Investor Presentation
October 2014
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause VYCOR MEDICAL's actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in VYCOR'S SEC filings. All forward-looking statements attributable to VYCOR herein are expressly qualified in their entirety by the abovementioned cautionary statement. VYCOR disclaims any obligation to update forward-looking statements contained in this estimate , except as may be required by law. The recipient acknowledges that Vycor Medical, Inc. is a publicly traded company. Recipient acknowledges that any confidential information constituting material nonpublic information that Vycor Medical, Inc. provides to the recipient is being provided to the recipient in reliance upon the agreement that the information will remain confidential. By accepting this material, the recipient acknowledges that it is aware of the applicable requirements of the federal securities laws relating to material non-public information and trading in securities of Vycor Medical, Inc.
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ViewSite NovaVision
Lead product is its ViewSite Brain Access System (VBAS) which is a revolutionary neurosurgical device used to gain access to a target within the brain e.g. Tumor
VBAS parts the brain tissue (retraction) and creates a working channel
Leader in the field of vision rehabilitation for neurological brain damage e.g. Stroke
Vision Restoration Therapy (VRT) NovaVision’s lead product , is the only FDA cleared medical device for the restoration of lost vision. It is a light based therapy done on a computer
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“It is the ideal system for providing deep brain access through a smaller incision.”
-Neurosurgeon Quote
Old Blade/Ribbon Retractor Technology
✘ Creates pressure on brain tissue
✘ Requires surgeon to “pull” tissue more than is safe; target shifting
✘ Limited visualization
✘ Requires larger corticotomy
✘ 5-10% reported injury rate with blade
VBAS Next Generation Technology
Evenly disperses and reduces pressure
More accurate target access, no target shifting
Superior field of view, clear working channel
Less invasive: requires smaller opening
IGS and inter-operative MRI compatible
No reported injuries with VBAS
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Hospital Acceptance
• Approved for use in approx 170 US hospitals
• Marquee names
– Johns Hopkins Hospital
– New York Presbyterian University Hospital of Columbia and Weill Cornell Medical College
– NYU Langone Medical Center
– Hospital of the University of Pennsylvania
– Stanford Hospital and Clinic
VBAS Adoption is Accelerating6
• Journal of Neurosurgery: pediatrics paper by Pablos Recinos, Cleveland Clinic, and George Gallo, Johns Hopkins
• Minimally Invasive Neurosurgery paper by A. Quinones Hinojosa et al, Johns Hopkins
• Two papers by Daniel Prevedello, Ohio State University Hospital
• Surgical Technology International paper by Konstantin V. Slavin, Univ of Illinois at Chicago
• 3D Endoscopic papers by Antonio Bernardo et al, Weill Cornell Medical Center
Clinical Studies
Significant New Clinical Data Anticipated7
“Her case would have been inoperable via a traditional surgery,because she was taking Avastin®, which delays surgical wound healing.The VBAS’ minimally invasive nature enabled the surgeon to gainaccess to the target through only a 3cm incision. The patient wasdischarged uneventfully and there were no issues regarding herwound” – Daniel Prevedello, MD, Director of the Minimally InvasiveCranial Surgery Program at the Ohio State University
“We would not have attempted this without this technology. It’s veryexciting” – Bullet fragment removal: Narayan Sundaresan, MD. ChiefNeurosurgeon, Lincoln Hospital and Prof. At Mt, Sinai, NYC
Previously Inoperable…Now Operable
Product Has Been Used in Previously Inoperable Procedures - Thus Saving Lives 8
Surgeon Discussions Indicate that VBAS Offers Large Savings for Hospitals:
Surgeon feedback indicates that VBAS can reduce the operating time by 30-60 minutes per procedure +
Shorten discharge times by around a day +
Reduced use of consumables during Operation
= Savings of Thousands of Dollars Per Procedure
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US Market Penetration
Greater Clinical and Scientific Data
New Product Development
Increased Focus on International Expansion
