Leadership Team

Leadership Team

Chris Richardson
Chris Richardson
President & Chief Executive Officer

Mr. Richardson has spent his 30-year career taking medical device 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).

Steve Sandweg
Steve Sandweg
Vice President Sales & Market Development

Mr. Sandweg has close to 30 years of sales, sales training, and sales management experience. Over the past 22 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 Market Development for Direct Flow Medical where he was responsible for all field operations supporting the SALUS TAVR Trial.

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

Amit Ashkenazi
Amit Ashkenazi
Vice President Research & Development & Chief Operating Officer

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.

Chris Richardson
President & Chief Executive Officer

Mr. Richardson has spent his 30-year career taking medical device 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).

Steve Sandweg
Vice President Sales & Market Development

Mr. Sandweg has close to 30 years of sales, sales training, and sales management experience. Over the past 22 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 Market Development for Direct Flow Medical where he was responsible for all field operations supporting the SALUS TAVR Trial.

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 in 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.

Amit Ashkenazi
Vice President Research & Development & Chief Operating Officer

Mr. Ashkenazi has more than 17 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.

Karen Jaffe
Vice President Regulatory Affairs, Quality Assurance, & Clinical Operations

Ms. Jaffe has more than 15 years’ experience in the pharmaceutical and medical device industry, specifically focused on pharmacovigilance, regulatory affairs, and quality assurance management. Ms. Jaffe holds a Master’s degree in Electrical Engineering, an MBA and a Master’s in Regulatory Science, and a BSc in Computer Science. Karen has experience preparing and submitting technical files for CE Mark, US FDA (Class 2 and Class 3), Health Canada, and other global regulatory authorities. Ms. Jaffe has conducted multi-national clinical trials for class III implantable devices, managed quality systems audits, transition from ISO13485:2003 to ISO13485:2016, and preparation for MDSAP certification. Ms. Jaffe holds ISO22442 certification and has managed global regulatory and quality strategies for many indications, including dental, orthopedic, and obesity, requiring oversight of sterilization, dose audits, environmental controls, and biocompatibility, packaging validation, design control execution, and shelf life. Karen has held RAC certification since 2012.

Interested in joining the Keystone Heart team? Learn more here.

Skip to content