NOEMÍ OLIVO

MSN, CCRP, Vice President, Regulatory Affairs and Clinical Research

Noemí Olivo is the vice president of regulatory affairs and clinical research. Noemí has over 25 years of experience in regulatory affairs, quality management, and clinical research with a focus on developing regulatory documentation for medical and in vitro diagnostic device (IVD) device FDA submissions, quality management systems, and clinical research studies. She is a Certified Clinical Research Professional (CCRP) and a member of the Regulatory Affairs Professional Society.

Noemí has held positions as vice president (for regulatory affairs, quality management, and clinical research for medical devices); senior director (for clinical research and quality management for IVD DNA sequencing, and medical device tissue-based cancer diagnostics); and director (for clinical drug trials and medical device studies).

As owner of CRO Services (an Independent CRO), Noemí has been contracted by device manufacturers, health care insurance plans, nonprofit organizations, and educational institutions to develop and oversee their regulatory and quality management infrastructures, prepare regulatory submissions, and to develop and monitor their clinical research studies.

RON SOAVE, DPM

Medical Monitor

Dr. Ron Soave brings years of experience to our team. He is board certified by the American Board of Foot and Ankle Surgery as well as the American Board of Podiatric Medicine, and a fellow of the American College of Foot and Ankle Surgeons.

Dr. Soave is the current dean of clinical education at the New York College of Podiatric Medicine and chief of podiatry at Maimonides Medical Center.

Previously, Dr. Soave served as director of a podiatric medicine and surgery residency program and medical administrative director of a wound care center at a teaching hospital.

He has served on national committees and is a recipient of the NYS Lifetime Achievement Award as well as an “Integrity and Excellence in Podiatry” award.

THEODORE J. GAETA

DO, MPH, FACEP

Dr. Theodore Gaeta is currently the chief research officer and vice chairman of emergency medicine at New York-Presbyterian Brooklyn Methodist Hospital and associate professor of emergency medicine in clinical medicine at Weill Cornell Medicine. He is the founding chair and professor of emergency medicine at St. George’s University School of Medicine.

Dr. Gaeta is a board-certified emergency physician, practicing academic emergency medicine for over 30 years. He has a wide-ranging background in research with extensive experience in funded, multicenter research. As a successful researcher, Dr. Gaeta has multiple national presentations and over 70 publications in peer-reviewed journals. From 2009 to 2013, Dr. Gaeta was the medical director for wound care and hyperbaric medicine at New York Methodist Hospital. In 2014, Dr. Gaeta joined the company in order to develop the research infrastructure and the CED therapeutic protocols necessary for CMS- approval.

TOM CROWLEY, JR.

Thomas A. Crowley, Jr., brings his executive, financial, investment, and management experience to our Scientific Advisory Committee. Tom has served as the chairman of the board of Vertical Spine, LLC, since July 2011. He has also served on the board of Cascade Medical Enterprises, LLC, since 2008. He is actively engaged in providing governance and business advice involving financial transactions, business strategy, and execution to two medical device companies. He also served as a chairman of Core Essence Orthopedics, Inc., from March 2011 to March 2012. Tom was a board member of Aircast, LLC, from September 2003 until May 2006, and was a board member of Freedom Innovations from March 2011 until June 2013, and a member of the Corporate Advisory Council and American Society for Surgery of the Hand from January 2010 and December 2011, respectively. Prior to his current role, Tom was president of Small Bone Innovations, Inc., from February 2008 until February 2011. He also served as a managing director, health care investment banking, at Friedman Billings Ramsey from September 2006 until January 2008. Tom holds a BA from Fairfield University as well as an MS from Columbia University School of Business, and he is a graduate of the U.S. Army Command and General Staff College, Ft. Leavenworth, Kansas.