After a six-month pandemic-related delay, TransMedics (NSDQ:TMDX) is set to have an FDA panel review the premarket approval application for its donor heart transport technology on October 7, 2020.
TransMedics’ organ care system (OCS) technology is designed to keep donated hearts, lungs and livers in near-living condition until transplantation. The FDA approved the Andover, Mass.-based company’s lung transport system in 2018.
If the panel votes in favor of approval following its virtual meeting, TransMedics expects the FDA to officially approve the device within 3 to 4 months, company CEO Waleed Hassanein said during the company’s second-quarter analyst call. TransMedics is also working toward PMA approval of its donor liver transport system, which Hassanein said he expects to be approved in 2021, according to the call transcribed by Seeking Alpha.
And it is developing a separate heart transport system designed for resuscitated hearts, or hearts donated after circulatory death (DCD). In a DCD procedure, the donation process can start only after the heart has stopped beating. Currently, DCD donors are not considered for heart transplantation due to the potential for injury once the heart stops beating and the inability to assess heart viability using cold static storage, according to the company.
TransMedics reported the first successful DCD transplants in December. Further studies remain on track to complete enrollment in 2020 and for a PMA submission in 2021, Hassanein said during the call.
The coronavirus pandemic not only delayed the company’s FDA heart panel, it also resulted in delayed transplant procedures and a hit to earnings. TransMedics posted losses of -$8.5 million, or -36¢ per share, on sales of $3.4 million for the three months ended June 30, 2020, for a 7.6% bottom-line gain on a sales decline of -40.2%. Adjusted to exclude one-time items, earnings per share were also -36¢, coming in 6¢ ahead of Wall Street projections.
TransMedics received more than $2.2 million from the federal government’s coronavirus Paycheck Protection Program in April. Hassanein remains upbeat for the company’s future.
“Overall, we fully expect that we will have all three OCS products approved and generating commercial revenue in the U.S. in 2021,” he told analysts.