mhealthpharma pitch deck - 2016-06-01

Copyright 2016. mHealthPharma Inc. All rights reserved.

Presenter

Presentation Notes

Makers of FDA-Cleared Mobile Prescription Therapies – centred, instead of existing text


How it All Started

Steven Orlov, MD Protocol for study of mobile app to treat

chronic disease as part of Graduate course

Leonid Orlov Experienced Computer

Programmer

Alex Berlin Business, Software

Engineering and Start-up expert

Founded July 2015

Team: Co-Founders / Directors • Dr. Steven Orlov , Co-Founder

• MD (Endocrinology) from University of Toronto • MSc in Clinical Epidemiology from McMaster University • Multiple research publications (New England Journal of Medicine, Diabetes Care)

• Alex Berlin, Co-Founder • Software Engineer and Architect with 30+ years experience • Experience in managing distributed technology teams of 30+ people with department

budgets of $5-10M/year • Startup experience (Multex); Digital marketing expertise

• Leonid Orlov, Co-Founder • Computer programmer with 25+ years experience • Experience with rapid application development • Experience with scientific startups (Plasma Plus)

• Isaak Karaev, Independent Director, Board Member, Active Early Advisor • Serial Entrepreneur, Founder and CEO of Multex, Instant Information, InfoNgen, AlfaNgen • Raised funding in the $10s of millions • 4 Exits


Team: Advisors

Medical / Regulatory • Dr. Leonid Poretsky – Chief of Division of Endocrinology, Lenox Hill Hospital, NYC • Dr. David Orlov – MD (Anesthesiology), expertise in Health Economics • Dr. Richard Lipsky – Co-Owner, Meadowlands Hospital Medical Center, New Jersey • Gary Howard – Eight successful FDA approvals for medical applications/devices

Technology/Business • Dimitry Poretsky – CEO of MainStar - Asset and Maintenance Management • Dmitry Rapoport – Entrepreneur and technologist, Tooltwist • Michael Berganovsky - Expert technologist, computer scientist and engineer • Felix Rabinovich – Experienced technologist, manager and entrepreneur • Valentin Chernyak – Software architect and engineer

A focused team of founders and committed advisors, employees and contractors bringing expertise in key required areas of medicine, technology, clinical trials and FDA regulations.


• mHealthPharma Inc. (mHP) was formed to design, build, market and sell FDA-cleared mobile prescription therapies for the management of chronic diseases

• First product being developed is a mobile health (mHealth) product for patients with hypertension (high blood pressure)


Company Mission

SOURCES: World Health Organization, U.S. Department of Health


Problem • Hypertension is the leading risk factor for mortality and

healthy life-years lost worldwide

• Affects 1 in 3 U.S. adults (70 million)

• Despite effective medications, only half (52%) of these people have their blood pressure (BP) under control • Infrequent BP checks during scheduled appointments • No utilization of remote patient monitoring

(home BP) • Therapeutic inertia (physicians lack BP data to

make decisions)

• Existing mHealth apps for hypertension lack evidence for medical effectiveness • They have not been shown to lower blood pressure


Medical Context

SPRINT Trial (NIH Sponsored – November 2015)

• Treatment of hypertension reduces the risk of cardiovascular disease outcomes: • incident stroke (by 35 to 40%), • myocardial infarction (by 15 to 25%), • heart failure (by up to 64%)

• Targeting a systolic blood pressure <120 mm Hg vs <140 mm Hg: • Lower rates of major cardiovascular events (HR 0.75, p <0.001) • death from any cause (HR 0.73, p = 0.003)

• The implementation of the 2014 JCN8 Hypertension Guidelines for U.S. adults between the ages of 35 and 74 years could potentially prevent about 56,000 cardiovascular events and 13,000 deaths annually, while saving costs.

