was the high $65-85,000 established direct capital cost to physicians and hospitals, Innova’s

unique marketing and distribution model overcomes this #1 barrier to sale, with details described further within this plan.

Since ECP’s first patent issuance in 1941 by a Harvard University Professor, Cardiomedics obtained 60 additional relative

Patents for therapeutic use, technology, utilization, components and for its graduated pressure regime. Further patents are

currently pending and another on the shear rate affect achievable only through is patented processes, shall be filed soon after

clinical trial completion in Germany by year end 2012.

Innova’s diverse product offerings also include patented, proprietary software and supporting consumables.

After clinical trial completion in Germany, which is also being conducted on a working proto-type home-based unit, Innova

plans to provide this supplemental home-based unit as a prescribed part of on-going therapy for cardiac patients, and via direct

B2C sales to consumers in the elective marketplace.

Critical Components

Critical to optimum health and vital function is the effective increase, transportation and utilization of oxygen and blood. In

layman’s terms, External Counter Pulsation (ECP) provides these core benefits which supports all critical systems and organs

within the human body.



Most of us suffer from a lack of oxygen, and thus proper blood function. Whether from improper breathing, poor diets, air

pollution or lack of exercise, our cells are being deprived of this vital element and thus weakens our immune systems.

Oxygen (O2) is one of the most important and critical components required to sustain life. Unhealthy or weak cells due to

improper metabolism lose their natural immunity and are thus susceptible to viruses and suscept the body to all manner

of infection and disease. Without O2, our health begins to suffer and we progress more quickly towards death.

O2 not only gives us life but destroys the harmful bacteria in our bodies, without affecting the beneficial bacteria that we need

for successful digestion, nutrient absorption, and toxin elimination. No antibiotic, herbal remedy, or surgical intervention can

provide these overall benefits.

Life styles today, in a modern world environment with depleted O2 levels in the atmosphere, actually requires our cells to use

more of this odorless/colorless gas to deal with several stresses on our body’s ability to function, and increases the risk of obesity,

cardiovascular disease, hypertension, and all other disease states. Conversely, reducing these major stressors through greater

oxygenation eliminates cellular toxins at an increased rate, increasing metabolism and assists in weight loss, and decreases

disease risk.

Specifically, ECP works by uniquely calibrated pressurization on the lower extremities, which increases blood flow and force

in between each individual’s heartbeat, and is maximized by the sheer rate affect, a patented process which individualizes the

expansion (and reduces the hardening affect) of collateral and arterial pathways, which improves oxygen and blood cell

transport. The effects of ECP further provide detoxification and purification of all of the body’s vital systems, which has proven

to be foundational in the body’s ability to heal itself…essential to restoring health and vitality.

ECP’s Benefits

Because of its improved oxygen transport to all vital organ, and its ability to regulate diastole and systolic blood flow and

pressure, ECP’s physical effect is seen through the expansion of arterial pathways, which in cardiac patients, creates a ‘natural

bypass’ around blockages in the heart. Overall, ECP has evidenced its ability to improve heart, lung, brain, and circulatory

function…and ultimately to extending life.

History

External counter pulsation has been clinically studied dating back to the 1960’s, when it was first introduced. It continues to

be studied today. The earliest studies were done in the areas of cardiogenic shock and acute myocardial infarction. Since 1990,

virtually all studies have been focused on either angina or heart failure.



In 1997, the first randomized, double‐blinded, placebo‐controlled study was completed (MUST‐ECP, 6 1995‐1997). It evaluated

the effect of external counter pulsation therapy, testing the reproducibility of benefits from earlier studies in cross-relational

modalities. Patients in the external counter pulsation group demonstrated a statistically significant increase in multiple areas,

and since 1997 clinical trial submissions to the World Health Organization’s International Registrar have more than tripled.

Likewise, the rise in patient numbers has seen a similar gain.

Clinical Evidence

ECP can be found today in major Cardiac Care facilities such as Mayo Clinic, Johns Hopkins University Hospital, Cleveland

Clinic, Stamford, Yale and Harvard Universities, among hundreds of other renowned cardiac centers worldwide.

Since its introduction clinical evidence continues to grow in support of ECP’s benefits beyond cardiovascular disease as an ef-

fective treatment and/or cure for other non-communicable diseases such as:

1. Diabetes 8. Sudden Deafness Syndrome

2. Acute Congestive Heart Failure 9. Renal (Kidney) Failure

3. Stoke 10. Macular Degeneration

4. Erectile Dysfunction 11. Infertility due to low sperm count

5. Obesity 12. Multiple sclerosis

6. Alzheimer’s 13. Stem Cell growth, where repair of internally damaged organs and other tissues in various disease states has been evidenced.

Subjects are currently being recruited for or clinical studies are underway on External Counter pulsation as a treatment for the

following, with exciting implications:

1) Vascular Hemodynamics in Cognitively Impaired Patients which will study the effects on Alzheimer’s

and dementia patients. ClinicalTrials.gov Identifier: NCT01659398

a) Secondary data from this study will be mined to support peer reviewed studies which have shown:

i) Change in Ophthalmic blood flow (OBF) affecting patients with macular (eye) degeneration

ii) Change in Blood Viscosity affecting patient with hypertension (high blood pressure)

and other blood disorders

iii) Cholesterol composition of the blood affecting patients with high cholesterol

2) Acute Ischemic Stroke: ClinicalTrials.gov Identifier: NCT00983749

3) Left Ventricular Systolic and Diastolic Function: ClinicalTrials.gov Identifier: NCT01112163

4) Subclinical Atherosclerosis which shall study the Shear Stress factor affecting the Intima-medial thickness of the

cervical artery and the underlying inflammation- related molecular mechanisms. ClinicalTrials.gov Identifier:

NCT01106495



5) Coronary Heart & Artery Disease which will study the effects on reductions in heart attacks:

ClinicalTrials.gov Identifier: NCT01198405

a) Secondary data from this study will be mined to support peer reviewed studies which have shown

i) Improved vascular endothelial function measurement of flexibility of peripheral artery

and flow-mediated dilatation (FMD)

ii) cardiac structure and change in chamber diameter, left ventricular wall thickness, ejection fraction

iii) reduction in rate of new-onset diabetes

Clinical trials are currently being co-funded with hospital partners in India utilizing our manufactured ECP devices.

Innova Medical plans to further its clinical development on the above modalities, and shall utilize corollary data evidenced from

clinicals to further its study of effects on Cancer, ADHD and Autism sufferers. Secondary clinical data currently recognizes corollary

effects on these additional modalities, and which the Company feels could easily be added to the growing list of healthful gains.

Regulatory Acceptance

ECP is cleared by the Food and Drug Administration (FDA) for use in treating a variety of cardiac conditions, and is currently

covered for the following conditions by Medicaid, Medicare and private insurers as follows:

ANGINA ICD-9 CM Office Codes or Medicaid/Medicare Office (CPT) Codes G0166, with sub-codes below:

•411.1IntermediateCoronarySyndrome

•413.0AnginaDecubitus

•413.1Prinzmetalangina

•413.9Other/unspecifiedanginapectoris

•414.9Chronicischemicheartdisease,unspecified

CONGESTIVE HEART FAILURE ICD-9 CM Codes

•428.0CongestiveHeartFailure

•428.1Leftheartfailure

•428.9Heartfailureunspecified

•402.01Hypertensiveheartdisease,malignantwithCHF

•402.11Hypertensiveheartdisease,benignwithCHF

•402.91Hypertensiveheartdisease,unspecifiedwithCHF

•494.01Hypertensiveheartandrenaldisease,malignantwithCHF

•404.11Hypertensiveheartandrenaldisease,benignwithCHF

•404.91Hypertensiveheartandrenaldisease,unspecifiedwithCHF



Current clinical submissions are pending the FDA’s 510(k) review and approval for Acute Congestive Heart Failure (ACHF),

and Diabetes.

ECP is unique in that U.S. reimbursable rates for angina and covered cardiac patients have steadily increased at an average of

5% year-to-year over the last 5 years. The Metro Atlanta market saw an increase from $151.00 per treatment hour, or $5,285.00

per treatment course, to $164.00 per treatment hour, or $5,740.00 per treatment course, reflecting an 8.6% increase from 2011

to 2012.

The increase in reimbursable rates are contrasted by record decreases in the same period for surgical and invasive procedures.

Professional Recognition

One of hundreds of testimonials from the professional community…

Journal of American College of Cardiology 2007;50:1523-31.

Department of Internal Medicine, The George Washington University, Washington D.C.; and the Cardiovascular Institute,

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

“Between 25,000 and 75,000 new cases of angina refractory to maximal medical therapy and standard coronary revascularization proce-

dures are diagnosed each year. In addition, heart failure also places an enormous burden on the U.S. Health care system, with an estimated

economic impact ranging from $20 billion to more than $50 billion per year. The technique of external counter pulsation, studied for

almost one-half century now, is considered a safe, highly beneficial, low-cost, non-invasive treatment for these angina patients, and now

for heart failure patients as well. Recent evidence suggests that external counter pulsation (ECP) therapy may improve symptoms and

decrease long-term morbidity via more than 1 mechanism, including improvement in endothelial function, promotion of collateralization,

enhancement of ventricular function, improvement in oxygen consumption (Vo2), regression of atherosclerosis, and peripheral training

effects similar to exercise. Numerous clinical trials in the last 2 decades have shown ECP therapy to be safe and effective for patients

with refractory angina with clinical response rate averaging 80+%, which is sustained up to 5 years. It is not only safe in patients with

coexisting heart failure, but also is shown to improve quality of life and exercise capacity and to improve left ventricular function long

term. Interestingly, ECP therapy has been studied for various potential uses other than heart disease, such as restless leg syndrome, sudden

deafness, hepatorenal syndrome, erectile dysfunction, and so on. This review summarizes the current evidence for its use in stable angina

and heart failure and its future direction.”

http://clinicaltrials.gov/ct2/results?term=external+counter+pulsation&Search=Search



12

Stakeholders Who Benefit: ECP uniquely satisfies these mandates while offering health solutions for 3 of the 4 Non-Communicable Diseases (NCD’s)

identified by WHO as leading Global Risks affecting the economic sustainability of our world. At the same time, the impact

of Innova Med’s Profit-Share Model (The Pulse Program) will be simultaneously felt on a corporate and investor level by

offering higher than average profitably, sustainability and Return on Investment to all of its stakeholders.

Success Indicators:

Innova Medical Technologies (“IMT”) shares twelve characteristics common to successful businesses investments,

while offering uncommon advantages.

1. Strong Industry Reputation:

Mayo Clinic, Stanford Hospital, Duke University, and Cleveland Clinic, ranked as the #1 cardiac care hospital in the

world, along with hundreds of other renowned hospitals via in-patient, out-patient programs, private clinical facilities and

cardiology practices Worldwide have used IMT’s External Counter-Pulsation (“ECP”) Cardiac Medical Equipment success-

fully has for over 25 years since receiving its FDA 510(K) clearance.

2. Robust Growth Potential:

Heart conditions affect nearly eight (8) million Americans. Heart failure is the only major cardiovascular disorder on the

rise. An estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year and the number of deaths in the

United States from this condition has more than doubled since 1979, averaging 250,000 annually. This year, America’s 50

and older population will reach 100 million. According to the US Population Division, 1 in 5 people are expected to be 65

or older by 2035. Our growth potential is inexplicably tied to these factors.

3. Emergent Industry Outlook:

Since 2002, annual industry production in medical device sector has

exceeded $70 billion and experienced approximately 6 percent annual

growth, driven primarily by demand from baby boomers that are living lon-

ger lives than previous generations, requiring more sophisticated and longer-

term healthcare. As the U.S. population ages, and pressures to contain costs

increase, expensive hospital stays will be discouraged, and health care will be

increasingly delivered in alternative settings, such as in primary care and other

out-patient facilities. Healthcare has always been and will continue to be a

primary personal need and common human experience and therefore will continue to be stable industry which exceeds

valuation standards by almost double.

1.4 Success Factors


1.4 Success Factors

4. Favorable Regulatory Environment:

Recent regulatory and insurance reforms have widened approval classes, which until recently was a hospital and

cardiology only market, providing the pathway for expansion into an untapped and unserved marketplace. Effective

January 1, 2012 non-surgical procedures offer Medicaid payment bonuses of 10% thru 2016 to physicians who elect

therapies such as ours over surgical interventions. Additionally, the Electronic Medical Records Act has a scaled

implementation schedule over the next several years which will facilitate patient identification and acquisition more

swiftly and exponentially.

5. High Barrier to Entry:

The medical device industry is highly regulated. Domestically, medical device firms devote considerable resources

toward product approval processes, clinical trials, user fees and plant audits. FDA approvals require an extensive

investment in time and capital limiting manufacturer’s market entry capabilities, thus protecting your profits.

6. Market Experience:

In addition to IMT’s prior proven lateral market sales program success, their Acquisition in September, 2012

of CardioMedics, Inc. (“CARDIOMEDICS”) provides the Company the benefit, valuation, goodwill, ongoing client

base, industry reputation, and all of the Intellectual Property it has spent 30 years developing, including 60 Patents,

FDA 510(k) clearances, CE and ISO certifications. With CE approval (the European regulatory, FDA-like standard

for quality acceptance), the Company has the certainty it needs that our ECP devices and consumable goods will be

accepted as an approved export for sale and distribution into international communities. The top 15 year National

Sales Director for competitor, ACS, David Gregory, shall operate together with IMT on its Board and as its National

Sales Director, to ensure program success in this medical device sector in the U.S. and abroad.

7. Unique Selling Proposition (“USP”):

Innova Med’s major market differentiator provides a superior distribution model which accelerates the market

capture rate via entrepreneurial ownership of the ECP equipment and exclusive geographic markets (creating

a “market owner”). Market owners facilitate the placement of ECP units, at no cost to Physicians, deriving income

through an agreed upon per treatment profit-share program - transmitted electronically to all eligible parties via

Innova’s proprietary software immediately after insurance reimbursement. This eliminates the main objection to price

seen in 2 out of every 4 direct selling or leasing situations. This unique facilitation, together with technology advan-

tages assures that the income producing and collection models will be far superior.

Companies that are in an industry with a HIGH BARRIER TO ENTRY are often

good investments for a value investor. When a company is working in an in-

dustry with a high barrier to entry, the company can easily raise prices without

losing many customers. This flexibility allows the company to adjust prices dur-

ing economic downturns while maintaining stable profit margin. Additionally,

firms that work in such a market are not likely to see many new competitors

entering the industry, also contributing to the stability in their profit margin.

An Example of an Industry with a High Barrier to Entry:

Drug and chemical companies have a high barrier to entry because their

products are usually very hard to produce. New enterprises that wish to com-

pete with existing drug and chemical companies would have to spend a lot

of money in research and development as well as years of clinical trial before

they can even enter the industry.

INNOVA MED HAS OVERCOME & WILL BENEFIT FROM HIGH BARRIER TO ENTRY STATUS.


1.4 Success Factors

8. Expert Business Plan: Over the last decade, Innova Med has developed proprietary marketing campaigns and sales approaches which have

proven successful in the dental/medical device and consumables marketplace offered as Turn-Key Business Solutions to

Market Owners. Having both manufacturing and B2C and B2B sales and marketing program development experience,

IMT plans to utilize its experience and overlay its historically successful sales and distribution models to expand the

sales channels in the ECP market exponentially beyond the prior hospital and cardiology channels to include General

Practitioner’s, D.O.’s, internists and other primary care physicians which represent over 400,000. Cardiologists represent

just over 14,000 in the U.S.

9. Short-term Cash Flow Performance: Proprietary software developed by CARDIOMEDICS, together with custom ‘ACH cash distribution’ software commis-

sioned by IMT of JP Morgan Chase Bank, combine exclusively for the benefit of IMT’s program to ensure electronic

funds transfers and immediate cash disbursements to all parties.

10. Long-term Income Streams:

Reimbursement rates for medical devices are a primary concerns for U.S. medical device companies, as an adequate

reimbursement rate usually determines whether a product will be viable in a given market. An over 87% angina and

coexisting heart patient effective treatment rate, with sustained benefits lasting 3-5 years in each of three 5-year

follow-up studies, has ensured consistent pay-outs and an average 5% increase, by all insurers year to year. Innova

Med requires only minimal market penetration to develop elective income streams within the currently untapped

Medical, Anti- Aging and Alternative Medicine environments to enhance the already lucrative guaranteed income

streams derived from insurance reimbursements. Our current business plan factors only insurance reimbursements to

achieve its high ROI. Physicians need only treat three (3) patients per month to exceed $200k in annually revenue,

which is more than double the national average G.P. income.

