At Medical 21, Inc. we have a long, proven history of creating incredible and lasting value in the medical device industry. Led by founder and CEO Manny Villafaña, Ph.D.Sc., our highly knowledgeable team has made it their mission to improve the quality of life for cardiac bypass surgery patients.
Through decades of collective experience and successes, our team has revolutionized the bypass surgery procedure with a breakthrough artificial graft that eliminates the need for vessel harvesting, which reduces pain, scarring, infection, and healthcare costs.
Manny Villafaña, Ph.D.Sc
Founder and CEO
Manny Villafaña, Ph.D.Sc.
Founder and CEO
Manny Villafaña has a substantial track record of founding companies that develop and deliver successful medical products to the healthcare market. Medical 21 is Manny’s eighth medical device company, and he has led his previous seven companies to an IPO financing.
As the founder of Cardiac Pacemaker, Inc. (CPI)/Guidant, he co-invented the first long-life lithium-powered pacemakers and defibrillators which revolutionized the pacemaker industry. The technology he developed in 1972 is still in use in virtually every defibrillator and pacemaker worldwide. CPI was purchased by Boston Scientific for $27 billion.
He was the founder of St. Jude Medical, Inc and the co-developer of the St. Jude heart valve – an innovative mechanical bi-leaflet heart valve that dramatically reduced the frequency of blood clots. This is the most commonly used prosthesis in the world, in approximately five million patients. St. Jude was purchased by Abbott Laboratories for $30 billion.
Manny went on to develop several other companies including ATS Medical, which introduced the new generation ATS open-pivot heart valve. ATS was purchased by Medtronic for $400 million.
Born in the South Bronx to Puerto Rican immigrants, Manny quickly showed aptitude as a salesman. In his early 20s, he went to work for Picker International, a medical device exporter, selling medical products on behalf of companies such as Minneapolis-based Medtronic Inc., which precipitated his relocation to Minneapolis.
Manny has received numerous awards and honors including:
Manny has guest lectured at Harvard, Universities of Minnesota, Iowa, Notre Dame, Miami of Ohio, Stanford, Brown, St. Olaf, and other notable universities, which led to receiving an honorary Doctor of Science Degree from the University of Iowa in 2014. He has donated generously to numerous charities and nonprofits, including the Kips Bay Boys’ and Girls’ Club of The Bronx, New York and the Smithsonian Institute in Washington, D.C..
Andrea Sweeney, B.S.
Andrea Sweeney earned her Bachelor of Science from the University of Minnesota. She has been a business and financial consultant for over 25 years. Andrea partnered with Medical 21 and is facilitating its current financing with CEO Manny Villafaña. Serving as Business Administrator, she fills a variety of additional finance and operation roles for this groundbreaking startup.
Eric Solien, B.S.
Senior Research Scientist
Eric, who has worked with Manny for approximately twenty years, is an accomplished pre-clinical surgeon and an expert in the pre-clinical development of bypass grafts. He has extensive experience in the application of Good Laboratory Practice (GLP) quality controls and methodologies. Eric previously served as Associate Director of the Cardiovascular Research Laboratory (ESS) at the University of Minnesota and Senior Surgeon at American Preclinical Services. He has participated in research studies involving devices used in interventional cardiac procedures and cardiovascular surgery. He is a Senior Technical Advisor to Dr. Villafaña.
Chaid Schwarz, Ph.D.
Head of Research and Development
Chaid received his Ph.D. in Biomedical Engineering from the University of Iowa. His research interests are in thin tissue-engineered constructs and biological membranes. These interests have intersected in the fields of cardiovascular biomechanics, biomaterials, and the mechanical assessment of soft tissues. While at the University of Iowa, he designed, developed, and tested materials for transcatheter deliverable heart valves, stents, and computationally modeled endovascular grafts for the treatment of abdominal aortic aneurysms. Additionally, he investigated the mechanical effects of severe diabetes on Descemet’s membrane, a thin membrane on the back of the cornea which impacts our vision. At Medical 21, he is leading research and development efforts including the technical design, testing, and preliminary manufacturing of our tissue-engineered arterial bypass graft.
Jeff Vreeman, B.S.
Head of Manufacturing
Jeff, who has worked with Manny for over ten years, received his B.S. in Mechanical Engineering from the University of North Dakota. His broad medical device experience includes roles in manufacturing, operations, process development, research and development, and quality, along with extensive expertise in nitinol support systems. Jeff previously served as Senior Engineer/Operations Manager and Senior R&D Engineer at MIVI Neuroscience, Inc.
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