investor presentation - vycor medical · 2015. 1. 9. · construed to be forward-looking statements...
TRANSCRIPT
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Investor Presentation
December 2014
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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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• Two distinct businesses – both with “game changing” products
• Devices are FDA-cleared, development risk now off the table
• Address significant markets – NovaVision ~$4bn in the US/Europe, up to ~$13bn globally – Vycor $700m globally
• Limited competition – NovaVision VRT only FDA cleared therapy targeted at vision loss from neurological brain damage such as stroke
• Significant barriers to entry:
Robust patent portfolio; 42 granted and 13 pending patents
Significant published clinical data underpinning technologies
Established international footprint
Strong new product pipeline
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ViewSite NovaVision
Lead product ViewSite Brain Access System (VBAS) 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. Suite of complementary therapies: • Vision Restoration Therapy (VRT)
targeted at restoration of lost vision • NeuroEyeCoach re-trains scanning and
makes the best of remaining vision
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Has a Suite of Complementary 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 Est. US/Europe $4bn, Globally up to $13bn
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Vision Loss from Stroke and TBI is a Big Unaddressed Issue
Visual Field Deficit is a Major Inhibitor to Daily Living 8
• The current pillar therapy areas are:
– Speech
– Physical
– Occupational
• NovaVision focuses on the critical missing therapy
Occu
patio
nal
Key Therapies
Vis
ion
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• VRT is the only FDA cleared therapy (510k) for restoration of vision loss from neurological damage
• A light based prescription stimulation therapy – “at home”
• Clinically proven to restore lost vision
• 20 clinical studies/papers approximately 70% of patients benefit
• Substantial IP portfolio: 33 granted/issued, 5 pending
• No clinically supported alternative
• No other real competitors – Sight Science the largest, purchased in 2012
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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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Ensure broad benefit from NovaVision therapies and not only 70% from VRT
Drive down cost of delivery inherent with “hardware centric” business model and processing costs to largely remove pricing barriers
Create a scalable business model capable of addressing the size of the mark
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Prototypes historically delivered on a custom
designed piece of hardware
Development Work Now Complete
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• Broaden benefit to all patients not only 70% provided by VRT through the introduction of new therapy in patients overall therapy regime
• Scientific Advisory Board recommended introduction of saccadic eye training program to complement VRT:
Scientifically supported to benefit patients
Previously only available on a large board requiring direct physician supervision
NeuroEyeCoach developed - First Commercially available computer-based eye movement therapy available at home
Supported by four decades of research and developed by Josef Zihl world leader in the space
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• Significant Physician and Rehab Center interest led to the development of two new Professional NeuroEyeCoach models:
Both programs now complete
Professional Center Program being trialed in largest rehab center in US
NovaVision has already commenced a three-center patient trial for NeuroEyeCoach in Germany, Austria and Italy
Preliminary data being presented at 5th Annual Conference of the DGNR (German Society of Neurological Rehabilitation) in early December
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• Web deliverable VRT development now completed
• Therapy suite of VRT and NEC commercially available first quarter 2015
Broader benefit to patients
Web delivery ensures scalability
Elimination of previously required hardware enables significant reduction in pricing: (~$3,000 today for VRT to approx $900 for both VRT and NeuroEyeCoach)
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• Most Stroke patients visit a rehabilitation center at some point in time
• Diagnostic component already part of VRT
• Rehab center derives financial benefit and improves patient outcomes
• Eligible candidates will then be referred for VRT to NovaVision
• Will also generate revenues from licensing and installation of devices
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NovaVision has received approval from HealthSouth to make available its VRT diagnostic to its 100+ hospital network, following a trial
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“It is the ideal system for providing deep brain access through a smaller incision.”
