Daniel T. Lemaitre
President and Chief Executive Officer
Mr. Lemaitre joined Direct Flow Medical as President and CEO as of May, 2015. Previously Mr. Lemaitre was the CEO of CoreValve, one of the early pioneers in transcatheter aortic valves. By 2009 revenue were at a $100 million annualized end market run rate. Dan led negotiations that resulted in the sale of CoreValve to Medtronic in an $800 million transaction. Prior to joining CoreValve, Mr. Lemaitre was a Senior Vice President at Medtronic where he headed-up strategic planning and corporate development. Dan was also a member of Medtronic’s executive and operating committees. Dan is currently Chairman of Bioventus, a North Carolina based orthobiologics company based in North Carolina with revenue in the $250 million vicinity. Lemaitre is also the lead director of Endologix (NASDAQ: ELGX) a major participant of the $1.5 billion worldwide abdominal aortic aneurysm market, where he also serves on the nominating/governance (chair) and audit committees. He is also on the board of Globus Medical (NYSE: GMED) one of the fastest growing spinal companies with revenue >$500 million per annum. Dan serves on the Globus audit and compensation committees. Earlier in his career Dan spent 28 years in the medical device field as an investment analyst. He began his career as a buy-side analyst in 1978 working at National City Bank in Cleveland and later, Standish Ayer & Wood in Boston. His sell-side career included 18 years with Cowen & Company, where he was a managing director and led the health care research team. In 1999, Dan moved his team to Merrill Lynch where he headed-up the medical technology effort for six years. During his Wall Street tenure, Dan was named to Institutional Investor’s All American research team for 19 consecutive years, capturing first place honors 8 times as the top-ranked medical device analyst in the country. Dan has a BA in Economics (1976) from Bethany College (West Virginia) and an MBA (1978) from Bowling Green State University in Ohio. He earned a Chartered Financial Analyst (CFA) in 1982.
Chief Technology Officer and Co-Founder
Mr. Bishop co-founded Direct Flow Medical in June 2004. Mr. Bishop was recruited from California Polytechnic State University to Arterial Vascular Engineering, Inc. (AVE) in 1999 where he led various stent projects, including the Driver™ stent, currently on the market in the US and Europe. The Driver stent introduced interventional cardiology to the cobalt chrome era and its improved visibility, deliverability and radial strength due to the stent’s unique material properties. The Driver stent emerged as the preferred cobalt-based alloy stent in Europe, and is the market-leading bare-metal stent in Japan. In addition to leading the Driver stent Project at AVE, Mr. Bishop served on the ASTM F04 committee alongside agents of the FDA and other industry representatives to establish standards for stent testing and modeling. He also provided the patent litigation team with engineering support, and was responsible for failure analysis of returned goods. Hired as a Senior Engineer at MitraLife, Inc,. Mr. Bishop was a lead engineer on a novel percutaneous approach to lessen mitral regurgitation by implanting a device into the coronary sinus. As the first start-up company in this space, MitraLife spawned many other investments in the field. MitraLife was acquired by ev3, Inc. a Minneapolis-based company. Mr. Bishop has a B.S. degree in Mechanical Engineering from California Polytechnic State.
Chief Financial Officer
Mr. Boyle was appointed Chief Financial Officer of Direct Flow Medical, Inc. in April 2015. He is an experienced healthcare financial executive with his financial career spanning over 30 years. He has served as CFO for several public companies including AVI BioPharma, Inc., Bionovo, Inc., Salix Pharmaceuticals, and XOMA Ltd. He has also held senior financial positions with the Ares Serono Group, Ogenx Therapeutics Corporation and Polycom, Inc. He began his career with Ernst and Young where he worked both in the US and Europe. Mr. Boyle has a B.A. degree from the Catholic University of America.
Vice President of Regulatory Affairs
Ms. Edwards possesses more than 30 years of regulatory and clinical affairs experience in the medical device industry, including more than 20 years in the cardiovascular space. She has served as Global Vice President of Regulatory Affairs for Medtronic Vascular, where she was responsible for the filing and approval of five PMAs. As Vice President of Regulatory and Clinical Affairs for C.R. Bard, she spearheaded multiple PMA approvals and 510(k) clearances. She was also the original regulatory affairs professional for W.L. Gore and Associates, where she served for 15 years. Ms. Edwards earlier provided independent regulatory and clinical consulting for several firms, and has held senior regulatory and clinical affairs roles with several women’s health companies.
Vice President of Global Clinical and Medical Affairs
Mr. Love Joined Direct Flow Medical March 2016. He previously was Vice President of Clinical Affairs for Endologix. During his tenure, Chuck and his team designed and ran the US pivotal trial for Nellix.While at Endologix, he oversaw a 300-patient post-market global registry for Nellix. Prior to joining Endologix, Chuck served as VP of Clinical and Regulatory Compliance at CircuLite. He has also served as a consultant and has held senior management level Clinical Affairs, Regulatory and Strategic Development positions for a variety of medical device companies and senior management and founder positions at Ramus Medical Technologies and Autogenics. He served on the Board of Directors for Loma Vista Medical, is on the Technical Advisory Board for Dexteritie Surgical, and serves as a board member for LimFlow. Chuck holds a B.A. in Biology from Westmont College. He holds numerous patents, is published in peer-reviewed journals, and has presented original data at major medical society meetings.