11. Multiple Sales Channels:

In addition to the guaranteed insurance reimbursements, peer reviews and clinical submissions are currently being

evaluated to validate ECP uses for Diabetic, Erectile Dysfunction, Stroke, Alzheimer’s, Parkinson’s and Weight Loss.

Seventeen other additional medical benefits are gaining recognition. While awaiting approvals by the Federal Health

Agency, IMT will market to consumers these elective benefits to develop additional income streams via multiple sales

channels as identified above, and will simultaneously sponsor consumer education and advocacy campaigns through our

wholly owned Non-Profit agency The International Wellness Foundation.

12. Superior Products and Performance: ECP is both an FDA APPROVED device and therapy. Since its introduction into the medical marketplace over 44 years

ago, it has achieved incomparable performance measured by an over 70% average clinical improvement rate industry

wide, and an average 87% improvement rate by patients using Cardiomedics ECP devices, who have suffered with an-

gina, heart disease and related conditions.


1.5 Investment Structure

Investment Offering: Innova Medical Technologies, Inc., doing business as IMT or Innova Med, (“We”, “Us”, “the “Company” or “IMT”) hereby offers FIFTY-FIVE (55) UNITS consisting of 100,000 EQUITY SHARES OF PREFERRED STOCK (the “Preferred Stock”) at a price of $50,000 per Unit, for a total of TWO MILLION SEVEN HUNDRED AND FIFTY THOUSAND DOLLARS ($2,750,000), representing TWENTY-EIGHT PERCENT (28%) of the Company’s Authorized Shares.

Minimum subscriptions of ONE (1) UNIT or a minimum capital investment of ONE HUNDRED THOUSAND DOLLARS ($100,000.00) is required. Lesser units shall only be considered on the basis of Board level or other instrumental and equitable contributions in-kind, on a case-by-case basis, and shall be approved by both majority owner/partners.

The Company, on a “best efforts” basis, is offering the Units (the “Offering”) and all proceeds from the sale of such Units shall be deposited in the Company’s general account upon its accep-tance of the subscription to meet the capital requirements of operation as indicated in this Plan and within the Company’s Private Placement Memorandum. The Company may terminate this Offering at any time.

Offering Type:This Offering is a Reg D (506)5 which requires a Form D Federal and State filing upon sale of its first securities. The company may sell its securities to an unlimited number of “accredited investors www.sec.gov/answers/accred“ and up to 35 other purchases. Accredited investors must meet minimum financial requirement thresholds to qualify as an accredited investor. For individuals, there is a minimum net worth test and income test which determinations shall be obtained via completion of the Qualifying Questionnaire provided by Innova Med.

Use of Funds: Innova is currently seeking Third Stage ‘Expansion Capital’ to enter the expansion/maturity phase which supports its recent acquisition of Cardiomedics. The capital will be used for funding capital expenditures, manufacturing, inventory and component purchases, hiring employees, marketing expenses and general working capital. The Founders of Innova Med have thus far contributed $250,000 in the form of a Promissory Note, $200,000 in seed round funding, and have raised another $275,000 in first round equity which has been used in since it began its pre-incorporation due diligence and business development efforts in November, 2011. This capitalization has been sufficient to sustain operations and been used for overhead, start-up, capital equipment and personnel expenses, where a priority was placed upon the creation of its outstanding team, which key staff have been intrinsically focused on achieving our goals together. In addition to its Founders roles, the Company’s key hires include John McCallum, President & Chief Operating Officer (COO) [Former President & CEO of Cardiomedics]; Da-vid Gregory, Chief Sales Officer (and supporting sales staff) [Former Industry Recognized 15 year sales leader with ECP device competitor Applied Cardiac Systems (ACS)]; Irwin Zucker, Chief Logistics Officer (CLO) over regulatory, inventory an manufacturing; Steve Porter, Chief Marketing Officer (CMO), responsible for marketing, media and web development strategies; and, Peter Helander, PR Director, responsible for online Search Engine Optimization (SEO) and social media; Kaleigh Kohrs, Operations/Administrative Director, and Fran Katz,, Accounting Manager, responsible for internal bookkeeping.

5Reg D (506) Definition: http://www.reg-d.com/rule-506 <%20http:/www.reg-d.com/rule-506

6Accredited Investor Criteria is detailed in the Appendix section of this Business Plan

Reg D (506)

$2,750,000

55 Units

$100,000 per unit


1.5 Investment Structure

Expansion Plans:

The Innova team thus far has developed the research, market tests and development of intellectual property including

business, online and program marketing plans, advertising and lead generation campaigns, negotiated manufacturing

agreements, third party and affiliate agreements and various other structural matters to facilitate Pulse program launch

activities.

Innova Med could continue to expand its Pulse program globally without expansion capital, however it’s Principals agree

that expansion capital would create exponential gains and more effectively expedite our rate of market entry, critical to

ensure the Company’s long-term success.

IMT understands that once industry players become aware of that their once ‘sleeper’ divisions being encroached upon

and profited from market making changes will begin to occur.

Exit Strategy:

By capturing the largest market share quickly under this innovative market expansion program, such efforts shall tranlate

to expedited higher rates of return, and greater shareholder value making possible the achievement of the Company’s

a multi-billion dollar projected valuation at FY 5. This valuation assumes various lucrative exit scenarios, creating the

ultimate investor reward as a result of investor confidence in us and our program.

Closing Disclosure:

As of September 30, 2012 pre-commitments have been made by only Accredited Investors and respective funding

commitments anticipate closing this Expansion Capital funding round of $2,750,000 on or near November 30, 2012.

The Company’s cash flow over the 5 years indicates that NO further Equity or Debt capitalization will be required, and

therefore anticipates NO further dilution of equity ownership to its Equity participants contemplated under this Plan.


1.7 Investment Capacity

Sophisticated Investor: Integrity is at the core of our business and we understand that it forms the basis of long‐term and mutually rewarding

relationships. Innova Med seeks to establish long‐term equitable, and integrity based investor partners. In order to establish

this basis, Innova Med’s Reg D (506) offering maximum does not require the more stringent disclosures that Rules

505 ($5M), or 506 (unlimited capital) require. Both of these Rules require that potential investors, either alone or with

a purchaser representative, must be ‘sophisticated’ — that is, they must have sufficient knowledge and experience in

financial and business matters to make them capable of evaluating the merits and risks of the prospective investment.

In the best interests of its potential investors, Innova Med is providing full disclosure as if issuing SEC securities regulated

investment and seeks only sophisticated investors.

We put ourselves in the shoes of our prospective investors and asked ourselves what information we would want to receive to make

a totally informed decision about your investment opportunity.

Therefore, Innova Med has agreed to conform to the more stringent requirements and to the antifraud prohibitions

of the federal securities laws, meaning no lies of commission or of omission. Under these laws, we also agree to provide

non‐accredited investors disclosure documents that are generally the same as those used in registered offerings.

Innova Med recommends your thorough investigation

of this truly unique, once‐in‐a‐lifetime opportunity

and suggests you fully read this Business Plan and sup-

porting documents for understanding together with any

additional due diligence research you may require.

Details substantiating Innova Med’s core technology,

success foundations, viability and sustainability are

detailed inside this Business Plan, along with research

citations and website links for ease. Innova Med will

also answer any investigative questions relative to this

investment as required.

Private Placement Memorandum and Qualifying

Questionnaire shall be provided separately.

7SEC Definition of Sophisticated Investor: http://www.sec.gov/rules/proposed/33-8041.htm#P66_8323


2. Company Overview

“ ““The secret of

success is consistency

of purpose”

Benjamin Disreali


Lisa Terry joined WhiteScience in March, 2007 as an outside Business Development Consultant. As a result of her

strategic marketing and business re-development efforts and the recognized 167% increase in profits over prior year, she

was offered and joined WhiteScience in March, 2008 as a Principal, serving in the capacity of EVP of Business

Development. She later transitioned into development of international markets in 2009 where she was responsible for the

company’s growth into 32 countries establishing multi-million dollar multi-year exclusive distributorships within same and

counted over 3,000 total independent distributors within the U.S. and around the world before resigning in November,

2011 to head Innova Medical together with George Nelson as Founding Partners.

WhiteScience was formed by George Nelson and acquired IMDS in 2002. Irwin Zucker was offered a minority interest

and operated as COO of WhiteScience and together manufactured and developed new sales channels within the cosmetic

segment of the oral care industry. In 2003, IMDS merged and began operating under the WhiteScience name.

Irwin Zucker was the Founding Principal and Owner of Innovative Medical & Dental Solutions, Inc. (IMDS), which

business began in the professional dental/medical industry 11 years ago. IMDS was born out of a Belgium based

internationally publicly traded R&D, a professional medical/dental device and technology manufacturer who operated as

both manufacturer and as a direct selling organization within the dental device and consumables products industry.

“ ““Success is determined by those who identify

the vision, no matter how impossible,

and then who prove the impossible, possible”

James W. Pence

2.1 Ownership


2.2 Experience

Relative Experience: The Founders and Principals of WhiteScience, now operating together under Innova Med, realized their lateral‐market

success in very keys ways, which provide the very essential foundation necessary for Innova Med to experience even

greater market advancements in the non‐surgical medical marketplace.

With its R&D and Engineering efforts led by Irwin Zucker, WhiteScience created scientific breakthroughs and

patented equipment, formulations and delivery methods in dental professional teeth whitening technology, and were

first to market to bring teeth whitening out of the dental office into the cosmetic retail and services marketplace.

WhiteScience utilized pre‐existing IMDS dental professional market channel client development experiences with

innovative sales approaches into the cosmetic personal services vanity market. The $4M invested into its original

patented products SpaWhite and WhiteIce were re‐packaged and marketed to an untested cosmetic marketplace

through simultaneous channels achieving swift multi‐millions dollar success. Multiple products were later develop and

are still marketed today.

Innovation: By re-inventing their ‘dental professional only’ products and service modalities, WhiteScience created demand for

ease, convenience and affordability, establishing the consumer trends that resulted in turning their once ‘boutique’

marketplace into a commodity. Its move outside the dental industry into the cosmetic segment in 2003 would later

recognize their ‘market-maker’ status, and allowed them to realize their earliest goal of becoming the industry leader in

the boutique ‘Cosmodent’ segment of the cosmetic oral care industry.

Acclaim: WhiteScience’s award-winning products have received international acclaim in dental/medical professional journals,

celebrity forums, and the media, and were the only manufacturer in the industry segment to receive the Seal of Approval

from the National Dental Laboratory Association NE, and acceptance of its whitening training into the curriculum

of the International Dental Education Congress, providing Continuing Education (CE) credits to dental professional

around the world.


2.3 Executable Strategy

Lateral Foundations for Success WhiteScience, who successful implemented its worldwide expansion of its goods and services through a multi-sales channel approach, saw its greatest profitability after implementation of creative distribution programs which created exponential market gains from 2008 forward.

WhiteScience was born out of the need for change, moving very mainstream dental professional industry products and service approaches through direct sales only channels into innovative entrepreneurial distribution sales approaches which created exponential gains for its stakeholders in record time. In doing so, WhiteScience established the foundation for what is now a multi-billion dollar cosmetic industry space with over $200M in sales in the last 6 years via wholesale, direct sales, B2B and B2C channels. Today, WhiteScience boasts over 3,500 independent dealers and distributors and operates in 32 countries around the globe.

Sustainable ApproachesThe Founders of IMT will utilize their executable strategies, branding, market channel and business development experience to create substantial profitability to its founding investors, entrepreneurial market buyers, and physicians within our distributor markets, in a more reputable and certain marketplace ripe for innovative approaches and patient-focused health care. With the additions of past President & CEO of Cardiomedics (now Innova’s President), John McCallum, and David Gregory,15 year industry acclaimed sales leader and Innova’s National Sales Director, hired from Applied Cardiac Systems (ACS) (Cardiomedics largest competitor), they now operate together under Innova Medical and call themselves the ECP Dream Team. The Company have established the very essential foundation of key talent, experience, and vision necessary for Innova Med to experience even greater market advancements in the non‐surgical medical marketplace.


2.4 Manufacturing Experience

Since 1986, CardioMedics, Inc. has been a trusted name in the field of cardiac instrumentation. A pioneer in the world of

external counter pulsation (ECP), together with Innova Medical Technologies, they are leading the way in the diagnosis,

treatment and management of cardiovascular disease and more than a dozen other elective modalities.

CardioMedics was the first industry manufacturer of ECP devices in the world beginning 30 years ago, were the first to

produce clinical studies and obtain 501(k) clearance on the ECP devices 12 years ago, CARDIOMEDICS has been the #1

manufacturer and direct seller of these devices in the industry having manufactured and placed over 1,000 units worldwide

in the last five years alone. At a price tag of $65,000 per unit, with competitive pricing at $85-90,000 direct to hospitals,

they hold an impressive record.

CARDIOMEDICS has long been committed to developing quality diagnostic and therapeutic devices. Their dedication to

providing innovative products has made CARDIOMEDICS a recognized leader in the medical industry.

CARDIOMEDICS holds FDA Certified Manufacturer status identified by FDA Registration # 2024089.

cardiomedics.com


3. Operations

“ ““Successful people aren’t born that way.

They become successful by establishing the habit

of doing things unsuccessful people don’t like to do.

The successful people don’t always like these

things themselves; they just get on and do them.”

Zig Ziglar


3.1 Milestones

To Date:

Since incorporation, the Company has achieved the following milestones:

Secured lease space in prominent professional office park in a business sector

of northern Atlanta which adjoins WhiteScience

Undergoing current build-out of 5,000 SF of office, warehouse and training facility

space to accommodate new staff

Developed the company’s name, logo and website located at innovamedecp.com

Developed Business and Marketing Plan and launched 1st phase Marketing Plan

Secured top Medical & Business Board Members & Formed Strategic Alliances

in the Cardiac Medical community

Recruited, hired and trained Director of Sales, EVP of Marketing, Creative Director,

Web Development Director, Lead and Acquisitions Manager, Operations Manager, and Trainer.

Submitted federal filings to secure Non-Profit 501(c)3 company, trademark

and service mark applications

Hired President & CEO of Cardiomedics, Inc. July, 2012

Acquired Cardiomedics for $15M September 28, 2012


3.2 Key Services

Director Focus

Innova Medical Technologies, Inc. will focus on developing close investor, entrepreneurial, client and medical community

relationships.

George Nelson, shall serve on the Board as Co-Chair together with outside Director and Chair, Dr. Charles Schwindt.

George continues to head his WhiteScience business operations, and has most largely contributed working capital in the

form of debt and seed funding. George provides thought leadership and evaluates the potential of other strategic partners

or alliances for the Company

Lisa Terry, shall serve on the Board as Treasurer and oversee Board Secretarial duties facilitated through Kaleigh Kohrs,

Operations Director. She will serve daily as CEO and shall lead business, marketing and financial program development,

and will develop business opportunities and investments synergistically aligned with the company’s goals both domestically

and internationally. Further, as Founding Chair of the Company’s Non-Profit she will also direct fund-raising efforts, patient

advocacy and regulatory reform initiatives.

John McCallum, shall serve as a Board Director, and daily in the role of President and COO. He will at first guide the

Company through its manufacturing and regulatory transitions necessary since acquisition. Thereafter, he will act as the

lead strategic and corporate planning Partner responsible for negotiating, developing and maintain key relationships to

ensure successful implementation of the company’s goals in corporate, strategic, clinical and regulatory capacities, and

ensure a continual supply of the Company’s key affiliate, medical, third-party distributor finance, and other potential

program affiliates and vendors on a cost effective and solution oriented basis.

Irwin Zucker, shall serve as a Board Director and act as CLO and head Manufacturing, R&D and Logistics. He will work

together with the Company’s Board on R&D initiatives; direct international markets logistics, development and

distribution; facilitate and direct warehouse and inventory personnel and supply chain logistics.

David Gregory, the lead sales channel director, will provide one-on-one training and consulting sessions with in-house

Trainers, Customer Service and Sales teams; Direct the sales programs and work together with in-house Market-

ing Director and personnel to ensure a constant flow of regular marketing campaigns and collateral to satisfy distributor

demand and client trends. He will conduct group sessions with client teams and conduct webinars of general interest to

clients and potential clients.

Innova Medical Technologies, Inc. has a team of support personnel which can be seen in the Company’s

organization chart that will provide sales and marketing program and plan development and implementation corporately

and for its distributor networks, research and analysis, administrative support, accounting, web development, PR, social

media, customer service and logistics.


