ANDOVER, Mass., April 6, 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) Circulatory System
Devices Panel of the Medical Devices Advisory Committee is meeting
today to review TransMedics' Organ Care System™ (OCS) Heart System.
The OCS™ Heart System is a portable organ perfusion and monitoring
medical device intended to preserve a donated heart in a
near-physiologic, beating and perfused state, while continually
monitoring and optimizing heart 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/april-6-2021-circulatory-system-devices-panel-medical-devices-advisory-committee-meeting#event-materials.
The Circulatory System Devices Panel of the Medical Devices
Advisory Committee reviews and evaluates data concerning the safety
and effectiveness of marketed and investigational devices for use
in the circulatory and vascular systems 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, 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, Inc.