TransMedics Announces Positive FDA Advisory Committee Vote for the OCS Liver System
The panel voted 14 to 0, that there is reasonable assurance that the OCS Liver System is effective and 14 to 0, that there is reasonable assurance of the OCS Liver System's safety. The panel voted 12 to 1, with 1 abstaining, that the benefits of the OCS Liver System outweigh its risks.
"This vote marks a key milestone as we move towards potential FDA approval of the OCS Liver technology, which stands to benefit
"The OCS Liver PROTECT Trial demonstrated that the OCS Liver has the ability to provide superior clinical outcomes and improve utilization of donor livers for transplantation. This is truly a game-changer in the field of liver transplantation," said Dr.
"Today's FDA panel vote brings us closer to potentially having all three OCS products FDA approved and commercially available in the
FDA Advisory Committees provide the FDA with independent opinions and nonbinding 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 ("PMA") for the use of the OCS Liver System for transplantation after completion of its review of the PMA.
The OCS Lung System is approved in the
The OCS Liver PROTECT trial met its primary effectiveness endpoint and demonstrated a significant reduction in early allograft dysfunction (EAD) with OCS (OCS 18% vs. Control 31%, p=0.009). OCS preserved livers also demonstrated a significant reduction in histopathological evidence of IR injury after reperfusion and significant attenuation of reperfusion syndrome in the recipient. OCS use was also associated with significant reduction in the incidence of ischemic biliary complications through one year, a leading cause of graft failure after liver transplant (OCS 2.6% vs. Control 9.9%, p=0.019). The OCS Liver System enabled ex-vivo liver allograft assessment, which resulted in a significantly higher utilization of livers from donors after cardiac death (DCD) (OCS 51% vs. Control 25%, p=0.007). PROTECT's safety endpoint was met with a low average number of liver graft-related serious adverse events (OCS 0.046 to Control 0.075, non-inferiority p<0.0001). Patient survival at one year was high at 94% for both OCS and Control arms.
About the OCS System
The OCS System is the only portable, multi-organ platform for donor lungs, hearts and livers for transplantation. The OCS System mimics the human body by providing donor organs with warm, oxygenated blood perfusion throughout preservation that maintains the organs in a living, functional state. The assessment capabilities of the OCS System enable diagnostic evaluation to allow for the analysis of organ function and viability prior to transplant. Normothermic perfusion on the OCS System optimizes the organ conditions and allows for therapeutic intervention through replenishing oxygen and nutrients.
This press release contains forward looking statements with respect to future events, including those that affect potential regulatory approvals for our OCS Liver System. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, 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 any factor, or combination of factors, may cause actual results to differ materially from those contained in or implied by any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed 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: that we continue to incur losses; our need to raise additional funding; our existing and any future indebtedness, including our ability to comply with affirmative and negative covenants under our credit agreement to which we will remain subject to until maturity, and our ability to obtain additional financing on favorable terms or at all; the fluctuation of our financial results from quarter to quarter; our ability to use net operating losses and research and development credit carryforwards; our dependence on the success of the OCS; the rate and degree of market acceptance of the OCS; our ability to educate patients, surgeons, transplant centers and private payors of benefits offered by the OCS; the impact of the outbreak of the novel strain of coronavirus and associated containment and remediation efforts; our ability to improve the OCS platform; our dependence on a limited number of customers for a significant portion of our net revenue; the timing of and our ability to obtain and maintain regulatory approvals or clearances for our OCS products; our ability to adequately respond to FDA follow-up inquiries in a timely manner; the performance of our third-party suppliers and manufacturers; the timing or results of clinical trials for the OCS; our manufacturing, sales, marketing and clinical support capabilities and strategy; attacks against our information technology infrastructure; the 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 avoid allegations that our products infringe, misappropriate or otherwise violate the intellectual property rights of third parties; our ability to obtain and maintain regulatory approvals or clearance for our OCS products; the pricing of the OCS, as well as the reimbursement coverage for the OCS in
View original content to download multimedia:https://www.prnewswire.com/news-releases/transmedics-announces-positive-fda-advisory-committee-vote-for-the-ocs-liver-system-301334292.html
Investor Contact: Brian Johnston, 631-807-1986, Investors@transmedics.com