TransMedics Stock Trading Halted Today; FDA Advisory Committee to Review Premarket Approval Application for the OCS Heart System
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.
SOURCE TransMedics, Inc.
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