United Therapeutics Corporation Announces FDA Approval of the LungFX™ Device for Centralized Ex Vivo Lung Perfusion

About this update from United Therapeutics Corporation

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the LungFXTM device (LungFX) for use in centralized ex vivo lung perfusion (EVLP), a procedure that enables donor lungs to be assessed outside the body after procurement and before transplantation. The PMA, submitted by United Therapeutics’ wholly owned subsidiary, Lung Bioengineering Inc., included comprehensive safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility. LungFX is indicated for centralized, ex vivo (outside the body) evaluation of deceased-donor lungs (single and double) that cannot be placed for transplantation by an organ procurement organization (OPO) with any of the matched candidates if using direct-to-recipient procurement and preservation procedures. LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution. LungFX is intended to allow for re-assessment, in a controlled environment, of the suitability of procured donor lungs for transplantation into male and female patients aged 18 years or older with end-stage lung disease awaiting first-time (double or single) lung transplantation. Lungs accepted for transplantation after LungFX require a second period of storage with cold static preservation solution, and cumulative preservation time of transplanted lungs is not intended to exceed 20 hours. To date, Lung Bioengineering has performed 1,100 EVLP procedures using other approved devices, with 600 lungs accepted for transplant. Lung Bioengineering expects to add LungFX to its available 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. “The FDA approval of our LungFX device also marks an important milestone on our path toward using advanced technologies to create an unlimited supply of transplantable organs.” “Too many donor lungs go unused today,” said Dr. Kenneth McCurry, M.D., Director of the Cleveland Clinic Enterprise Transplant Center and investigator in the LungFX pivotal trial. “EVLP with this device provides a...

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