About Us

 

ELSA CHI ABRUZZO, RAC, FRAPS

Ms. Abruzzo, 46, is a uniquely qualified medical device and biotechnology executive with proven experience, vision, and results driven passion.  As an entrepreneur and president of the boutique regulatory and clinical consulting firm Cygnus Regulatory (formerly ARAC, LLC); Elsa has a 25+ year successful regulatory, quality, clinical, engineering, manufacturing, and project management track record.   Cygnus Regulatory’s areas of expertise include cardiovascular, neurovascular, orthopedic, CRM/active implantables, imaging/diagnostic, OTC monograph drugs, human tissue banking/processing, animal tissue devices, mHealth, Health IT, and point of care diagnostic devices.  Some of the disruptive medical solutions Ms. Abruzzo has helped develop and bring to market include: transcatheter heart valves, tissue heart valves, implantable biomaterials, surgical adhesives, embolic agents, stents (bare metal, covered, and drug eluting), atrial fibrillation ablation devices, neuromodulation devices, human tissues, and point of care lipid and glucose analyzers.

 At Cygnus Regulatory, Ms. Abruzzo’s international clients, primarily startups, technology incubators, and emerging growth companies, span a variety of medical disciplines.   Cygnus Regulatory specializes in regulatory and clinical strategy and execution, business development, due diligence audits, and engineering project management.   As an exceptional relationship builder, Elsa successfully headed numerous development and operations project teams at a variety of start-up ventures.

Prior to staring Cygnus Regulatory, Ms. Abruzzo worked at companies such as Baxter, Cordis JNJ, CryoLife, Percutaneous Valve Technologies (acquired by Edwards LifeSciences), AtriCure, InnerPulse, Merlin MD, and Polymer Technology Systems (PTS) Cardiochek.  As head of regulatory and clinical affairs, she designed, developed, and managed domestic and international clinical trials, including Bayesian adaptive designs and break-through first-in-man studies; and regulatory strategies resulting in global commercialization of numerous technology platforms and products.

Ms. Abruzzo has a B.S. in engineering from the University of Miami (Coral Gables, FL) and is regulatory affairs certified (RAC) and a Regulatory Affairs Professional Society (RAPS) Fellow (inducted in 2010).    Elsa is also actively involved in the Cincinnati Community and in national healthcare and business professional organizations. As a thought leader in regulatory and clinical affairs, she has been invited to present at the University of Cincinnati Medical Device Innovation and Entrepreneurship Program, the Ohio Valley Affiliated LifeSciences (OVALS), CincyIP, Innov8 Health IT Accelerator, the Regulatory Affairs Professional Society, Xavier Universities Quality Institute, Good Promotional Practices.com (regular blogger), and ADVAMED.  Elsa has been recognized for her leadership in Regulatory and Quality by MDDI Magazine 2007.  Ms. Abruzzo was also inducted into the Cincinnati USA Regional Chamber of Commerce Leadership Cincinnati Class 2011-2012 and was one of the Finalist at The WE (Women Excel) Celebrate Awards for Best Product/Service 2012.   She is also the co-founder of and a host of Think Talk LAF a Cincinnati based radio show and national orbital network dedicated to building community awareness for navigating the healthcare system.  Elsa is married to Dr. Todd Abruzzo and has four sons.

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