About Sunshine Heart

C-Pulse Device

Executive Team

Sunshine Heart's employees have a wealth of experience in medical technology and heart assist therapy development and commercialization.

Sunshine Heart has a world class team dedicated to commercializing the C-Pulse® System.

 


David Rosa

Chief Executive Officer; Board of Directors

Dave Rosa is Sunshine Heart's Chief Executive Officer. Mr. Rosa has spent the past 19 years in a variety of positions in the medical device industry. He was appointed CEO in October of 2009.

Prior to joining Sunshine Heart, he was President and CEO of Milksmart, Inc., a privately held company developing a unique stent-like agricultural technology that increases milking efficiencies, output and quality. From 2004-2008, Rosa was Vice President of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical, Inc. While at St. Jude, he directed the launch of twenty seven new products within the Company's cardiovascular division.

From 1999-2004, Rosa held executive management positions at privately held A-Med Systems, Inc., an emerging medical technology company that designs, develops and commercializes percutaneously placed ventricular assist devices (pVADs) for acute heart failure. His roles included Vice President of Marketing and Sales, Senior Vice President of Marketing and Business Development, Chief Operating Officer and Chief Executive Officer. From 1995- 1999, he served as Product Manager for Angioplasty Balloons and Director of Intravascular Ultrasound at SCIMED Life Systems, a privately held company that was engaged in the development, manufacture and marketing of medical devices to treat cardiovascular disease. SCIMED was acquired by Boston Scientific Corporation and now operates as a subsidiary of Boston Scientific.

Mr. Rosa holds an M.B.A. in Marketing Management from Duquesne University and a B.S. in Commerce and Engineering from Drexel University.

 


Claudia Drayton

Chief Financial Officer

Claudia Drayton joined Sunshine Heart in January 2015 as Chief Financial Officer. Ms. Drayton spent the prior 15 years at Medtronic, Inc., a global leader in the medical device industry. During her tenure, she held multiple senior managerial finance positions in Medtronic’s Corporate Finance organization and its Cardiac Rhythm Management division, culminating with a two year assignment in Europe serving as Chief Financial Officer of the Peripheral Vascular Business and most recently, as Chief Financial Officer and Senior Finance Director of the Integrated Health Solutions business. In these capacities her responsibilities and experiences included profitability management, strategic planning, mergers and acquisitions, planning and forecasting, business integrations and implementation of financial best practices.

Before Medtronic, Ms. Drayton was an Audit and Business Advisory Manager at Arthur Andersen for seven years. She is a certified public accountant, graduated with a BS in Accounting from the University of Mary Hardin-Baylor and holds an MBA from the University of Minnesota’s Carlson School of Management.

 

 

Debra Kridner

Executive Vice President of Regulatory Affairs

Debra Kridner joined Sunshine Heart in November 2009 as Vice President, Clinical Research and Regulatory Affairs. Kridner brings more than 30 years of experience in clinical research, quality and regulatory affairs for the medical device industry.

Prior to joining Sunshine Heart, Kridner owned a consulting firm focused on clinical research and regulatory affairs. Before founding her own business, she served as Vice President, Clinical Research and Regulatory Affairs for Cardiac Surgery and Interventional Cardiology for the Cardiovascular Division of St. Jude Medical, Inc. Prior to St. Jude, Kridner held senior management positions in clinical, regulatory, and quality at Medtronic in the areas of cardiac surgery and neurology.

In addition Kridner also held executive management position as the Vice President of Regulatory and Quality for Medsource, an eleven facility medical device contract manufacturer. Her career also included several medical and scientific research and development companies including Edwards Lifescience/Baxter Edwards and, Gish Biomedical.

Debra is also on the Advisory Board for the St. Cloud University Masters Degree Program for Clinical Research and Regulatory Affairs. Kridner holds a B.A. in Biology from University of California Fullerton.

 



Kim Oleson

Senior Vice President, Clinical Affairs

Kimberly Oleson has joined Sunshine Heart in April 2014 as Senior Vice President, Clinical Affairs. Ms. Oleson brings more than 25 years of visible achievements in the medical device industry related to clinical affairs, preclinical research, quality systems and regulatory affairs.

