Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other structural heart procedures.

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Meet Keystone Heart

Keystone Heart, Ltd. is a medical device company developing and manufacturing cerebral embolic protection (CEP) devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.

The company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation, and other cardiovascular procedures. The TriGuard™ and TriGUARD 3™ product pipelines are designed to help interventional cardiologists and electrophysiologists to preserve brain reserve in patients undergoing these procedures.

Headquartered in Israel, with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The company’s management team has extensive experience in the fields of interventional cardiology and medical devices.

Keystone Heart holds and maintains a comprehensive IP portfolio and is ISO certified.

OUR VISION & MISSION

Our Vision
Keystone Heart aspires to be the world leader in cerebral embolic protection (CEP) during cardiovascular procedures.

Our Mission
To develop and manufacture novel devices that protect the brain from emboli to reduce the risk of brain infarcts during transcatheter aortic valve replacement (TAVR), atrial fibrillation ablation (AF ablation),  and other structural heart procedures.

Cerebral function is essential to maintaining quality of life. Preserving brain reserve during medical procedures is a key component to procedural success and patient care.

ManagementTeam

Chris Richardson

President & Chief Executive Officer

Mr. Richardson has spent his 25-year career taking cardiac startup companies from the clinical trial phase through worldwide commercialization and into acquisition. Prior to joining Keystone Heart, Mr. Richardson was international president and CCO of Direct Flow Medical, a transcatheter aortic valve company, and general manager of Abbott Vascular Structural Heart, a global company focused on percutaneous mitral valve repair, which he joined through its acquisition of Evalve. Mr. Richardson has also held leadership positions at Boston Scientific’s Cardiac Rhythm Management business and GSC Management Development at Guidant, Heartport (acquired by Johnson & Johnson) and Devices for Vascular Intervention (acquired by Guidant).

Amit Ashkenazi

COO & Vice President Research & Development

Mr. Ashkenazi has more than 10 years of experience in research and development of medical devices, mainly in the field of interventional ultrasound guidance and labor progress monitoring. Prior to joining Keystone Heart, Mr. Ashkenazi served as Director of Engineering for Trig Medical Ltd. where he was responsible for the product development and commercialization of guidance systems and disposable products.

Ron Nitzan, Ph.D.

Vice President Quality and Regulatory Affairs

Dr. Nitzan has more than 15 years of experience in the field of medical devices, serving in various positions including R&D, application manager, quality assurance, clinical studies and regulatory affairs. Prior to joining Keystone Heart, Dr. Nitzan served as Global Director of Clinical and Regulatory Affairs at Given Imaging Ltd, managing clinical studies world-wide.

M. Pauliina Margolis, M.D., Ph.D.

Vice President & Chief Medical Officer

Dr. Pauliina Margolis joined Keystone Heart as Vice President and Chief Medical Officer 2012. Prior to Keystone Heart, Dr. Margolis served as CMO and VP Scientific Affairs at Volcano Corporation 2001-2012. Formerly, she served as medical consultant to different start-up companies including Transvascular Inc, Point BioMedical, PharmaSonics, American Biosciencies, Target Therapeutics, and VasConnect, different Venture Capital firms and larger companies in CA, Silicon Valley, USA. Dr. Margolis has authored over 100 original scientific publications including several reviews and book chapters, holds over 20 patents. Her university lectures and teaching include Human Physiology, Oulu, Finland, Cardiology, Cincinnati, USA and Cardiology Edinburgh, UK. Dr. Margolis did her post-doctoral fellowship in experimental coronary ischemia in the University of Cincinnati, UK, specialty in internal medicine, University of Helsinki, Finland, interventional cardiology training, University of Edinburgh, UK, and Early Business Development and Executive Management at Stanford Business School, Stanford University, CA, USA.

Steve Sandweg

Vice President Sales & Market Development

Mr. Sandweg has 25 years of sales, sales training, and sales management experience. During the past 19 years, he has held roles of increasing responsibility within the cardiovascular and structural heart space for Boston Scientific, Medtronic, and Direct Flow Medical. While with Medtronic, he helped to launch several strategic products to include, Endeavor and Resolute, the companies first drug eluting stents. He also served on the original US Sales Management Team responsible for launching CoreValve and CoreValve EVOLUT, the companies first transcatheter aortic valve devices. Prior to joining Keystone Heart, Mr. Sandweg served as the Director of US Field Operations for Direct Flow Medical and was responsible for all field operations supporting the SALUS TAVR Trial.

Board ofDirectors

Vince Burgess

Executive Chairman

Mr. Burgess is a venture partner at OrbiMed Advisors LLC with over 20 years of experience in healthcare operations, business development and venture capital. Vince was on the founding executive team at Volcano Corp., serving as group president, advanced imaging systems. During his tenure, Volcano grew from a raw start-up to a global company with a market cap of over $1.2 Billion. Previously, Mr. Burgess served as a general partner of San Diego-based Sorrento Ventures, focusing on healthcare investments.

Nissim Darvish, M.D., Ph.D.

Director

Dr. Darvish is a senior managing director at OrbiMed. He has more than 15 years of experience in the life science industry, covering medical technology development, corporate leadership and investment management. Dr. Darvish spent eight years with Pitango, where he was a general partner managing life science investments. Previously, he was the founder and CEO of Impulse Dynamics.

Mark Maciejewski

Director

Mr. Maciejewski is experienced in venture capital and private equity funding within the global community, including US, China, Europe and Middle East, and has long-standing public and private life science company relationships, with specialization in joint venture formation and transactions.  With broad operational expertise, Mr. Maciejewski has held several CEO-level executive positions with large multi-national device firms and small venture backed start-ups, and founded, formed and funded numerous early-stage companies including: AngioGuard, Devax, Symphony Medical, Suturtek, Celleration, RegenRx and Venus MedTech. He has also assumed responsibilities for “cross border transactions” between  China (listed and private PRC companies) and US entities.

David P. Bonita, M.D.

Director

Dr. Bonita is a private equity partner at OrbiMed Advisors LLC. Prior to joining OrbiMed, Dr. Bonita worked as a corporate finance analyst in the healthcare investment banking groups of Morgan Stanley and UBS. He has also published scientific articles in peer reviewed journals based on signal transduction research performed at the Harvard Medical School.

Chris Richardson

Director

Mr. Richardson has spent his 25-year career taking cardiac startup companies from the clinical trial phase through worldwide commercialization and into acquisition. Prior to joining Keystone Heart, Mr. Richardson was international president and CCO of Direct Flow Medical, a transcatheter aortic valve company, and general manager of Abbott Vascular Structural Heart, a global company focused on percutaneous mitral valve repair, which he joined through its acquisition of Evalve. Mr. Richardson has also held leadership positions at Boston Scientific’s Cardiac Rhythm Management business and GSC Management Development at Guidant, Heartport (acquired by Johnson & Johnson) and Devices for Vascular Intervention (acquired by Guidant).

Jack B. Yang

Director

Mr. Yang is Founding Partner of Ming Capital (focused on global medical devices VC investment) with over 25 years of M&As or investment experience, and serves on the board of a European cardiovascular company and its Remuneration Committee. He was Investment Committee member of New Hope Industry Fund I (USD) and successfully managed high-tech funds covering medical devices in China. Prior to that, he worked mainly with Rothschild Investment banking in London and Hong Kong, doing M&As in Europe and East & Southeast Asia, respectively. He also worked with CITIC Group in Beijing and Tokyo.