Chief Executive Officer
Barry Wolfenson is senior executive with over 15 years of experience in the advanced wound care industry. He previously served as CEO of Sano, LLC, a medical diagnostics company focused on the early detection of inflammation in various disease states. Prior to that, he served as President of the Advanced Wound Care division within Derma Sciences, after having led the creation of that division. While at Derma Sciences he ran one of the largest drug development programs in the field of advanced wound care, was responsible for all business development activities of the division, and managed the sales, marketing, and clinical departments. He also served in a variety of roles at Bristol-Myers Squibb, and was a consultant at Andersen Consulting. Barry received an MBA at the University of Michigan, and a BS in Economics with a Pre-Med Concentration at Franklin & Marshall College.
Chief Scientific Officer
Mitchell Sanders MS, PhD, has over 30 years of experience in preclinical animal models and clinical product development in advanced wound care. With ECI Biotech and Alira Health, Mitchell has produced over 12 peer-reviewed publications and 40 world wide patents in medical device and in vitro diagnostics. Mitchell is an expert in clinical and translational research and is a reviewer for the Wound Healing Society, Wounds International, Tissue Engineering, CIMIT, MassVentures, MIT, WPI, TechSandbox, PiranhaPond, SBANE and the Venture Forum. Mitchell has an MS and PhD from WPI in molecular biology and biomedical sciences with 2 Postdocs (biochemistry and pathogen genetics) at the Whitehead Institute/MIT.
Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics and biotech industries. She has successfully authored over 170 510(k)s, multiple PMAs, two De Novo submissions and has been responsible for several clinical trials. In addition, she has strong regulatory knowledge of global regulatory practices and registrations in Europe, Korea, and Australia having work on many technical files and CERs. Most recently, Mary was responsible for US regulatorystrategy at Intrinsic Therapeutics, VP of Regulatory and Clinical Affairs at Echo Therapeutics, Director of Regulatory Affairs at Z-Medica, and Director of Regulatory Affairs and Quality Assurance at Molecular Biometrics.Prior to Molecular Biometrics, Mary was in regulatory consulting for 17 years at Medical Device Consultants, Inc