Dive Brief:

• FDA has scheduled an advisory committee meeting to gather expert input on whether to approve TransMedics' device for preserving donor livers.

• The Gastroenterology and Urology Devices Panel will meet virtually on July 14 to discuss the filing for premarket approval of the OCS Liver system, designed to mimic the conditions of the human body to keep donor organs viable for longer.

• TransMedics has already come through one advisory committee this year, when the experts in circulatory systems convened in April by FDA voted 12 to 5 that the benefits of OCS Heart outweigh the risks.

Dive Insight:

TransMedics has lined up a series of regulatory milestones for 2021 that will shape its future. By the end of the year, the Massachusetts-based medtech company aims to have won FDA approval for all three major transplant indications. FDA approved OCS Lung in 2019 and the advisory committee backed OCS Heart in April, raising the likelihood of a FDA approval and leaving the liver application as one of the last hurdles to the realization of TransMedics' goal for the year.

FDA is yet to publish background materials for the OCS Liver advisory committee meeting.

The agency used the April OCS Heart meeting to get the input of experts on potential issues with the design and conduct of the key supporting study and their effect on the interpretability and validity of the results.

Last month, an analyst asked TransMedics CEO Waleed Hassanein what stumbling blocks the company could encounter as FDA scrutinizes the data on OSC Liver. The question prompted a bullish response from Hassanein about the dataset TransMedics has put together to support approval of OSC Liver. 

"Our liver data is the cleanest and the highest number of statistical superiority endpoints that we've ever achieved in any trial we've conducted in the history of TransMedics. I'm sure the FDA could pick on something that is relevant,"  the CEO said. "But from a clinical perspective, from an implementation perspective, we feel very strongly that our liver data is what I just described. It's the cleanest. It's the highest rate of endpoints achieving statistical superiority in any trial we've conducted."

TransMedics shared top-line data from the pivotal OCS Liver clinical trial more than one year ago. The readout linked use of the system to a significant reduction in the incidence of early allograft dysfunction compared to control.