- The stock price of TransMedics Group (NASDAQ: TMDX) increased by over 10% pre-market. This is why it happened.
The stock price of TransMedics Group (NASDAQ: TMDX) – a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure – increased by over 10% pre-market. Investors appear to be responding to the company announcing 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 had voted 12 to 5 (with 1 abstaining) that the benefits of the OCS Heart System outweigh its risks. And the panel voted 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel had voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System’s safety.
The FDA Advisory Committees provide the FDA with independent opinions and non binding recommendations from outside medical experts. And 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.
The OCS Heart EXPAND trial had met its primary effectiveness endpoint. And it showed that the use of the OCS Heart System resulted in successfully transplanting 84% – more than 8 out 10 of the extended-criteria donor hearts that are seldom used for transplant today in the U.S. using cold ischemic storage preservation. And the post-transplant rate of severe Primary Graft Dysfunction was 8% – which is well below the rates reported in the literature and there were no unexpected safety findings. The patient survival at 30-days post-transplant was 97%. And all-cause survival was 92% at 6 months and 87% at 12 months. Importantly, cardiac-related survival was 96% at both 6 and 12 months, these survival rates are comparable to U.S. standard heart transplant outcomes.
“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. 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 deliberations on this important PMA. We are now laser focused and looking forward to our next important business milestones planned for 2021: the scheduling the OCS Liver FDA Advisory Panel Meeting, the final readout of the OCS Heart DCD trial and the filing of the DCD Heart PMA supplement to eventually expand our OCS Heart indication into DCD heart transplantation in the U.S.”
— Waleed Hassanein, MD, President and Chief Executive Officer
“For decades we have talked about heart transplant being supply limited. If approved by the FDA, with the use of OCS Heart System for extended criteria donors, and DCD hearts, we can access to a significantly greater suitable donor poll. As the donor pool expands, more patients can have access to this life saving therapy. If the OCS Heart System is approved, I believe the industry will reverse its thinking and open up the ‘demand’ to a greater patient population that never had a chance at a new heart and a better life.”
— Dr. Jacob Schroder, surgical director of heart transplantation at Duke University Medical Center and the principal investigator for the OCS Heart EXPAND Trial
“The potential opportunity to expand the donor pool for our heart transplant candidates using the TransMedics device in select patients would be a major advance in the field of heart transplantation.”
— Dr. Maryjane Farr, medical director of the transplant program at Columbia University Irving Medical Center
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.