Вы находитесь на странице: 1из 21

CUVASLAR

Investment Opportunity
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
Page 2

Page(s) 3 4 5 6-7 8-9 10-11 12 13 14 15 16-19 20 21

Vascular Anastomosis Market


Vascular 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.

Current Hand-Suturing Treatment


Page 3

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.
Page 4

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.
Page 5

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

Page 6

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.
Page 7

Annual Procedures (Millions)

US Vascular Surgery Industry Trends

Competition
There is only one device currently available in the US that facilitates vascular anastomosis. The GEM Microvascular Anastomotic Coupler, by Synovis.
Page 8

Cuvaslar is a Faster, Easier and Better Coupler For the Same Price

Synovis / Cuvaslar Comparison:


Cuvaslar

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

$100 per use (wholesale)

$100 per use (wholesale)

Page 9

Cuvaslar: The Solution to Hand Suturing


Patent-pending in the US and EU

Page 10

Cuvaslar Coupler

Ranging from 1 to 7mm

Full working prototypes have been developed and tested.


Page 11

Milestones Accomplished
Prototypes Developed Proof of Concept and Feasibility Completed Patents Filed in US and EU Technology Acquired From University of Utah

Page 12

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

FDA 510(k) submission

FDA 510(k) approval


Filings begin with EU and Canada

Page 13

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
Page 14

Future Milestones For Growth


Obtain FDA 510(k) approval Deploy and expand manufacturing Work with Health Canada to obtain approval to sell Work with Notified Bodies in the European Union to obtain CE Mark (approval to sell) Develop and launch marketing to key customers in the US, Canada and European Union Develop a network of independent distributors globally Expand the product portfolio by Year 4
Page 15

Medvantage Leadership Team CEO: 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 problemsolving 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 16

Medvantage Leadership Team Chairman: Corey Park


Mr. 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, 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).
Page 17

Medvantage Leadership Team Inventor: Jay Argawal, MD


Jay 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 18

Medvantage Leadership Team Chief Medical Officer: Dr. Larry Fan


Larry 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.
Page 19

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

Page 20

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
Page 21

Вам также может понравиться