ANDOVER, Mass., January 5, 2022 / PRNewswire / – TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company transforming organ transplant therapy for patients with end-stage lung, heart and liver failure , today announced the publication of OCS ™ Liver PROTECT Trial Results in JAMA surgery, member of the Journal of the American Medical Association (JAMA) network. The publication, titled Impact of portable normothermic blood-based machine infusion on liver transplant outcomes, was published online at January 5, 2022. The OCS ™ Liver System has been approved by the United States Food and Drug Administration (FDA) for the storage and evaluation of donor livers for donor transplantation after brain death (DBD) and after circulatory death. (DCD) on September 29, 2021.
“The PROTECT trial showed superior clinical results in the short and medium term and a higher number of donor livers used for transplantation,” said Dr. James F. Markmann, chief of the transplant surgery division at Massachusetts General Hospital and senior author of the manuscript. “We concluded that the advent of portable extracorporeal and extracorporeal donor liver perfusion offers for the first time a practical and effective approach to clinically assess and improve donor liver function, thereby improving the safety of transplantation, expanding the pool of liver donors and reducing the waiting list – This is a game-changer in the area of liver transplantation. “
“We believe that these superior clinical results represent a revolutionary step for liver transplantation,” said Walid Hassanein, MD, President and CEO. “This publication is further evidence that the OCS Liver System, along with our OCS Lung and OCS Heart Systems, will dramatically improve patient outcomes and expand the pool of eligible donors, thereby saving more lives. “
About the OCS ™ Liver PROTECT Trial
The OCS ™ Liver PROTECT trial was a pivotal, two-arm, multicenter, prospective, randomized, controlled trial to evaluate the efficacy and safety of the OCS ™ Liver for preserving and evaluating donor livers for transplantation. The trial enrolled 300 patients, including 153 patients randomized for transplantation using the OCS ™ Liver and 147 patients randomized to the control group, who used cold storage methods. Registration ended in October 2019 with transplants performed in a network of 20 major liver transplant centers in the United States
The primary endpoint of study efficacy was the incidence of ADE during the first 7 days after transplant procedures. The primary safety endpoint of the study was the mean number of serious adverse events (SAEs) related to liver transplantation per patient measured over the 30 days following transplant procedures. The study also measured the rate of DCD and DBD donor utilization, the incidence of ischemic biliary cholangiopathy, and other clinical parameters throughout the first year after liver transplantation.
The results of the study demonstrated that the primary efficacy endpoint was achieved by a significant decrease in ADE (27 out of 150 [18%] against 44 out of 141 [31%]; P = .01) and that the preserved livers from the OCS ™ liver showed a significant reduction in histopathologic evidence of ischemia-reperfusion injury after reperfusion (eg, less moderate to severe lobular inflammation: 9 of 150 [6%] for OCS ™ Liver vs 18 out of 141 [13%] for ischemic cold storage (ICS); p = 0.004). The OCS ™ Liver resulted in significantly higher utilization of donor livers after cardiac death (28 of 55 [51%] for OCS ™ liver vs 13 of 51 [26%] for the SCI; p = .007). OCS ™ Liver was also associated with a significant reduction in the incidence of CSI 6 months (1.3% vs. 8.5%; P = 0.02) and 12 months (2.6% vs. 9.9 %; P = 0.02) after the transplant.
About TransMedics Group, Inc.
TransMedics is the world leader in portable extracorporeal warm infusion and evaluation of donor organs for transplantation. Based at 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 before transplantation, and potentially increase utilization. donor organs for the treatment of end-stage heart, pulmonary and hepatic insufficiency.
This press release contains forward-looking statements regarding future events, including the marketing of OCS Liver. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. In addition, 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 one factor, or combination of factors, may cause a risk. substantial difference between actual results and those contained or implied. by any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances mentioned 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 factors that could cause actual results to differ include: our continuing to incur losses; our need to raise additional funds; our current and future indebtedness, including our ability to comply with positive and negative covenants under our credit agreement to which we will remain subject until maturity, and our ability to obtain additional financing or to refinance debt existing under favorable conditions or not at all; the fluctuation in our financial results from quarter to quarter; our ability to use net operating losses and research and development credit carry-overs; our dependence on the success of the SCO; the rate and degree of market acceptance of the OCS [including our efforts to develop a national OCS program]; our ability to educate patients, surgeons, transplant centers and private and public payers of OCS services; the impact of the outbreak of the novel strain of coronavirus and associated efforts at containment, remediation and vaccination; our ability to improve the OCS platform and develop the next generation of our OCS technology platform; our dependence on a limited number of customers for a significant portion of our net sales; when and our ability to obtain and maintain regulatory approvals or authorizations for our OCS products; our ability to adequately respond to FDA follow-up requests in a timely manner; the timing and our ability to market and market our OCS products; the performance of our third-party suppliers and manufacturers; the schedule or results of post-approval studies of any clinical trials for OCS; our manufacturing, sales, marketing and clinical support capabilities and strategy; attacks against our IT infrastructure; economic, political and other risks associated with our foreign operations; our ability to attract and retain key personnel; our ability to protect, defend, maintain and enforce our intellectual property rights relating to the OCS and to avoid claims that our products infringe, misappropriate or infringe the intellectual property rights of others; the pricing of the OCS, as well as the reimbursement coverage of the OCS in United States and internationally; regulatory changes in United States, European Union and other jurisdictions; the extent and success of competing products that are or may become available; the impact of any product recalls or misuse of our products; our use of proceeds from our stock offerings; our estimates of revenues, expenses and additional funding requirements; and the risks identified under the heading “Risk Factors” and elsewhere in our annual report on Form 10-K for the year ended December 31, 2020, our quarterly reports on Form 10-Q and in any subsequent filing with the Securities and Exchange Commission (“SEC”). Additional information will be made available through our annual and quarterly reports and other documents that we make from time to time with the SEC. These forward-looking statements speak only as of the date of this press release. Factors or events that could cause our actual results to vary may occur from time to time, and we cannot predict all of them. We assume no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by applicable law.
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SOURCE TransMedics Group, Inc.