UPDATE: Sept. 29, 2020: TransMedics announced Monday the FDA has again delayed a planned advisory panel to review the premarket approval application for its OCS Heart product. The company said the agency believes extra time will allow experts to review "additional, already collected, short and longer-term data" from the company's clinical trials. The meeting had already been rescheduled due to the pandemic from April 16 to Oct. 7.
CEO Waleed Hassanein said in a statement the company is "very disappointed by this unforeseen delay," but that FDA's cardiovascular devices office told the company it will aim to reschedule the meeting "in the near future. TransMedics' stock fell roughly 10% following the announcement.
- FDA plans to convene a group of circulatory system device experts April 16 to vote on recommendations regarding TransMedics' premarket approval submission for a system that helps preserve potential hearts for transplant.
- The Andover, Massachusetts-based medtech is seeking U.S. approval for its portable ex-vivo organ perfusion and monitoring system it hopes will be indicated for "resuscitation, preservation, and assessment of donor hearts."
- If approved, the heart transplant technology would build on FDA's 2018 approval of the lung version of TransMedics' Organ Care System, which the agency expanded last summer. The company also has a liver transplant product in the works it's said it plans to submit for premarket approval in the second quarter of 2020.
The company is currently running the DCD Heart trial to assess patient outcomes in those who receive a donation after cardiac death, or DCD, donor heart transplant versus those who receive a standard donor heart transplant. It's also conducting the EXPAND CAP trial, which is further examining safety and effectiveness of the TransMedics system in preserving and assessing donor hearts outside of standard acceptance criteria.
The company reportedly closed out 2019 with 15 U.S. centers trialing the OCS Heart technology.
Under the proposed indication FDA will review, donor hearts meeting one or more certain criteria could be used with the system, with the intent to transplant into a recipient "in a near-physiologic, normothermic, and beating state."
TransMedics' lung product is indicated for "preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation." FDA reported receiving an 18-month update on TransMedics' post-approval study for the device in September. A transplant tech competitor on the lung front, Xvivo Perfusion, gained premarket approval in mid-2019.
In earnings reported March 2, the company said it made $23.6 million in net revenue last year, up from $13 million in 2018. Net loss in 2019 totaled $33.5 million.
For 2020, TransMedics anticipates revenues between $40 million and $43 million, which would represent up to 82% year-over-year growth. During its earnings call, CEO Waleed Hassanein noted the company expects to benefit from a CMS move to change organ transplantation standards in the U.S.
With the meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee set to take place just over a month from now, it's unclear how social distancing efforts to mitigate spread of COVID-19 might disrupt the event. FDA did not respond to a request for comment on the matter in time for publication.