Ablative Solutions, Inc., was founded in 2011 with a vision to address the significant unmet clinical need of systemic hypertension.
Ablative Solutions is certified to ISO 13485, a comprehensive quality management system standard for medical device manufacturers.
David Fischell, PhD – Chairman and Founder
Dr. David Fischell is a serial entrepreneur who has founded 14 biomedical device companies in the last 20 years, including Angel Medical Systems, that has developed an implantable heart attack detection and patient alerting system, eNeura, Inc (2002) Transcranial Magnetic Stimulation systems for Migraine Headaches; NeuroPace, Inc. (1997) implantable brain pacemakers to treat epilepsy and Ablative Solutions (2011) to develop chemical based renal denervation catheters to treat hypertension. He currently has 156 issued U.S. patents, mostly medical devices, and from 1998 through 2003 was the primary designer of coronary stents, including the BX Velocity™ and Cypher™ Stents for Cordis now implanted in more than 7 million patients.
Tim Fischell, MD, FACC – Chief Executive Officer & Chief Medical Officer
A practicing interventional cardiologist, prolific inventor and entrepreneur, Dr. Fischell is currently Professor of Medicine at Michigan State and Medical Director of the Borgess Heart Institute Department of Cardiovascular Research and the Interventional Cardiology Fellowship Program. An inventor and co-inventor on over 70 patented devices, he co-designed the stent upon which the J&J drug-eluting stent platform is based. Co-founder of several biomedical start-up companies (Angel Medical Systems, Svelte, Ostial Solutions, etc.), his honors include the Thorax Center Andreas Gruentzig Award for Inventor of the Year in 1997. Dr. Fischell has presented over 200 papers and authored more than 110 articles in peer-reviewed journals and 20 book chapters.
Nicole Haratani, RN, BSN – VP Global Clinical and Regulatory Affairs
Nicole Haratani’s extensive background includes both clinical expertise in the medical device industry and practical nursing experience in trauma, the Cardiac Cath lab, and Cardiac Surgery ICU. Prior to Ablative Solutions, Inc., she was Vice President of Clinical Affairs at Guided Delivery Systems. She held director or senior director positions with Boston Scientific, Sadra Medical, and the Cardiovascular Research Foundation. Her clinical affairs experience includes Abbott Vascular, Guidant, and St. Jude Medical. She has co-authored numerous scientific papers and presented at multiple medical device conferences.
Mary Adams, BA, CQA – VP Global Quality Systems and Compliance
Mary Adams has held key positions in global Regulatory and Quality Systems Management in the medical device industry over the past 20 years. Her experience includes management roles at Endologix, Bausch & Lomb, and Biosense Webster/J&J. Most recently she was a Principle Consultant with Leave A Mark Consulting. Mary is a member of the Regulatory Affairs Professional Society and is an ASQ Certified Quality Auditor.
Helen Parise, PhD – VP Biometrics
With over 20 years of experience in medical research and clinical trials, Helen Parise has collaborated on the design, implementation and analysis of global clinical studies and research driven investigations as a Research Assistant Professor at Boston University, Director of Biostatistics at Veristat, Inc., a CRO, and more recently as Director of Biometrics, Executive Director of the Clinical Trials Center and Chief Statistical Officer at the Cardiovascular Research Foundation and Columbia University School of Medicine. With a doctorate in Biostatistics from Harvard University School of Public Health, Hele n has over 100 collaborative publications and has given numerous talks on the nuances of cardiovascular device trials.
Research and Development
Through a strategic partnership, Rev.1 Engineering plays an active role on the Ablative Solutions team. Rev.1 Engineering is a comprehensive product design, development and engineering company specializing in medical device innovation. Rev.1 is comprised of a team of passionate, highly qualified engineers, technicians, program managers and quality engineers.
Board of Directors
David Fischell, PhD (Chairman)
CEO, Angel Medical Systems – Shrewsbury, NJ
Tim Fischell, MD, FACC
Chief Executive Officer & Chief Medical Officer, Ablative Solutions – Kalamazoo, MI
Steven L. Almany, MD, FACC
Corporate Vice Chief of Cardiology, William Beaumont Hospital – Royal Oak, MI
David Rosen, BS, DVM
President & CEO, eNeura, Inc. – Baltimore, MD
Dale Grogan, CSCIP
Managing Director, Michigan Accelerator Fund – Grand Rapids, MI
Fischell TA, Fischell DR, Ghazarossian VE, Vega F, Ebner A, Next generation renal denervation: chemical “perivascular” renal denervation with alcohol using a novel drug infusion catheter, Cardiovasc Revasc Med. 2015 Jun;16 (4): 221-7.
Fischell TA, Vega F, Raju N, Johnson ET, Kent DJ, Ragland RR, Fischell DR, Almany SL, Ghazarossian VE, Ethanol-mediated perivascular renal sympathetic denervation: preclinical validation of safety and efficacy in a porcine model, EuroIntervention. 2013 May 20; 9(1):140-7.