TransMedics (NSDQ:TMDX) said today that it won an expanded indication from the FDA for the transportation system for lung transplants it designed.
In April 2018, Andover, Mass.-based TransMedics won pre-market approval from the FDA for its OCS Lung device for standard double-lung transplantation procedures; in Europe, the OCS Heart and OCS Lung devices are already on the market.
Today the company said the federal safety watchdog extended the OCS Lung indication to cover the preservation and ex-vivo assessment of both standard-criteria donor lungs and a larger pool of donor lungs initially deemed unacceptable using traditional cold static preservation.
TransMedics said the new indication, which also covers organs from donors after brain death and circulatory death, means it can expand its post-market registry study to collect long-term data from all recipients of lungs preserved using the OCS device.
“We are pleased with the FDA approval, which uniquely positions the OCS Lung system as the only technology approved for both standard criteria and initially deemed unacceptable donor lungs for transplantation,” CEO Dr. Waleed Hassanein said in prepared remarks. “With this approval, the OCS Lung system could enable a significant increase in donor lung utilization for transplantation in the U.S. from those DBD and DCD donors that were initially deemed unacceptable based on limitations of cold storage. Now, these lungs can be preserved and assessed ex-vivo using our OCS Lung system to determine their suitability for transplantation. This marks a major milestone forward in our drive to expand access to life-saving transplant procedures for patients suffering from end-stage organ failure.”
“Lung transplant surgeons now have access to a technology that enables preservation and assessment and use of lungs from a wide range of donors. Importantly, the OCS Lung system enables these capabilities from the minute the donor lungs are procured until they are ready to be transplanted into the recipient across wide distances,” added Dr. Gabriel Loor, principal U.S. investigator for the OCS Lung Expand trial.
“This important milestone offers the promise to further expand the number and improve the quality of donor organs for sick patients waiting for lung transplant worldwide,” international principal investigator Dr. Dirk Van Raemdonck said.
Last month TransMedics closed an initial public offering that, including a fully subscribed over-allotment, grossed nearly $105 million.