SOURCES: Randomized Trial of Intensive versus Standard Blood-Pressure Control.N Engl J Med 2015; 373:2103-2116 Cost-Effectiveness of Hypertension Therapy According to 2014 Guidelines. N Engl J Med 2015; 372:447-455.


mHealthPharma’s mobile app for patients with hypertension - myHTN

Solution myHTN

Presenter

Presentation Notes

Suggestion – myHTN may have negative connotation. ?myHealth-HTN


Evidence-Based Clinical Guideline Recommendations

• Recommendations based on latest (2014) Evidence-Based Guidelines for Management of High Blood Pressure in Adults (JCN8, JAMA), and can be updated

• BP measurements from FDA-Approved personal blood pressure device

Solution myHTN: Evidence-Based


Enhanced Doctor-Patient relationship through timely, proactive alerts/notifications


Solution myHTN: Connected to Physician

5.3mmHg ↓BP / 6 mo.

• Validated effectiveness (BP reduction) assessed through randomized controlled trial • Immediate attention to obtain FDA clearance



Solution myHTN: FDA Cleared

Mobile Prescription Therapy Prescribed by Health Care Practitioner



Solution myHTN: Prescribed by Physician




myHTN:


The first mobile prescription therapy for hypertension

www.mhealthpharma.com/info

http://www.mhealthpharma.com/info�

Offer product as Mobile Prescription Therapy

• Prescribed by physician • Covered by CMS (Medicare/Medicaid) / private insurers • Approach market by convincing practicing

physicians to use the product / prescribe it to their patients

Does not replace your doctor and hypertension drugs • Complements the relationship, improves compliance, provides timely notification & recommendations

Product Differentiation: Mobile Prescription Therapy


Not just a technology startup • Active participation of medical research experts • Dr. Steven Orlov, Dr. Leonid Poretsky, Dr. Richard Lipsky and Dr. David Orlov

Clinically validated measurement and algorithmic management • According to 2014 JNC8 Hypertension Guidelines • Medication tracking and personalized BP analysis Proprietary data processing methodology • Alerts/notifications (to patients and physicians) for treatment

adjustment based on data mining and analytics

Product Differentiation: Medical Research Expertise



Product Differentiation: Patent-Pending Proprietary Methodology

Patent-Pending Technology • Patent filed with US Patent and Trademark Office (Feb 2016) • Medical Condition Management System

Randomized clinical trials to demonstrate efficacy

Competitive advantage in FDA approval process • File as Class II Medical Device • Dedicated team focusing on FDA documentation and process • Past experience with 8 successful FDA clearances of software-based

medical devices • Reduce time, effort and cost of FDA application by leveraging

technology and automation in producing required documentation

Product Differentiation: FDA Cleared and Clinically Validated



Presenter

Presentation Notes

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Top 10 Chronic Diseases for mHealth Innovation

Business Scalability: Multiple Chronic Diseases

SOURCE: Topol EJ. Transforming medicine via digital innovation. Sci Trans Med, 2010; 2, 16cm4.

Copyright 2015. mHealthPharma Inc. All rights reserved. Copyright 2016. mHealthPharma Inc. All rights reserved.

Presenter

Presentation Notes

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• Will grow to $26B by 2017 according to MIT Technology Review

http://www.technologyreview.com/view/532661/mobile-medical-apps-a-market-on-the-move/

• May grow to $84.8B by 2020 according to Innovative People (Innoppl) White Paper Report

http://innopplinc.com/whitepaper/the-top-10-ways-mobile-technology-is-revolutionizing-healthcare-in-2015.php?gclid=CNOtg-qBjccCFQktaQodXKYO4A

• Expected to grow at compounded annual growth rate of 33.5% from 2015 to 2020 according to Allied Market Research

https://www.alliedmarketresearch.com/mobile-health-market

mHealth Market Forecasts

http://www.technologyreview.com/view/532661/mobile-medical-apps-a-market-on-the-move/�

http://innopplinc.com/whitepaper/the-top-10-ways-mobile-technology-is-revolutionizing-healthcare-in-2015.php?gclid=CNOtg-qBjccCFQktaQodXKYO4A�

http://innopplinc.com/whitepaper/the-top-10-ways-mobile-technology-is-revolutionizing-healthcare-in-2015.php?gclid=CNOtg-qBjccCFQktaQodXKYO4A�

https://www.alliedmarketresearch.com/mobile-health-market�


mHealth Market Forecasts

Mar 12 2016 “Things are looking app”

http://www.economist.com/news/business/21694523-mobile-health-apps-are-becoming-more-capable-and-potentially-rather-useful-things-are-looking

http://www.economist.com/news/business/21694523-mobile-health-apps-are-becoming-more-capable-and-potentially-rather-useful-things-are-looking�






























