TransMedics Group (TMDX) Announces Trading Halt as FDA Advisory Committee to Review Premarket Approval Application for the OCS Heart System
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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.
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