Published on October 21, 2013
“…advancing, refining, and improving cardiac surgery.” October, 2013
Disclaimer Statement Certain statements in this presentation are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. Forward-looking statements involve risks and uncertainties which could cause results to differ materially from those projected and are detailed from time to time in our SEC filings, including our annual report on Form 10-K filed on August, 2013 and subsequent periodic reports. We encourage you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release.
Our Founder, Chairman and CEO Manny Villafaña is our founder and the Chairman and CEO of Kips Bay Medical. Mr. Villafaña is globally recognized as a “Living Legend of Medicine”, an award-winning USA Master Entrepreneur, a member of the Minnesota Business and Science & Technology Halls of Fame and the past founder of medical device companies that have transformed the industry of cardiac surgery and improved the lives of millions. Co-inventor of the first lithium powered pacemaker and founder of Cardiac Pacemakers, Inc./Guidant. All pacemakers now incorporate this technology. 1 Co-developer of the St. Jude heart valve and founder of St. Jude Medical, Inc. This is the most commonly used prosthesis in the world. Co-inventor of the ATS heart valve and founder of ATS Medical, Inc. (now part of Medtronic, Inc.) Founder of Kips Bay Medical, Inc. Page 3
A Long History of Value Creation $27.2 Billion $15.4 Billion Market Cap $400 Million Page 4
Coronary Artery Bypass Grafting (CABG) What is CABG? Coronary Artery Bypass Grafting involves the construction of an alternative path to bypass a narrowed or occluded coronary artery and restore blood flow from the aorta to an area past the occlusion. Page 5
Coronary Artery Bypass Grafts Vein Grafts Don’t Last as Long as Arterial Grafts G r a f t Internal Mammary Artery P a t e n c y Saphenous Vein Synthetic Graft Implant Years 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Page 6
What We Do eSVS® Mesh = external saphenous vein support The eSVS Mesh is a kink-resistant, extravascular prosthesis made of knitted nitinol (nickel/titanium alloy) wire and is designed to give an implanted vein the physiological attributes of an artery. Page 7
CABG - Standard of Care for Multi Vessel Disease Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery, or “SYNTAX”, study Published in the New England Journal of Medicine March 2009 Evaluated long-term patient outcomes based upon survival rate and need for re-intervention 12 months after surgery Concluded CABG is the more effective long-term treatment for coronary artery disease January 2008 study compared drug-eluting stents with CABG in multi-vessel coronary disease New York study as Published in the New England Journal of Medicine Determined death rates and revascularization rates were higher in patients receiving drugeluting stents than in patients receiving CABG CABG was superior in spite of patients receiving CABG being older and having more severe coronary disease Practice Guidelines Recommend Bypass Surgery for Triple Vessel and Left Main Disease American Heart Association journal Circulation 2009 CABG is the only appropriate method of coronary revascularization for patients with triple vessel disease or left main disease Page 8
Annual World-Wide Market CABG Procedures: 800,000 annually with 3.5 Grafts per Procedure of which 2.5 Grafts per Procedure are Saphenous = 2.0 Million Potential eSVS MESH Grafts Annually Wholesale ASP @ $1,200 per unit Retail ASP @ $2,500 per unit 70%+ margin potential Page 9
FDA Clinical Progress of the eSVS Mesh • International Feasibility Trial – CE Mark Approval – May 2010 Created significant questions for the FDA We answered questions and concerns with follow-up angio’s from first International Trials • Dubai, UAE – single center experience • Germany, Italy, Spain, Switzerland – multiple center experience • 5th of February! First USA Implant for feasibility trial for U.S. FDA. Texas Heart, Mayo Clinic, Emory Heart, N.E. Georgia have now enrolled patients. 10 Page 10
Dubai, UAE Retrospective Study • Dr. Uwe Klima, Professor, MD - American Hospital Dubai • Retrospective implant study with prospective follow-up of commercially implanted eSVS Mesh • All eligible SVGs treated with eSVS Mesh • Patients underwent follow-up CT angiography 7-12 months post implant • Approx. 40 eSVS Mesh devices implanted Patency Rates at 7-12 months 100% 90% 93.3% 86.3% 80% 70% 60% Klima Study Patients International Control Group Page 11