Prior to joining Sunshine Heart, Ms. Oleson was Vice President of Global Clinical Operations at Medtronic Inc., one of the world’s largest medical technology companies. She was the strategist responsible for building the company's first centralized clinical operations organization serving the company's broad portfolio of clinical trials and developing contemporary methods related to total product lifecycle risk management and clinical trial risk management.

Trained as a biostatistician, Ms. Oleson's distinguished career includes positions of increasing responsibility across large and venture-based businesses within Medtronic, resulting in the global commercial release of multiple medical therapies in the fields of cardiology, interventional cardiology, cardiac electrophysiology, neurourology and drug delivery.

In addition to her clinical trial expertise, Ms. Oleson has co-authored 10 peer-reviewed publications and is credited with 4 issued/filed patents. She is an industry representative for regulatory standard technical committees including the International Standards Organization which published the ISO 14155:2011 Good Clinical Practice standard for medical device clinical trials. Ms. Oleson holds a B.A. in Biometry from the University of Minnesota.

 



Brian Brown

Senior Vice President of Operations and Technology

Brian Brown joined the company in 2014 as the Senior Vice President of Technology and Operations. He brings over 24 years of experience in the medical device industry. Prior to Sunshine Heart, Brown spent 24 years at Boston Scientific in a number of leadership roles. He most recently served as the Vice President of Research and Development for the past 10 years. He participated on the executive leadership team for their Interventional Cardiology business unit, and directed the worldwide cardiovascular research and development activities. This included the launches of implantable stents, drug delivery technologies, disposable catheters, and structural heart technologies. Through active involvement with the New Business Development team Brown was also able to achieve the acquisition of numerous long term strategic technologies, which included carotid, bifurication and abluminally coated stents, along with left atrial appendage closure devices.

Brown earned a Mechanical Engineer degree from North Dakota State University. He is proficient at identifying, assessing, and transforming new technologies and products into revenue growth. He has successfully developed products for the treatment of cardiovascular disease, peripheral vascular disease, cerebral vascular disease and structural heart defects. His expertise also includes combining the domestic experience of a small company leader with the global perspective of a large multinational corporation, providing him with the experience to make research , development, and operations decisions

Brown holds an impressive 53 issued U.S. patents in stent geometries, nitinol, balloon catheters, thrombectomy catheters, infusion catheters and ePTFE processing.

 


Molly Wade

Vice President of Worldwide Patient Recruitment and Marketing

Molly Wade joined Sunshine Heart in October of 2013 as Senior Director of U.S. Patient Recruitment. She was appointed as Vice President, Worldwide Patient Recruitment and Marketing in August of 2014. Molly brings more than 14 years of market development and sales experience in both the medical device and pharma industries.

Prior to joining Sunshine Heart, Wade spent 6 years at CVRx, a small privately held company, conducting clinical research in both hypertension and heart failure. At CVRx, Molly showed that she is extremely skilled in her ability to drive patient recruitment. She led the U.S. team to complete enrollment of their Pivotal IDE trial months ahead of schedule. Molly also has worked for Medtronic, CR Bard, and Eli Lilly in various sales capacities.

Molly holds a B.S in Marketing from the University of Minnesota Carlson School of Management.

 

Dimitrios "Jim" Georgakopoulos

Chief Scientific Officer

Dr. Dimitrios “Jim” Georgakopoulos joined Sunshine Heart Inc. in December 2014 as Chief Scientific Officer. He has nearly 15 years of combined medical device industry experience and academic research. Jim’s area of expertise includes hemodynamics, cardiac and arterial mechanics, and neural control of the circulation; particularly as applied to heart failure and hypertension. Prior to joining Sunshine Heart, Jim was a Research Fellow at CVRx Inc. 

Jim completed his undergraduate training at the University of Toronto in Systems Physiology and Physics followed by graduate training at The Johns Hopkins University, in the Schools of Public Health and Medicine where he received a doctorate degree in Cardiovascular Physiology. He currently holds 6 patents and more than 40 peer reviewed publications and is a reviewer for several scientific journals.