Rindex Medical, Inc.
25422 Trabuco road Suite 105-606
Lake Forest, CA 92630
Alexander Arrow, M.D., C.F.A., has served on Rindex’s Board of Directors since 2011, and the Board of Biolase, Inc. (Nasdaq: BIOL) from 2010 through 2014. He was the President and Chief Operating Officer of Biolase from June 2013 through September 2014 and was responsible for leading the six operational divisions: Operations, R&D, Regulatory, Clinical Affairs & Education, Marketing, and IT. Prior to that, he served as the Chief Medical and Strategic Officer of Circuit Therapeutics, Inc., a Stanford-affiliated neurological device company seeking to commercialize optogenetics-enabled products, from 2012 through 2013. From 2007 through 2012, Dr. Arrow was the Chief Financial Officer of Arstasis, Inc., a 115-employee cardiology device manufacturer. From 2002 to 2007, Dr. Arrow headed medical technology equity research at the global investment bank Lazard, where he was particularly known for his cardiovascular, neurologic, and wound care device research coverage. Dr. Arrow also spent two years as Chief Financial Officer of the Patent & License Exchange, Inc., and three years as the senior medical technology analyst at Wedbush Morgan Securities. He holds an M.D. from Harvard Medical School and a B.A. in Biophysics, magna cum laude, from Cornell University.
Kay Fuller has more than 35 years experience developing and commercializing complex cardiovascular and neurosurgical medical devices. She has led successful global clinical studies and regulatory marketing authorization submissions for more than 35 Class II & Class III medical devices and combination products, via the U.S. FDA IDE, IND, 510(k), PMA and E.U. CE mark processes, which have enabled over $5B in global medical product sales. She founded MDRS, LLC, a national regulatory consulting firm that specializes in providing strategic FDA and global regulatory, quality and clinical research support to biotechnology companies. Prior to establishing MDRS, she developed the IND/IDE Faculty Investigator Assistance Program (MIAP) at the University of Michigan Medical School’s Institute for Clinical and Health Research (MICHR). A seasoned regulatory executive, advisor and author, Kay has guided many organizations toward gaining FDA enforcement action resolutions, including those associated with FDA 483 Observations, Warning Letters and Consent Decrees. A frequent Regulatory Sciences guest speaker at UM and nationally, Kay was a member of the UM Coulter Translational Partnership Program Technical Oversight Committee and a founding member of the National NIH CTSA Regulatory Working Group IND/IDE Support Taskforce during her tenure at UM’s MICHR. Kay has held regulatory, quality, clinical and R&D positions of increasing responsibility with global medical device companies, including W. L. Gore & Associates, P-S Medical (acquired by Medtronic), C. R. Bard, Terumo Corporation, Cohera Medical, and Tangent Medical. Kay received her undergraduate degree in Veterinary Technology from Texas State Technical College and is board certified in medical device and pharmaceutical regulatory affairs.
Denis Hickey has served on Rindex’s Board of Directors since June 2011. He has been working in management, contracts, purchasing, logistics, and supply chain for the last ten years. From 2000 – 2005, Mr. Hickey implemented policies and procedures for two staff property managers and 14 construction workers on large real estate redevelopment projects. In 2009, Mr. Hickey manages staff at 250 units that together generate $1.8 million in revenue per year. He he studied Business and Economics at Oregon State University with a concentration in Managerial Economics.
The Mission of Rindex Medical, Inc. is to establish a productive working team dedicated to developing the world’s first diagnostic device that can predict the onset of Atrial Fibrillation before it occurs.
Existing commercially-available devices can detect AF once a patient already has it. But surprisingly, clinicians today have no diagnostic tool other than their own intuition to help them predict whether or not a give patient in their care who doesn’t yet have AF will go on to develop what has become the world’s most common arrhythmia.
The device that we believe may be capable of making clinically useful predictions about whether an individual patient will go on to develop AF is in development in our R&D department. Its working name is the Rindex Medical A-50 Atrial Fibrillation Risk Index System. Because it is still in its prototype stage, we’ve made no claims about its capabilities. The A-50 AF Risk Index System is a development stage medical device and is not for sale in the United States or any other country.
Our goal is to create a safe, effective A-50 that will fulfill the vision of The Cleveland Clinic-based researcher team, lead by Dr. C. Allen Bashour, of a tool to enable AF to be treated prophylactially — before it occurs — by clinicians armed with a scientifically-sound predictive Index – an Index of AF likelihood for each patient in their care.
We take our mission seriously. We’ve built Rindex Medical and the Rindex Corporate Mission around this goal. Our clinical advisory board is in-formation and we welcome dedicated thought leaders in the AF field from around the world.