SOURCES: Medical Expenditures Panel Survey, Agency of Healthcare Research and Quality


http://meps.ahrq.gov/mepsweb/data_files/publications/st404/stat404.shtml

Hypertension Market Size: U.S. Only

Total Available Market

• 70M People

• $25B/year spent on anti-hypertension medications

Served Addressable Market (suitable patient w/ mobile device ~60%)

• 40M People

• Total Market Potential – $4.8B • 40M People x $120/year*

*Annual Cost: $2,600/year $2,500/year

http://meps.ahrq.gov/mepsweb/data_files/publications/st404/stat404.shtml�

SOURCES: Business Insights. Cardiovascular Market Outlook to 2016 http://download.bioon.com.cn/view/upload/201303/16084307_4163.pdf

US

Germany

UK

Italy

France

Spain

Japan


Hypertension Market Size: U.S.+EU5+Japan

$4.8B

$1.9B

$1.5B

$1.5B

$1.0B

$1.2B

$2.9B

US Market Potential: $4.8B Global Market Potential: $14.5B

http://download.bioon.com.cn/view/upload/201303/16084307_4163.pdf�

Subscription Model • Monthly cost, similar to other prescription medications • Covered by CMS (Medicare/Medicaid) / private insurers

Marketing and Advertising Revenue • Sharing anonymized user data (pharma, insurers, researchers) • Serving ads

Cost Covered out of Billings for Telemedicine • Physicians use platform to bill for remote patient monitoring


Commercial Models

Presenter

Presentation Notes

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Market as a medical device • Patients

• Digital marketing campaign – Web, Twitter, YouTube, Facebook, WebMD

• Social networking between patients, family, friends, caregivers, etc.

• Physicians • Educate medical community through medical

journals, conferences and door-to-door sales • Payers

• Medicare / Medicaid / Private insurers

Strategic partnership with:

• pharmaceutical companies • health insurance companies


Marketing

Presenter

Presentation Notes

Patient network – recommending it to their friends/families


To reach 1M patients • Need 5.6K MDs (less than

2% of MDs who treat HTN) Assumptions • US – 800K MDs • 300K Internal Medicine (IM) • 1000 patients / IM MD • 300 patients / MD have HTN • 180 patients / MD in addressable market

SOURCE: Statistica.com, Young A (2011) Census of US Physicians . J Med Regulation.

Milestones: Market Penetration and Subscription Revenue

0

60

120

180

240

0

500

1,000

1,500

2,000

Reve

nue

Run

Rate

($M

illio

ns)

Use

rs (T

hous

ands

)

Free users Paying Users Revenue run rate

Presenter

Presentation Notes

- Shown here are dates, paying/free user subscription and revenue run rate Main penetration will come through physician acquisition to prescribe


Mobile Prescription Therapy vs. Conventional mHealth Apps

Presenter

Presentation Notes

Feel free to stylize


Go To Market Strategy

Iterate every 3-6 months

Presenter

Presentation Notes

Can you re-fromat this slide to have a repeating circle / loop – clincal trial, conference, attract more users

• Many smartphone apps that contend they address hypertension make medical claims without clinical validation or FDA approval according to a report in Journal of American Society of Hypertension

http://www.modernhealthcare.com/article/20141224/BLOG/312249932 http://www.ashjournal.com/article/S1933-1711(14)00899-7/pdf

Consumers have a strong tendency to download and favorably rate apps that are advertised to measure blood pressure and heart rate, despite a lack of validation for these apps. There is a need for greater oversight in medical app development for HTN, especially when they qualify as a medical device.

