United Therapeutics Corporation (NASDAQ:UTHR) said Monday that the U.S. Food and Drug Administration (FDA) has granted premarket approval for its LungFX device, marking a significant step in the company’s efforts to increase the number of donor lungs available for transplantation.
The approval covers the use of LungFX in centralized ex vivo lung perfusion (EVLP), a process that allows donor lungs to be evaluated outside the body after they are procured and before transplantation.
FDA Clears Device For Centralized EVLP Procedures
The premarket approval application was submitted by United Therapeutics’ wholly owned subsidiary, Lung Bioengineering, and included safety and efficacy data supporting the use of LungFX in centralized EVLP facilities.
LungFX is designed to assess deceased-donor lungs that cannot initially be matched to recipients through traditional direct-to-recipient procurement and preservation methods.
The system provides normothermic perfusion and ventilation for donor lungs that have been preserved using cold static storage.
It enables transplant teams to reassess whether lungs previously deemed unsuitable could ultimately be transplanted into adult patients with end-stage lung disease awaiting their first single or double lung transplant.
Under the approved labeling, lungs transplanted following LungFX evaluation must undergo a second period of cold storage, with total preservation time not intended to exceed 20 hours.
Company Sees Opportunity To Increase Organ Availability
To date, Lung Bioengineering has conducted approximately 1,100 EVLP procedures using other approved systems, resulting in about 600 lungs being accepted for transplantation. The company expects to incorporate LungFX into its service offerings in 2027.
Martine Rothblatt, chairperson and chief executive officer of United Therapeutics, said the approval represents progress toward reducing the more than 80% of donor lungs that currently go unused. Rothblatt added that the clearance also supports the company’s long-term goal of developing technologies capable of creating an unlimited supply of transplantable organs.
Dr. Kenneth McCurry, director of the Cleveland Clinic Enterprise Transplant Center and an investigator in the LungFX pivotal trial, said the technology provides transplant teams with additional clinical information that can help determine whether donor lungs that might otherwise be discarded are suitable for transplantation.
LungFX is the first EVLP device approved specifically for use in centralized facilities, said Brandi Zofkie, associate vice president of Lung Bioengineering, noting that it potentially allows transplant programs to access EVLP services without establishing capabilities within their own hospitals.
UTHR Stock Price Activity: United Therapeutics shares were up 0.53% at $545.52 at the time of publication on Monday, according to Benzinga Pro data.
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