Business
TransMedics Announces Temporary Postponement of OCS Heart FDA Advisory Panel Committee Meeting Due to COVID-19 Emergency
ANDOVER, Mass., March 17, 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., March 17, 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 Company and FDA/CDRH have mutually agreed to postpone the originally scheduled April 16th FDA Advisory Committee meeting to review the OCS Heart System due to the national emergency status relating to the COVID-19 Cornavirus. TransMedics and the Office of Cardiovascular Devices at FDA have agreed to continuously monitor the situation and work to reschedule the panel meeting as soon as possible.\n “We are disappointed by this unforeseen delay; however, TransMedics, FDA, and the nation are facing current unprecedented challenges and we will do everything possible to act and work collaboratively with the Office of Cardiovascular Devices to hopefully overcome these challenges in the near future,” said Waleed Hassanein, M.D., President and Chief Executive Officer. “We look forward to announcing the revised date of our panel as soon as it is rescheduled.” About TransMedics Group, Inc.TransMedics is the world’s leader in portable ex-vivo 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. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our results of operations, commercial opportunity and the rate of adoption and benefits of the OCS. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to our anticipation that we will continue to incur losses in the future; our potential need to raise additional funding; our existing and any future indebtedness, including our ability to comply with affir...