Management’s 4 Pronged Strategy to Drive Revenue and Shareholder Value
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Drive US Market Penetration:
• Well defined target market of 3,500 neurosurgeons being aggressively marketed to directly with clinical data
• Strengthening distributor network
• Broaden the products usage beyond “deep and difficult procedures”
• Focus on key teaching hospitals
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Continue to Get Clinical Data Supporting the Products Superiority:
• Increase number of peer reviewed papers supporting products superiority
• Develop hard clinical data supporting cost benefit and reduced white matter damage versus incumbent “blade retractors”
• Address surgeon pigeon holing of the product by developing clinical evidence as to the products broader applicability
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Strong New Product Pipeline to Drive Adoption and Enable GreaterApplicability:
• Two smaller VBAS devices
• New IGS compatible devices
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IGS Design IGS Prototype
Greater Focus on International Markets
• Systematic focus on International Markets
• Target countries where it has patent protection and/or clear regulatory path
• Utilize distributors with experience in neurosurgical devices
• Vycor has full regulatory approvals in Australia, Canada, China, Europe, Korea and Japan and is seeking or has partial regulatory approvals in Brazil, India, Korea, Russia, Taiwan and Vietnam
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USA Europe Rest of World Total
Currently addressable procedures (000s)
198 237 579 1,014
Current VBAS market potential $118m $89m $218m $424m
Additional procedures addressable with future product extensions (000s)
128 154 377 660
Total VBAS potential including future product extensions
$194m $147m $359m $700m
*Based on study of industry reports and internal company estimates
• VBAS is Both an Access System and Retractor, So No Direct Competition
• Retractors: Cardinal Health (V.Mueller), Aesculap, Integra, Codman (J&J) 15
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Therapies Address Patients with Visual Field Deficits Resulting from Stroke, Brain Injury or Other Neurological Trauma
Visible object
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• 8 million Stroke survivors in US. 480,000+ new stroke survivors a year
• 28% of Stroke victims suffer from visual disorders
• 20% experience permanent visual field deficits
Significant Target Market Estimated Globally at > $13bn, US Alone ~ $2bn
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Compensation Restoration
• Prisms
• Saccadic Training
• VRT
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Prisms Traditional Saccadic
• Tries to project blind area into seeing field
• Complaints of double vision/headaches
• Reported low compliance
• Effective in retraining patients ability to
make the most of their remaining vision
• Meaningful improvement in visual search
• Capital good, requiring physician involvement
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Visual cortex
• Retina receivesstimulation and relays itto visual cortex throughvisual pathways
• NovaVision’s VRTis a light basedstimulation therapy forStroke and Brain Trauma
• VRT is delivered on acustomized medical device/computer
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VRT Permanently Reduces Visual Field DeficitsPre-VRT Post-VRT
• Over 70% success rate• Improvement within the central field of vision is vital to
activities of daily living • Results are permanent• Time since injury does not matter• Results are not age or gender dependent
Pre-VRT Post-VRT
“My vision began coming back after the first month of therapy…I passed my driving test, can read normally, and enjoy driving my boat on the lake…my life is back to
normal.” – Stroke survivor and VRT patient
Illustration of the Impact of the Improvement in a Patient’s Visual Field and Consequently on their Ability to Get Around Unassisted
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- Each 1mm² of a nerve bundle carries up to 1 million nerve fibers
- Brain injury often affects an extensive network of connectivity
- Some networks in the brain are duplicated and some are not
- Improvements are probably related to “extensive redundancy” of
connectivity enabling usage of alternative routes following systematic stimulation
