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TransMedics Announces Scheduling of OCS Liver FDA Advisory Committee Meeting
ANDOVER, Mass., June 10, 2021 /PRNewswire/ -- TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ
About this update from Transmedics Group, Inc.
[{"type":"text","content":"ANDOVER, Mass., June 10, 2021 /PRNewswire/ -- TransMedics Group, Inc. (\"TransMedics\") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced that the U.S. Food and Drug Administration (\"FDA\") has announced the scheduling of a public advisory committee meeting during which it will review information regarding TransMedics' premarket approval application for the OCS Liver System. The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet on on July 14, 2021 to discuss, make recommendations, and vote on a recommendation for approval of the OCS Liver system. \n\n \n \n \n \n \n \n\n \n\"This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by FDA in 2021,\" said Waleed Hassanein, M.D.\"We are looking forward to presenting the OCS Liver PROTECT data to the advisory committee panel in support of our PMA for the OCS Liver System. This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by FDA in 2021,\" said Waleed Hassanein, M.D., President and Chief Executive Officer. \nAbout TransMedics Group, Inc. TransMedics is the world's leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure.\nForward-Looking StatementsThis press release contains forward-looking statements with respect to, the anticipated timing of the Advisory Committee meeting to review TransMedics' premarket approval application for its OCS Liver and likelihood of regulatory approval. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our busin...