United Therapeutics receives FDA approval for LungFX EVLP device

• United Therapeutics (NASDAQ:UTHR) announced FDA premarket approval of its LungFX device for centralized ex vivo lung perfusion.
• LungFX enables assessment of donor lungs outside the body, potentially increasing the number of transplantable organs.
• United Therapeutics’ subsidiary Lung Bioengineering has performed 1,100 EVLP procedures to date, resulting in 600 transplanted lungs.

United Therapeutics (NASDAQ:UTHR) announced that the U.S. Food and Drug Administration has granted premarket approval of the LungFX device for use in centralized ex vivo lung perfusion.

The PMA was submitted by United Therapeutics’ wholly owned subsidiary, Lung Bioengineering, and includes comprehensive safety and effectiveness data.

LungFX is indicated for centralized evaluation of deceased-donor lungs that cannot be placed for transplantation using standard procedures.

Lung Bioengineering has performed 1,100 EVLP procedures using approved devices, with 600 lungs accepted for transplant, and expects to add LungFX to its services in 2027.

“Today’s approval is a big step forward in reducing the large number of donor lungs — over 80% — that are unfortunately left behind instead of being transplanted,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics.

Lung Bioengineering operates centralized EVLP facilities in Silver Spring, Maryland, and Jacksonville, Florida, dedicated to extending preservation and assessing donor lungs.