ANDOVER, Mass., July 14, 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 review and discussion of TransMedics' clinical evidence from
the OCS Liver PROTECT trial, the Gastroenterology and Urology
Devices Panel of the Medical Devices Advisory Committee convened by
the U.S. Food and Drug Administration ("FDA") has issued a
favorable vote in support of approval of 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
U.S. patients with end-stage liver failure. We are looking forward
to working collaboratively with the FDA to finalize the review of
the OCS Liver PMA," said Dr. Waleed
Hassanein, President and Chief Executive Officer. "I want to
take this opportunity to thank the OCS Liver PROTECT Trial
investigators, trial coordinators, patients who enrolled in the OCS
Liver PROTECT Trial, and the TransMedics Liver team."
"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.
James F. Markmann, Chief of the
Division of Transplantation Surgery at Massachusetts General
Hospital and the lead investigator of the OCS Liver PROTECT Trial.
"The OCS Liver System allows surgeons to both assess and enhance
donor liver function before transplantation, which can improve
transplant safety and enables the use of donor livers that would
otherwise go unused. If approved by the FDA, I believe the OCS
Liver will allow us to provide more life-saving transplants for
patients with end-stage liver disease."
"Today's FDA panel vote brings us closer to potentially having
all three OCS products FDA approved and commercially available in
the U.S. for lung, heart and liver transplantation," Dr.
Waleed Hassanein concluded.
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 U.S., and the OCS Heart
System is currently under review by the FDA after receiving a
positive vote by the FDA's Circulatory System Device Advisory Panel
in April.
PROTECT Trial
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.
About TransMedics Group, Inc.
TransMedics is the
world's leader in portable extracorporeal 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 Statements
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
the United States and
internationally; 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 filings with
the Securities and Exchange Commission ("SEC"). Additional
information will be made available by our annual and quarterly
reports and other filings 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 differ may emerge from time to time, and it is not
possible for us to predict all of them. We undertake no obligation
to update any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by applicable law.
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SOURCE TransMedics Group, Inc.