“We continue to be encouraged by the early clinical results demonstrated by the Parachute® implant. In all of our previous studies we have seen similar improvements in treated heart failure patients.”Thomas Engels, Vice President of Clinical Affairs of CardioKinetix Inc.
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 years of 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.
Serjan Nikolic co-founded Cardiokinetix with late Brano Radovancevic, MD of Houston, TX and serves as a Director and Chief Technical Officer since its inception. He has more than 10 years experience in the medical device industry and 25 years in the academic medical research at Albert Einstein College of Medicine and Stanford University. Serjan’s previous industry positions include management positions at Neovasys, CardioSynopsys, Advance Closure Systems and Somnus (Acquired by Gyrus). He holds advanced degrees in Biophysics, Biomedical Engineering and Cardiovascular Physiology from Yeshiva University and Albert Einstein College of Medicine in New York City. He is a member of several professional societies including Fellow of American College of Cardiology. Dr. Nikolic is extensively published in cardiovascular field with more than 150 original research papers and publications. He is also a named inventor on numerous US patents.
Mr. Engels joined CardioKinetix in February 2010. He has over 15 years experience in the clinical research arena spanning pharma, biotech, and nearly 10 of the years with medical devices at Guidant / Abbott. He has filled many different roles within clinical research, most recently as the Director of Clinical Research at Abbott Vascular in Santa Clara, CA where he was responsible for over 30 global trials, ranging from small first-in-man trials to large post-marketing efforts. He had the opportunity to work on the predicate device trials through the PMA submission, FDA Panel, and launch of XIENCE VTM. At Guidant, he led the implementation of web-based clinical trials, as well as process alignment across business units and geographies. His previous work history also includes clinical research management positions at PAREXEL, Covance, and Pennington Biomedical. Mr. Engels holds a BS from Louisiana State University, MBA degrees from the Columbia Business School and the Haas School of Business, UC Berkeley and certifications in Advanced Project Management and Organizational Design through Stanford University.
Ms. Mateus joined CardioKinetix in January 2012. She has 15 years of regulatory experience with Class III medical device/drug combination implants. Prior to her current role with CardioKinetix, Ms. Mateus served as the Regulatory Affairs Director for Abbott Vascular. In this role, she was responsible for international submissions in Europe, Middle East, Africa, Canada and Latin America for all Abbott Vascular products. She was responsible for the first of its kind approval for a novel technology, the ABSORB Bioresorbable Vascular Scaffold. In addition, her US focused regulatory roles supporting drug eluting stents, resulted in the successful FDA Advisory Panel and PMA approval for the XIENCE V Everolimus Eluting Coronary System. Prior to that role Ms. Mateus held regulatory roles with increasing responsibilities at Abbott, Guidant and Medtronic supporting a broad range of cardiovascular based products. She has a B.S. Mass Communication – Journalism from San Jose State University and a Regulatory Affairs Certification.
Mr. Templin joined CardioKinetix in 2011. He has over 12 years of experience in clinical research and engineering, primarily within the medical device industry. Most recently, prior to his current role with CardioKinetix, Mr. Templin served as the Global Clinical Program Director for Abbott Vascular. In that role, he led multiple coronary and endovascular trials (DES, BMS, Bioresorbable, and BDC), interfaced with clinical thought leaders, and is published in medical journals. In addition, he led the landmark vulnerable plaque natural history study, PROSPECT, which is now published in the NEJM. Prior to that role Mr. Templin held engineering roles with GE Aircraft Engines (Six Sigma Project Leader) and Guidant (DES Product Development), and then clinical positions with both Guidant and Abbott. Mr. Templin holds a BS in Mechanical Engineering from Rose-Hulman Institute of Technology, MBA degree from Duke, and certifications in Advanced Project Management and Organizational Design through Stanford University.
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. Fam has over 20 years of experience in the medical device industry having held general management, sales, marketing and clinical roles for small and large organizations globally. Ms. Fam was leading European operations for Concentric Medical, Inc. as Vice President, EMEA from February 2010. Concentric Medical, Inc. was acquired by Stryker Neurovascular in October 2011, and Ms. Fam was named Vice President, International Marketing. Ms. Fam led the commercial operations, new technology introductions and product development input, garnering her strong thought leader connections. During the Stryker Neurovascular acquisition, she led the international integration of the organization. Ms. Fam has also provided a European footprint for medical device “start-up” organizations to gain access to the European market at an early stage from 2007 when she first resided in the United Kingdom. From 2005 to 2007, she was the Director of Marketing for Concentric Medical, Inc in the United States, and prior to this held various sales, marketing and clinical roles with Guidant Corporation in Santa Clara, CA and also led these functions for Guidant Asia’s operations. She has also held various sales and marketing roles with increasing responsibility for Johnson & Johnson and Mallinckrodt (now Covidien) for Australian/New Zealand regions. Ms. Fam received a Diploma in Nuclear Medicine Technology from Sydney University in Australia as well as a Bachelor of Health Administration from the University of New South Wales, Australia. In 1996 she was awarded her MBA from University of Technology, Sydney, Australia.