Howard J. Leonhardt, Chairman of the Board, Executive Chairman, Chief Technology Officer, MyoStim Pacers, Inc. Leonhardt also serves as Executive Chairman of Leonhardt Ventures a cardiovascular life science plus social good impact investment fund, angel network and innovation accelerator www.leonhardtventures.com. He is an inventor and serial entrepreneur with over 20 issued patents and numerous pending for products for treating cardiovascular and heart disease. His inventions have treated over 200,000 patients worldwide and have generated over $3 billion in revenues. His TALENT stent graft holds a world leading market share today as part of Medtronic Vascular. Leonhardt is the primary inventor of two of the three MyoStim Pacers pioneering patents along with Juan Chachques for utilizing electrical stimulation to recruit stem cells and differentiate them into heart muscle. He led the acquisition of the Kanno patent for utilizing electrical stimulation to stimulate new blood vessel formation. In 1983 Leonhardt was Export Sales Manager, and the first founding employee, of American General Medical Corporation in Hardeeville, SC that built and supplied cardiac cath labs and intensive care units in foreign markets. In late 1984 he joined International Marketing Advisors – Medical Group, Inc. in Fort Lauderdale, Florida as VP of International Sales. In early 1986 he founded World Medical Corporation a firm which helped manufacturers of cardiovascular devices to reach export markets. In 1988 he invented a series of improved cardiovascular balloon catheters and founded World Medical Manufacturing Corporation in Sunrise, Florida, that went on to develop over a dozen cardiovascular products including the TALENT stent graft for repairing aortic aneurysms without surgery, the first percutaneous heart valve, electrical stimulation devices for improving blood flow and the first stem cell delivery catheter systems, ProCell. The firm grew from just 2 employees to over 500 and merged with Arterial Vascular Engineering of Santa Rosa, California in April of 1998. In November of 1998 the combined firms were acquired by Medtronic, Inc. of Minneapolis, Minnesota. Leonhardt served as President & CEO of World Medical Mfg. Corp. from 1988 until June of 1999. From November 1998 to June 1999 he duly held the position of Vice President of Emerging New Therapies at Medtronic, Inc. In June 1999 Leonhardt founded Bioheart, Inc. with locations in both Florida and California with a focus on utilizing living stem cells for heart repair and personalized medicine. Bioheart introduced the first patented cardiovascular genetic test on the U.S. market in 2000. Leonhardt patented a biological pacemaker made entirely of living calls, and acquired the King patent, at Bioheart which is now the basis of the spin out company BioPace. He led Bioheart’s MyoCell into Phase II/III trial stage and the company is now in finalizing enrollment in its Phase III pivotal trial. Leonhardt served as Executive Chairman and CEO up to Bioheart’s IPO road show in 2007. In February 2008 following the NASDAQ IPO he moved full time to California to form his innovation accelerator with an initial focus on finding homes for Bioheart’s non-core spin out technologies. He has since served remotely as Chief Technology Officer, Chairman of the Scientific Advisory Board and as a member of the board of directors for Bioheart up to January 2013 where he shifted his focus entirely to serving MyoStim Pacers and his innovation accelerator in California. Leonhardt Ventures has raised and put to work $145 million in 28 innovation developments to date. Leonhardt serves on various boards including the Cell Therapy Foundation. He attends over 20 major cardiology meetings a year with an exhibit booth and side Technology Showcases highlighting MyoStim Pacers and other cardio innovations from his innovation accelerator and Leonhardt Ventures portfolio. He holds a diploma in International Trade from Anoka Technical College in Minneapolis and attended the University of Minnesota and Anoka Ramsey Community College. He has an honorary Doctorate in Biomedical Engineering from the University of Northern California, and is an honorary alumnus of both the University of Florida and Florida International University where he has been a substantial contributor to their entrepreneurship programs. He serves with the UCLA Bioengineering CE and UCLA Business of Science Center programs, as well as the USC Saben Research Institute, where he duly recruits talent to help advance forward Leonhardt Ventures innovations. In the spring of 2013 the Leonhardt Ventures innovation accelerator announced their partnership with the Alfred Mann spin out Core Manufacturing in Valencia, CA, where Leonhardt now has an office and laboratory, for advancing forward R&D and cGMP manufacturing of cardiovascular devices, including MyoStim Pacers.
Dr. Nicolas Chronos is an interventional cardiologist well known for his pioneering research in the treatment of heart disease. His cardiology practice focuses on general cardiology, coronary artery disease management, and heart failure management. He is an expert in cardiac regenerative medicine, cardiovascular medical device assessment, and translational cardiovascular medicine.
Dr. Chronos established Cardiology Care Clinic at Lake Oconee in 2012 with his wife and cardiology physician’s assistant, Heather Chronos, to bring his modern approach to the treatment of heart disease to the lake community he cares about so deeply.
Tom Newman has over twenty years of sales and sales management expertise working with well known companies such as Johnson & Johnson, Pfizer, and Biomet. Tom has built two medical distribution companies and also has served as a business development leader for two small startup companies.
