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TransMedics Announces Temporary Postponement of OCS Heart FDA Advisory Panel Committee Meeting
ANDOVER, Mass., Sept. 28, 2020 (GLOBE NEWSWIRE) -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming
About this update from Transmedics Group, Inc.
[{"type":"text","content":"ANDOVER, Mass., Sept. 28, 2020 (GLOBE NEWSWIRE) -- 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 has temporarily postponed the Advisory Committee meeting to review TransMedics’ premarket approval application for its OCS Heart. The postponement of the meeting, which was-previously scheduled for October 7th, 2020 will allow the FDA time to review additional, already collected, short and longer-term data from the OCS Heart EXPAND trial and EXPAND Continued Access Protocol. The FDA’s Office of Health Technology 2 (Cardiovascular Devices) has communicated to TransMedics that it will review the additional data expeditiously to allow rescheduling of the Advisory Panel meeting to occur in the near future.\n “While we are very disappointed by this unforeseen delay, this development demonstrates the collaborative work TransMedics and FDA are doing together to ensure that FDA regulatory decisions related to the OCS Heart are made with the most informative and complete scientific data. We remain highly confident that the results of the OCS Heart EXPAND trial and the associated EXPAND Continued Acccess Protocol support FDA approval of the OCS Heart to help patients in need of heart transplant in the U.S.,” said Waleed Hassanein, M.D., President and Chief Executive Officer. About 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. Forward-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 comp...