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TransMedics Announces Positive Top Line Results From the U.S. Randomized OCS DCD Heart Trial

Published: 2021-11-04 11:00:00 ET
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ANDOVER, Mass., Nov. 4, 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, today announced positive topline results from its OCS donors after circulatory death (DCD) Heart Trial.

(PRNewsfoto/TransMedics, Inc.)

The OCS DCD Heart Trial was designed as the first and only randomized trial to compare post-transplant clinical outcomes between hearts transplanted from DCD donors that were resuscitated and assessed on OCS Heart System and hearts transplanted from donors after brain death (DBD) that were preserved using the current standard of cold storage in the U.S. The primary goal was to assess the effectiveness and safety of OCS Heart technology to expand the heart donor pool to include DCD donors. Heart transplant candidates were randomized 3:1 into two groups: DCD Heart Possible (DCD) or DBD cold stored hearts (Control). The trial protocol compared the post-transplant outcomes from recipients of DCD hearts preserved on OCS (DCD) to all those who received standard criteria DBD hearts preserved with cold storage (DBD Control).

The OCS DCD Heart trial achieved its primary clinical objectives by meeting the primary effectiveness endpoint of 6 months patient survival post-transplant which was 95% for OCS DCD arm vs. 89% for DBD Control arm. Even when the outcomes were adjusted for all risk factors between the two groups the results were 94% for OCS and 90% for Control (non-inferiority p