3.3 Personel Letter from the CEO

Dear Potential Investors & Friends,

I’d like to share with you a little bit of my Grandma’s Wisdom. I am personally very inpatient and with just 20 years left until retirement, and am attempting to take advantage of the time I have left to invest of myself into something that provides much greater rewards than those just for myself. As I’ve aged, I’ve realize the value in helping others and just how precious life is, but I’ll admit, in our ‘whitewater change’ world, I still struggle with the whole ‘Take time to smell the roses’ thing…

When my grandmother used to tell me “Without your health you have nothing”, I thought it was just something old people said because they were old and didn’t have their health. As I’ve aged I found out she was right about your health, and left as part of her legacy to 5 children and 44 grand and great-grandchildren her wisdom and other truisms that I’ll never forget “The greatest wisdom comes from age and experience”, “Experience is just another word for failure”, “Learn to better each day what you’ve done before”, and her personal motto “live for more than yourself, do good for others, and good will find you”. Interestingly, her wisdom is personified in what we have cre-ated in this opportunity we present to you.

I think that we can all agree that diversification of your portfolio is essential to meeting the goals you have set for yourself and your family. For clarity, by diversification we are not talking about Vegas slots or Florida swamp land. If you’ve invested there, this opportunity may not be right for you. My Grandma warned me about Vegas and Florida land, and would never hesitate to ask me every time we talked…

I’m certain we all agree that the stock market today is a much different animal than when you likely began investing, and in fact some may compare it to the Vegas slots. For most of us we are as uncomfortable investing the majority of our case money into the slots as we are into a market that has proven to be incredibly volatile and speculative. Whether the fault of the real estate bubble that burst, Florida swamp land that never got those federal highway funding dollars, international influences or super-computing – the game has been changed. For most of us, our home is our primary real estate investment, unless of course yours is in the Bayou… not saying vacation homes are a bad thing. Those fortunate enough to have capitalized on the lowered home values by purchasing rental homes or for renovation to flip the properties, realize how much work this truly is simply managing tenants or contractors is a business of its own! It is a full-time job with potential long-term gains… for the very dedicated and patient. I’d rather be on a beach in Jamaica! I’ll share with you one last grandma-ism…

“Don’t sit on the porch of life waiting for an opportunity tree to grow in your front yard. You gotta work the ground, plant the seed, and put your hand to cultivating it to get the biggest and bestest fruit!” Okay, so she wasn’t always grammatically correct, but through wisdom earned and by endeavoring to do better than what we’ve done before, through this opportunity, we will do good for many others, while finding much good along the way for ourselves.

I’m sure you’ll agree that sitting on the porch waiting for stock gains, real estate equity, or our interest bearing accounts to actually become profitable is a fruitless endeavor.

So, what’s next? Recognize that if you want to become wealthy in less than 15-30 years, you have to leverage more than your money and the financial markets. You have to leverage yourself. There’s more to the wealth equation than spending less and saving more… you also need to reinvent yourself and devise new strategies for earning more. That’s what Innova Med is all about. I hope that you decide to join us in our journey.

Thank you for your interest.

Sincerely -


3.3 Founder’s Bio | Lisa Terry

SUMMARY BIOS:

Innova Medical Technologies, Inc.’s most valuable asset is the expertise and experience of its founders,

George Nelson and Lisa Terry

CHIEF EXECUTIVE OFFICER | Lisa R. Terry

From Her earliest academic successes as a member of the President’s Junior Achievement Council throughout her middle

and high school years, to her nomination as Class President in her Jr. & Sr. years, to being among the first students selected

for the International Baccalaureate Program within the State of Florida, Ms. Terry has always enjoyed learning, growing

and leading and has never been satisfied with less than superior accomplishments. Her first achievement in the professional

world was evidenced when she became the youngest Registered Investment and Insurance Annuities Broker for Prudential

Bache Securities.

Ms. Terry attended Rollins College as part of the IB program during her Sr. high school year and transferred to the Uni-

versity of Central Florida with a major in Psychology. From there, she translated her education into sales and business

psychology and has spent the past 25 years in business and market development. After several years in investment sales,

she divested her interests into business consultation first developing a wireless telecom start-up, GlobalComm, where she

structured a PPM, negotiated the acquisition of a failing broker-dealership, brought it in-house and managed a staff of 176,

which securities staff underwrote and sold over $119M in private placement shares. She successfully negotiated a merger-

acquisition with the public company MetroCall/USA Mobility 6 years later, who still utilizes today the IVDS technology

they developed. She sold her stock position to MetroCall as the second largest shareholder position which profits she

invested into her own publication and commercial real estate holdings. She served as the youngest and only female on the

GlobalComm Board.

An entrepreneur at heart, she formed and built a national magazine publication, which exit strategy equaled a buy-out from

the #7 magazine in the world. Her gains led to personal investment and later consultation in SE regional commercial real

estate developments, which exclusive JV’s, acquisitions and developments grew a $20M p/yr Georgia based brokerage into

a regionally recognized retail development concern posting over $240M annual sales within 4 yrs. Receiving professional

accreditation through the SEC and National Association of Realtors, Ms. Terry understands that knowledge is power, and

worked for two years to obtain her Executive MBA in International Entrepreneurship (MBA/IEnt) graduating in 2011 from

the J. Mack Robinson College of Business at Georgia State University in Atlanta, Georgia, Her successful consultative and

development practice experience led her to WhiteScience five years ago where she was engaged by Mr. Nelson to develop

and execute creative sales solutions and distribution methods for WhiteScience’s primary product lines and to head Inter-

national Acquisitions. The unique opportunity developed into a lucrative role as an active Board Member and Principal,

which combined accomplishments have been evidenced by the successful development of exclusive entrepreneurial market

distribution programs growing Net income of $2M per year to over $20M per year each year.


3.3 Founder’s Bio | George Nelson

CHIEF FINANCIAL OFFICER | George P Nelson

MANAGING PARTNER, George P. Nelson Innova Medical was formed by George P. Nelson and Lisa R. Terry, both equal

founding equity partners and majority owners.

Mr. Nelson’s 40 years of entrepreneurial and investment success has included experience as a Wall Street investment

advisor and personal representative of Mr. Fred Kassner, Owner of Sea Escape Cruises and Liberty Travel, during which

he developed the most successful travel incentive certificate program in the travel industry; ownership of the third largest

advertising agency in Florida, and separately a promotional sales and marketing firm, together with franchise ownership.

A simple dental visit 11 year ago to receive a very painful teeth whitening spurred his innovative thinking to create a better

solution. Within a year he invested and acquired controlling interest in Innovative Medical & Dental Solutions, Inc.

(IMDS). IMDS was an internationally publicly traded R&D company, dental device and technology manufacturer. In

2003, IMDS was merged to form WhiteScience. He holds a B.S. Degree in Finance from Michigan State University.

8 years ago, WhiteScience uniquely positioned itself by making the R&D and capital investments necessary to move outside

the dental industry into the cosmetic industry as the first cosmetic teeth whitening ‘market-maker’, and in doing so brought

teeth whitening out of the dental office creating the new teeth market segment in a multi-billion dollar cosmetic industry space.

WhiteScience spent over $4M in the creation of patents and proprietary technologies that today remain superior in the

industry in both equipment and products in the dental industry.

These technology advancements made it possible for exclusive market owners, distributors, spas, salons, malls, and resorts

to offer their customers professional grade teeth whitening products and zero side-effect procedures, using self-administered

applications that uniquely removed stains rather than bleaching teeth, and eliminated the need for licensed dental professionals.

WhiteScience was born out of the need for change, offering more diverse, convenient and affordable solutions to consumers,

and a result boasts over 3,500 independent dealers and distributors. The exclusive international distributor program

expanded the WhiteScience product lines worldwide over the last 3 years into 36 countries.


3.3 Founder’s Bio | John McCallum

PRESIDENT and COO | John McCallum

John McCallum, was born in Scotland, UK, and attended The Metropolitan University of Manchester where he gradu-

ated with an Honors degree in Biological Sciences. Mr. McCallum has nineteen years experience in business development,

product sales, and distribution management in the medical device and healthcare industries and is responsible for leading

the Innova Medical Technologies team and creating a global success for the company.

Mr. McCallum began his career in the medical industry as a local sales representative for Cardiokinetics, a capital equip-

ment distribution company in the UK, before relocating to the US where he held the position of Sales Manager of Asia

Pacific and Latin America for Medical Graphics Corporation. He then became the Vice President of Sales and Marketing

at Compumedics based in Australia and Cortex GmbH of Leipzig, Germany before becoming President and CEO of Car-

diomedics Inc., a manufacturer of non invasive cardiac therapeutics for the treatment of Angina and Congestive Heart

Failure in the United States.


3.3 Management

CHIEF LOGISTICS OFFICER | Irwin Zucker

Mr. Zucker is a founding partner of WhiteScience and has been instrumental in driving its

engineering, R&D, operations, product design and packaging, as well as marketing communica-

tions design and content. In his long career, he profitably brought to market hundreds of mixed-

technology products, many wining prestigious Design and Engineering Awards.

He has served in leadership positions in R&D, Product Development and domestic and interna-

tional marketing for a number of multi-national firms, including a Fortune 1000 company and

a large, Japanese multi-national. He has also managed operations, including manufacturing,

design and regulatory compliance for enterprises regulated by FDA as well as foreign govern-

ment compliance agencies.

His background is wide and varied, having served — at the request of major creditor Bank of

America — as the acting president of a defrauded public company, operating it while under

compliance with Federal bankruptcy court rulings. There he successfully restructured the firm

and brought it to operating break even within a few weeks. He subsequently broke the firm into

separate operating units, selling off each one individually.

Mr. Zucker served for four years in the volunteer post of Chairman of one of the key standards-

setting committees for the Electronic Industries Association, where he led the creation of many

design standards for analog and digital devices.

He holds a Bachelor’s degree in Business Administration from California State University

where he also completed extensive post graduate work in communications. He studied engi-

neering while a member of the U.S. Army, where he was certified as and served as an instructor

of technology. He furthered his studies at UCLA Graduate School of Business, participating

in a seminar course in Management of New Product Development, and a Cal Tech Extension

where he studied Robust Design and Total Quality Management. He is also an award-winning

writer and photographer.

“The Founders share a

core set of principles,

including ‘Bring only

the best to market”’

Having a perfectionist

mindset ensures that

services, products

and programs exceed

expectations, surpass

consumer standards

and most importantly

provide unsurpassed

customer satisfaction.”


3.3 Management

CHIEF SALES OFFICER | David Gregory

Having a 25 year impressive capital medical equipment sales record, and with 15 years in sales with Applied Cardiac

Systems, Inc. (ACS) as their top national producer, David Gregory has agreed to head the Pulse Sales program.

David is a graduate of Georgia College and State University. He began his career with a National Automotive Parts

Wholesaler and managed a rapid expansion throughout the Southeast. He developed new product branding as well

as distribution centers across the Sun Belt from Texas to South Florida.

In 1998, he joined ACS where he quickly became a top producer. He has consistently ranked as number one sales

representative across both Hospital and Physician sales groups.

David currently resides in Covington GA where he serves on both civic as well as professional boards.

Mr. Gregory primary residence is in Georgia near the corporate offices of Innova Medical. He will facilitate a

trans tion away from the industry’s long-held direct sales model to our Pulse O2 distribution program, which

implementation has already begun.

Mr. Gregory has also agreed to serve on the Board of Innova Medical.

“CardioMedics together with Innova Med have made a commitment toward the

progress of detecting and treating various forms of heart disease.

Together we will continually strive to develop innovative medical and patient development

solutions for health care providers, profitable investor and entrepreneurial opportunities,

and spearhead consumer cardiac education and advocacy campaigns to expand the

knowledge of the truth about non-surgical alternatives and better health

alternatives for people everywhere.”


3.3 Management

CHIEF MARKETING OFFICER | Steven M Porter

Award-winning Creative Director Steve Porter has spent the last 25 years honing his skills as a graphic designer and market-

ing consultant. He joined Innova Med in March of 2012 to direct the company’s creative, advertising, collateral and media

campaigns. Multiple successes within the medical field in these same areas won the attention of the Innova Med principals.

After graduating with honors from Kent State University, Steve started his career working for a small advertising agency as

art director and rapidly moved up to the creative director position with the firm.

With a strategic move to Houston, he was hired as creative director for a couple of large ad agencies. As CD for Bozell &

Jacobs, Steve handled the Exxon Oil account exclusively. He then joined Ogilvie & Mather as CD and handled several

large medical accounts as weel as vaiety of other business to business accounts. After leaving O&M, he was hired as the

marketing and creative director for a high-end boating manufacturer in Florida where he concentrated his efforts to help

build the firm into an internationally successful boating and recreation company.

Tired of working for large ad agencies, Steve struck out on his own forming Porter Design in 1991 working as a creative

marketing consultant and designer producing award winning marketing material for Fortune 500 firms as well as other

business to business firms.

Steve’s strong suit is print however, in 1997, he saw the wave of the world wide web approaching and got on board with

designing interactive websites and then helping companies build a following utilizing social media and SEO endeavors.

Steve also has a very strong background in photography which aids him as the driving force behind every creative project

he takes on.


3.3 Management

SEO and ONLINE PR DIRECTOR | Peter Helander

Peter Helander is an experienced marketing professional that likes to help companies grow and be the best they can be and

is very passionate about it. He is a visionary that is driven and makes sure to deliver. During the last 15 years he has worked

mostly with online marketing and helped many large companies to get their websites to support their business goals and

in many cases increased sales by 30-40%. He has mainly worked with SEO, PPC, Affiliate Marketing, UX (Usability) and

Analytics. He feels that his background, experience, education and business acumen would be a perfect fit for this position

and a perfect next step in his career. He is very excited about the concepts as well as all cross-promotional-, selling- and

marketing opportunities that lies ahead.

In online marketing I have managed small teams up to 11 people and in the offline word I have managed creative groups

at two agencies in Sweden that were also fairly small 4 to 7 people.

Peter has an MBA in Technology Management, a BS in International Marketing and a DRMI/Associate in Public Relations

and is also Certified Web Master, Google Certified and Yahoo certified.

AREAS OF EXPERIENCE AND EXPERTISE:

•SEO

•PPC

•AffiliateMarketing

•emailMarketingandsurveys

•UX

•Analytics

•PublicRelations


3.4 Hiring Plan

SUMMARY:

Summary: Innova Med has not only developed, but has prepared to launch a remarkably expansive program that has the

capacity to ensure the better health of millions of people worldwide, and grant them a quality of life never achievable before.

Our exceptional workforce with a long history of employee retention, as well as key management personnel such as

David Gregory, National Sales Director with 15 years in capital medical ECP sales; Peter Helander, Marketing Director,

who holds an MBA in SEO and online marketing and prior 10 years with IKEA as EVP of Brand Development; Kelvin

Morgan,Product Development Director with a BS in Mechanical Design and 20 years with companies such as Toyota,

Coca‐Cola, and other Fortune 500’s in relative positions.

Owners George Nelson, CEO and Managing Partner with a BS in Business and 40 years of successful entrepreneurial

experience; Lisa Terry, COO and Managing Partner with a BS In Finance and MBA in International Entrepreneurship;

and, Irwin Zucker as Logistics Officers who holds several degrees in engineering, logistics, and business. IMT’s Board

of Directors include Kimberly Bingaman, MD, a prominent Board Certified neurosurgeon, and head of Neurology at Texas

Hospital, and Mickey Korpman, MD and innovative medical patents researcher with well recognized industry accomplish-

ments; Gray Bishop, EVP of Medical Services Associates of America and owner of 9 clinics and nursing facilities, together

with David Gregory, Kelvin Morgan and Mark Zamalloa, a successful business entrepreneur and investor make up a well‐

rounded team of experts and advisors.

Personnel Required:

In order to launch the business we do not need additional personnel, but will hire personnel as reflected on the chart

hereafter within the next 30 to 60 days for a total operational requirement for the 1st year of 20.


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4. Industry Analysis

“ ““No enterprise can exist for itself alone.

It ministers to some great need,

it performs some great service, not for itself,

but for others... or failing therein,

it ceases to be profitable and ceases to exist.”

Calvin Coolidge

Facts: ‐

•Cardiovasculardiseaseaffectsmorethan70millionpeopleintheUSandistheleadingcauseofdeathforAmerican men and women, accounting for nearly 1 million fatalities every year. ‐

•Afterdiagnosis,mensufferingfromheartfailurehaveamediansurvivalofonly1.7years,andwomenhaveamedian survival of only 3.2 years. Furthermore, heart disease is a leading cause of premature and permanent disability among working adults in the US. ‐

•Theeconomicimpactofcardiovasculardiseaseisstaggering:thissinglehealthissuewillcosttheUSapproximately $400 billion this year, including healthcare expenditures and lost productivity due to disability and death.


