TransMedics Announces Positive FDA Advisory Committee Vote for OCS Heart System

About this update from Transmedics Group, Inc.

[{"type":"text","content":"Panel votes 12 to 5 that benefits of OCS Heart System outweigh risks\n\n\nANDOVER, Mass., April 6, 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, announced today that after the review of TransMedics' clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol (\"CAP\") results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. Food and Drug Administration (\"FDA\") has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2 (Cardiovascular Devices). The panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System's safety.\n\n \n \n \n \n \n \n\n \nPanel votes 12 to 5 that benefits of OCS Heart System outweigh risksFDA Advisory Committees provide the FDA with independent opinions and non binding recommendations from outside medical experts. While the FDA will consider the opinions and recommendations expressed at the Advisory Committee, the FDA will make a decision regarding whether to approve the premarket approval application for the use of the OCS Heart System for donor hearts currently utilized and unutilized for transplantation after completion of its review of the application. \n\"This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review,\" said Waleed Hassanein, MD, President and Chief Executive Officer. \"We are grateful for the help and support of our investigators, the patients who enrolled in our trials, and the donor families who gave our patients the gift of life by supporting organ donation. In addition, we want to thank the respected members of the Advisory Panel and the FDA review team for their thoughtful discussion and delibera...

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