TransMedics Stock Trading Halted Today; FDA Advisory Committee to Review Premarket Approval Application for the OCS Liver System

Rhea-AI Summary

TransMedics Group, Inc. (Nasdaq: TMDX) announced on July 14, 2021, that trading of its common stock has been halted by Nasdaq. The halt coincides with a meeting of the FDA's Gastroenterology and Urology Devices Panel, which is set to review TransMedics' Organ Care System™ (OCS) Liver System. This medical device aims to preserve donor liver organs in a near-physiologic state, enhancing their viability for transplantation. Investors are advised to monitor the outcome of the FDA meeting as it may impact future stock performance.

Positive

• The FDA Advisory Committee is reviewing the OCS Liver System, which could lead to future approvals and market opportunities.

Negative

• Trading of TMDX stock has been halted, indicating potential uncertainty or regulatory issues.

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.

FAQ

Why is TransMedics' stock trading halted?

TransMedics' stock trading was halted by Nasdaq to coincide with the FDA Advisory Committee's review of the OCS Liver System.

What is the OCS Liver System by TransMedics?

The OCS Liver System is a portable organ perfusion device designed to preserve donated livers in a functioning state for transplantation.

When is the FDA Advisory Committee meeting for TransMedics?

The FDA Advisory Committee meeting to review the OCS Liver System occurred at 9:00 a.m. ET on July 14, 2021.

What are the implications of the FDA meeting for TMDX stock?

The outcome of the FDA meeting could greatly affect TransMedics' future approvals, market opportunities, and subsequently, TMDX stock performance.

How does the OCS Liver System benefit organ transplantation?

The OCS Liver System aims to maintain liver organs in a near-physiologic state, potentially improving their viability and success rates for transplantation.