Vice President of Quality Assurance
Ms Nagel joined Direct Flow Medical, Inc. in January 2015. She has over 25 years of experience in the medical device and pharmaceutical industries. Prior to joining Direct Flow Medical, she was at Edwards Lifesciences, LLC, a global leader in the science of heart valves and hemodynamic monitoring, from 1997 to 2015. At Edwards, she served in a variety of leadership positions, including Senior Director, Corporate Quality; Senior Director, Regulatory Affairs, Critical Care; Senior Director, Quality, Critical Care; and Director of R&D Project Management. Previously Ms Nagel held positions of increasing leadership responsibility at Allergan, Inc., a global technology driven multi-specialty healthcare company. She led both anti-glaucoma and BOTOX projects from roles in R&D project management, regulatory affairs, marketing and business development. Ms Nagel holds a BA in Biological Sciences from the University of California, Berkeley.
Chief Commercial Officer EMEA
Mr. Schnelle has over 28 year’s experiences in the medical device and diagnostic business. He has a deep familiarity with major international markets, including in-country management experience in leading European markets, Asia/China and Middle East/Turkey. In all his assignments with growing responsibilities he held leadership positions in general management, sales and marketing with international leading premium product suppliers. During his 28 year endeavor with Johnson & Johnson, Edwards Lifesciences, St. Jude Medical, Ev3 Covidien and Terumo he successfully developed, evolved and lead organizations and teams in market segments such as General Surgery, Urology and Women’s Health, Interventional Cardiology & Radiology and Heart Surgery in emerging and developed international markets. He introduced prosperously with his teams the stapling- and minimal invasive surgery technique in General Surgery (J&J), the minimal invasive surgery technique into Heart Surgery with Heart Port (J&J and Edwards Lifesciences) and TAVR Technology (Edwards Lifesciences) in Cardiology and Heart Surgery in mid-2000. As the General Manager of D A CH at this time he was decisive directing the introduction of the new innovative therapy in his region as well as developing and leading the, at current state, valid professional educational processes and parameters. In addition, he played an important role in the preparation and achievement of the NUB status leading into the current reimbursement rating of the TAVR Technology in Germany. In addition Mr. Schnelle is certified as European Business and Talent coach.
Vice President of Worldwide Marketing
Mr. McIntee joined Direct Flow Medical Inc. January 2016. He has 30 years medical device marketing experience in diverse device environments ranging from startups to Fortune 500 companies, with 20 years’ experience in cardiovascular device marketing. Prior to joining the company Mr. McIntee was responsible for global marketing at Edwards Lifesciences Heart Valve Therapies business where he launched new surgical heart valve products and developed strategic and tactical marketing programs for product commercialization. Previous to Edwards, Mr. McIntee co-founded a medical device company, led marketing at an emerging heart failure device company and spearheaded global marketing for Edwards AAA stent graft business. Mr. McIntee also held positions with increasing responsibility at Medtronic, Pfizer, and Boston Scientific. He holds BSBA and MBA degrees from the Carlson School of Management at the University of Minnesota.
Vice President of Research and Development
Mr. Colone joined Direct Flow Medical in July 2016. He has over 34 years of medical device experience, including over ten years as President of Endomed, Inc. until its sale in February 2005. Mr. Colone has vast knowledge of PTFE and endovascular prostheses, and is recognized for his contributions to endoluminal technology and vascular surgery. He most recently served as Director of Research and Development, and later Director of Aortic Procedure Development, for Endologix. Mr. Colone directed the development of the Nellix Endovascular Aneurysm Sealing System through design completion, CE trial completion, CE Mark approval and OUS commercial launch. He also contributed to the procedure development and training for the US IDE investigation centers leading to the fastest enrolled IDE trial for an EVAR device. Mr. Colone holds 13 US patents for medical devices with others pending. He also served as Director of Operations for IMPRA, Inc. (now Bard Peripheral Vascular) prior to founding Endomed. Mr. Colone holds a Bachelor’s Degree in Chemical Engineering from Arizona State University where he is a member of the ASU Advisory Committee for Chemical and Materials Engineering. Mr. Colone also served as an Associate Faculty Member at ASU from 2004 through 2007 and was a Founding Member and Board Member of the Arizona Technology Investor Forum.
Vice President of Operations
Mr. Abraham joined Direct Flow Medical in October of 2016. Mr. Abraham brings with him 30 years of medical device experience, the majority of which has been in the cardiovascular space. Mr. Abraham served as VP, Global Operations at Endologix, a publicly traded medical device company from, 2010 through 2015 where he scaled operations to support over 400% growth and established international distribution capability to enable significant global expansion. Prior to joining Endologix, Mr. Abraham held several senior management positions at Edwards Lifesciences, a publicly traded medical device company, between 2001 and 2010 including VP/GM, Glucose Monitoring, VP Global Supply Chain & Logistics, and VP Manufacturing. Prior to joining Edwards Lifesciences, Mr. Abraham served as VP/GM of Sterilis, Inc., a privately-held medical device company. Mr. Abraham began his medical device career Cordis, a Johnson & Johnson Company, where he spent 14 years holding several positions of increasing responsibility in operations and product development. Mr. Abraham holds a B.A. in Economics from Duke University and completed graduate work in Engineering Management at the University of South Florida.