Jeff Donofrio has 25 years of Medical Sales and Sales management experience and has served as a senior consultant for several CardioVascular companies. These include WL Gore & Associates, Edwards Lifesciences and Cardiac Assist, Inc. Jeff was the co-founder of Big Sky Medical Inc. which was built and successfully sold for a nice profit to a larger company. He has experience in building both direct sales forces as well as distribution networks.
Dr. Jorge Genovese serves as Vice-President of the Tissue Engineering Society International and as a member among other institutions, of the Latin American Biomaterials and Artificial Organs Society and a founding member of the Latin American Association of Tissues Banks. Dr. Genovese serves as Research Associate of Cardiac Stem Cells Therapies of the McGowan Institute program and as Research Professor of the Department of Surgery of the University of Pittsburgh Medical Center. Dr. Genovese has been devoted to different fields of tissue engineering including understanding how skeletal myoblasts might be used as a cell therapy for patients with heart disease. His research has also included testing the effects of electrical stimulation of myoblasts and adipose-derived stem cells prior to implantation. Dr. Genovese has been Member of Scientific Advisory Board at Bioheart, Inc. since January 17, 2007. He serves as Honorary President of the Tissue Engineering Committee of the National Academy of Science and Medicine of China. Dr. Genovese serves as a member of the editorial board of J. Stem Cells and the advisory board of Basic and Applied Myology. Dr. Genovese received his M.D. from the School of Medicine of Buenos Aires University, where he also obtained his Ph.D. after completing a thesis on TGF-Beta, an important growth factor involved in cell development and regeneration.
Dr. Stuart Williams received his Ph.D. in cell biology from the University of Delaware, followed by postdoctoral training in pathology at the Yale School of Medicine. During the period 1980 to 1990 he held a faculty appointment at Jefferson Medical College, where he was director of research in the department of surgery. In 1990 Dr. Williams joined the faculty at the University of Arizona and established the section of surgical research in the department of surgery. In 1997 he founded the University of Arizona biomedical engineering program, creating a research and educational link between the medical school and the college of engineering. He held faculty positions jointly in biomedical engineering, surgery, physiology and materials science and engineering.
Dr. Williams’ research interests have focused on medical devices, regenerative medicine and infection control. He developed and patented the first methods to use fat-derived stem cells for therapeutic use. He has maintained continuous funding from the National Institutes of Health since 1979.
Dr. Williams has authored over 300 scientific publications. His entrepreneurial spirit has resulted in 16 issued US patents with numerous patents pending. He has founded three biotechnology companies, maintained active managerial positions and has been an active consultant to the medical device and pharmaceutical community. He is a fellow of the American Heart Association and a fellow of the American Institute of Medical and Biological Engineering.
Mr. Hardy is a life long entrepreneur. Starting his first design and marketing company at the age of 18 in Fort Lauderdale, Florida. He has founded many businesses over the years including a trade show exhibit house creating custom exhibits for clients such as the United States Army, M & I Bank, Interactive Toys and many others. From 2005-2008 he owned & operated a full service sign company, creating custom signs for companies like Ben & Jerry’s, Pita PIt, and Green Mountain Coffee. In 2008, he founded 4ColorFlyers.com. A fully-automated process allowing clients to track the progress of their print projects. 4 Color Flyers also does a wide variety of web design for clients such as LeonhardtVentures.com, CalStockExchange.com, HayleyBear.com, and LeonhardtVineyards.com. Mr. Hardy has over 13 years experience in graphic design, web design, and marketing industry.
Dr. Robert O. Becker
Author of the Body Electric
Consultant to Leonhardt Ventures 1985-87
Cardiologist. Former Chairman of Cardiovascular Medicine University of Minnesota. Author 240+ publications. Investigator in > 80 clinical trials. Editor leading textbook on Stem Cell Therapies for Cardiovascular & Heart Disease.