J Am Soc Hypertens 2015;9(2):130–136.


mHealth Landscape

http://www.modernhealthcare.com/article/20141224/BLOG/312249932�

http://www.ashjournal.com/article/S1933-1711(14)00899-7/pdf�

• Numerous non-effective apps of entertainment value • iBP, Withings, Blood Pressure Checker • MediSafe • Tactio Healthcare

• Medically Effective / Clinically Validated • Existing anti-hypertensive medications • WellDoc – BlueStarTM (for diabetes)


mHealth Landscape


mHealth Landscape

• BlueStarTM by WellDoc – first FDA-approved mobile prescription app • Helps patients with type 2 diabetes


• WellDoc Inc, Facts: • Formed in 2005 by an MD. Based in

Baltimore, MD • Obtained FDA approval for their app (2014) • Reportedly raised $27M prior 2014 • Raised $20M from Merck in 2014 to actively

market BlueStarTM

• Recent partnership with Samsung - $22M raised • Covered by Ford Motors, Rite Aid, Dexcom and

other Fortune 500 companies • Prices their app at around $2400/year

• Roughly corresponds to 1/3 of cost of medications

Case Study: WellDoc

• MedisafeTM - Leading mobile app for medication management and pill reminders


• Medisafe Inc, Facts: • Formed in 2012. Based in Boston, MA • Free app from App Store/Google Play

• Store / remind user-entered meds • Revenue model based on collecting user data for

marketing • Over 2.2 M downloads, taking 220M meds • Simple BP Study – Reported 20mmHg SBP

reduction • Reportedly declined $25M acquisition offer;

raised $6M • Several important contrasts to mHealthPharma

Case Study: MediSafe

Presenter

Presentation Notes

FDA approval, No biometric data,


Comparison with Selected Products

Patient Reminders

Patient Alerts

Biometric Tracking/ Analytics

Physician Decision-Aids

Clinical Trial

Prescription Therapy

Cost

Scales to Multiple Chronic Diseases

- - -

- - - - - - - 0 - -


Product Development

Product Development Initial

prototype definition

Pilot clinical trial definition

FDA submission

Published Product v1.0

Full-scale clinical trial

Software Development Initial

prototype Pilot trial

ready FDA ready Full-scale ready Version 2.0 work

FDA Documentation Through all phases of definition, design, development,

testing and clinical validation

Clinical Validation Pilot clinical

trial FDA

submission Full-scale

clinical trial

Patent Protection Prepared and Submitted Patent Application Patent Issued

Completed To Be Completed In Progress

Pre-Submission Completed

• Current Team • 3 Co-Founders; 1 Independent Board Member • 4 Senior Software Engineers; 1 Graphic/UI Designer • 1 Highly Experienced FDA Specialist • External Mobile Development Vendor (Tooltwist)

• 4 Mobile Developers with medical app experience

• Working towards starting Pilot Clinical Trial in Q3 2016 • Developed initial prototype – mobile and web • Filed patent application - USPTO patent-pending • Gained initial traction with FDA (510(k) pre-submission) • Organizing pilot clinical trial protocol / logistics


Team and Progress Update

PHASE 2 Series A Round: $6M-10M. • Publish free App for download • Conduct full scale Clinical Trial • Publish and promote Clinical Trial results • Grow Marketing and Sales teams with expertise to sell product to the doctors/healthcare providers • Launch marketing campaign across multiple channels • Establish and work towards goals and track progress

for: a. Number of downloads b. Number of regular users c. Number of participating doctors d. Number of paying users – 1K, 10K, 100K, 1M

• Generate revenue. Achieve profitability. • Identify and start building products for other

chronic diseases

PHASE 0 Self-funded. COMPLETED. • Developed working prototype

of the mobile and back- end components

• Filed patent application (USPTO)

• Achieved traction with FDA • Downloadable through the

Apple App Store • Ready to start Pilot

Clinical Trial (30 patients)


PHASE 1 Friends, Family & Angels: $250K-300K • Complete Pilot Clinical Trial • Improve , adjust and tune

product based on results • Implement additional product

functionality • Clear product with FDA • Ready to start full-scale Clinical

Trial. • Recruit sales, marketing and

bus-dev leader with industry experience

• Pursue foreign fillings of the patent (Q4 2016)

• CONTACT INFO

• Steven Orlov - [email protected]

• Alex Berlin - [email protected]

• Leonid Orlov - [email protected]

• General - [email protected]

Thank You!



myHTN:


The first mobile prescription therapy for hypertension

mhealthpharma pitch deck - 2016-06-01

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