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

Rhea-AI Summary

TransMedics Group, Inc. (NASDAQ: TMDX) announced a halt in trading of its common stock as the FDA's Circulatory System Devices Panel meets to review its Organ Care System™ (OCS) Heart System. The OCS™ is designed to preserve a donated heart in a near-physiologic state for monitoring and eventual transplantation. The meeting is set for 9:00 a.m. ET, with more details available on the FDA's website. This review is crucial for advancing TransMedics' innovative technology aimed at improving organ transplantation outcomes.

Positive

• FDA advisory committee reviewing the OCS™ Heart System could lead to potential approval.
• TransMedics is positioned as a leader in organ transplantation technology, addressing critical needs.

Negative

• Trading halt may lead to increased uncertainty among investors.
• Potential risks associated with the FDA review process could affect stock performance.

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.

View original content to download multimedia:http://www.prnewswire.com/news-releases/transmedics-stock-trading-halted-today-fda-advisory-committee-to-review-premarket-approval-application-for-the-ocs-heart-system-301262582.html

SOURCE TransMedics, Inc.

FAQ

What caused the trading halt for TransMedics (TMDX) on April 6, 2021?

The trading halt was announced ahead of the FDA's review of TransMedics' OCS™ Heart System by the Circulatory System Devices Panel.

What is the purpose of the OCS™ Heart System from TransMedics?

The OCS™ Heart System is designed to preserve a donated heart in a nearly physiologic state for monitoring and optimizing its function before transplantation.

When is the FDA advisory committee meeting for the OCS™ Heart System?

The meeting is scheduled for 9:00 a.m. ET on April 6, 2021.

How could the FDA review impact TransMedics (TMDX) stock?

Approval from the FDA could enhance market confidence and drive stock performance, while rejection could lead to negative market sentiment.