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TransMedics Announces Scheduling of OCS Heart FDA Advisory Committee Meeting
ANDOVER, Mass., March 1, 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., March 1, 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 FDA's Office of Health Technology 2 (Cardiovascular Devices) has communicated its intent to hold a Circulatory Systems Device Advisory Panel meeting on April 6, 2021 to review TransMedics' premarket approval application for the OCS Heart System. \n\n \n \n \n \n \n \n\n \n \"We are looking forward to this important milestone and to hopefully achieving a positive conclusion of the FDA's review process of our OCS Heart PMA application,\" 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 Heart 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 business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in or implied by any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Some of the key...