ANDOVER, Mass., June 10, 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, today announced that
the U.S. Food and Drug Administration ("FDA") has announced the
scheduling of a public advisory committee meeting during which it
will review information regarding TransMedics' premarket approval
application for the OCS Liver System. The Gastroenterology and
Urology Devices Panel of the Medical Devices Advisory Committee
will meet on on July 14, 2021 to
discuss, make recommendations, and vote on a recommendation for
approval of the OCS Liver system.
"This is another important milestone to bring TransMedics closer to
having all of our three organ platforms approved by FDA in 2021,"
said Waleed Hassanein, M.D.
"We are looking forward to presenting the OCS Liver PROTECT data
to the advisory committee panel in support of our PMA for the OCS
Liver System. This is another important milestone to bring
TransMedics closer to having all of our three organ platforms
approved by FDA in 2021," said Waleed
Hassanein, M.D., President and Chief Executive
Officer.
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, the anticipated timing
of the Advisory Committee meeting to review TransMedics' premarket
approval application for its OCS Liver and likelihood of regulatory
approval. 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: 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 timing or results of
clinical trials for the OCS; regulatory developments in
the United States, European Union
and other jurisdictions; and the risks identified under the heading
"Risk Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2020, which is available
on the SEC's website at www.sec.gov. 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.