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CUVASLARInvestment Opportunity Faster, Safer, and Easier Vascular Anastomosiswww.medvantageintl.com515 East Las Olas Blvd. Suite 120Fort Lauderdale, FL 33301
Table of Contents Page(s)Vascular Anastomosis Market 3 Clinical Needs 4 Cuvaslar Benefits 5 Customer / Industry Information 6-7 Competition 8-9 Cuvaslar Technology 10-11 Milestones Accomplished 12 Regulatory Strategy 13 Financials 14 Tactics for Future Growth 15 Leadership Team Information 16-19 Investment Overview 20 Summary 21Page 2
Vascular Anastomosis MarketCurrent Hand-Suturing TreatmentPage 3Vascular anastomosis (the reconnection of blood vessels) is a critical part of microvascular, hand, vascular and transplant surgery procedures. It is estimated that 370,000 vascular anastomosis operations are performed in the US each year with a market size of $75 million.
Slow and time-consuming, taking 12-20 minutes per anastomosis.Technically demanding with a high risk of surgeon error.Suturing is more likely to result in vessel thrombosis, leakage or collapse. No existing device facilitates the vascular anastomosis of both arteries and veins.Page 4Clinical NeedsVascular anastomosis is typically performed by hand suturing (stitching), which has several issues/risks:
Cuvaslar BenefitsRequires 83-85% less surgical time (2-3 minutes) than suturing (12-20 minutes) per anastomosis.Easy to use device that can be used for arteries and veins of different sizes for repair or connection. Minimizes human error and surgeon fatigue associated with manual suturing.Significantly reduces the amount of specialized training required to complete microvascular repair.Reduces the risk of thrombosis and thrombosis-related tissue or limb loss complications that are common with suturing.Reduces the risk of leakage and collapse that occur with suturing.Page 5
US Customer SegmentsCuvaslar’s primary customers will be hospitals and specialized surgical centers, and the users will be surgeons. There are over 5,800 general medical and surgical hospitals in the U.S. Listed below are the most likely surgeries to use Cuvaslar in the US.Page 6
US Vascular Surgery Industry TrendsVascular procedures are increasing due to the aging population in the US.Vascular procedures involving vascular anastomosis is estimated to be 23% of total vascular surgery. Note that the European Union and Canada are our next target markets.Annual Procedures (Millions)Page 7
There is only one device currently available in the US that facilitates vascular anastomosis. The GEM Microvascular Anastomotic Coupler, by Synovis.CompetitionPage 8
Synovis / Cuvaslar Comparison:Cuvaslar is a Faster, Easier and Better Coupler For the Same PricePage 9
Cuvaslar: The Solution to Hand SuturingPatent-pending in the US and EUPage 10
Cuvaslar CouplerRanging from 1 to 7mmPage 11Full working prototypes have been developed and tested.
Milestones AccomplishedPrototypes DevelopedProof of Concept and Feasibility CompletedPatents Filed in US and EUTechnology Acquired From University of UtahPage 12
Regulatory StrategyPage 13Complete finalproduct design/performance testingFDA 510(k)presubmissionand responseFDA 510(k)submissionFDA 510(k)approvalFilings begin withEU and Canada Goal-Obtain Approval within 12 Months of Capitalization
FinancialsPage 14Assumptions:US Revenue begins Year 2 after FDA approvalCanada Revenue begins Year 3 (12 months after the US)EU Revenue begins in Year 4 (18 months after the US)COGS increase due to higher international feesYear 6 Revenue = $23,887,485, Year 6 EBITDA = $3,887,524*EBITDA CAGR calculation is based on Year 3 to Year 5 numbers only
Future Milestones For GrowthObtain FDA 510(k) approvalDeploy and expand manufacturingWork with Health Canada to obtain approval to sellWork with Notified Bodies in the European Union to obtain “CE Mark” (approval to sell)Develop and launch marketing to key customersin the US, Canada and European UnionDevelop a network of independent distributors globallyExpand the product portfolio by Year 4Page 15
Page 16Medvantage Leadership TeamCEO: Tzvi Milshtein, P.E.Tzvi Milshtein is a technology and marketing executive with a strong R&D, Computer Science and Information Technology background. He has outstanding research and problem-solving skills and strong orientation to customer satisfaction. Mr. Milshtein holds an engineering degree from the Technion Institute, is a Professional Engineer, and has worked over the last 25 years in product development, structural and design engineering, management, prototype development, and product and technology. He is a founder and owner of Nunka Corp., an FDA approved medical device for pain management and an owner/developer of Apollo Devices, a company that develops non-invasive neuromodulation devices.