eMESH I Trial Sites • OUS Sites – – – – – – – – University Hospital Bern, Switzerland - Dr. Lars Englberger (International PI) Bordeaux University Hospital, Pessac, France - Prof. Louis Labrousse C.H.U. Dupuytren, Limoges, France - Dr. Marc Laskar G. Pasquinucci Heart Hospital, Massa, Italy - Dr. Mattia Glauber Brothers of Mercy Hospital, Trier, Germany – Prof. Ivar Friedrich University Hospital, Munster, Germany – Prof. Sven Martens University of Freiburg, Germany - Dr. Matthias Siepe 8th site tbd • Potential US Sites (include 4 US hospitals – – – – – – – - first four to receive approval) Cleveland Clinic, Cleveland, OH - Dr. Joseph Sabik Mayo Clinic, Rochester, MN – Dr. Hartzell Schaff Texas Heart Institute, Houston, TX – Dr. Billy Cohn Emory University Hospital, Atlanta, GA - Dr. John Puskas (USA PI) Lenox Hill Hospital, New York, NY – Dr. Gregory Fontana Beth Israel Medical Center, New York, NY – Dr. Robert Tranbaugh NE Georgia Health System, Gainsville, GA – Dr. Alan Wolfe Page 12
“eMESH I” Clinical Feasibility Trial A multi-center, randomized study designed to demonstrate feasibility, initial safety and performance of the eSVS Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass: • Prospective, randomized study of up to 120 patients. • 8 investigational sites in Europe and 4* in the U.S. • FDA requires 25 implants for each size (3.5mm, 4.0mm and 4.5mm) with a minimum of 80 total patients. • Primary safety endpoint is the rate of major adverse coronary events (MACE) within 30 days of the procedure. • Primary efficacy endpoint is the Angiographic patency rate at six months (<75% stenosis). • Post study – annual telephone follow-ups for five years. * Staged enrollment in the U.S. – FDA requiring early review of results from 10 U.S./O.U.S. patients prior to allowing full U.S. enrollment. Currently approved for 15 patients in the U.S. Page 13
International Marketing Strategy Independent distributor model We require distributor to have an established client base in cardiac surgery All contracts in US dollars Mr. Villafaña has established commercially successful independent distributor networks in past companies: Cardiac Pacemakers, Inc./Guidant Corporation St. Jude Medical, Inc. ATS Medical, Inc. Early phase of commercial sales with approximately $250K in annual sales in 6 countries Page 14
Solid Intellectual Property Position Our issued patents and pending patent applications include claims directed towards: • • • • • resilient and compliant structure. providing structural support which inhibits vessel expansion. providing a graft with physiological attributes similar to those of an artery. methods critical to the surgical procedure. delivery system design and implant deployment method. 5 issued patents and 2 applications pending in the US 6 issued international patents and 6 applications pending • includes 1 patent from the European Patent Office which has been registered and validated in 8 countries. Page 16
Platform for the Future Synthetic Grafts for CABG CABG Surgery Knitted Nitinol Technology Peripheral Bypass Surgery Dialysis Access Grafts Page 17
Capitalization June, 2013 Debt --- 0.00% Common Stock ($0.01 par value, 40M authorized) Outstanding today 26,979,079 93.13% Granted & Outstanding (WA exercise price $3.11) 1,387,500 4.79% Total Option Pool 1,387,500 4.79% Option Pool: Underwriters’ Options Total Common and Potential Options 603,125* 28,969,704 2.08% 100.00% Page 18
Investment Highlights New medical technology in a company founded by Manny Villafaña. CE Mark approval & over 500+ implants to date – early indication of device success. Experienced management team with history of success. eSVS MESH technology to address limitations in CABG surgery with world-wide potential for 2.0 million eSVS Mesh grafts annually. Very low (venture capital level) market capitalization. Feasibility trial for U.S. FDA is in process. Platform technology; ideal growth opportunity for strategic partner. Strong IP position with 14 patents covering core device technology & design issued in 12 countries. Clean & efficient capital structure: - Low cash burn rate. - No debt / No preferred stock. Page 19
“…advancing, refining, and improving cardiac surgery.” Thank You!
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