ANDOVER, Mass., June 8, 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 that
the complete results of the OCS™ Liver PROTECT Trial ("PROTECT")
were presented virtually at the American Transplant Congress on
Tuesday June 8th, 2021.
The presentation won the People's Choice Award for the most
impactful presentation at the ATC 2021.
"The PROTECT trial results demonstrated superior short and mid-term
clinical outcomes and improved utilization of donor livers for
transplantation," - Dr. Markmann, Chief of the Division of
Transplantation Surgery at Massachusetts General Hospital
Dr. James F. Markmann, Chief of
the Division of Transplantation Surgery at Massachusetts General
Hospital and the lead investigator of the PROTECT trial, presented
the results, which included 12-month follow up data and were also
highlighted in an abstract entitled Superior Post-transplant
Clinical Outcomes Using Portable Normothermic Perfusion and
Assessment with the Organ Care System (OCS) Liver System: 1-year
Outcomes of the OCS Liver Protect Randomized Controlled Trial.
The OCS Liver system premarket approval (PMA) application is
currently under review by FDA and an Advisory Panel Meeting is
expected to review the PROTECT results in the near future.
At ATC 2021, Dr. Markmann reported that PROTECT 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 of ischemic biliary complications at 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 and resulted in 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 low mean 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.
"The PROTECT trial results demonstrated superior short and
mid-term clinical outcomes and improved utilization of donor livers
for transplantation," said Dr. Markmann. "The advent of a portable
extracorporeal donor liver machine perfusion offers a convenient
and effective approach to both assess and enhance donor liver
function, thereby improving transplant safety, expanding the liver
donor pool, and reducing waitlist mortality."
"We would like to congratulate Dr. Markmann and all of the
PROTECT trial investigators on these superior and potentially
transformative results in liver transplantation," said Waleed Hassanein, MD, President and Chief
Executive Officer. "We are looking forward to our upcoming FDA
Advisory Panel meeting to discuss the potential approval of the OCS
Liver System based on these PROTECT trial results."
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, 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.