fda-approval
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Andrea Ashford-Hicks
Andrea Ashford-Hicks is the CEO of Cayuga Biotech, an early-stage platform biotechnology company developing biomimetic polyphosphate therapies for severe bleeding. She joined in 2022 after two decades in biopharma, including leading the FDA approval and commercial launch of RETHYMIC at Enzyvant Therapeutics and progressive roles at Johnson & Johnson, Pfizer, Agenus, EMD Serono and Schering-Plough. She holds dual degrees in biology and finance from the University of Pennsylvania and the Wharton School.
John McCutcheon
John McCutcheon is President, CEO, and Director of EBR Systems, Inc., the Sunnyvale-based medical device company behind the WiSE CRT system - the world's first FDA-approved leadless solution for left ventricular pacing. With over 40 years in medical device sales, marketing, and general management, McCutcheon has shepherded EBR through pivotal clinical trials, FDA Breakthrough Device Designation, and the landmark FDA approval in April 2025. Before EBR, he led Ceterix Orthopaedics to a $105 million acquisition by Smith & Nephew. He brings a track record of building and selling medical device companies, now steering EBR's commercial launch of a technology that could transform how heart failure patients receive cardiac resynchronization therapy.