32

14.1 Critical Questions

Are you aware that people over the age of 55 make up the largest percentage of the population in

the U.S. and will continue to grow at the same time as birth rates decrease?

HINT: Those ages 65 and older now exceed 35 million, a number poised to explode. January 2011 ushered in the first of approximately

77 million Baby Boomers, born from 1946 through 1964 and are surging toward the gates of retirement. Between 2000 and 2010,

the 45 to 64 population grew 31.5 percent to 81.5 million, and now makes up 26.4% percent of the total U.S. population. This

rapid growth is due to aging of the Baby Boom generation. Each year more than 3.5 million Boomers turn 55. Their swelling numbers

predict that…

By 2012, America’s 50 and older population will reach 100 million. And according to the UN Population Division, 1 in 5

people are expected to be 65 or older by 2035.

Read more: www.transgenerational.org/aging/demographics.htm#ixzz1np3ZOMql

Do you believe that the aging population will equate to a similar increase in cardiac related diseases?

HINT: Heart failure is the most common human ailment, but is often misdiagnosed. It affects nearly 8 million Americans. Heart

failure is the only major cardiovascular disorder on the rise. An estimated 400,000 to 700,000 new cases of heart failure are

diagnosed each year and the number of deaths in the United States from this condition has more than doubled since 1979,

averaging 250,000 annually.The 5 million Americans suffering from heart failure received $28.7 million in research dollars. In

comparison, lung cancer research, which affects 390,000 Americans, received $132 million.

Read more: www.hfsa.org/heart_failure_facts.asp

Do you believe that the insurance companies, given the economic instability over the last 5 years are

looking for ways to mitigate their risk, both from wrongful death and practices suits, in addition to

reducing their claims expense on unnecessary surgical procedures in favor of non-surgical FDA

approved procedures costing them 50-75% less?

HINT: Health policies and regulatory guidelines have already become effective beginning in 2011 that provide the above benefits,

increase patient choice, give Physicians a 10% bonus for choosing in favor of such alternatives, and with the use of our non‐surgical

medical device for cardiac therapy actually sees an 89% cure rate and a 36% reduction in the mortality rate over surgical procedures,

which procedures proved to be ineffective 85% of the time and un‐necessary 50% of the time in the COURAGE study provided in

full as a supplement to our business plan.

Read more: Industry reports attached to business plan


4.2 Medical Device Industry Snapshot

Medical device and equipment manufacturers

have faced their share of challenges over the

last several years. Healthcare reform, increased

regulatory scrutiny, reduced hospital budgets,

tight credit markets, and a sluggish economy

have all negatively impacted the valuations of

companies in the $300 billion global industry.

Device and equipment merger & acquisition

(“M&A”) activity, which is typically robust,

has also slowed due to the economic downturn.

Despite these tribulations, an aging population

and consumer expectations for better healthcare

driving technological advancement advances in

medical technology are expected to keep demand

for medical devices and equipment strong

which should translate to a revived M&A market

in the long run, as credit loosens, the economy

improves, and management teams are more

confident in the growth prospects for the industry.

Industry Structure

Life Cycle Stage Growth

Revenue Volatility Medium

Capital Intensity Medium

Industry Assistance Medium

Concentration Level Low

Regulation Level Heavy

Technology Change High

Barriers to Entry Medium

Industry Globilization Medium

Competition Level High


4.3 Medical Device Industry Forecast

Global Top 10 Medical Devices Market (2010 – 2015)

By: www.marketsandmarkets.com Publishing Date: June 2011/ Report Code: MD 1620

The study of global top 10 medical devices market is important mainly due to continuous technological advancements

in the medical devices industry and rising demand for medical devices owing to increasing healthcare issues. This report

not only provides a full estimate of the global top 10 medical device technologies market but also gives a detailed analysis

of their most critical micro‐markets, which have remained unexplored so far. The medical devices market is a major

contributor to the overall healthcare industry with the pharmaceuticals industry leading the healthcare sector. The rising

incidence of various diseases in the areas of Cardiovascular devices (CVD), respiratory, oncology, neurology, and many

others have expanded the need for faster and better medical devices for treatment and diagnosis.

The global top 10 medical devices market was expected to be worth $164 billion in the year 2010 and is estimated to

reach $228 billion by 2015, growing at a Combined Aggregate Growth Rate (CAGR) of 6.8% from 2010 to 2015. The

cardiovascular devices, orthopedic devices, and diagnostic imaging devices markets are the major revenue generators for

the medical devices industry.

Scope and Rank:

Due to the globally rising incidence of lifestyle diseases and the increasing healthcare delivery at the private

physician level.

The following markets offer steady growth opportunities, in order of highest growth to lowest.

1. Cardiovascular devices 6. Anesthesia and respiratory care devices

2. Orthopedics devices 7. Dialysis products 8. Ophthalmology devices

3. Diagnostic imaging devices 8. Ophthalmology devices

4. Minimally invasive devices 9. Patient monitoring devices

5. Diabetes devices 10. Point‐of‐care diagnostic devices

Point‐of‐care diagnostic devices Reverse innovations and collaborations form the major growth strategies, especially due

to the growing emphasis on preventative healthcare, and the rising need for more technologically advanced products

such telemetry devices. The $19 billion economic stimulus package for healthcare IT, passed by U.S. Congress in 2009,

has also encouraged collaborations between OEM’s and IT system providers.


5. Customer Analysis

“ ““Success can be obtained if you:

...care more than others think is wise;

...risk more than others think is safe;

...dream more than others think is practical;

...expect more than others think is possible.”

Karen Ravn


5.1 Our Customers

Primary:

Medical Device Distribution Companies (“Distributors”) who wish to act in a market or territorial owner capacity who

have established distribution through the Company’s Primary Care Physician target marketplace. Such Distributors shall

accept the Company’s requirement to act as ‘change agents’ in and conduct their sales in a VENDING-like capacity, and

shall be able to identify and place within five (5) Physician Practices FREE non‐surgical medical devices, such as the External

Counter‐Pulsation (ECP) device and other such products as the Company shall provide within established time frames, and

achieve minimum patient acquisitions through implementation of the Company’s Pulse program.

Secondary:

Primary Care Physicians (PCP’s) such as General Practitioner’s, Internists, Doctors of Osteopathy, are medical doc-

tors who the first contact for a person with an undiagnosed health concern, as well as continuing care of varied medical condi-

tions, not limited by cause, organ system, or diagnosis. PCP’s are the target market of our Distributors, for which we provide turn‐

key business packages inclusive of business plan, training, marketing, branding, advertising and sales campaign and col-

lateral support at all levels from overall business development, target market (physician) development, and physician/

patient support and retention.

Tertiary:

Individuals with target criteria as outlined below:

1. 70,000,0009 people within the U.S. and, who suffer from some form of Cardiovascular Disease10,

and the 970 million people worldwide who have elevated blood pressure (hypertension) and are

at highest risk for cardiovascular disease

2. 150,000,000 people worldwide who are estimated to be suffering today with Erectile Dysfunction:

a. It is well known that over the past 50 years the number of men with Erectile

Dysfunction has more than tripled.

b. According to statistics, about 5‐10% of men at the age of 40, and 15‐25% of men

over 60 years old suffer from Erection Dysfunction.

c. Vascular diseases, such as atherosclerosis (hardening of the arteries), hypertension,

and high cholesterol, cause up to 70 percent of erectile dysfunction in men with physical causes.

Atherosclerosis alone accounts for between 50 and 60 percent of erectile dysfunction cases

in men over age 6011.

9 Centers for Disease Control; http://www.cdc.gov/nchs/fastats/heart.htm

10 http://heart‐disease.emedtv.com/cardiovascular‐disease/cardiovascular‐disease‐statistics.html


5.1 Our Customers

Tertiary:

General Population (cont’d)

3. 285,000,000 worldwide Diabetes suffers12

4. Others in the U.S. and worldwide diagnosed or who are classified at risk of Non‐Communicable Diseases (“NCD’s”)

such as Stroke, Alzheimer’s, Parkinson’s, Macular Degeneration, Multiple Sclerosis, and Obesity among other illnesses

and diseases. Since the nervous system plays a vital part in achieving and maintaining an erection, it is common for

men with diseases such as stroke, multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease to also experience

erectile dysfunction.13

See Appendix for more detail.

12World Diabetes Foundation; www.worlddiabetesfoundation.org/composite‐35.htm

13U.S. News Health Report in conjunction with Cleveland Clinic; www.health.usnews.com/health‐conditions/sexual‐health/erectile‐dysfunction

“ECP Gave Us Our Lives Back!” 2010 Recipients of the Orange County

Health Care Agency’s Medical Services Initiative Santa Ana, CA


6. Core Business Model

“ ““Here’s to the crazy ones, the misfits, the troublemakers,

the round pegs in square holes… the ones who see things

differently – they ‘re not fond of rules… you can quote them,

disagree with them, glorify or vilify them, but the only thing

you can do is ignore them because they change things… they push

the human race forward, and while some may see them as the

crazy ones, we see genius, because the ones who are crazy

enough to think that they can, are the ones that do.”

Steve Jobs


6.1 Problems We Solve

Health Care Deficiencies:

The World Health Organization (WHO) published a Package of Essential Non‐communicable

Disease Interventions for Primary Health Care (“PEN”) in December 2008 after a preparatory

meeting was held in the WHO headquarters in Geneva on 22–24 August 2007 with 32 WHO

Member Countries, including the United States. The meetings were organized by the Chronic

Disease Prevention and Management unit of the department of Chronic Diseases and Health

Promotion, and Non‐communicable Disease in collaboration with WHO regional offices.17 The

2008-2012 Action Plan developed by WHO and United Nations (UN) Joint Healthcare Task Force requires governments to

shift away from specialty, expensive, invasive, profit centered patient care as its primary approach, and concerning the top 4

Non-Communicable Diseases (NCD’s), which follow:

[All Nations] “Must implement and monitor cost-effective approaches for the early detection

of cancers, diabetes, hypertension and other cardiovascular risk factors” and “Establish standards

of health care for common conditions like Cardiovascular Disease, cancers, diabetes and chronic

respiratory diseases integrating whenever feasible their management into Primary Health Care.”

Global Economic Threats:

The World Economic Forum’s Annual Global Risks Report identifies NCD’s as the top four

global risks and one of the most important threats to businesses and economies independently

and collectively. 35,000,000 people die every year from these silent NCD killers, and 14

million of those are premature deaths that could have been averted or delayed. NCD’s are

everyone’s problem. Rising rates of chronic disease Increasing burden of illness and long-term

costs of treatment threaten recent societal gains in life. However, the democratization of

health information, growth in self‐care technology, increased level of social interaction through social media and

liberation of the Web through mobile platforms are shifting worldwide attitudes and can support person‐centered health.

Mobilization of social forces and people outside of specialized medicine is critical as it is clear that chronic diseases are

affecting social and economic capital globally.18

17Package of Essential Non‐communicable (PEN) Disease Interventions for Primary Healthcare http://whqlibdoc.who.int/publications/

2010/9789241598996_eng.pdf


6.1 Problems We Solve

HealthCare Poverty:

In its substantive session in July 2010, The United Nations (UN) reported that the NCD

epidemic threatens to overwhelm national health systems, and estimated that there will

be a 210% increase in the demand for health care by 2025, indicating that treatment

of cardiovascular diseases alone will account for 21% of total health care expenditures.19

When looking at the first Millennium Development Goal established by the United Nations

which focus was on implementing the internationally agreed development goals and commitments in regard to global public

health, today’s reality is far different and today’s goals need to reflect this reality, in particular the eradication of extreme

poverty and hunger. This is particularly poignant when taking into consideration how the epidemic increase in NCD’s is

working against our combined international poverty reduction mission. The UN reports:

•TheNon‐CommunicableDiseases(NCDs)epidemicisgrowingfasterinpoorcountrieswithNCD’s

than in richer ones;

•StudiesbytheWHOinforty‐twocountrieshaveshownthat2%–3%ofhouseholdsfacecatastrophic

health care expenditures and that1%–2% is pushed into poverty when they become sick.

•Globally,apatternemergesacrosscontinentswhichshowsthatthoseburdenedbyNCD’slackaccess

to primary care services, must pay out of pocket in the private specialty sector for necessary care,

and consequently are impoverished by the cost of care.

FACTS:

The NCD epidemic slows economic growth. ‐

•Asaleadingcauseofprematuredeaths,NCDsreduceincentivesforsavings(intheexpectationof

a shorter life) and they reduce social capital (the death of a teacher or skilled laborer eliminates the

investment in the development of their skills and forgoes the benefit of their future work to society). ‐

•Thesocio‐economiccostofNCDsandinjuriesisenormousandisrisingrapidly.Theseconditions

cause considerable disability and premature death leading to lost productivity.

•Therapidlyincreasinghealthcostsareimpoverishing,andinactionisatremendousburdento

sustainable development.

19The United Nations; http://www.un.org/en/ecosoc/julyhls/pdf10/crp_3_coord_segment_inputs_by_agencies.pdf INNOVA MED is poised to

become a major global contributor providing guidance on ECP therapy as an integrated, cost‐effective intervention for the majority of NCD’s

at Primary Care levels.


Core Solution:INNOVA MED offers core health and wellness solutions via utilization of its External Counter Pulsation (ECP) medi-

cal devices which offer non‐surgical therapy in Primary Health & Regenerative Clinical Care settings and which uniquely,

among medical devices and therapies worldwide, has the capacity to meet all primary WHO Package objectives, which

objectives are: 20 ‐

•Significantly improve individual health, life spans and quality of life for hundreds of millions of people worldwide ‐

•SignificantlydecreaseriskandtheepidemicnumberofdeathsfromCVD’sandNCD’sglobally‐

•Uniquely address the core stated objectives of the World Health Organization and its Member Countries

6.2 Solutions We Provide

ECP Has Been Proven to Treat/Improve: Evidence Supporting Additional Benefits:

1 Cardiovascular: Eliminate/reduce Angina Pectoris (Recurrent Chest Pain); Treat/improve ischemic Improvement of blood flow resulting in organ (diseased) heart tissue; and positively improve tissue regeneration and repair congestive heart failure; Peripheral Artery Disease

2 Stroke Stimulates angiogenesis (growth of new arteries)

3 Diabetes Reduces/reverses arterial stiffness (blood pressure)

4 Erectile Dysfunction (the 1st sign of Heart Disease in men) Improves Neuro-hormones

5 Eye Disease Improves function of endothelial (arterial) system

6 Renal Failure (Kidney Disease) Improves brain function and memory

7 Multiple Sclerosis Increased Exercise Duration and Stamina

8 Shortness of Breath and/or Fatigue Sports Enhancement

9 Leg Pain (Restless Leg Syndrome) Long-term, sustained effects

10 Poor Circulation Stem cell regrowth

11 Obesity Anti-aging affects



Proof Points: Clinical research has shown ECP promotes angiogenesis described as growth of new collaterals for blood to naturally flow around blocked arteries. In Jan. 2010, scientists published a study in the journal Frontiers in Bioscience explaining that ECP is a regenerative therapy and stimulates growth of stem cells.

Professionals in the field of ECP are discovering more about how ECP positively affects the body’s circulation, inflammation and cardiovascular health by repairing, restoring, rejuvenating and re-growing organs and tissue throughout the body.

Hundreds of clinical research studies prove that ECP positively influences cardiovascular health in a variety of ways.

Positive Economic Impact: The basic summary principles of the UN & WHO are what is referred to worldwide as the “Alma Ata Primary Health Care Approach’, and highlight the strong evidence that Primary Care interventions can deliver better health outcomes at lower cost, providing beneficial economic gains globally.

Quality of Life: In addition to its positive economic impact, INNOVA MED’s innovative approach and unique introduction of ECP therapy into Primary Health Care channels shall provide solutions to the core objectives sought by the world’s leading Health Or-ganizations, and improve the health, quality of life that has the capacity to beneficially change forever and impact the world

for all future generations.