-Neurosurgeon Quote
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Old Blade/Ribbon Retractor 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. 5-10% reported injury rate with blade
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VBAS Next Generation Technology
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Surgeon Discussions Indicate that VBAS Offers Savings for Hospitals:
Surgeon feedback indicates that VBAS can reduce the operating time
Shorten discharge times
Reduced use of consumables during Operation
= Potential Savings of Thousands of Dollars Per Procedure 18
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“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 gain access to the target through only a 3cm incision. The patient was discharged uneventfully and there were no issues regarding her wound” – Daniel Prevedello, MD, Director of the Minimally Invasive Cranial Surgery Program at the Ohio State University “We would not have attempted this without this technology. It’s very exciting” – Bullet fragment removal: Narayan Sundaresan, MD. Chief Neurosurgeon, Lincoln Hospital and Prof. At Mt, Sinai, NYC
Previously Inoperable…Now Operable
Product Has Been Used in Previously Inoperable Procedures - Thus Saving Lives 19
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Drive US Market Penetration
Increase Focus on International Expansion
Secure More Clinical and Scientific Data
Focus on New Product Development
Management’s 4 Pronged Strategy to Drive Revenue and Shareholder Value
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Progress Year to Date:
• Well defined target market of 3,500 neurosurgeons being aggressively marketed to directly with clinical data
• VBAS continues to gain traction with neurosurgeons: VBAS approved in 23 hospitals year to date bringing total to >170
• Strong pipeline of hospitals going through the approval process
• Strengthening distributor network with 4 new distributors added YTD
• Broadening the product’s usage beyond “deep and difficult procedures” – new “VBAS Brain Atlas” being worked on by Weill Cornell
• Strategic partnerships being evaluated to joint-market and co-sponsor teaching events
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Progress Year to Date:
• Systematic focus on International Markets
• Target countries where it has patent protection and/or clear regulatory path
• Utilize distributors with experience in neurosurgical devices
• Entered into distribution or evaluation agreements with Brazil, France, India, Russia, South Africa, Sri Lanka and Taiwan
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• Strong Support from leading neurosurgeons at Weill Cornell Medical Center:
Submitted two peer reviewed papers using Vycor’s VBAS bringing total to 7 peer reviewed/published studies
Presented their work with the VBAS in Xian China, Prague, Paris and most recently the CNS in Boston
Pipeline of new studies anticipated culminating in a published “VBAS Atlas of the Brain” which should be completed next year
• Ohio State University, Minimally Invasive Cranial Surgery Program Animal Study now complete with publication anticipated next year
Progress Year to Date:
Significant New Clinical Data Anticipated 23
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Progress Year to Date:
• Two smaller VBAS devices now going through manufacturing process in Asia
• Finalization of design and testing on New IGS compatible devices. Co Marketing and Co Promotion Agreement being explored. Broad compatibility strategy being adopted.
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IGS Design IGS Prototype
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Publicly Traded on OTCQB, VYCO
Current share price (11/24/14) $2.18
Shares Ent. Value (1)
Common 10.9m $21.6m
Common and Preferred 12.0m $24.0m
Fully diluted (for options and warrants) 17.9m $27.7m
Cash Balance 9/30/14 $2.5m
Operating Cash Burn Q1-3 2014 (2) $1.1m
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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 9 months Sep 30, 2014, before: amortization of acquired IP; stock compensation; offering costs; losses on
debt exchange and warrant extension
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Peter Zachariou - Chief Executive Officer David Cantor- President
Management Presenting
Corporate Headquarters
6401 Congress Avenue Suite 140 Boca Raton, FL. 33487
www.vycormedical.com
www.vycorvbas.com
www.novavision.com
www.novavisionvrt.com
www.neuroeyecoach.com
www.sightscience.com
German Office
Klausenerstr. 12 39112 Magdeburg, Germany
UK Office
Life Science Innovation Building Cornhill Road Foresterhill, Aberdeen AB24 3FX, Scotland, UK
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Our Websites
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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
Cantor President
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
Girgenti Director
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
Rush Director
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
Bronsther Director
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
Mangiardi Director President of Rougemont Management Services 28
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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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• 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 of Neuroplasticity is Not Known: