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Faster, Safer, and Easier Vascular Anastomosis www.medvantageintl.com 515 East Las Olas Blvd. Suite 120 Fort Lauderdale, FL 33301
Table of Contents
Vascular Anastomosis Market Clinical Needs Cuvaslar Benefits Customer / Industry Information Competition Cuvaslar Technology Milestones Accomplished Regulatory Strategy Financials Tactics for Future Growth Leadership Team Information Investment Overview Summary
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Clinical Needs
Vascular anastomosis is typically performed by hand suturing (stitching), which has several issues/risks:
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.
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Cuvaslar Benefits
Requires 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.
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US Customer Segments
Cuvaslars 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.
Reconstructive Surgery 5.6 million 1% Vascular Surgery Transplant Surgery 340 thousand 3-4% (estimate) 2012 Surgeries (US Only) Annual Growth 30 thousand (estimate) Varies by year
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Vascular 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.
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Competition
There is only one device currently available in the US that facilitates vascular anastomosis. The GEM Microvascular Anastomotic Coupler, by Synovis.
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Cuvaslar is a Faster, Easier and Better Coupler For the Same Price
GEM-Synovis
Usable only for veins 3 - 8 minutes Does not easily accomodate different sized vessels 1.0mm - 4.0mm
Versatility
Usable for veins & arteries 2 - 3 minutes Easily accomodates different sized vessels 1.0mm - 7.0 mm
Procedure time
Vessel Matching Coupler Sizes
Cost
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Cuvaslar Coupler
Milestones Accomplished
Prototypes Developed Proof of Concept and Feasibility Completed Patents Filed in US and EU Technology Acquired From University of Utah
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Regulatory Strategy
Goal-Obtain Approval within 12 Months of Capitalization
JanuaryMay
Complete final product design/ performance testing
May July
FDA 510(k) presubmission and response
September
December
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Financials
5-Year Annual P&L Overview
Year Revenue COGS Gross Profit Gross Margin % Total Operating Costs EBITDA* 1 $0 $0 $0 N/A $500,000 ($500,000) 2 $1,158,750 $509,850 $648,900 56% $1,037,500 ($388,600) 3 $3,313,659 $1,458,010 $1,855,649 56% $1,543,276 $312,373 4 $7,066,592 $3,250,632 $3,815,960 54% $2,560,324 $1,255,636 5 $16,951,020 $7,966,980 $8,984,041 53% $5,516,238 $3,467,803 CAGR 145% 150% 140% 82% 233%
Assumptions: US Revenue begins Year 2 after FDA approval Canada 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 fees Year 6 Revenue = $23,887,485, Year 6 EBITDA = $3,887,524 *EBITDA CAGR calculation is based on Year 3 to Year 5 numbers only
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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, CRADAs 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).
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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.
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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.
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Investment Overview
Management 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 expenses
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CUVASLAR
Faster, Safer, and Easier Vascular Anastomosis: Fastest Coupler Device Easy to Use Shorter Healing Time Reduces Risk of Thrombosis, Leakage and Collapse Matches Arteries & Veins of Different Sizes Significantly Less Training Required Compared to Suturing
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