1. Cardiac: Angina, CVD, Hypertension, Congestive Heart Failure, Stroke

2. Metabolic: Diabetes

3. Circulatory: Erectile Dysfunction in men

4. Biological: Infertility in men with low sperm count

5. Brain: Multiple Sclerosis, Alzheimer’s, Parkinson’s, Memory

6. Renal: Kidney Disease, Renal Insufficiency

7. Respiratory: COPD, Improved Lung Function & Oxygen Uptake Capacity

8. Stem Cell: Creation of new stem cells; Repair of damaged organ tissue

9. Digestive: Detoxification of all vital organs and improved elimination

10. Cellular: Eliminates cellular toxins, improves cell strength

11. Immunity: Improves immune function

12. Circulatory: Phlebitis, Restless Leg Syndrome, Thrombosis

13. Macular: Macular Eye Degeneration; Cataracts

14. Metabolism: Increased metabolic rate resulting in weight loss*

15. Mental: Decreases depression and improves overall sense of well-being

16. Energy: Improved stamina, exercise tolerance, duration and effectiveness of exercise through improved oxygen flow

Ask your MD or ND about this innovative approach to effectively treat and in most cases eliminates the recurrence of both the symptoms and disease itself:



Action-Oriented Responses:

INNOVA MED provides an innovative and action-oriented response to the challenges presented. The

Company’s Corporate Sales Representatives and Distributor Partners shall each place five (5) ‘free’ ECP

medical devices within each single zip code identified as a prime target market, into Primary, Specialty,

Clinical or Alternative Care Physicians’ offices to address the ‘first level diagnostic and long-term patient

care’ need identified as critical core initiatives of global concern by the UN and WHO Member countries.

Distributors shall act together with the Physician and ‘Profit-Share’ the guaranteed insurance reimburse-

ment in exchange for the ‘free’ FDA approved ECP medical device. These same ECP devices have been

in use in the U.S. exclusively through Cardiologists and Cardiac specialty facilities until 2010, when U.S.

Health Reform, driven by global mandates, federal medical budget deficits, health insurer constrictions,

and consumer demand for non-surgical alternatives incited change.

ECP devices have only been sold directly by three major manufacturing competitors, GE Healthcare Sys-

tems (GE), through its VasoMedical division; Berkshire-Hathaway (B-H) through its Scott Care division;

and, Cardiomedics, Inc. – Innova Med’s Acquired company. Retail sale prices of between $80-95,000 have

consistently been realized through direct sales to top hospitals such as the Mayo Clinic, Cleveland Clinic,

John Hopkins University Hospital, Stamford University Hospital and hundreds of other re-knowned re-

search, cardiac and NCD treatment facilities in addition to Cardiologists worldwide. Although patented 44

years ago, FDA 510(K) clearance for the treatment of CVD’s has tripled industry sales since its approval

12 years ago.

Cardiomedics has consistently outperformed it public company competitors by a 2 to 1 margin year to year

since FDA and insurance approval were granted in 2001. Cardiomedics’ primary sales channel focus has

been direct to Cardiologists, versus hospitals and facilities - the primary sales channels of GE & B-H.

Cardiomedics chose INNOVA MED to develop strategic and innovative sales and marketing programs to

take advantage of opportunities present within the current medical environment, via joint venture exclu-

sive partnership before Innova acquired them. Cardiomedics established itself in the worldwide cardiac

community over 31 years ago by acquiring the patent, development, manufacturing and marketing, and

had become THE name to be trusted in cardiac medical devices. Cardiomedics has proven itself to be

the industry leader in innovative cardiac technologies, patented, unique ‘ cloud-based ’reporting tools and

superior U.S. made, ISO certified medical devices with lifetime warranties and 24/7 support unique within

the industry.


6.3 Implementation Snapshot

Action-Oriented Responses:

Innovative Approaches:

Within this Business Plan, INNOVA MED will share the financial model and plan detail which outlines the realistic ECP

treatment basis of 1,260,000 million treatments performed at 18 months, derived from average historical treatment data from

ECP devices in service within hospitals/cardiologists over the last 11 years (period of data availability).

INNOVA MED will share how simply 200 Distributors, each placing just 5 devices, with each device servicing just three (3)

new patients a month per Physician has the capacity to create a projected FY1 gross income of over $66M.

PATIENT

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PATIENTPATIENT

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PATIENTPATIENT

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X 12 MONTHS

ECPPHYSICIANS

ECPPHYSICIANS

ECPPHYSICIANS

ECPPHYSICIANS

ECPPHYSICIANS

200ZIP CODES

$44M

* 10 zip codes surrounding Top 20 U.S. medical markets


123

6.4 Stakeholder Snapshot

INNOVA MED meets the needs of its employees, investors, distributors, medical professionals and individuals in various capacities:

It’s Equity Investment Partners by offering a quality investment with 12 top ranked stable performance criteria and a 2-tier

Return on Investment program to ensure the security of your investment while maximizing profitable gains. Plus, this opportunity

offers its capital investors a true legacy opportunity with generational impact.

Channel Partners & Distributors by offering distribution solutions through the trade lines and specialty target markets of those

already in business serving the medical and physician community, on a local, regional, state and or nationwide basis. Innova shall

offer turn-key business and marketing programs designed for quick and certain implementation through a company’s established

sales force. The opportunities to such entities and their supporting individuals equal the potential for greater net profits; high

individual earnings and low-risk potential; requires minimal vending-like operational and sales program implementation, with

re-produce ability in mind. Supporting Channel Partners & Distributors shall also receive the benefit of the Company’s FDA

approved devices and solutions with guarantee income streams, all within a high-barrier to entry marketplace, with international

influence and expansion capabilities.

The local, regional, national and international Medical Community and the individuals it serves by offering a

prioritized set of cost-effective interventions that can be delivered to achieve an acceptable quality of care, even in resource-poor

settings, at a Primary Care level never before available until now.

*See business plan for complete financials and third party validation of 5 year average industry valuation multiple of 11.8X

ROYALTIESFY 1

$20,365

ROI

FY 1 81.5%

FY 5 1230%

ROYALTIESFY 1-5 TOTAL

$332,656

EXITSTRATEGY

Valuation* at FY 5

At 5X multiple = $3.4M

At 10X multiple = $6.7M

Single UnitInvestment

$25,000


6.5 Stakeholder Benefits

Investors Channel Partners

Physicians Patients Payors

• High ROI

• Proven Industry & Therapies• FDA Approved & Insurance Reimbursed

• Elective Income Growth & Diversity

• NO investment

• Use established physician base

• Corporate Sales & Marketing Support

• $200k + Annual Income

• Ability to offer complete non-invasive treatment regiments at NO costs

• Patient Retention & Marketing Assistance• $200K + Annual Income

• Non-invasive proven treatments with 80% average cardiac cure rates

• Minimal out of pocket• Elective options• Better Quality of Life

• A more cost effective alternative to costly, high-risk invasive procedure


6.6 Civic Impact

Civic Responsibility:

INNOVA MED will reinforce health system strengthening by contributing to the building blocks of the health system. Selected

ECP interventions will help to make limited individual, State and Federal resources go further and the user-friendly nature of

the tools that INNOVA MED & Cardiomedics have developed, will empower primary care Physicians as well as allied health

workers to contribute to NCD care.

Overall, INNOVA MED shall initiate and sustain the processes of research, education,

awareness, and advocacy through its Industry Research, E-Communications, Healthcare

Lobbyist, Patient Advocacy, and Indigent Care programs developed and operated through

its wholly-owned non-profit subsidiary, The Quality of Life Advocacy (QOLA). QOLA will

work to institute universal coverage reforms to ensure that health systems contribute to health equity, social justice,

community solidarity and human rights.

As part of INNOVA MED’s commitment to help women improve their health for the near and far term, the QOLA

Health Resource Center, has established the People’s Health Research Registry. The registry is a database of health

information shared by those whose participation in clinical research trials can contribute to the well-being of future

generations.

Information in this comprehensive database is a vital component towards discovering new and better ways to

diagnose and combat debilitating non-communicable diseases worldwide

Enrollment for possible participation in future clinical research trials will be made available through our QOLA Health

Research Registry website.

INNOVA MED shall donate 10% of its gross revenues on a quarterly basis to the QOLA to support physicians practice

and patient retention efforts, patient advocacy, industry research, clinic trials, consumer education, national health

reform and global change.

10% of Innova Revenues


7. Marketing Plan

“ ““Playing it safe. Following the rules.

They seem like the best ways to avoid failure.

Alas, that pattern is awfully dangerous.

The current marketing “rules” will ultimately

lead to failure. In a crowded marketplace,

fitting in is failing. In a busy marketplace,

not standing out is the same as being invisible.”

Seth Godin


7.1 Core Approach

ECP:

The one, very powerful non‐invasive, non‐surgical treatment modality offered by IMT is External Counterpulsation (ECP)

an FDA approved computer‐driven medical device that the cardiac community refer to as “a nonsurgical bypass.”

ECP is a less invasive non‐surgical therapy with side little to no adverse effects than is true

of other mainstream surgical treatments. In‐a‐word, it mechanically and effort-

lessly increases blood flow to organs and tissues including the heart, and also facilitates

the growth of new blood vessels.

External Counter Pulsation increases the blood flow to the heart through sequential

compression of the lower extremities of the body in synchronization with the patient’s elec-

trocardiogram. This therapy has been proven in the treatment of heart attacks (myocardial

infarction), cardiogenic shock, chronic (stable) angina, and congestive heart failure.22

ECP treatment is typically provided on an outpatient basis in 35 one‐hour sessions over a

period of approximately seven weeks. Additional hours may be safely and effectively added

to this standard regimen if the physician evaluation of the patient’s response to treatment

will result in greater relief of angina symptoms. In certain circumstances, adjusting the

patient’s treatment regimen to two hours per day can make it more comfortable for the patient to complete a course of ECP

therapy. Full treatment sessions will cost consumers $5,600… once, versus $50‐$100,000 for angioplasty/stent procedures

which may be done multiple times.

In a randomized study published in the Journal of the American College of Cardiology Vol. 48, No. 6, 2006 a team

of scientists laid out findings that indicated that ECP increased exercise tolerance, heart, lung and brain function for a

sustained minimum 5 year follow‐up period, in males improved erectile function, and in all participants weight loss benefits

were noticeable.

FDA Approval:

After 44 years of beneficial improvements and reduced mortality rates in cardiac patients, the FDA and U.S. Department of

Health and Human Services, the authority governing Medicaid and Medicare, approved its use for cardiac related therapies

in 2001.

Insurance Acceptance:

Medicare recognizes the value of ECP and has increased reimbursement for this treatment steadily every year since

approved. Nationally, the average increase in Medicare reimbursement for ECP from 2002 to 2003 was a substantial 35%

the largest reimbursement increase for a treatment in cardiology.

$20,000

Average

Angioplasty/Stent

Procedure @ 20%

out of pocket cost

$5,600ECP

Therapy


7.2 Core Focus

Elective Procedures:

Although not considered or depicted in the Company’s financial projections or statements, the Company fully expects to

derive consistent, profitable cash‐flow from this elective marketplace to those suffering with Diabetes, Erectile Dysfunction

(ED), Alzheimer’s, Parkinson’s, Multiple Sclerosis, Obesity and Macular Degeneration for which published peer review

studies consistently purport its benefits to sufferers.

The Company’s first targeted approaches were launched within the proven Cardiac marketplace, for which guaranteed insur-

ance reimbursements apply, but shall also simultaneously market the elective benefits to those affected by conditions above.

Diabetes:

Cardiomedics has recently made clinical submissions for FDA 510(K) approval for treatment of Diabetes, which has

undergone successful peer review studies for years. Given the FDA Fast Track submission allowance given its prior

ECP device approval status, the Company anticipates its 510(K) approval by fourth quarter 2012.

Facts about Diabetes:23

25.8 million children and adults in the United States—8.3% of the population—have diabetes. ‐

•Peoplewithdiabeteshavemedicalexpendituresthatare2.4times higher than those without the disease. ‐

•Themostcommoncomplicationofdiabetesiscardiovasculardisease(CVD), making‐up $17.6 billion of the $91.8 billion in direct medical costs for diabetes in 2002. ‐

•Thepercapitaannualcostofhealthcareforadiabeticincreasedfrom$10,071 in 1997 to $13,243 in 2002‐‐an increase of more than 30% compared to only $2,650 on every person without diabetes in 2002, which costs consume 25% of Medicare spending. ‐

•Indirectmedicalexpenditurestotaled$40.8billionandincludedcostsfromlost work days, restricted activity days, mortality, and permanent disability. ‐

•17.1%orover51,000,000Americansareuninsuredaccordingtogovernmentstatistics. A recent U.S. Department of Labor report estimates that that 44.6% of workers have no employer sponsored healthcare. ‐

•Anestimated5millionofthosewithouthealthinsuranceareconsidered“uninsurable”

because of pre‐existing conditions24.

23Alliance for Aging Research; http://www.silverbook.org/browse.php?id=45

24http://en.wikipedia.org/wiki/Health_insurance_coverage_in_the_United_States#Estimates_of_the_number_uninsured


7.3 Core Offerings

Viability:

Considering the excessive individual out‐of‐pocket costs, loss of activity and income, increased risks of CVD’s, disability

and death to individual sufferers, combined with the high percentage of federal dollars paid out to Medicare and Medicaid

patients, IMT is certain that FDA clearance will be approved for this very important and beneficial therapy. With or without

insurance approval, IMT is confident that the Elective Payer market is also currently marketable and profitably viable.

Income Potential:

If just 1% of current diabetic patients elected ECP Therapy, 258,000 individuals would generate 9,030,000 treatments

sessions at a cost of $150 per. Gross Revenue of $1,354,500,000 would be generated, of which IMT would expect to receive

23%, or $40 per treatment, or $361,200,000.

$140,000

$120,000

$100,000

$80,000

$60,000

$40,000

$20,000

$0Diabetic Treatment ECP Therapy

$132,430

$5,600

Annual Expense Single Therapy 10 Year Cost


7.3 Core Offerings

Erectile Dysfunction:

Through IMT’s Non‐Profit, the Company plans to underwrite necessary clinic trials for (ED). However, given the Elective

market that currently exists and money spent out‐of‐pocket for care by sufferers, the Company also projects substantial

income potential from this industry segment.

Facts about ED:

The first sign of heart disease is Erectile Dysfunction, but the majority of patients are not properly tested and mortality rates

within one year are over 32%. ‐

•Theaverageuserageis5325. The average life expectancy is 77.6 years26 ‐

•138,000,000menintheU.Salone,1outof5hastakenViagraorCialis, or 27,600,000 men.

‐ •12,309,600uninsuredorself‐payindividualsspendbetween$1,440and$1,800peryearforEDdrugs

‐ •22%ofmenwhotakeEDmedicationareages18‐40. 78% of those over age 53 who will pay

for these prescriptions out‐of‐pocket for 24 years. ‐

•9,601,688menwilleachspend a total average of $34,560 to $43,200 on Viagra or its

equivalent over 24 years. ‐

•Mostinsurance companies will not cover these so‐called “lifestyle drugs”. Those that do only cover

the cost of just four pills per month. Out of pocket they cost $12 to $15 a tablet. ‐

•EDislisted as a pre‐existing condition and increases the risk of loss of overall coverage and/

or loss of health insurance coverage. ‐

•Therisk of death to ED sufferers for those taking nitrates for heart related conditions is more

than tripled. ‐

•Themarketfor these virility drugs still top $5 billion in annual sales to tens of millions of men.

25http://www.4‐men.org/viagra/viagra‐for‐recreational‐sex.html

26The Harvard Health Report; http://www.health.harvard.edu/press_releases/average‐life‐expectancy

1% (123,096) of erectile dysfunction sufferers electing ECP

(35 treatments X $40 per) = $172,334,400 of revenue to Innova Med


7.4 Core Marketing Competencies

Innova’s core strengths and facilitate accelerated growth, increase productivity, generate greater

profits and add shareholder value.

Identification:

Innova’s primary core marketing competencies include the ability to identify with the wants and needs of the target

customer and communicate our brand image and product value in such a way as to elicit a favorable reaction from our

target customers.

Targeted Responses:

Trend identification, strategic planning, message creation, targeted advertising and effective communication in written and

graphic form are all core strengths of Innova’s in‐house marketing team. Creation of value propositions to consumers to drive

demand by consumers to Primary Care Physicians shall be a key marketing and advertising strategy of Innova Med.

AWARENESS

OPINION

CONSIDERATION

PREFERENCE

PURCHASE

BRANDING

DIRECT RESPONCE

SEARCH


7.5 Core Selling Competencies

Selling is the first stage of customer service, creating the initial customer experience with Innova Med.