- fMRI shows increased activity when stimulated by VRT
Exact Mechanism is Not Known:
Vision Loss from Stroke and TBI is a Big Unaddressed Issue
Visual Field Deficit is a Major Inhibitor to Daily Living25
• The current pillar therapy areas are:
– Speech
– Physical
– Occupational
• NovaVision focuses on the critical missing therapy
Occu
patio
nal
Key Therapies
Vis
ion
• VRT is the only FDA cleared therapy (510k) for restoration of vision loss from neurological damage
• 20 clinical studies/papers showing approximately 70% of patients benefit
• Substantial IP portfolio: currently 33 granted/issued,
5 pending
• No clinically supported alternative
• No other real competitors – Sight Science was the largest and was purchased in 2012
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• Introduced new complementary therapy so that all patients will have increased benefit from expanded NovaVision therapy regime
• Significantly reduce the cost of delivery – hardware, patient handling, business processing – to make it affordable (~$900)
• Create a truly scalable business model to deliver NovaVision’s therapies to the mass market
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• Developed by Prof. Josef Zihl – Scientific Advisory Board member and recognized world leader in compensatory techniques
• Supported by four decades of scientific work and clinical data
• Increases the efficiency of a patient’s eye movement and re-train the patients’ ability to make the most of their remaining vision
• Achieves significant improvement in visual search performance and reduction in visual disability
• Designed to have a real positive impact on activities of daily living
• Highly complementary to VRT, and will be provided in combination
• Also substantial standalone market – US >$400M1 and Worldwide >$2.5BN1
1. Based on study of industry reports and internal company estimates 28
• Introducing new complementary therapy so that 100% of patients will have increased benefit from combined NovaVision therapy regime
• Significantly reduce the cost of delivery – hardware, patient handling, business processing – to make it affordable (~$900)
• Create a truly scalable business model to deliver NovaVision’s therapies to the mass market
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• Hardware based delivery mechanism
Today Tomorrow
• Heavy clinical involvement (monthly adjustment) and patient handling
• Manual business process costs
• Approx 70% of patients benefit from VRT, 30% show little/no improvement
• $2,900 for 6 months therapy VRT, $500 refundable deposit for device
• Internet delivered onto patients’ own computers
• Self-adaptive, reduces clinical and patient handling time
• Automated business processes
• VRT and NeuroEyeCoach; restitution combined with compensation to give 100% of patients increased benefit
• ~$900 for 6 months for VRT and NeuroEyeCoach combined
Lower Cost of Delivery + Lower Cost to Patient + Increased Benefit to Patient + 100% of Patients Benefit = Scalable Model for the Mass Market
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NovaVision Nearing Completion of its Development Plan Largely Removing Execution Risk:
• Web deliverable VRT development work will be completed by the end of 2014
• New complementary therapy NeuroEyeCoach™ recently launched which will add further benefits to all patients
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• Most Stroke patients visit a rehabilitation center at some point in time
• NovaVision will supply rehabilitation centers, be it in-patient or
out-patient, with the diagnostic component of VRT
• Potential revenue from licensing and installation of devices
• Rehabilitation center will then refer eligible patients for VRT to NovaVision
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NovaVision is Currently Exploring a New Rehabilitation Center Model:
• Operates through two distinct businesses
• Devices are FDA-cleared and revenue generating
• Limited competition
• Products are “game changers” with growing acceptance
• Address significant well identified markets. NovaVision globally > $13bn, US ~ $2bn. VBAS globally ~ $700m with product extensions
• 42 granted and 13 pending patents
• Significant published clinical data underpinning technologies
• Established international footprint
• Strong new product pipeline
• World class Scientific Advisory Team
