Tivic Health Systems, Inc. announced that its Board of Directors has appointed Michael K. Handley as Chief Executive Officer of Tivic, effective 04 March 2026 . Mr. Handley succeeds Jennifer Ernst, who has served as CEO since its founding in 2016 and is stepping down from the CEO role, effective March 2, 2026, as the Company enters its next chapter. Ms. Ernst will continue to support the Company through this strategic transition.
Mr. Handley, 54, is a successful life sciences business professional with over two decades of experience in drug and device commercialization, regulatory and clinical affairs, operations, strategic transactions, market development, and partnering/licensing. He has served as the Company?s Chief Operating Officer and President of Tivic Biopharma since February 18, 2025. Prior to joining the Company, Mr. Handley served as President, Chief Executive Officer, and Chairman of Statera Biopharma, Inc. from July 2021 to February 2025.
From July 2019 to March 2020, he was the Chief Executive Officer and a director of Immune Therapeutics. Earlier, from 2012 to 2018, he served as Chief Executive Officer and a director of Armis Biopharma, a development-stage healthcare company, where he was responsible for day-to-day operations, global product approvals, intellectual property strategy, commercialization, business development, and financing. Mr. Handley founded Vessix Vascular, Inc. in 2011 and served as its Vice President of Clinical, Quality, and Regulatory until its acquisition in 2012.
He later served as Global Head of Regulatory at Acclarent, Inc. from 2010 to 2011 until it was acquired. He also held senior executive roles at Spectranetics, a medical device company, and Accelapure Corporation, a biotechnology company. Earlier in his career, Mr. Handley worked in consulting and drug development roles at biotechnology companies including Genentech, Inc., Amgen Inc., and Gliatech Inc. Mr. Handley graduated cum laude from Colorado State University in 1995 with Bachelor of Science degrees in molecular biology and physiology, along with minors in chemistry and neurobiology.
He also attended the Graziadio Business School of Pepperdine University, where he completed his Executive Master of Business Administration. Mr. Handley has contributed to the U.S. approval and commercialization of seventeen products, generating billions of dollars in revenue and providing treatments to tens of thousands of patients. His leadership experience and background in life sciences are expected to support Tivic?s strategic focus on the high-growth biopharma sector, including the advancement of late-stage immunotherapies and the launch of its contract biomanufacturing subsidiary, Velocity Bioworks.
