Ms. Sainz has over 20 years of experience in the medical device industry having held commercial and general management positions in the US and Europe with small companies and large corporations. Ms. Sainz served as the President and CEO of Concentric Medical, Inc. since April 2008. In October 2011, Concentric Medical was acquired by Stryker Corporation where she was named General Manager of the business unit of Stryker Neurovascular. From 2006 to 2008, Maria led integration activities following the acquisition of Guidant by Boston Scientific. From February 2003 through July 2006, Ms. Sainz served as President of the Cardiac Surgery division of Guidant Corporation/Boston Scientific. From January 2001 through February 2003, Ms. Sainz served as Vice President, Global Marketing for the Vascular Intervention division of Guidant Corporation. From late 1998 through early 2001, Ms. Sainz served as Vice President of the Intermedics Cardiac Rhythm Management business of Guidant Corporation in Europe. Prior to that Ms. Sainz held several sales and marketing assignments of increasing responsibility in Guidant’s European operations. Ms. Sainz received an M.A. in Languages from the University Complutense in Madrid, Spain and a Masters in International Management from the American Graduate School of International Management.
Mr. Hale joined CardioKinetix in February 2013. He has over 15 years of experience as a financial professional with over 10 years in the medical devices industry. Prior to joining Cardiokinetix, Mr. Hale served as the Chief Financial Officer at Vibrynt, Inc. and Concentric Medical, Inc. Immediately prior to these roles, Mr. Hale held the positions of Sr. Director of Finance & Administration at Concentric Medical, Inc. and Corporate Controller at Emphasys Medical. Prior to his employment with Emphasys Medical, he held roles of increasing responsibility during his five years at Guidant Corporation/Boston Scientific in strategic planning, sales finance, financial planning, and internal audit. Prior to his experience in the medical device industry, Mr. Hale worked as an Assurance Manager at PricewaterhouseCoopers in Chicago. Mr. Hale holds a B.S. in Accounting and an M.B.A. both from Indiana University and is a Certified Public Accountant.
Dr. Griffin has provided consulting services for FDA and clinical trial strategy as well as serving as interim CEO or Chief Medical Officer. He has been a member of the Boards of Directors of over a dozen pubic and private companies including current service on the boards of three private, development stage companies. From 1999-2006 Dr. Griffin was President, CEO and a Director of POINT Biomedical Corp. where he led the company through the clinical development and submission of a New Drug Application (NDA) to the FDA for a novel pharmaceutical agent for ultrasound myocardial perfusion. Prior to joining POINT, Dr. Griffin, was Executive Vice President of InControl, Inc., a cardiovascular medical device company. Dr. Griffin was responsible for overseeing In Control’s clinical and regulatory programs and establishing a worldwide strategy for its devices for treating atrial fibrillation, a major cardiovascular disorder. Dr. Griffin was Professor of Medicine at the University of California at San Francisco and held a faculty position in cardiology there from 1984 to 1995. He also served on the faculties of Stanford University Medical School and Baylor College of Medicine. He holds a B.S. degree from the University of Southern Mississippi, an M.D. degree from the University Of Mississippi School Of Medicine, and received his Cardiology training at Stanford University Medical Center.
Mr. Nicholas has over 18 years of experience in Operations in the Medical Device industry. For the past ten years, Mr. Nicholas served as VP of Operations for Concentric Medical, Inc., as a global, commercial stand-alone entity all through the acquisition by Stryker Corporation in 2011. Prior to Concentric Medical, from 2001 to 2002, Mr. Nicholas served as General Manager West Coast Operations for MedSource Technologies, a contract OEM medical device manufacturer, where he was responsible for the manufacturing of Ethicon / J&J products. From 1994 to 2001, Mr. Nicholas was Director of Operations for Heartport Inc. Mr. Nicholas’s spent the first 12 years of his career in electronics manufacturing and operations where he had several roles with increasing responsibilities in production, materials and operations. He received his A.S. degree in Design & Drafting Technologies from the College of San Mateo.
Ms. Isaac has over 25 years of experience in the regulated industry including basic research, regulatory affairs, clinical affairs, clinical research, quality assurance, and corporate compliance. She has worked with medical devices, in vitro diagnostics, biologics, drugs and combination products in various therapeutic areas. She most recently successfully completed the first De Novo under FDASIA for NeoTract’s UroLift product. At NeoTract she was the Vice President of Regulatory Affairs, Clinical Affairs and Quality Assurance. Prior to NeoTract, Ms. Isaac was Vice President of Regulatory Affairs and Quality for Neuraltus Pharmaceuticals. Before Neuraltus, she was Senior Vice President of Clinical and Regulatory Affairs, and Quality Assurance for Broncus Technologies, Inc. Before joining Broncus in 2005, she was on the operating committee and served as the VP of Regulatory and Quality for Aerogen. When she left Becton Dickinson, she was the World Wide VP of Regulatory and Quality for BD Biosciences. She was until recently also Senior Counsel for Longwell and Associates, a Palo Alto based Food and Drug Law firm and in that capacity worked on numerous submissions, FDA strategies and compliance activities. Ms. Isaac holds a B.S. in Cell and Molecular Biology from San Francisco State University, a J.D. from Boston University School of Law with a concentration in Health Law as well as a Masters in Public Health and Law from Harvard School of Public Health. She is a member of the California Bar.
Gretchen Gary – Vice President, Global Therapy Advancement
Ms. Gary joined CardioKinetix in May 2015. She has 15 years of cardiac surgery and interventional cardiology clinical experience and over 18 years of medical device industry experience, primarily in the pioneering arena of Structural Heart. Prior to joining CardioKinetix, Ms. Gary served as Senior Director, Market Development for Direct Flow Medical, Inc. Immediately prior to Direct Flow Medical, Ms. Gary was with Evalve and then Abbott Structural Heart where she served in a number of key leadership roles including Director of Sales/European Country Manager, Director of Global Training and Director of US Market Development where she was responsible for driving patient enrollment into a landmark US clinical trial for percutaneous mitral valve repair which eventually led to CE mark and ultimately FDA approval. Prior to her employment with Evalve, she enjoyed successful careers at St. Jude Medical, Heartport, Inc., and Bard Vascular Systems. Ms. Gary has a B.A from Northwestern University and received her Cardiovascular Perfusion training from Tufts University School of Medicine.