Healthcare Industry News: HSMN NewsFeed
News Release - October 6, 2010
Minnow Medical Bolsters Management TeamNew Chief Product Development Officer, Clinical and Regulatory Executive Round Out Management Team
LAGUNA HILLS, Calif., Oct. 6 -- (Healthcare Sales & Marketing Network) -- Minnow Medical, Inc., a developer of a novel platform technology employing radiofrequency thermoplasty for the treatment of in-stent restenosis and other peripheral vascular conditions, announced today the appointment of two veteran medical device executives.
Prabodh Mathur has been named chief product development officer and Michael K. Handley has been named vice president of quality, clinical and regulatory affairs.
"Both Prabodh and Michael are experts in their respective fields and have the experience, drive and passion to assist Minnow in executing the remaining clinical, regulatory and product development activities necessary to gain clearance for the use of our ZCath™ System to treat occlusions in the leg arteries of patients with peripheral vascular disease," said Raymond W. Cohen, CEO of Minnow. "Minnow's technology has already been proven to be safe in human clinical studies in Europe. The goal of the new management team is to become one of the first companies to establish efficacy and gain U.S. Food and Drug Administration (FDA) clearance to treat patients who have already received stent implants in their peripheral leg arteries and are suffering from in-stent restenosis - a dangerous build-up of plaque inside the stents."
About the Executives:
Mathur is a seasoned technical executive with a proven track record of developing complex, innovative, Class III medical devices from concept, through design exploration, IP review, engineering, manufacturing transfer, regulatory clearance to market launch. Mathur held numerous engineering leadership positions, including chief technical officer, with publicly traded Cardiac Science over a 15-year period until 2009. Earlier, Mathur was, for nine years, vice president engineering of Medstone International, a manufacturer of transportable lithotripters.
Over the past years, Mathur has been involved in developing products including a catheter-based biopolymer delivery system, fully automatic public-access defibrillators, multi-parameter patient monitors, lithotripters, cryoablation delivery systems, therapeutic diode laser and fiber-optic delivery systems, and an industrial high-power carbon dioxide laser and robotic system. Cumulative revenues from products designed under his leadership exceed $1 billion. Mathur holds a M.S. in Engineering from Missouri University of Science and Technology and a B.S. in Mechanical Engineering from Indian Institute of Technology in Kanpur, India.
Handley, who has more than a decade of quality, clinical and regulatory experience in the healthcare field, was until recently chief compliance officer, vice president of global regulatory affairs at publicly traded Spectranetics Corporation. Handley joined Spectranetics in 2007 as manager of regulatory affairs and was promoted to director, global regulatory affairs and compliance and subsequently to chief compliance officer.
Prior to joining Spectranetics, Handley served as vice president, regulatory affairs for AccelaPure, a company providing pre-clinical and clinical services for biotechnology companies. Prior to that, Handley was senior principal at Pittiglio Rabin Todd & McGrath, a nationally-recognized management consulting firm for the biopharmaceutical and medical device industries. Handley holds a B.S. in Molecular Biology, Physiology, and minors in Chemistry and Neurobiology from Colorado State University and an M.B.A. from the Graziadio School of Business and Management at Pepperdine University.
About Minnow Medical, Inc.
Minnow Medical, founded in 2003, is a privately-held, venture-backed development stage company developing novel radiofrequency thermoplasty technology directed toward patients with peripheral vascular disease. The Company is ISO 13485 Compliant and FDA registered.
Minnow's initial product, the ZCath System, combines a patented low-pressure percutaneous transluminal angioplasty balloon catheter combined with uniformed and controlled RF energy intended to safely reverse and prevent the progression of peripheral vascular disease by restoring blood flow, reducing plaque burden and reducing restenosis without vessel trauma. The product has advanced from pre-clinical to clinical stage testing and has achieved CE Mark for use in reducing plaque in peripheral leg arteries. The Company has also filed a 510(k) with the FDA seeking marketing clearance in the United States for the aforementioned clinical indication.
Source: Minnow Medical
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