Page 17Medvantage Leadership TeamChairman: Corey ParkMr. Park is a Certified Hedge Fund Professional (CHP), with additional (CHP) certifications at the highest level in Portfolio Analytics & Risk Management. He also attended the Notre Dame Mendoza College of Business (Leadership & Management) and has served in executive leadership positions for over 20 years. Mr. Park has taken companies he founded public, closed several acquisitions and multimillion dollar lines of credit from hedge funds; as well as negotiated and / or closed many mergers, strategic partnerships, license agreements, CRADA’s and joint ventures. As a lifelong student of business strategy, he has read, studied and applied numerous books and countless articles relating to business strategy (According to the Wall Street Journal, the most sought after executive skill set is strategic thinking).
Page 18Medvantage Leadership TeamInventor: Jay Argawal, MDJay Agarwal, MD, is an assistant professor in the Department of Surgery, Division of Plastic Surgery, at the University of Utah School of Medicine and a Huntsman Cancer Institute investigator.His clinical interests include aesthetic plastic surgery, hand surgery, and reconstructive microsurgery with a focus on reconstruction of traumatic injuries and defects caused by cancer. He emphasizes using perforator flaps, a cutting-edge technique that uses the patient's own tissues to reconstruct the breast, head and neck, and extremities.Agarwal graduated from medical school at Case Western Reserve University in Cleveland, Ohio, and completed residency training in both general surgery and plastic surgery at the University of Chicago. After six years in Chicago, he went on to specialize in hand surgery and microvascular surgery at the Buncke Clinic in San Francisco.
Page 19Larry Fan, MD is dedicated to the development of innovative medical technologies for patient care. Dr. Fan has served as an executive, board member, investigator, consultant, or active investor to numerous healthcare companies including Johnson & Johnson, Allergan, Ethicon Endo-Surgery, Miramar Labs, Exploramed, and The Foundry. He is also a well-known plastic surgeon.Dr. Fan has an AB and AM in Biology with a minor in engineering from Harvard University, where he graduated magna cum laude with highest honors. Dr. Fan also has an MD from the University of California at San Francisco and completed his residency in general and plastic surgery at UCSF. He also completed a fellowship in the Biodesign program at Stanford University. Dr. Fan previously held the position of Research Scientist at UCSF. He has authored 21 peer reviewed papers and abstracts and has been an invited speaker at leading medical conferences throughout the world. Dr. Fan is a Member of the American Society of Plastic Surgeons and Founding Director of 77 Plastic Surgery.Dr. Fan has been voted one of Americas Top Plastic Surgeons for the past 5 years by the Consumers Research Council of America. He is also an accomplished scientist and has received several national awards for his research in Plastic Surgery. He has been a speaker at the American Society of Plastic Surgeons and the American College of Surgeons. Dr. Fan has been featured on national media outlets such as NBC, ABC, and Us Weekly. Medvantage Leadership TeamChief Medical Officer: Dr. Larry Fan
Investment OverviewManagement is seeking $1 million in capital.These funds will be used for:- Completion of Cuvaslar development- FDA, EU & Canada approval process expenses- Initial costs for manufacturing and distribution, including ISO certification expensesPage 20
CUVASLAR Faster, Safer, and Easier Vascular Anastomosis: Fastest Coupler DeviceEasy to UseShorter Healing TimeReduces Risk of Thrombosis, Leakage and CollapseMatches Arteries & Veins of Different SizesSignificantly Less Training Required Compared to SuturingPage 21