Lead Generation:

Our primary core selling competencies include a highly streamlined and effective lead generation program, diagramed

below, proven to develop prospects created through our marketing efforts. Our lead development process flow is

triggered upon a prospects completion of our online web based Request For Information Form, and/or qualification form,

which information quickly qualifies and rates prospects; captures data electronically; generates timely auto‐responses,

electronically syncs all data and events within CRM, which triggers guide our Second Phase Acquisitions Cycle.

Inbound MarketingLead Conversion Funnel

Website Traffic

MOFUMiddle of the Funnel

TOFUTop of

the Funnel

BOFUBottom ofthe Funnel

Profiable CustomerRelationships

Traffic Generators:

• Website• Blog Post• SEO• Social Media• SEM

Traffic Converters:

• Call-To-Action• Landing Page• Advanced Content• Lead Nuturing• Analytics

Top of Funnel - TOFU

White Papers E-Books

Slide Shows Webinars

Free Trial Free Consult

Middle of Funnel - MOFU

Bottom of Funnel - BOFU


7.5 Core Selling Competencies

Experience:

Leading our in‐house marketing team are two highly educated and experienced key managers. Peter Helander, our EVP of

Strategy & Marketing, holds an MBA in SEO and online marketing and whose prior career for over a decade included a

senior role as VP of Marketing & Branding for IKEA; together with Steve Porter, Creative Director & Web Development

Director, who holds a Master’s of Communication from Kent State Univeristy, and a B.A. in Graphic Design and Photogra-

phy and has over 25 years in the communication industry, will direct the strategy, develop the campaigns and ensure timely

execution of all marketing initiatives.

Use of Technology:

Supporting staff members provide their expertise in Graphic Design, Videography, Social Media, Public Relations and

Administration. Our team will utilize the latest software technology to create relevant websites and landing pages, targeted

online web based lead generation portals, whitepapers and advertising messages through all forms of media, in addition to

creating consumer education, non‐profit advocacy, market owner business development and physician level collateral to

facility acquisitions and retention at every level.

Trending:

During our Qualification Phase, the potential clients due diligence period, Acquisitions Specialists utilize methodical

approaches to contribute to their value as a salesperson by acting as an information gatherer for the benefit of total company

intelligence. These sales agents must be able to convey marketplace attitudes and trends to the marketing department for

future use.

Acquisitions:

From appointment scheduling, to presentation of product’s value proposition, to Discovery Day booking and closing the

sale, our Acquisitions team has demonstrated a higher than industry average conversion rate from qualification to close of

over 65%, and an average sales cycle of less than 35 days. Within 24 hours of closing, clients (the Entrepreneurial Exclusive

Territory Owners) are transitioned to the Account Management Team.

Account Management:

Our Account Managers ensure the timely, damage free delivery of our turn‐key business collateral, wholesale goods and

medical equipment; schedule training; develop referrals, and over time advise on strategic marketing approaches to improve

Physician and patient acquisition, retention and loyalty. Account managers also ultimately document testimonials for future

use in marketing and sales presentations.


7.6 USP

The Innova Medical Technologies, Inc. brand will focus on the Company’s unique value proposition

which strategy is based on a differentiated customer value proposition.

The Company recognizes that satisfying customers, whether investors, distributors, physicians or

patients… are the source of sustainable value creation.

Revolutionary Approach:

There is a strong alignment of perspectives between Innova and Cardiomedics around the current consumer need for alter-

native, non-surgical cardiovascular procedures, the need for unique and differentiated offerings in both the domestic and

international markets, and the business assets and strategy required to best capitalize on these opportunities.

Innova’s Unique Selling Proposition (USP) otherwise known as our differentiated position in the marketplace, is exceptional

on its merits and dubbed ‘the perfect storm’ by many insiders given the current favorable regulatory environment, recent

insurance classification benefits, cardiology sector movements, and consumer demand for less invasive health alternatives.

We firmly believe the unique contributions of both Innova and Cardiomedics will result in maximum impact making us the

leading provider of consumer solutions in this cardiovascular therapy segment of the medical industry, worldwide.

Innova Med’s Pulse program will offer ECP devices at no cost to Primary Care Physicians, Cardiac Specialists, Clinics and

Hospitals while nearly doubling an individual Physician’s annual net income by adding an average of $200,000 in additional

revenue to their practice each year by simply treating only 3 new ECP patients per month.

The significant changes Innova Med is poised to launch will challenge the direct sales methodologies and long held archaic

industry selling standards. Innova will draw on its prior decade of experience, shifting to exclusive Territory owner profit-share

program implementations within Primary Care Physician practices such as General Practitioners, D.O.’s and Internists which

has never been endeavored before.

To date there has been no challenge to these stale standards, as until recently insurance

reimbursements were less scrutinized, especially in the cardiology segment where

cardiac surgeons have held long-standing respectability, as evidenced by the higher

than medical industry average reimbursements. To date, industry manufacturers

have targeted Hospitals and cardiologists alone.


7.6 USP

Innova fully intends to utilize a variety of synergistic sales methodologies to strengthen and support the

growth of our Pulse program and ensure market development expansion by executing the following:

•THECOMPANYshalldevelopacorporatedistributionmodelthatwouldmarketandsell‘allthe

benefits of a franchise, without the franchise fees or royalty requirements’, in a Turn-Key business

package to qualified Entrepreneurs developed through its lead generations and branding campaigns.

•THECOMPANYshallbeginitsDistribution Vending program model by initiating its market

development plan in the Atlanta, GA market to achieve Ad Hoc experience and to regularly test

new marketing and patient development strategies and concepts closest to home in order to quickly

evaluate and when necessary, shift to increasingly greater profit models.

•THECOMPANYshallhiresalesrepresentatives, with an emphasis on past experience in pharmaceutical

or medical equipment sales, combined with on-staff marketing, SEO and web marketing strategists, tele-

marketers, lead acquisitions and development personnel to acquire physicians in the Atlanta market

whom will use the CARDIOMEDICS ECP equipment in the practice.

•THECOMPANY shall develop a five system minimum ECP unit purchase for exclusive market owners

and shall grant exclusivity to the market owner an a year to year basis, based upon performance

•THECOMPANY shall take advantage of joint promotional opportunities and co-branded campaigns with

medical colleges, industry trade associations and any other beneficial groups on a grass-roots basis.

•THECOMPANYplanstobegintelevisedcampaignswithinthe4thequarterfollowinginceptionviamedical,

Discovery’s Medical channel. Dr. Oz, or other applicable media outlets which target the key demographic

audience for CARDIOMEDICS, and at such time as the top 200 regional domestic markets have been

acquired by Exclusive Distributors, campaigns will be developed for direct to consumer advertising.

•Theseinitial‘infomercial’formatswoulddisplaythemanybenefitsofuse

of the CARDIOMEDICS ECP treatment, with anticipated physician appeal

which would be quite substantial over non-targeted advertising solutions

•Asdirect and corporate sales, potential treatment center store openings

and other highly developed distribution channels become more identifable

to consumers, local television commercials airing on primary stations will

be factored into the television advertising strategy.

•THE COMPANY shall corporately own ECP facilities beginning in the

U.S., through joint venture partnerships or as franchises into the world

marketplace, as determined after further analysis and at such time as

profitability and growth milestones position us for reinvestment into

this untapped marketplace.


7.7 Core Income Model

The potential that exists for both short-term and long-term cash flow is easily recognized in the model

below, and forms the basis of our business.

Innova ECP Model Summary

Distributors

# Distributors 200

Units Per Distributor 5

# ECP Units Placed 18 Mo. 1,000

Physicians

# Physicians 1,000

# Patients Per Physician 36

Total ECP Patients 18 Mo. 36,000

Patients

Total # ECP Patients 36,000

X Min. Treatments p/Patient 35

Total Treatments 18 Mo. 1,260,000

Innova Med

Total # Treatments 1,260,000

X Net Billable Per Treat to IMT $35

Gross Revenue to IMT $44,100,000


7.8 Promotion Strategy

The world has changed. We are in the midst of an unprecedented shift of power to the consumer fueled by the virtual

megaphone handed to them through social media outlets. When a customer is angry or has a bad experience with a product or

service, the old rule of thumb was that they told an average of 10 people about it. In today’s world some could easily be telling

10,000 (or more!). On the flip side, happy customers can be telling many more than the old average of 3 people about their

good experience.

Marketing executives just need to design initiatives that enable and activate them to do so. That shift can be represented

through adapting one of every marketer’s favorite marketing conceptual frameworks, the funnel.

Innova Med will seek to engage and interact effectively through the various forms of media

indicated in the graphic ‘funnel’ displayed here.

With the expansion of the marketer’s toolbox to include social media, marketing is no longer about pushing out one way

communications. The marketing world is no longer defined solely by impressions; it’s now a world of interactions. Today’s

marketing includes the customer’s voice throughout the process, whether it’s intentional or not. Customers will talk online and

comment on a brand’s marketing campaigns, products, services, and even how a company treats employees. It’s not enough

to think about how companies communicate outwards; it’s just as important to think about how customers can communicate

back, with each other, and arguably most importantly, with new prospects.


8. Products

“ ““Business is not just doing deals; business is

having great products, doing great engineering,

and providing tremendous service to customers.

Business is a cobweb of human relationships.”

Ross Perot


8.1 Core Medical Device

Primary Device:

The fact remains that we cannot stop time or the aging process. But, is there anything that we can to stop or even reverse

the harmful effects that aging and atherosclerosis have on the heart and cardiovascular system? Fortunately, there is.

CardiAssist® 4500GS ECP System

Cardiomedics newest device is the CardiAssist Model 4500GS ECP System. The Model 4500GS is the latest generation of ECP

devices developed by Cardiomedics, the pioneer of ECP and the first manufacturer to obtain a FDA 510(K) clearance for mar-

keting ECP. Years of research and development have brought about the most technologically advanced ECP System to date.

Advancements include:

•PatentedHeartSmart® Graduated Low Pressure Regimen - Cardiomedics is the only ECP manufacturer

with a patented regimen in the treatment of Congestive Heart Failure (CHF). Developed in conjunction

with Cardiomedics’ published, peer-reviewed study of Congestive Heart Failure where an 85.7% reduction

in re-hospitalizations was shown. Download the CHF clinical here.

•CloudBackup-All patient files are encrypted and backed up on a regular basis to a secure, remote server

which reduces the chance of these files being corrupted or deleted. If a 4500GS’s back pack malfunctions

and is replaced, patient files can be downloaded from the cloud backup and treatments can resume

uninterrupted.

•iPadCompatibility - Each 4500GS includes an Apple® iPad. The iPad seamlessly links to the CardiAssist

4500GS and allows the user to interface with the ECP System untethered. Coupled with the 4500GS’s

new touchscreen, icon-driven user interface, the marriage of these technologies provides a simple,

intuitive experience.

•Smallandportable-The 4500GS can be housed in a small space and is easily moved from patient to

patient or room to room.

•Quiet - Developments have been made in reducing the decibel level the CardiAssist 4500GS emits.

A quieter device facilitates sleeping or reading should a patient which to do so during treatment.

•Removable “Back Pack” - The 4500GS’s new design makes use of a removable back pack that houses

the bulk of the device’s electronics. Should a malfunction stem from a component located in this unit,

a replacement unit is shipped, often overnight, and the faulty back pack can be replaced in under

ten minutes.


8.2 Supporting Devices

Secondary Device:

Cardiomedics Inc. was the first company to introduce a 4-8 minute sub-maximal cardiopulmonary

exercise test (the CardiAssess CPD) for the diagnosis and management of cardiovascular risk.

A non-invasive way of tracking a patient’s physiological changes, the CardiAssess can be used

to make an initial diagnosis and also track the efficacy of ANY medical treatments a patient

is receiving.

ECP is a non-invasive technology that has proven to be a safe and effective alternative or complement to invasive,

high-risk procedures such as angioplasty and bypass surgery. Unlike these conventional treatments that target indi-

vidual blockages, ECP treats heart disease as a chronic system-wide illness. By recruiting and helping to develop new

collateral blood vessels, ECP maximizes blood flow to the heart, as well as throughout the entire body.

ECP has helped people throughout the world enjoy a greater quality of life indicating an improved clinical response

rate of 80-89% on average, which has proven sustainable up to five years (study periods), while reducing mortality

rates by over 36% over those choosing surgically invasive heart procedures. It has given new hope to many of those

suffering from heart disease. Numerous clinical trials in the last two decades have shown ECP therapy

to be safe and effective for patients with refractory angina.


9. Competitive Analysis

“ ““Whether it’s Google or Apple or

free software, we’ve got some fantastic

competitors and it keeps us on our toes.”

Bill Gates


9.1 Industry Competitors

Manufacturing:

Innova Medical Technologies, Inc. competes indirectly with any company which manufactures and sells ECP durable

medical equipment.

The following manufacturers are located within the United States and provide its manufactured goods through tradeshows to

Cardiologists or to hospitals directly. Innova Med’s creative and visionary approach to unchallenged standards in the industry of

Capital Medical Equipment sales is certain to bring attention to and competition from industry competitors

from manufacturers, to sales to distribution companies.

There are numerous competitors in the capital medical equipment manufacturing industry. There are just three FDA approved

ISO certified ECP device competitors in the U.S.

Innova Med has entered into an Exclusive Joint Venture Partner relationship with CardioMedics (“CARDIOMEDICS”) to

develop this new and innovative business endeavor. CARDIOMEDICS offers numerous advantages in software, technology,

customer service, warranty and service support. CARDIOMEDICS has remained the industry leader in ECP direct sales for

nearly 15 years.

The remaining three competitors are:

1. GE Healthcare, facilitating direct sales through its exclusively licensed sales partner, VasoMedical, Inc.

2. Berkshire-Hathaway facilitating direct sales through its wholly-owned subsidiary, Scott Care.

Berkshire is Warren Buffett’s company.

3. Applied Cardiac Systems, Inc. – the only privately held re-manufacturer whose sales model is

limited to cardiologists only and who retain only several independent sales agents around the U.S.

Advantageous to Innova Med is that two are public companies which capital expenditure approval cycle typically takes a year

or more, and as such IMT anticipates a future buy-out offer versus competitive positioning.

Sales/Marketing:

As a result of the Company’s innovative approach to marketing and sales

of ECP devices through Distributors, which are then offered to Physicians

for free in exchange for profit share per treatment vs. direct sells to

individual Physicians or Hospitals only, the Company has no

direct competition.

Innova Med has concentrated its focus and has the passion to

not only compete in this lucrative marketplace, but to exceed

all expectations of ourselves, our investors and our competition.


“

“

9.2 Competitive Advantage

Key Advantages:

Innova Medical Technologies, Inc. enjoys several advantages over its competitors. These advantages include: ‐

•Costleadership:IMThasthelowestcostofoperationintheindustry.

o Our cost leadership advantages are driven by our Company’s efficiency, size, scale, scope

and cumulative experience in the distribution marketplace, unlike our competitors who

have no such experience.

o Our medical device cost is nearly $20,000 per unit below wholesale offered by CARDIOMEDICS

directly or by any other competitor. This factor alone, separate entirely from profit-share revenue,

adds $8.800.000 to the Company’s income forecasts.

o These patterns consist in simultaneous cost leadership, superior customer service and

product leadership.

•Costleadershipisdifferentfrompriceleadership.Mostcompaniescannotcompeteonbothlevels,

but given its unique Joint Venture arrangement, which removes the costs of manufacturing and relative

overhead to the expense line, IMT is also able to compete on the basis of being the lowest cost producer,

yet not offer the lowest‐priced products or services

o This provides the company a higher than average profitability as a result of its low cost

structure and minimal management requirements. ‐

•Differentiation27 is a concept used in business strategy and describes one of the three ways to establish

competitive advantage. which occurs when a firm delivers greater services for a non‐unlimited higher

price than its competitors. They are collectively known as positional advantages because they denote the

firm’s position in its industry as a leader in either superior services or cost. Product differentiation is what

will allow Innova Med to operate as monopolistic competition (a market structure) and sell our ECP

devices at $42,500 to Distributors, vs at the minimum industry wholesale of $55‐90k. This differentiation

factor occurs as a result of our ability to sell our products at different prices, even though they are essentially

the same. Economies of scale and the resultant cost advantages will be realized as our enterprise expands.

“Surgery is always second best. If you can

do something else, it’s better.”

Dr. John Kirklin


10. Financial Highlights

“ ““Business is not financial science,

it’s about trading...buying and selling.

It’s about creating a product or service

so good that people will pay for it.”

