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BiVACOR Appoints Veteran Medical Device Executive Raymond W. Cohen as Chairman of the Board of Directors
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BiVACOR, Inc. (Nasdaq: BVCR) announced the appointment of Raymond W. Cohen as chairman of its board of directors. The company also received FDA approval for a first-in-human clinical feasibility study of its total artificial heart (TAH) system. The study will evaluate the safety and feasibility of the TAH as a bridge to heart transplant in the treatment of subjects with biventricular heart failure. Approximately 100,000 patients suffering from severe heart failure could benefit from BiVACOR's unique TAH, according to the U.S. National Institutes of Health.
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HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--
BiVACOR, Inc., a clinical-stage medical technology company developing a total artificial heart (TAH), today announced that Raymond W. Cohen has been appointed chairman of its board of directors.
Mr. Cohen is an accredited public company director with over 40 years of experience in the life sciences industry. He currently serves as chief executive officer and member of the board of directors of Axonics, Inc. (Nasdaq: AXNX), an Irvine, Calif. based global medical technology company that he co-founded in 2013 and took public in October 2018. Axonics ranked No. 1 on the 2021 Deloitte Technology Fast 500™ and the 2022 Financial Times ranking of the 500 fastest growing companies in the Americas.
Mr. Cohen also serves as an independent director of SoniVie Ltd., a clinical-stage venture backed company developing a denervation technology for uncontrolled hypertension. In late 2020, Mr. Cohen was named as Entrepreneur of the Year by Ernst & Young for the Pacific Southwest United States.
In late November, BiVACOR announced that the U.S. Food and Drug Administration approved an investigational device exemption allowing the company to conduct a first-in-human clinical feasibility study of the BiVACOR TAH. The study will evaluate the safety and feasibility of the TAH as a bridge to heart transplant in the treatment of subjects with biventricular heart failure. Initially three patients will be enrolled at The Texas Heart Institute in Houston. The study is anticipated to commence in the first half of 2024.
“A total artificial heart is designed to take over the complete function of a patient’s failing heart and represents an advanced treatment option for people waiting on a heart transplant or those who do not qualify for certain reasons,” said Mr. Cohen. “The work done by BiVACOR over the past 15 years to develop the TAH system is impressive. I’ve spent much of my career in cardiology and consider it a privilege to join Dr. Timms and Dr. Cohn on this amazing journey.”
According to the U.S. National Institutes of Health, approximately 100,000 patients suffering from severe heart failure could benefit from BiVACOR’s unique TAH. For these patients, drug therapy is limited and without intervention, they have a bleak outlook given the low number of donor hearts available globally.
About BiVACOR®
BiVACOR is a clinical-stage medical technology company developing the BiVACOR Total Artificial Heart, designed to be the first long-term therapy for patients with severe biventricular heart failure. The TAH is designed to replace the naive heart and address the global unmet need of patients with end-stage heart failure by providing a next-generation life-extending solution. BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including founder and chief technical officer Daniel Timms, Ph.D., and chief medical officer William Cohn, M.D.
Business and Investor Relations Contact:
Niv Edward Caviar
CFO and COO
admin@bivacor.com
Source: BiVACOR, Inc.
FAQ
Who has been appointed as the chairman of BiVACOR, Inc.'s board of directors?
Raymond W. Cohen has been appointed as the chairman of BiVACOR, Inc.'s board of directors.
What did the U.S. Food and Drug Administration approve for BiVACOR, Inc.?
The U.S. Food and Drug Administration approved an investigational device exemption allowing the company to conduct a first-in-human clinical feasibility study of the BiVACOR TAH.
What is the purpose of the first-in-human clinical feasibility study for BiVACOR, Inc.?
The study will evaluate the safety and feasibility of the TAH as a bridge to heart transplant in the treatment of subjects with biventricular heart failure.
How many patients could benefit from BiVACOR's TAH, according to the U.S. National Institutes of Health?
Approximately 100,000 patients suffering from severe heart failure could benefit from BiVACOR's unique TAH, according to the U.S. National Institutes of Health.
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