Management Team
Kenneth G. Hayes, Jr., President and Chief Executive Officer
Ken joined Biomerix Corporation as President and CEO in March 2008. He has established and led executive teams through the product development, clinical research, and commercial rollout of a wide range of medical devices. He has a track record of identifying and successfully executing substantial business partnerships and brings to Biomerix a breadth of financial, strategic and operational experience and relationships.
Ken previously served as President and CEO of Radiant Medical, which was acquired by Zoll Medical in 2007. From 1997 to 1999, Ken was President of Surgical Navigation Technologies and on the Management Board of Sofamor Danek which was acquired by Medtronic in 1999. Prior to that, Ken served as President of USCI, a division of C.R. Bard, as President/CEO of MDI Instruments which he helped to found, and as President/COO of American Surgical Technologies. Ken began his medical device career with Johnson & Johnson, where he spent 17 years in a range of progressively more senior positions with Ethicon Endo-Surgery, Vistakon and Ethicon, Inc. He started his career with Procter & Gamble after graduating with a B.S. degree in Business Administration & Marketing with honors from Marist College.
Maybelle Jordan, Vice President Business Development
Maybelle has over 15 years of business development, clinical and strategy experience in the medical technology industry. Prior to joining Biomerix, Maybelle was Vice President of Business Development at Pluvita Corporation, a development stage biotech company. She was responsible for in-licensing and out-licensing activities to support the company’s core oncology discovery platform. Maybelle helped to start two Ascent Biomedical Venture medical technology services companies, – Eminent Research Systems, a clinical research organization, and Clinsights, a post-market clinical services company as Vice President of Business Development. Her additional experiences include Director of Strategic Planning at Manor Care Health Services, a publicly traded long-term care provider, and Case Team Leader in the health care practice at The Boston Consulting Group. Maybelle graduated magna cum laude with a B.S. in Biology from Yale University and received her M.B.A. from Harvard Business School.
David Pearce, Vice President of Manufacturing and Operations
Dave has over 25 years of pharmaceutical/medical device development and manufacturing experience. He started his medical device career as a Production Engineer at Vicra Inc., a manufacturer of long-term use intravenous catheters (ultimately acquired by Baxter). Dave has also held positions as Operations Manager, Plant Manager, and Director of Site Operations for Abbott Laboratories from 1982 to 1998. Over the next 7 years, Dave was Senior Director of Manufacturing and Supply Chain Operations at a pulmonary drug delivery start-up, Aradigm and most recently Vice-president of Operations at catheter-based robotics developer Hansen Medical. Dave has a B.S. in Industrial Engineering from the University of Texas.
Arindam Datta, Ph.D., Distinguished Materials Fellow
Arindam has 18 years of experience in developing medical devices made from absorbable and non-absorbable polymers, composites and collagen. He has worked in research, product development, and product commercialization and has extensive experience in leading both technology development and project teams in the areas of tissue repair, tissue regeneration and drug delivery. Prior to joining Biomerix, Arindam was the Manager of Biomaterials Process Development at Ortec, a developer of collagen-based tissue engineered cellular skin substitutes for chronic and acute wounds. Previously, he worked for the Ethicon division of Johnson & Johnson and was involved with the development of bio-degradable medical devices in the areas of tissue repair, orthopedics, cardiovascular, drug delivery and urology applications. He has authored several patents and technical papers. Arindam has a B.S. in Chemical Engineering from Indian Institute of Technology, Kharagpur, a M.S. in Thermal Engineering from Southern Illinois University, and a Ph.D. in Chemical Engineering from Virginia Tech.
Lawrence P. Lavelle, Jr., Vice President Materials R&D and Operations
Larry has over 10 years of experience manufacturing specialty reticulated polyurethane materials. Prior to joining Biomerix, Larry was Vice President of Manufacturing for Crest Foam Industries Incorporated where he was responsible for the development and production of innovative reticulated urethane materials and the processes to manufacture them. Larry is a senior member of the American Institute of Chemical Engineers. Larry graduated with a B.S. degree in Chemical Engineering from the Pennsylvania State University and a M.B.A. degree, concentrating in the Management of Technology and Innovation, from Rutgers University.
Kavita Bouknight, Senior Director of Marketing
Kavita has over 10 years of health care experience with 6 of those years in medical device. Prior to joining Biomerix, Kavita was the Director of Marketing at FoxHollow Technologies. Kavita initiated her healthcare career with Deloitte Consulting in their Healthcare Practice working on strategic planning projects for payors, providers and biotech firms. While working on her M.B.A., she was employed as a Consultant for GE Healthcare’s Diagnostic’s Division in India and served as a Marketing Associate with Ethicon Endo-Surgery, a Johnson & Johnson company. Kavita graduated with a B.S. in Supply Chain Management from Michigan State University and received her M.B.A. from the University of Michigan Business School.
Christina Kichula, Senior Director of Regulatory Affairs, Quality Assurance, Clinical Affairs
Christina has over 15 years of regulatory and clinical experience in the healthcare industry. As a former member of the Regulatory Affairs Department at Eminent Research Systems, Inc., she was responsible for the management of regulatory approval efforts for clients. She assisted with the preparation and review of FDA submissions (IDE, HDE, PMA, 510(k), and RFD) and analysis of proposed and final regulations and their potential impact on clients’ business operations. Her experience includes the following therapeutic areas: cardiovascular, neurological, orthopedic, peripheral vascular, surgical, and combination products (drug/device and biologic/device). Christina previously served in the Division of Cardiovascular, Respiratory, and Neurological Devices of the U.S. Food and Drug Administration (FDA) for nearly five years and has spent six subsequent years with regulatory consulting firms. Christina received her B.S. in Biomedical Engineering from The Catholic University of America.
