Manny Villafaña

Manny is our Founder and the Chairman/CEO of Kips Bay Medical. Manny started his career with Medtronic, Inc. as the company's first international sales administrator. Manny went on to found Cardiac Pacemakers, Inc. (CPI), a CRM company that revolutionized the pacemaker industry by introducing a long life lithium iodine pacemaker, a technology still utilized today by 100% of the market. CPI was ultimately acquired by Eli Lilly & Company, which spun out CPI as Guidant, which in turn was recently acquired by Boston Scientific, Inc. After CPI, Manny founded St. Jude Medical, Inc. Manny led St. Jude Medical's development of a novel heart valve that still dominates the mechanical valve replacement market. Manny has also founded and led the public offering for medical technology companies such as GV Medical, Inc., ATS Medical, Inc. and CABG Medical, Inc. Every year 250,000 Americans receive a life saving medical device developed by Manny

Manny has received numerous awards and honors for his accomplishments, including the "Living Legend of Medicine" award from the International Society of Cardio Thoracic Surgeons; the Ellis Island Medal of Honor; the Grand Prize Recipient - Mediterranean Institute of Cardiology; the Ernst & Young LLP; National Master Entrepreneur of the Year; the Top 100 Hispanics in USA; the Boys and Girls Club of America Hall of Fame; and induction into the Minnesota Business Hall of Fame. Manny, a native of the South Bronx of New York, attended Cardinal Hayes High School, Bronx, New York.

Michael E. Reinhardt

Michael is our Vice President of Sales & Marketing. He has nearly 25 years of experience in the medical device industry. He most recently served as Vice President of Global Marketing for ATS Medical Inc. based in Minneapolis, MN which was focused on cardiac surgery and engaged in the development and commercialization of prosthetic heart valves, valvular repair devices and cryoablation products. ATS Medical was purchased in August, 2010 by Medtronic, Inc. Prior to ATS Medical, Mr. Reinhardt has held several senior management level positions at companies including; St Jude Medical’s Cardiac Surgery Division; C.R. Bard’s Electrophysiology Division; Boston Scientific’s Scimed Division; and Ethicon Endosurgery. He also has considerable International experience having worked extensively in the European and Asian markets. He’s broad spectrum of experiences ranges from working in the fields of general surgery, laparoscopic surgery, interventional cardiology, electrophysiology and cardiothoracic surgery. Mr. Reinhardt holds a B.A. in Marketing from Ohio University and a M.B.A. from Baruch College in New York, New York.

Randy LaBounty

Randy is our Vice President of Regulatory and Clinical Affairs. Randy has over 20 years of experience in medical device research with 16 years of experience in cardiovascular medical devices. Prior to joining Kips Bay Medical, Randy served as Vice President of Clinical Research at Osprey Medical, Inc. and Vice President of Clinical and Regulatory Affairs at Lumen Biomedical, Inc. He has also had held Director level positions at Atritech, Inc., ev3, Inc. and IntraTherapeutics, Inc.

Randy has extensive experience with Class II and Class III medical products. He has been involved in all phases of the medical device approval process including the development of clinical and regulatory strategies, clinical trial execution, obtaining FDA Investigational Device Exemptions (IDE) and Post Market Approval (PMA) and 510(k) submissions. Internationally, he has successfully brought medical devices from initial clinical trials through to CE Mark approval. Randy has a Master of Science degree in Biostatistics and Bachelor of Science degree in Genetics and Cell Biology from the University of Minnesota.

Scott Kellen

Scott is our Vice President of Finance/CFO. From 2007 to 2009, Scott served as Director of Finance for Transoma Medical, Inc., including during the preparation of its proposed initial public offering, which was withdrawn in February 2008 due to deteriorated market conditions. From 2005 to 2007, Scott served as the Corporate Controller for ev3 Inc. during the company's initial public offering and during additional follow-on offerings. From 2003 to 2005, Scott served as Senior Audit Manager of Deloitte & Touche, LLP (now Deloitte LLP), providing auditing and consulting services to mid-size public companies after the passage of the Sarbanes-Oxley Act. Altogether, Scott has spent more than 12 years in the medical device industry, serving early stage and growth companies that produced Class II and III devices. Scott began his career with Deloitte & Touche in 1987.

Eric Solien

Eric is our Director of Research and Development. He has over 20 years experience in pre-clinical cardiovascular research. Eric began his career with the University of Minnesota's Cardiovascular Research Laboratory (known today as Experimental Surgical Services) and held several positions there before leaving as the Associate Program Director. He served as Study Director and Senior Research Surgeon at Surpass Incorporated (previously River Valley Farms and Charles River Labs, Interventional and Surgical Services) and was a member of the research teams developing novel devices for coronary artery bypass at HeartStent Corporation and CABG Medical. Eric is a certified Surgical Research Specialist and has a Bachelor of Science degree in Biology.