http://player.vimeo.com/video/3990319933
Publicly Traded on OTCQB, VYCO
Current share price (10/23/14) $2.19
Shares Ent. Value (1)
Common 10.7m $21.0m
Common and Preferred 11.9m $23.4m
Fully diluted (for options and warrants) 17.8m $27.2m
Cash Balance 6/30/14 $2.8m
Operating Cash Burn Q1-2 2014 (2) $737k
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(1) Enterprise Value is market cap less cash net of debt; fully diluted enterprise value adjusts for warrant exercise proceeds(2) Non-GAAP operating loss for 6 months to June 30, 2014, before: amortization of acquired IP; stock compensation; offering costs
Peter Zachariou - Chief Executive Officer
David Cantor- President
Management
Corporate Headquarters6401 Congress Avenue Suite 140Boca Raton, FL. 33487
Our Websites
www.vycormedical.com
www.vycorvbas.com
www.novavision.com
www.novavisionvrt.com
www.neuroeyecoach.com
www.sightscience.com
German OfficeKlausenerstr. 12 39112 Magdeburg, Germany
UK OfficeLife Science Innovation Building Cornhill Road Foresterhill, Aberdeen AB24 3FX,Scotland, UK
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Supplemental Group Information
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Name Title Experience
Peter
Zachariou
CEO &
Director
Extensive operating experience over range of manufacturing businesses
Active investor in variety of companies and industries, both public and private,
specializing in capital formation/raising and development companies
David
CantorPresident
22 years experience of Investing in, raising money for and providing strategic advice to
growth companies across a broad range of sectors
Investment Banking (Citigroup, Donaldson, Lufkin & Jenrette, Lehman Brothers)
Adrian
Liddell
Chairman
and CFO
Over 30 years of strategic, corporate and financial advisory and company investment
Private equity (Phoenix Equity Partners); Investment Banking (Citigroup, Donaldson,
Lufkin & Jenrette, Lehman Brothers)
Chartered Accountant
Steven
GirgentiDirector
Pharmaceutical and healthcare executive with 45 years experience
Managing partner of Medi-Pharm consulting, providing strategic advice to healthcare
companies
Former President and CEO of DermWorx and former Chairman of Ogilvy Healthworld
Lowell
RushDirector
CEO of Direct Incite, Inc.
Former COO of Cosmetic Dermatology Inc.,CFO of Bijoux Terner and Little Switzerland,
and has held operational and financial roles at SunGlasses Hut, Burger King and Knight-
Ridder. CPA and MBA
Dr. Oscar
BronstherDirector
Clinical professor at George Washington Univ. and Director of Transplant Services at Kaiser Permanente Medical Group. Previously Associate Prof. at Univ of Rochester, Univ of
Pittsburg and Univ. of California San Diego
Pascale
MangiardiDirector President of Rougemont Management Services 37
Name Experience and Affiliations
Dr David Langer
Vycor
Director of Cerebrovascular Neurosurgery at St. Luke’s-Roosevelt, Beth-Israel and Long
Island College Hospitals (New York, NY)
Dr Konstantin Slavin
Vycor
University of Illinois at Chicago (Chicago, IL); Alexian Neuroscience Center (Elk Grove
Village, IL); Director of Illinois Gamma Knife Center
Dr Ezriel Kornel
Vycor
Director, Institute for Neurosciences at Northern Westchester Hospital Center (Mount
Kisco, NY); President-elect New York State Neurosurgical Society; Board of Directors,
Medical Liability Mutual Insurance; Director for Center Neurochiropractic Education
Prof. Arash Sahraie
NovaVision
Professor, Chair in Vision Sciences at Univ. of Aberdeen (UK); PhD in Optics and Visual
Science, City Univ. (London, UK); Founder of Sight Science Ltd
Alvaro Pascale-Leone,
MD/PhD
NovaVision
Professor of Neurology at Harvard Medical School; Director of Research, Cognitive
Neurology Unit, Beth Israel Deaconess Medical Center; MD/PhD Neurophysiology, Albert-
Ludwigs Univ (Germany); Former Medical Fellow National Institute of Health; Author 450+
Scientific papers as well as several books
Jason S. Barton, MD
NovaVision Professor of Neurology, Ophthalmology and Visual Sciences, University of British Columbia
Joseph Zihl, MD
NovaVision
Professor of Neuropsychology at Department of Psychology, Univ. of Munich (Germany),
Head of Neuropsychology Research Group at the Max Planck Institute of Psychology
Jose Romano, MD
NovaVision
Chief of Stroke Division and Professor of Neurology at the University of Miami Miller School of Medicine
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