crudeoil24
4年前
TransMedics Late Tuesday Announced FDA Advisory Committee Panel Voted 12 To 5 That Benefits Of OCS Heart System Outweigh Risks
6:58 am ET April 7, 2021 (Benzinga) Print
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 after the review of TransMedics' clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol ("CAP") results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. Food and Drug Administration ("FDA") has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2 (Cardiovascular Devices). The panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System's safety.
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
crudeoil24
4年前
Transmedics group, Inc. is a commercial-stage medical technology company. It is focused on developing organ transplant therapy for end-stage organ failure patients across multiple disease states. The Company has designed and developed organ care system (OCS) a portable organ perfusion, optimization and monitoring system that utilizes customized technology to replicate near-physiologic conditions for donor organs outside of the human body. It has developed three OCS products, one for each of lung, heart and liver transplantations. Its OCS clinical programs include OCS Lung INSPIRE Trial, OCS Lung Expand Trial, OCs Heart EXPAND and PROCEED II Trials. Its organ care system (OCS) technology platform to perfuse donor organs with warm, oxygenated, nutrient-enriched blood, while maintaining the organs in a living, functioning state; the lung is breathing, the heart is beating and the liver is producing bile. It is also focused on developing additional OCS products for kidney transplantation.
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