Biomerix

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.

Balakrishna Haridas, PhD., Chief Technology Officer

Bala has over 17 years of experience and expertise as a senior product development executive, technologist, and entrepreneur in medical device development. Prior to joining Biomerix, Bala was Director of NSF Minimally Invasive Medical Technologies Center (MIMTeC), a Government-Industry research consortium at the University of Cincinnati. He was also the Co-Director of Medical Device Innovation at the University of Cincinnati. Bala has served as President of Device & Implant Innovations (DII), a specialty consulting firm supporting product R&D for major US medical device companies. He is well-published in peer reviewed journals, international meetings, and serves as editor/reviewer of many journals. He also officiates on the jury panel for the Medical Design Excellence Awards competition for the US medical device industry. Bala graduated with a B.E. in Civil Engineering from Bangalore University in India, an M.S. in Engineering Mechanics from the University of Alabama, and a Ph.D. in Engineering Mechanics/Biomechanics from the University of Cincinnati.

Maybelle Jordan, Chief Operating Officer

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 of Biomaterials Production

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.

Randal Chatman, Vice President of Global Sales & Market Development

Randy has 20 years of medical device experience in Sales, Marketing, Sales Management, Corporate Accounts and Business Development. Prior to joining Biomerix, Randy was Sr. Director of US Sales at FoxHollow Technologies. Randy was recruited from Cordis Cardiology, a J&J Company where he held the position of US Director of Corporate Accounts. Prior to this Randy held the position of Vice President of National Accounts at Tyco Healthcare. Randy started his career in Sales with Sage Products moving into roles such as Product Manager, Director of Marketing and ultimately back to sales as a Regional Sales Manager. Randy received his B.A. from the University of Oklahoma and an Associate Fellowship from the Wharton School of Business—The Leonard Davis Institute of Health Economics.

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.

Gene Park, Senior Director of Research and Development, Soft Tissue Repair

Gene has over 18 years of R&D experience at notable companies, such as Medtronic, Guidant Corporation, Tissue Banks International, Genencor International, Procter and Gamble, and The Clorox Company. Prior to joining Biomerix, he served as a Program Manager and Advanced Technology Manager with Medtronic CardioVascular's Talent Thoracic and Abdominal Endograft programs, where he was responsible for leading a core team from project concept to completion for a US PMA and Japan Shonin regulatory filing and approval. While at Guidant, he served as Program and R&D manager for a drug eluting stent program and held the position of Director of Operations at Tissue Banks International. Gene graduated with a Bachelor of Science degree in Chemical Engineering from the University of California at Berkeley and a Master of Business Administration, Transnational Executive MBA Program, from California State University, Hayward.

Steve Meyer, Senior Director of Research and Development, Neurovascular

Steve has more than 19 years of medical device experience, and has held various engineering positions at SciMed (Boston Scientific), and director level R&D positions at Interventional Innovations (later became XRT Corp.), Intella Interventional Systems, and Paracor Medical. He has been actively involved with all stages of product development, including early design concepts, pre-clinical testing, regulatory submissions, transfer to manufacturing, and clinical trial support. Prior to joining Biomerix, his focus has included devices for the interventional cardiology and neuroradiology markets, such as PTCA catheters, guidewires, stents, local drug delivery and thrombolysis catheters, and an intravascular brachytherapy ("soft x-ray") catheter for preventing coronary restenosis, as well as a minimally invasive delivery system and elastic restraint implant for treating heart failure. Steve holds a B.S. in Mechanical Engineering with a business management minor from the Uni versity of Minnesota, and has six issued and ten pending patents.