MyoStim Management Team
Alan Remen – CEO
Mr. Remen has over 25 years as a serial entrepreneur and business generalist with C level management experience in aerospace, agriculture, data communications, telecommunications, industrial instrumentation and out-sourced engineering services industries. In his aerospace company, Mr. Remen pioneered the reclamation of expensive hydraulic and dielectric fluids for the U.S. Military. In his agriculture company, Mr. Remen pioneered the continuous feeding of crops using liquid fertilizers dispensed in parts per million by a patented positive displacement, variable capacity pump into pressurized irrigation systems, thus vastly increasing the efficiency of the delivery of nutrients to crops. Mr. Remen’s data communications company pioneered in the hot replacement of redundant communication modules for high-density modem banks used extensively in the early days of the Internet. In addition, Mr. Remen brings international experience in Australia, Brazil, China, France, India, Germany, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Romania, Spain, Turkey and the UK. He currently also serves as the Managing Director of Private Capital Network (PCN), as Managing Director of Airspeed Equity, and as an Entrepreneur-in-Residence for CONNECT. Mr. Remen earned his degree in Business from San Diego State University after his service in the US Marine Corps.
Howard Leonhardt – Executive Chairman & Chief Technology Officer
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.
David W. Kramer - CFO
Mr. Kramer’s CFO experience spans 25 years of helping companies grow from start-up to over $100 million in sales, from high tech to life sciences. Most recently, he was CFO at Somanta Pharmaceuticals, Inc., a start-up, where he helped take the company through a reverse merger onto the NASDAQ. Earlier, at Anadys Pharmaceuticals, Inc., an emerging company, as CFO he helped raise $38 million in venture capital. Previously, at Gen-Probe, Inc., an international manufacturer and marketer of human diagnostic products, as CFO he assisted in the company’s growth from $5 million to $120 million in sales over 11 years. While there, he also served as CFO for a sister therapeutics company. Prior experience includes senior financial positions at Fujitsu Systems and in start-up electronics. Mr. Kramer has also consulted as a CFO for startups across a range of industries. He is a long-time volunteer at CONNECT Springboard, an incubator for small companies. Mr. Kramer’s memberships include Financial Executives International (20 years) and Corporate Directors Forum (5 years). He earned a BA, cum laude, from Yale and an MBA from Harvard Business School.
Dennis F. Bandyk, MD FACS
Section Head, Division of Vascular & Endovascular Surgery
Professor of Surgery
Sulpizio Cardiovascular Center
University of California San Diego
Dennis Bandyk, MD, is a Professor of Surgery at the University of California San Diego School of Medicine and Chief, Division of Vascular & Endovascular Surgery located at the Sulpizio Family Cardiovascular Center. He received his undergraduate (BSE–Aerospace Engineering), masters (MSE-Bioengineering), and MD (AOA) degree from the University of Michigan finishing in 1975. He completed his general surgical residency training and vascular surgery fellowship at the University of Washington, training under Dr. D.E. Strandness Jr. Dr. Bandyk joined the U of W faculty in 1981 and began his VA Merit Review funded research in the areas of vascular graft infection and arterial repair surveillance. In 1983, he assumed the position of Chief of Vascular Surgery at the Milwaukee VA and rose to the position of tenured Professor of Surgery at the Medical College of Wisconsin. In 1991, he became Division Chief of Vascular Surgery at the University of South Florida College of Medicine in Tampa FL. He was Program Director of the RRC-accredited 2 yr independent and developed the new 5-yr integrated vascular surgery resident training program in 2007. He has trained 32 vascular surgeons since 1981. Dr Bandyk is Program Director of the UCSD vascular surgery fellowship program and plans to start a 5-yr integrated vascular surgery training program in July 2013.
Dr. Bandyk is past president of the Florida Vascular Surgery Society, a Distinguished Academic Fellow of the Society for Vascular Surgery, and a member of the American Surgical Association. He is editor of the journal, and has served on the editorial board for the Journal of Vascular Surgery, and is an ad hoc Vascular & EndovascularSurgery reviewer for 8 other journals, including Annals of Surgery, Vascular Surgery, Vascular Medicine, Archives of Surgery, and Circulation. He has authored or coauthored over 210 peer-reviewed articles, 80 book chapters, and is co-editor of the textbook Noninvasive Vascular Diagnosis. He was a surgeon interventionist for CREST carotid endarterectomy vs. stenting trials, principal investigator for the Cook TX2 Low Profile thoracic endografting trial, and has participated in over 30 other major clinical trials. He has served on the Vascular Surgery Board of the American Board of Surgery as a senior board examiner, and question writer for VESAP curriculum. Dr. Bandyk has been recognized by his peers with a “Best Doctor” distinction in the specialty of vascular surgery for more than 10 years.
Dr. Bandyk’s clinical interests include carotid intervention, complex aortic surgery and endografting, treatment of critical limb ischemia, complex AV access (including treatment of arterial steal), and pediatric vascular conditions (renovascular hypertension, mid-aortic syndrome). He has extensive expertise the management of thoracic outlet syndrome, reflex sympathetic dystrophy, and hyperhidrosis. His current research studies at UCSD involve bone marrow stem cell injection therapy for lower limb critical ischemia, duplex surveillance of peripheral endovascular interventions, and treatment of vascular surgical site infections.
Tina Huth – Director, Corporate Development
Tina Huth is a leader in strategic planning and securing funding for research and development firms. During the past 15 years, she has assisted technology-based firms in growing research and improving infrastructure during start-up, restructuring, and growth phases in multiple industries - biotechnology, healthcare, defense, and higher education. At Celladon Corp, Xeris Pharmaceuticals, Avanir Pharmaceuticals, and Advanced Tissue Sciences, she was a key player in planning and developing research initiatives and contributed to the successful growth of sponsored research through securing federal grants. At M Ship Co., LLC, Ms. Huth was a key player in securing Department of Defense (DoD) funding and developing infrastructure processes and strategies to maintain contract management. At the University of California, San Diego, SDSU Research Foundation, and Children's Hospital, she managed research grants and assisted principal investigators with proposal development, federal compliance/guidelines, and fiscal/technical reporting. Ms. Huth remains an active member in several professional organizations including San Diego Biotech, Biocom, Connect, San Diego Chamber of Commerce, Society for Research Administrators (SRA), and the Regulatory Affairs Professional Society (RAPS). Additionally, she serves as a grant reviewer for CCAT (Center for Commercialization of Advanced Technologies) program. Funded by the Department of Defense, San Diego-based CCAT program identifies, evaluates, funds and fast-tracks the development of technologies for use by the DoD, the Department of Homeland Security (DHS), and the private sector.
Ms. Huth received her undergraduate degree from California State University, San Diego and her MBA from National University.
Brian Hardy - Marketing Communications
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.
Tom Newman – Sales
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 – Sales
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.