Anita Roddick


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DO NOT DUPLICATE, TRANSMIT OR DISSEMINATE WITHOUT THE EXPRESS WRITTEN PERMISSION OF LISA R. TERRY AND/OR INNOVA MEDICAL TECHNOLOGIES


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11. Reimbursement

Angina ICD-9 CM Office Codes:

411.1 Intermediate Coronary Syndrome

413.0 Angina Decubitus

413.1 Prinzmetal angina

413.9 Other/unspecified angina pectoris

414.9 Chronic ischemic heart disease, unspecified

Medicare Office Code is G0166-(unable to bill Non-Medicare CPT codes with G0166)

Non –Medicare CPT Codes:

92971- Cardiac Assist, external method

93922- Non invasive physiologic study (finger pleth)

93041- ECG 3 lead continuous

99211- EM by non physician (therapist)

93799- Unlisted cardiovascular procedure

Hospital APC Code 0972

Non- Medicare CPT Codes:

92971- Cardiac Assist, external method

93922- Non invasive physiologic study (finger pleth)

93041- ECG 3 lead continuous

99211- EM by non physician (therapist)

93799- Unlisted cardiovascular procedure


11.1 Important Clinical Studies


12. Reference Resources

23. American Heart Association: Heart Disease and Stroke Statistics‐2008 Update. AHA, Dallas, Texas, 2008

24. British Heart Statistics report

25. “WHO Disease and injury country estimates”. World Health Organization. 2009. Retrieved Nov. 11, 2009.

26. Vanhecke TE, Miller WM, Franklin BA, Weber JE, McCullough PA (Oct 2006). “Awareness, knowledge, and perception of heart disease among adolescents”.

Eur J Cardiovasc Prev Rehabil. 13 (5): 718–23. doi:10.1097/01.hjr.0000214611.91490.5e.PMID 17001210.

27. Highlander P, Shaw GP (2010). “Current pharmacotherapeutic concepts for the treatment of cardiovascular disease in diabetics”. Ther Adv Cardiovasc Dis. 4: 43–54.

28. NPS Medicinewise (1 March 2011). “NPS Prescribing Practice Review 53: Managing lipids”. Retrieved 1 August 2011.

29. Kvan E., Pettersen K.I., Sandvik L., Reikvam A. (2007). “High mortality in diabetic patient with acute myocardial infarction: cardiovascular co‐morbidities contribute

most to the high risk”. Int J Cardiol 121: 184–188.

30. Norhammar A., Malmberg K., Diderhol E., Lagerqvist B., Lindahl B., Ryde et al. (2004). “Diabetes mellitus: the major risk factor in unstable coronary artery disease even

after consideration of the extent of coronary artery disease and benefits of revascularization. J”.Am Coll Cardiol 43: 585–591.

31. DECODE , European Diabetes Epidemiology Group (1999). “Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria”.

Lancet 354: 617–621. doi:10.1016/S0140‐6736(98)12131‐1. PMID 10466661.

32. Wang TJ, Gona P, Larson MG, Tofler GH, Levy D, Newton‐Cheh C, Jacques PF, Rifai N, Selhub J, Robins SJ, Benjamin EJ, D’Agostino RB, Vasan RS (2006). “Multiple

biomarkers for the prediction of first major cardiovascular events and death”. N. Engl. J. Med. 355 (25): 2631–billy bob joe9. doi:10.1056/NEJMoa055373. PMID 17182988.

33. Wang TJ, Larson MG, Levy D, et al. (Feb 2004). “Plasma natriuretic peptide levels and the risk of cardiovascular events and death”. N Engl J Med. 350 (7): 655–63.

doi:10.1056/NEJMoa031994. PMID 14960742.

34. a b c d NHS Direct

35. Ignarro, LJ; Balestrieri, ML, Napoli, C (2007 Jan 15). “Nutrition, physical activity, and cardiovascular disease: an update.”. Cardiovascular research 73 (2): 326–40.

PMID 16945357.

36. World Heart Federation (5 October 2011). “World Heart Federation: Cardiovascular disease risk factors”. Retrieved 5 October 2011.

37. The National Heart, Lung, and Blood Institute (NHLBI) (5 October 2011). “How To Prevent and Control Coronary Heart Disease Risk Factors NHLBI, NIH”.

Retrieved 5 October 2011.

38. Siri‐Tarino, PW; Sun Q, Hu FB, Krauss RM (2010). “Meta‐analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular

disease.”. The American Journal of Clinical Nutrition 91 (3): 535–46. doi:10.3945/ajcn.2009.27725.PMC 2824152. PMID 20071648.

39. William C. Stanley, Keyur B. Shah, M. Faadiel Essop (2009) “Does Junk Food Lead to Heart Failure? Importance of Dietary Macronutrient Composition in

Hypertension”American Heart Association 54: 1209‐1210, Published online before print October 19, 2009, doi: 10.1161/HYPERTENSIONAHA.109.128660

40. Are refined carbohydrates worse than saturated fat?, Frank B Hu, American Journal of Clinical Nutrition, June 2010 vol. 91 no. 6 1541‐1542

41. Siri‐Tarino Patty W, Sun Qi, Hu Frank B, Krauss Ronald M (2010). “Saturated fat, carbohydrate, and cardiovascular disease”. American Journal of Clinical

Nutrition 91 (3): 502–509.

42. Walker C, Reamy BV (April 2009). “Diets for cardiovascular disease prevention: what is the evidence?”. Am Fam Physician 79 (7): 571–8. PMID 19378874.

43. “Vitamins and minerals: not for cancer or cardiovascular prevention”. Prescrire Int 19(108): 182. August 2010. PMID 20939459.

44. Berger, JS; Lala, A, Krantz, MJ, Baker, GS, Hiatt, WR (2011 Jul). “Aspirin for the prevention of cardiovascular events in patients without clinical cardiovascular

disease: a meta‐analysis of randomized trials.”. American heart journal 162 (1): 115‐24.e2.PMID 21742097.

45. Ornish, Dean, “et al.” (Jul 1990). “’Can lifestyle changes reverse coronary heart disease?’ The Lifestyle Heart Trial.”. Lancet 336 (8708): 129–33.

doi:10.1016/0140‐6736(90)91656‐U. PMID 1973470.

46. Ornish, D., Scherwitz, L. W., Doody, R. S., Kesten, D., McLanahan, S. M., Brown, S. E. “et al.” (1983). “Effects of stress management training and dietary changes

in treating ischemic heart disease”. JAMA 249 (54): 54. doi:10.1001/jama.249.1.54.PMID 6336794.

47. Ornish, D., Scherwitz, L. W., Billings, J. H., Brown, S. E., Gould, K. L., Merritt, T. A. “et al.” (1998). “Intensive lifestyle changes for reversal of coronary heart

disease”. JAMA 280 (23): 2001–7. doi:10.1001/jama.280.23.2001. PMID 9863851.

48. “WHO Disease and injury country estimates”. World Health Organization. 2009. Retrieved Nov. 11, 2009.

49. “United Nations High‐level Meeting on Noncommunicable Disease Prevention and Control”. www.who.int.

50. Coronary Heart Disease and Physical Activity of Work by J. N. Morris and Margaret D. Crawford, British Medical Journal 1958 ; 2(5111): 1485–1496 [1]

51. Karakas M, Koenig W (December 2009). “CRP in cardiovascular disease”. Herz 34 (8): 607–13. doi:10.1007/s00059‐009‐3305‐7. PMID 20024640.

52. 20448212

53. Venuraju SM, Yerramasu A, Corder R, Lahiri A (May 2010). “Osteoprotegerin as a predictor of coronary artery disease and cardiovascular mortality and morbid-

ity”. J. Am. Coll. Cardiol. 55 (19): 2049–61. doi:10.1016/j.jacc.2010.03.013. PMID 20447527. 54. ^ Andraws R, Berger JS, Brown DL (Jun 2005). “Effects of antibiotic thera-

py on outcomes of patients with coronary artery disease: a meta‐analysis of randomized controlled trials”.JAMA 293 (21): 2641–7. doi:10.1001/jama.293.21.2641. PMID 15928286.

55. http://my.clevelandclinic.org/heart/disorders/cad/eecp.aspx

56. http://www.eecpclinic.com/benefits_of_eecp.html


12.1 ECP Overview

Overview of ECP Therapy

The ECP device provides a non‐invasive treatment for patients with Angina and/or Congestive Heart Failure. ECP treatment is

typically provided on an outpatient basis in 35 one‐hour sessions over a period of approximately seven weeks. Additional hours

may be safely and effectively added to this standard regimen if the physician evaluation of the patient’s response to treatment

will result in greater relief of angina symptoms. In certain circumstances, adjusting the patient’s treatment regimen to two hours

per day can make it more comfortable for the patient to complete a course of ECP therapy. To receive ECP therapy, the patient

reclines on a treatment table. Three sets of comfortable, inflatable cuffs (similar to blood pressure cuffs) are snugly and securely

wrapped around the patient’s calves, thighs and buttocks. The cuffs are inflated sequentially at the onset of diastole and deflated

before the onset of systole. The inflation and deflation are specifically timed with the patient’s ECG to optimize thera-

peutic benefit. This sequence increases coronary perfusion pressure and venous return to the right heart (increasing preload

and cardiac output). The simultaneous deflation, at the onset of systole, rapidly decreases cardiac afterload (creating systolic

unloading) of the heart.

Effects of ECP Therapy

Taguchi et al demonstrated that ECP therapy produces hemodynamic effects very similar to the Intra‐Aortic Balloon Pump

(IABP) in patients with Acute Myocardial Infarction. Michaels et al also demonstrated the hemodynamics of ECP in the cath

lab. They determined that the therapy unequivocally and significantly increases central aortic and intracoronary diastolic

pressure and intracoronary blood flow velocity. Mean aortic and intracoronary pressure is increased, and left ventricular systolic

unloading occurs during the therapy. Pressure tracing at baseline (ABC) and at increased inflation pressure of 120 mmHg. Note

the diastolic pressure (E) has increased, whereas the systolic pressure (D) has decreased. This is attributable to systolic unloading

as the inflation pressure is increased.


12.2 ECP Treatment Overview

External Counter Pulsation (Also Called ‘ECP’)

External Counter Pulsation (Also Called ‘ECP’) There are a large, increasing number of patients who have persistent anginal

symptoms, who have exhausted the standard treatments for revascularization and remain severely restricted. External Coun-

terpulsation (ECP) may stimulate the openings or formation of collaterals (small branches of blood vessels) to create a natural

bypass around narrowed or blocked arteries.

Who is a candidate for ECP? You may be a candidate if you:

•Havechronicstableangina

•Arenotreceivingadequaterelieffromanginabytakingnitrates

•Donotqualifyasacandidateforinvasiveprocedures(bypasssurgery,angioplasty,orstenting)

What happens during ECP treatment? ECP is a non‐invasive, outpatient therapy. During treatment:

•Patientsliedownonapaddedtableinatreatmentroom

•Threeelectrodesareappliedtotheskinofthechestandconnectedtoanelectrocardiograph(ECG)

machine. The ECG will display the heart’s rhythm during treatment. Blood pressure is also monitored.

•Asetofcuffsiswrappedaroundthecalves,thighsandbuttocks.Thesecuffsattachtoairhosesthat

connect to valves that inflate and deflate the cuffs. Patients experience a sensation of a strong “hug”

moving upward from calves to thighs to buttocks during inflation followed by the rapid release of pressure

on deflation. Inflation and deflation are electronically synchronized with the heartbeat and blood

pressure using the ECG and blood pressure monitors.

How does ECP work?

•TheECPtreatmentgentlybutfirmlycompressesthebloodvesselsinthelowerlimbstoincrease

blood flow to your heart. Each wave of pressure is electronically timed to the heartbeat, so that the

increased blood flow is delivered to your heart at the precise moment it is relaxing. When the heart

pumps again, pressure is released instantaneously. This lowers resistance in the blood vessels in the

legs so that blood may be pumped more easily from your heart.

•ECPmayencouragebloodvesselstoopensmallchannelsthatbecomeextrabranches.Thesechannels

or collaterals may eventually become “natural bypass” vessels to provide blood flow to heart muscle.

This contributes to the relief of angina symptoms.

How often are patients treated?

•Patientswhoareacceptedfortreatmentmustundergo35hoursofEECPtherapy.Treatmentis

administered 1‐2 hours a day, five days a week, for 7 weeks.

•Publishedstudiesconductedatnumerousmedicalcentershavedemonstratedbenefitsfor

most patients including:

•Lessneedforanti‐anginalmedication

•Decreaseinsymptomsofangina

•Increasedabilitytodoactivitieswithoutonsetofsymptoms

•Abilitytoreturntoenjoyableactivities

Resources:CoronaryArteryDisease;CoronaryArteryDiseasewebchattranscripts;CenterforAdvancedIschemicHeartDiseas


12.3 ECP Critical Component

ECP’s primary benefits are derived from the increase of oxygen to all of the critical systems

and organs of the body.

The Importance of Oxygen

Most of us suffer from a lack of oxygen. Whether from improper breathing, poor diets, air pollution or lack of exercise, our cells are

being deprived of this vital element and thus weakening our immune system.

Oxygen (O2) is one of the most important elements required to sustain life. Without it, our health begins to suffer and/or we die.

Unhealthy or weak cells due to improper metabolism lose their natural immunity and are thus susceptible to viruses and lead the way

to all kinds of serious health problems.

O2 not only gives us life but destroys also the harmful bacteria in our bodies without affecting the beneficial bacteria that we need.

No antibiotic or drug can make that claim. I believe that God’s plan for mankind was for us to lead a physically productive life in a

clean environment, following His dietary laws and not require drugs to remain healthy...our bodies would then receive the sustenance

it needs.

Life styles today, in a modern world environment with depleted O2 levels in the atmosphere, actually requires our cells to use more of

this odorless/colorless gas to deal with several stresses on our body’s ability to function, increases the risk of obesity. Conversely,

reducing these major stressors through greater oxygenation eliminates cellular toxins at an increased rate, increasing metabolism and

assists in weight loss as a benefit of therapy.

The major causes of stress are:

•Toxicstress:Aconstantneedforcellulardetoxificationfromchemicalexposure.

•Emotionalstressrequiringtheproductionofadrenalineandandrenalhormones

•PhysicaltraumathatreducescirculationandO2supply

•InfectionsthatuseupO2tocombatbacteria,fungiandviruses.

•Anacidicdietproducinganexcessivenumberofhydrogenionsinthetissuesthatcombinewith

and also use up O2. Acidity also stresses the body to balance itself and become more alkaline by

taking calcium from our bones.

Yeast infections, such as candida albicans occur most frequently in an oxygen poor environment in the body. Currently, I would

say that, we have an epidemic of common yeast infections in our modern society. Yeast cells produce large amounts of acetalde-

hyde which cause cellular damage, interfere with intestinal absorption and disrupt white and red blood cell functions.

Increasing O2 levels in our body and eliminating commercial yeast and sugary foods from our diets will lessen this problem.

A primary solution to these problems is the use of External Counter Pulsation as a means of rebalancing,

regenerating and revitalizing the body to ensure a long and healthy life.

Reproduced by permission from Heal Your Heart with ECP Debra Braverman, M.D & Dr. Morris S. Keller, Founder, Natural Healing Research Associates


12.4 How ECP WorksCirculatory assistance provided by CardioAssist 4500gs™ ECP Therapy results in external augmentation pressure increasing

coronary and systemic perfusion. CardioAssist 4500gs™ ECP Therapy may be indicated when physiological changes have

reduced, or have the capacity to reduce, the heart’s pumping action. It may also be indicated when the quality of life is

compromised due to ischemic heart disease.

The patient lies on a treatment table where compressive cuffs (similar to large blood pressure cuffs) are securely wrapped around

the patient’s calves, thighs and buttocks. These cuffs inflate in a distal to proximal sequence in early diastole, and deflate

simultaneously in late diastole just prior to the onset of systole. Inflation and deflation are specifically timed to the patient’s

ECG to optimize therapeutic benefit.

Approximately 70% of myocardial perfusion with arterial blood occurs during diastole. It is during diastole that CardioAssist

4500gs™ ECP Therapy produces an increase in pressure within the aorta, increasing perfusion to the coronary arteries and to

the arterial and vascular system. Relaxation of the cuff pressure during cardiac systole lowers the resistance to blood flow in the

patient’s legs, reducing the back pressure on the heart as it ejects its bolus of blood. The combination of increased coronary flow

(augmentation) and reduction of cardiac work (afterload) by CardioAssist 4500gs™ ECP Therapy improves cardiac function.

The overall effect is to increase oxygen supply while reducing oxygen demand.