1982-1996 Saint Louis University: Assistant Professor Medicine and Surgery;
1982-1996: Director of the Coronary Care Unit
1986-1989: Associate Professor of Medicine and Surgery; Director of the Heart Transplant and Mechanical Support Program
1989-1996: Professor of Medicine and Surgery
1996-1997: Sabbatical leave: University of Alberta, CA with Dr Phiillp Halloran focused in immunology and immunosuppression, and Dr Alexandra Lucas on vascular biology
1997-2007: Professor and Chair of the Division of Cardiology, Univ of Minnesota;
Director of the Heart Transplant and Mechanical Assist Program, and
Director of the Cardiology Fellowship Program
2005-2007: Founding Director of the Lillehei Heart Institute, U of MN
2007-2010: Chair of the combined Division of Cardiology Georgetown University
and Washington Hospital Center
Proctor Harvey Distinguished Professor of Cardiology, Georgetown Univ
Director of the Heart Transplant and Mechanical Support Program
Director of the Cardiology Fellowship Program
2010-2013: Chairman the Department of Cardiology Univ South Florida
Edward C. Wright Professor of Cardiovascular Medicine
Director of the Cardiology Fellowship Program
2012-2013: Director of the Cardiovascular Institute
2013-2016: Director of Heart Failure Morton Plant Hospital
2016-current: Chief Medical Officer, Leonhardt Ventures
1988-2009: Founder and Chair: Working Group of Transplant Cardiologists
1995-1997: President of American Society of Transplant Physicians
1997-1998: President of International Society of Heart and Lung Transplantation
1999: Citation of Merit: University of Missouri, Outstanding Alumnus
1999-2006: Board of Directors of Cardiovascular Translational Research Society
2014- : Chairman of the Board of the Alliance for the Advancement of Stem Cell Research
2013- : Board of Directors International Congress of Cardiology
Brett Burton has 9 years experience in both teaching and implementing image-based, computational modeling techniques as they relate to bioelectric field simulations. He has contributed to over a dozen peer reviewed publications while pursuing his Ph.D in Bioengineering and has given several invited presentations on topics ranging from general computational modeling to cardiac bioelectricity to uncertainty visualization in 3D.
In addition to his research experience in cardiac electrophysiology, Brett has led and advised multiple teams of graduate student entrepreneurs through commercialization efforts of multiple University of Utah owned technologies while he serving as a student associate director in the Lassonde New Venture Development’s Graduate Program for Tech Commercialization His experience includes business model development & advising, lean canvas methods, clinical study design & management, in-hospital clinical study implementation & administration, IRB preparation, patient consent, data analysis, etc.
Brett’s entrepreneurial involvement concurrently bled into venture capital where he spent 2 years at the University Venture Fund (now the University Growth Fund) leading deal screens, venture investment, and follow-on investments while also providing market analyses and value add projects to existing portfolio companies such as Lyft, Lineagen, Instructure, Tute Genomics, and other privately held entities.
Alex S. Richardson, Founder of CORE Manufacturing, has 30 years of experience in high-reliability manufacturing. After serving in the United States Air Force as an Avionics Navigation Engineer, Richardson launched his professional career in the private sector in engineering, quality, operations, business development and key executive roles for distinguished OEMs and manufacturers such as ITT Gilfillan, JPL/NASA and Stellar Microelectronics (Flextronics). Over the last three decades, he has been instrumental in launching a myriad of complex products in the military/aerospace and medical device market sectors with a forte in radar systems, unmanned aerial vehicles (UAVs), military radios, countermeasures, Class II and III implantable medical devices, and other products that push the technology envelope. Richardson has spent the last 14 years supporting several Alfred Mann companies and maintaining successful partnerships with other medical device entities such as Advanced Bionics, Biotronik, Boston Scientific, GE Medical, Medtronic, St. Jude Medical and other world-class organizations.
Senior level executive leader who thrives in technical business environments with in-depth experience in the manufacturing of high reliability electronics, microelectronics, and complex devices.
Dr. Kellar is the Founder and President of AxoLotl Biologics and Development Engineering Sciences, LLC, a biomedical consulting firm. He has over 15 years of experience in the development and regulatory approval of medical devices, cell-based products, and tissue engineered technology. Previously, Dr. Kellar was VP of Research and Development at Histogen, Inc. where he led multi-functional project teams for all aspects of product development. Prior to Histogen, Dr. Kellar was a product specialist for the first FDA-approved thoracic endograft at W.L. Gore and Associates where he served a lead role in development, regulatory, clinical trials, marketing, sales, and business for the thoracic device and the product portfolio. Previous to this position, Dr. Kellar was a product specialist for the Global Oral Health Business at W.L. Gore & Associates (both Gore-Tex® Regenerative Membranes and the entire resorbable membrane portfolio). Prior to Gore, at Advanced Tissue Sciences, Inc. he led cardiovascular research programs and managed the Anginera® program. Dr. Kellar previously served on the Scientific Advisory Board for Theregen, currently serves on the Scientific Advisory Board for MyoStim, and is on the Faculty in Biological Sciences and Mechanical Engineering at Northern Arizona University. Dr. Kellar also serves on the Board of Directors for the Surfaces in Biomaterials Foundation and Flagship Biosciences, a digital pathology company. He serves as an Advisory Board Member for Protein Genomics, a protein polymer medical device company. He earned his Ph.D. in Physiological Sciences from the University of Arizona.
Jeremy Koff has over 25 years experience in the medical device industry most of those years with Alfred Mann Companies including Advanced Bionics. He currently serves as a consultant with a focus in the bioelectric and neuro modulation sectors. Jeremy Koff is the nephew of the legendary Los Angeles biomedical industry pioneer Alfred Mann.
Dr. Mark Cunningham is a degreed engineer as well as a physician, scientist, business manager and entrepreneur. He is Chief of Mechanical Circulatory Assist Support and at USC Keck Cardio-Thoracic Surgery Department and Former Chief of Staff of USC Keck.