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 Nasdaq has halted trading of the company's common stock.
The U.S. Food and Drug Administration's (FDA) Gastroenterology
and Urology Devices Panel of the Medical Devices Advisory Committee
is meeting today to review TransMedics' Organ Care System™ (OCS)
Liver System. The OCS™ Liver System is a portable organ perfusion
and monitoring medical device intended to preserve a donated Liver
a near-physiologic, normothermic, and functioning state while
continually monitoring and optimizing Liver function for eventual
transplantation into the recipient.
The Advisory Committee meeting is scheduled for 9:00 a.m. ET. The briefing materials can be found
on the FDA website at
https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-14-2021-gastroenterology-and-urology-devices-panel-medical-devices-advisory-committee-meeting#event-information.
The Gastroenterology and Urology Devices Panel of the Medical
Devices Advisory Committee reviews and evaluates data concerning
the safety and effectiveness of marketed and investigational
gastroenterology, urology and nephrology devices and makes
appropriate recommendations to the FDA.
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 relating to certain future events. These
risks and uncertainties include those identified under the heading
"Risk Factors" 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.