$10 Billion Market
“With our past experience and successes, we feel we are ready for the challenge of pursuing the ‘holy grail’ of cardiac surgery and its great market potential. The pursuit of a small diameter graft for bypass surgery has evaded many manufacturers and health institutions over the last 50 years.”
Manny Villafaña, Ph.D.Sc., Founder and CEO
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Manny Villafaña, Ph.D.Sc.
The Living Legend of Medicine
Founder, Chairman, CEO | Medical 21, Inc.
Over the last 50 years, Manny Villafaña has revolutionized the cardiac device industry. His contributions led to the most significant advances in cardiac health and have impacted the lives of millions of people.
founded CPI/Guidant; co-inventor of the first lithium-powered pacemakers and defibrillators
founded St. Jude Medical, Inc; co-developer of the St. Jude heart valve
founded ATS Medical, Inc.; co-inventor of the ATS heart valve
co-inventor of the nitinol support
Medical 21’s competitive advantage is its breakthrough in medical technology. Hearts are strong, complex organs that pump about 40 million times per year, putting incredible pressure on the vascular system. An artificial graft needs to be just as strong and flexible to bear the contractions and constant movements of the circulatory system. Over the last 50 years, companies have failed to create a graft that can meet these requirements. Our MAVERICS graft is biocompatible, stronger, and more flexible than tests of similar technology thus far.
The MAVERICS graft system aims to create a less intrusive surgery. The traditional cardiac bypass surgery procedure requires blood vessel harvesting — a grueling process that creates additional pain, scarring, disfigurement, and recovery time for patients while effectively alienating patients who do not have viable veins for harvesting. The MAVERICS graft is designed to eliminate the need for vessel harvesting.
Use of Proceeds
The above is based on successful completion of 100% of the target $40M Regulation A raise. For a detailed discussion in the event lower targets are reached, see the 1-A offering circular available at https://Medical21.com/invest.
Medical 21 Leadership Team
Manny Villafaña, Ph.D. Sc.
Founder and CEO
Manny Villafaña, Ph.D.Sc., is a nationally-recognized entrepreneur and medical device developer with over 50 years of industry experience. As the founder and CEO, Manny started Medical 21 with the goal to significantly improve the quality of life for cardiac bypass surgery patients.
He is globally recognized as a “Living Legend of Medicine,” an honor bestowed on him by The World Society of Cardiothoracic Surgery in 2006.
Chaid Schwarz, Ph.D.
Head of R&D
Chaid received his Ph.D. in Biomedical Engineering from the University of Iowa. His research focus is in the field of cardiovascular biomechanics, biomaterials, and the mechanical assessment of soft tissues. 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.
Eric Solien, B.S.
Senior Research Scientist
Eric Solien is an expert in the preclinical development of bypass grafts and served as Senior Surgeon at the American Preclinical Services. As an accomplished preclinical surgeon, he has extensive experience in the application of good laboratory practices (GLP) quality controls and methodologies.
Head of Manufacturing
Jeff Vreeman is a mechanical engineer and medical device expert with extensive experience in nitinol support systems, process development, manufacturing, operations, R&D, and quality control in the medical technology field.
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 Regulation A+ financing with CEO Manny Villafaña. Serving as Business Administrator, she fills a variety of additional finance and operation roles for this groundbreaking startup.
Medical 21 Medtech/Business Advisors
John Babitt Partner
Life Sciences, Ernst & Young
· 30 years of leadership with a focus on medical technology
· President of a publicly traded medical technology company with Manny Villafaña.
· Frequent lecturer and guest speaker at The Medtech Conference (AdvaMed)
Robert Emery Jr., M.D.
Cardiac Surgeon (Ret.)
· Initial research work on St. Jude Heart Valve
· Co-Founder & First President of Int’l Society of Minimally Invasive Cardiac Surgery
· Medical Director, Cardiovascular Surgery, St. Joseph’s Hospital, St. Paul, MN
David Joyce, M.D.
Director of Cardiac Transplantation, Medical College of Wisconsin
· Associate Professor, Cardiac Surgery, Medical College of Wisconsin, Milwaukee
· Former Professor, Mayo Clinic
· Harvard Medical School
· Fellowship, Stanford University
· Resident, Johns Hopkins
Lyle Joyce, M.D., Ph.D.
Professor of Surgery, Medical College of Wisconsin
· Section Chief, Adult Cardiac Surgery, Medical College of Wisconsin
· Co-surgeon on first permanent implant of the Jarvik 7 total artificial heart
· First to implant a total artificial heart in a woman.
Gene Myers, M.D.
· Principal at Florida Inst. for Angiography & Gene E. Myers Cardiac/Vascular Consultants
· Completed 20,000+ coronary/peripheral procedures
· Discovered cervical precordial angina disease
· Medical device & EMR patents
· US Navy, Lieutenant Commander
M.L. Suresh Raghavan, Ph.D.
Professor of Biomedical Engineering, Univ. of Iowa
· Fulbright Distinguished Chair
· 25 years experience in cardiopulmonary biomechanics and device design, critical care therapies, soft tissue mechanics, and computational modeling
· Ph.D. in Bioengineering, University of Pittsburgh
· Fellow, American Institute of Medical & Biological Engineering
This Opportunity is Open to Everyone
Medical 21 is open to investors through Regulation A+ fundraising, which allows accredited investors and the general public alike to participate.
Learn how you can join us in reshaping the future of cardiac bypass surgery.