Elsa Chi Abruzzo

medical solutions Ms. Abruzzo has helped develop and bring to market include: transcatheter heart valves (TAVR), tissue heart valves, implantable biomaterials, surgical adhesives, embolic agents, stents, atrial fibrillation ablation devices, LAA closure devices, neuromodulation devices, human tissues, drug delivery systems and combination products, orthopedic navigation systems, microinvasive spinal implants, tissue containment and retrieval systems, homeostasis devices, and point of care lipid and glucose/A1c analyzers. She has authored or contributed to 4 granted US FDA Breakthrough Devices Designations.

Cygnus Regulatory, her former boutique consulting firm, specialized in regulatory and clinical strategy and execution, business development, due diligence, and engineering project management. Elsa has also successfully headed numerous development and operations project teams at a variety of start-up ventures.

Prior to staring Cygnus Regulatory and co-founding Anuncia, Inc. and becoming its President, Ms. Abruzzo worked in leadership roles at companies such as Baxter, Cordis JNJ, CryoLife, Percutaneous Valve Technologies (acquired by Edwards LifeSciences), AtriCure (IPO), InnerPulse, Merlin MD, Sapheon (acquired by Covidien/Medtronic), and PTS Diagnostics (acquired by Sinocare).

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). She is an inventor on US Patent 10,940,290 for fluid delivery systems and methods (held by Alcyone). Elsa has been a speaker at numerous professional conferences and was recognized for her leadership in Regulatory and Quality by MDDI Magazine 2007. She was also a 2012 Cincinnati Businesses Courier WE Celebrate Award recipient for top women in business. Ms. Abruzzo was born in Cuba and speaks Spanish fluently.