CardioAssist 4500gs™ ECP Therapy is typically provided in 35 one-hour treatment sessions over a period of approximately

seven weeks. Additional hours may safely and effectively be prescribed if physician evaluation of the patient’s response

to treatment determines additional sessions will result in greater relief of symptoms. In certain circumstances, adjusting the

patient’s treatment regimen to two hours per day can make it more comfortable for the patient to complete a course of

CardioAssist 4500gs therapy.

• Retrograde aortic pressure wave

• Increased diastolic pressure

• Increased intracoronary perfusion pressure

• Increased myocardial perfusion

• Increased venous return

• Increased preload

• Increased cardiac output

• Decreased systemic vascular resistance

• Decreased cardiac workload

• Decreased myocardial oxygen consumption

• Decreased afterload


12.5 Beneficial Mechanism of ECP

Schecter, Hod et al report that the mechanisms of action for ECP therapy are not yet definitely defined. Many clinical studies

however, identify components of the hemodynamic, physiological and neurohormonal cascades that ECP initiates.

The many beneficial effects that ECP produces appear to emanate through arterial diastolic augmentation. The retrograde

pressure wave increases coronary perfusion pressure, which creates a gradient between ischemic and nonischemic areas of the

myocardium that can recruit latent conduits and increase myocardial perfusion. Increased nitric oxide (NO) and atrial natri-

uretic peptide (ANP), and decreased endothelin (ET‐1) and brain natriuretic peptide (BNP) raise the possibility of peripheral

benefits as well as restored coronary flow reserve. Increased endothelial shear stress releases growth factor, which can improve

endothelial function.

Bonetti, et al have concluded that external counter pulsation is associated with an acute improvement in peripheral endothelial

function, as is demonstrated by the acute increase in RH‐PAT index observed in response to ECP during the first three days of

treatment. By increasing coronary blood flow, ECP is thought to promote myocardial collateralization via opening of pre‐formed

collaterals. Increased blood flow and shear stress may also improve coronary endothelial function favoring vasodilation and

myocardial perfusion.

FOR OVER 3,546 CLINICAL EVALUATIONS, USES, AFFECTS, FOLLOW-UP STUDIES

AND DIAGRAMS ON ECP, LINK TO PUBMED ON THE WEB AT:

https://www.ncbi.nlm.nih.gov/pubmed/

Enter “PubMed” link under the POPULAR category, then type in external counter pulsation in the search box

– OR –

Specifically type in this URL below

https://www.ncbi.nlm.nih.gov/pubmed?Db=pubmed&term=external%20counterpulsation%20therapy


12.6 Reimbursement

As part of Innova Medical’s commitment to advancing patient access to CardioAssist 4500gs™ ECP Therapy, we closely monitor national coverage decisions with the Centers for Medicare and Medicaid Services (CMS), public and private health insurers, and industry stakeholders to ensure appropriate reimbursement for services involving our products. Patients should contact their primary care physician, cardiologist or local ECP therapy center to discuss eligibility for treatment and reimbursement coverage.

CMS – Centers for Medicare and Medicaid Services

Section 20.20 (formerly 35-74) of the Medicare Coverage Issues Manual now provides national Medicare coverage for external counter pulsation (ECP). The Centers for Medicare and Medicaid Services cover treatment with CardioAssist 4500gs™ ECP Therapy systems for patients diagnosed with disabling stable angina (Class III or IV Canadian Cardiovascular Society or equivalent ), who in a cardiologist or cardiothoracic surgeon’s opinion are not amenable to surgical.

Patients with stable congestive heart failure of ischemic etiology are covered if they also present with symptoms of angina pectoris. Coverage for congestive heart failure of idiopathic etiology is not currently provided under Medicare. The Centers for Medicare and Medicaid Services provide additional information, including sections on national and local coverage and information about the national coverage decision (NCD) for external counter pulsation.

Private Insurance

Most all third-party commercial insurance carriers reimburse ECP Therapy and have coverage criteria similar to Medicare. Hundreds of third-party payers cover CardioAssist 4500gs™ ECP Therapy.

1. Their condition is inoperable

2. Their coronary anatomy will not allow to such procedures; or

3. They exhibit high-risk co-morbid states.

Code

G0166HCPCS Level II Code for external counter pulsation, per treatment session

HCPCS Level II Code for external counter pulsation, per treatment session

Same as above

CPT® Code for unlisted cardiovascular service or procedure

CPT Code for CardioAssist-method of circulatory assist; external

Suffix -76 is used when a patient receives two one-hour treatments on the same day.

Medicare carriers sometimes require this code along with G0166 when a patient receives two treatments on the same day. Consult Medicare for guidelines.

An individual CPT code has not yet been assigned for ECP, but some private payers that won’t accept G0166 will allow 92971.

Although G0166 is a Medicare-specific code, most private payers reimburse this procedure code. Verify this code with private payers before billing it.

Includes 92971, 93000*, 93005*, 93010*, 93040, 93041, 93042, 93720, 93721, 93722, 93922*, 93923*, 93924, 93965*, 97016, M0302. If the component code is a separately identifiable service and has a subscript * it may be billed with a -59 modifier and would be allowed. If there is not a subscript, the service may not be unbundled and may not be billed separately.

$151.23

$99.21

G0166-76

93799

92971

G0166Bundle

Procedure Misc.2011 National AverageMedicare Payment Rate


12.7 Patient Criteria

ECP is a safe and effective therapy that provides sustained duration of benefit in patients with disabling angina and angina

equivalents, Left Ventricular Dysfunction (LVD) and Congestive Heart Failure. ECP therapy is indicated for use in angina,

congestive heart failure, myocardial infarction, and cardiogenic shock.

ECP at peak diastolic to peak systolic (D/S) Ratios of 1.5:1 to 2:1 has been shown to produce optimal results in the treatment of

stable angina. New data shows that statistically, lower pressures and D/S Ratios have significantly reduced mortality, increased

LVEF’s, reduced NYHA CHF Class and hospital admittances by using Cardiomedics’ new Graduated™ Pressure Regimen.

Patients who benefit from ECP Therapy with Angina and Angina equivalents who:

1. Have coronary anatomy unsuitable for surgical or catheter‐based revascularization

2. Have co‐morbid conditions that increase the risk of revascularization procedures

(diabetes, heart failure, pulmonary disease, renal dysfunction)

3. Are inoperable or at high risk of operative/interventional complications

4. No longer respond to medical therapy

5. Are unwilling to undergo additional invasive procedures

6. Have Left Ventricular Dysfunction (EF <40%)

7. Restrict their activities to avoid angina symptoms

8. Diabetic patients who have small vessel disease known to be a greater risk for post‐procedural complications

9. Elderly patients at high risk for morbidity and mortality associated with invasive coronary interventions

10. Heart Failure patients who:

11. Have ischemic or idiopathic cardiomyopathy

12. Ejection Fraction <40%

13. Co‐morbid conditions that increase the risk of complications or revascularization procedures


12.8 Important Clinical Studies

External counter pulsation has been clinically studied dating back to the 1960’s. It continues to be studied today. The earliest

studies were done in the areas of cardiogenic shock and acute myocardial infarction. Since 1990, virtually all studies have been

focused on either angina or heart failure. The first randomized, double‐blinded, placebo‐controlled study was completed in 1997

(MUST‐ECP, 6 1995‐1997). It evaluated the effect of external counter pulsation therapy, testing the reproducibility of benefits

from earlier studies. Patients in the external counter pulsation group demonstrated a statistically significant increase in time

to exercise‐induced ST segment depression when compared to both sham and baseline. This group also reported a statistically

significant decrease in the frequency of angina episodes when compared to both sham and baseline.

Schecter, Hod et al (Circulation 2003) investigated the influence of short‐term external counter pulsation (ECP) therapy on

flow‐mediated dilation (FMD) in patients with coronary artery disease (CAD).

They found that in patients with CAD, the vascular endothelium is usually impaired and modification or reversal of endothelial

dysfunction may significantly enhance treatment. Although ECP therapy reduces angina and improves exercise tolerance in

patients with CAD, its short‐term effects on FMD in patients with refractory angina pectoris have not yet been described. “We

prospectivelyassessedendothelialfunctionin20consecutiveCADpatients(15males),meanage68•11years,withrefrac-

tory angina pectoris (Canadian Cardiovascular Society [CCS] angina class III to IV), unsuitable for coronary revascularization,

before and after ECP, and compared them with 20 age‐and‐gender matched controls. Endothelium dependent brachial artery

FMD and endothelium‐independent nitroglycerin (NTG)‐mediated vasodilation were assessed before and after ECP therapy,

using high‐resolution ultrasound.”

“Externalcounterpulsationtherapyresultedinsignificantimprovementinpost‐interventionFMD(8.2•2.1%,p•0.01),com-

paredwithcontrols(3.1•2.2%,p•0.78).TherewasnosignificanteffectoftreatmentonNTG‐inducedvasodilationbetween

ECPandcontrols(10.7•2.8%vs.10.2•2.4%,p•0.85).Externalcounterpulsationsignificantlyimprovedanginalsymptoms

assessedbyreductioninmeansublingualdailynitrateconsumption,comparedwithcontrols(4.2•2.7nitratetabletsvs.0.4•

0.5nitratetablets,p0.001and4.5•2.3nitratetabletsvs.4.4•2.6nitratetablets,p•0.87,respectively)andinmeanCCS

anginaclasscomparedwithcontrols(3.5•0.5vs.1.9•0.3,p0.0001and3.3•0.6vs.3.5•0.5,p•0.89,respectively).”


12.9 ECP Cinicals: Benefits to Patients, Clinically, Biochemically28

1. Long Term sustained benefit

2. Reduction in Angina episodes

3. Improvement in CCSF class

4. Improvement in QOL

5. Reduction in Nitrate use

6. Decrease in BNP levels

7. Increase in VEGF levels

8. Decrease in Endothelin levels

9. Increase in Nitric Oxide levels

10. Increase in Exercise Tolerance

11. Increase in Ejection Fraction

12. Increase in ST depression

13. Increase in Cardiac Output

14. Increase in Intracoronary pressure

15. Increase in Blood Flow Velocity

16. Increase in Cardiac Contractility

17. Increase in Peak Oxygen Consumption

18. Decrease in Systolic Pressure

19. Reduction in Systemic Vascular Resistance

28http://www.cardiomedics.com/cardiassist.htm


12.9 Physicians Q&A

General responses to selected questions:

Moderators: Joel Braunstein, MD, of Johns Hopkins University and Joseph Toscano, MD.

Question:

I would like to thank you for your kind and valuable response about ECP. Sir may I know one more thing about ECP that is “ may

I know the success rate of ECP =? Does it have any kind of side effects or after affect and is the patient totally cured? I would

be grateful to you if you can kindly clarify my query as my father is being advised ECP.

Answer:

Thank you for your timely question. Enhanced external counterpulsation therapy (ECP) is an emerging and exciting approach

to managing individuals with persistent symptoms of heart‐related chest pain (angina), despite being on optimal medical

therapy. ECP is a technique where pneumatic cuffs are wrapped around an individual’s calves, lower thighs, and upper thighs.

These cuffs inflate and deflate in synchrony with relaxation and contraction, respectively, of the heart. Each ECP treatment

generally lasts one hour per day and is performed five days per week for a total of seven weeks. While ECP does not “cure” heart

disease, multiple studies have clearly demonstrated that the treatment reduces angina symptoms, improves functional status,

improves quality of life, and reduces individuals’ reliance on other chest pain controlling medications, among other benefits.

For those in whom ECP is indicated, it portends a fairly high success rate. An estimated 80% of individuals experience a

reduction in their chest pain frequency and severity, achieve greater exercise tolerance levels, and generally experience a

better quality of life and longer life span. Studies support a 36% reduction in the mortality rate for ECP therapy vs. patients

surgically intervened.

In general, ECP is very well tolerated. Patients undergoing ECP equate the procedure with a deep massage. While there are no

serious short or long‐term risks associated with ECP, some patients may experience mild headaches, dizziness, fatigue, muscle

aches, or mild skin irritation around the cuff sites.

Should your father decide to undergo treatment with ECP, I wish him luck and hope that it affords him the same benefits it has

afforded to so many other individuals thus far29.

29Excerpted from interview; http://www.healthcentral.com/heart‐disease/ask‐doctor‐44714‐70.html


12.9 SEC Accredited Investor Definition

Accredited Investor

Under Rules 505 and 506 of Regulation D, a company may sell its securities to what are known as “accredited investors.” Accredited investors have certain financial criteria they must meet in order to be classified as an accredited investor. These criteria are as follows: ‐

•abank,insurancecompany,registeredinvestmentcompany,businessdevelopmentcompany,orsmall business investment company; •anemployeebenefitplan,withinthemeaningoftheEmployeeRetirementIncomeSecurityAct, if a bank, insurance company, or registered investment adviser ‐ •makestheinvestmentdecisions,oriftheplanhastotalassetsinexcessof$5million;‐ •acharitableorganization,corporation,orpartnershipwithassetsexceeding$5million;‐ •adirector,executiveofficer,orgeneralpartnerofthecompanysellingthesecurities;‐ •abusinessinwhichalltheequityownersareaccreditedinvestors;‐ •anaturalpersonwhohasindividualnetworth,orjointnetworthwiththeperson’sspouse, that exceeds $1 million at the time of the purchase; ‐ •anaturalpersonwithincomeexceeding$200,000ineachofthetwomostrecentyearsorjoint income with a spouse exceeding $300,000 for those years and a reasonable expectation of the same income level in the current year; or •atrustwithassetsinexcessof$5million,notformedtoacquirethesecuritiesoffered,whosepurchases a sophisticated person makes.

Un Accredited Investor

Under Rules 505 and 506 of Regulation D, a company may sell its securities to what are known as “accredited investors.” Accredited investors have certain financial criteria they must meet in order to be classified as an accredited investor. These criteria are as follows: ‐ •abank,insurancecompany,registeredinvestmentcompany,businessdevelopmentcompany,orsmall business investment company; ‐ •anemployeebenefitplan,withinthemeaningoftheEmployeeRetirementIncomeSecurityAct,ifabank, insurance company, or registered investment adviser makes the investment decisions, or if the plan has total assets in excess of $5 million; ‐ •acharitableorganization,corporation,orpartnershipwithassetsexceeding$5million;‐ •adirector,executiveofficer,orgeneralpartnerofthecompanysellingthesecurities;‐ •abusinessinwhichalltheequityownersareaccreditedinvestors;‐ •anaturalpersonwhohasindividualnetworth,orjointnetworthwiththeperson’sspouse,thatexceeds $1 million at the time of the purchase; ‐ •anaturalpersonwithincomeexceeding$200,000ineachofthetwomostrecentyearsorjointincome with a spouse exceeding $300,000 for those years and a reasonable expectation of the same income level in the current year; or trust with assets in excess of $5 million, not formed to acquire the securities offered, whose purchases a sophisticated person makes.


13. Disclaimer

The information provided within these documents is for assistance only and is not intended to be and must not be taken alone

as the basis for an investment decision. Each recipient of this information should make such investigations as it deems necessary

to arrive at an independent evaluation of an investment in the securities offered hereby, and should consult legal counsel and

financial, accounting, regulatory and tax advisors to determine the consequences of such an investment.

The securities offered hereby have not been and will not be registered under the Securities Act of 1933, as amended, or the

securities laws of any state or any other jurisdiction, and are being offered and sold in reliance upon exemptions from the

registration requirements of the Securities Act and such laws. In addition, Innova Medical Technologies, Inc. will not be

registered as an investment company under the Investment Company Act of 1940, as amended.

The securities offered have not been approved or disapproved by the securities authority of any state or any other jurisdiction,

or the Securities and Exchange Commission of the United States, nor has any other authority or commission passed upon or

endorsed the merits of this offering or the accuracy or adequacy of any supporting documents. Any representation to the

contrary is unlawful.

The securities being offered are suitable only for sophisticated investors for whom an investment in the securities does

not constitute a complete investment program and who fully understand, are willing to assume, and who have the financial

resources necessary to withstand the risks involved in the investment. Each purchaser of the securities offered hereby must be

an “Accredited Investor” within the meaning of Regulation D promulgated by the SEC under the Securities Act and will be

required to make certain representations and provide documentation to assure compliance by the Partnership with applicable

anti‐money laundering laws.


14 Contact Innova Med

Innova Medical Technologies, Inc.

1005 Alderman Drive

Suite 211

Alpharetta, GA 30005

877.909.1080

Primary Principals Email:

Lisa Terry

email | [email protected]

George Nelson


John McCallum


David Gregory


I n n o v a M e d E C P. c o m

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Documents

proprietary information

business plan

imt principal

core business model

management bio steve

management bio john

management bio david

management bio irwin