Lungpacer Achieves Commercial Milestone As Leading U.S. Hospital Performs First Aeropace® Procedures To Help Patients Liberate From Mechanical Ventilation

(MENAFN- GlobeNewsWire - Nasdaq) AeroPace temporary transvenous diaphragm neurostimulation system now available to help critically ill patients breathe independently faster

EXTON, Pa., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical, a leader in innovative respiratory care neurostimulation technologies, today announced that physicians at one of the nation's largest healthcare providers and top hospitals has performed the first commercial procedures using the company's FDA-approved AeroPace® System, marking a major milestone in the clinical adoption of diaphragm neurostimulation for the temporary treatment of ICU patients on mechanical ventilation.

AeroPace activates and strengthens the diaphragm-the body's primary breathing muscle-through minimally invasive temporary transvenous neurostimulation. Critically ill patients on mechanical ventilation often experience rapid diaphragm weakening, which can prolong ventilator dependence and complicate recovery. By restoring diaphragm function, AeroPace helps patients regain independent breathing more quickly, reduces time on the ventilator, and supports durable recovery.

The first patient treated with AeroPace recovered after struggling with severe respiratory failure. The patient-who was admitted for pneumonia, had chronic COPD and already spent more than 30 days in the hospital-had been on mechanical ventilation for 3 weeks and was unable to wean before receiving AeroPace therapy. After twelve days of treatment using AeroPace, the patient progressed from full mechanical ventilation support to breathing independently with a trach collar and was discharged home two days later, just before Thanksgiving. Throughout treatment, the patient's X-rays, arterial blood gases, and PEEP levels steadily improved, reflecting meaningful gains in lung function and overall stability.

Driving the next generation of ICU innovation

“The transition of AeroPace from research to real-world patient care is the start of a new era in critical care,” said Doug Evans, CEO of Lungpacer Medical.“We are deeply grateful to the physicians and nurses at the hospital whose leadership and compassion made this milestone possible. Every patient who gets off ventilation faster means more days of strength, more time with family, and more hope for loved ones watching them fight to breathe on their own again. We're committed to bringing this therapy to leading medical centers across the U.S. to help ICU patients breathe independently again and solve a major healthcare challenge.”

Lungpacer's AeroPace System received FDA Breakthrough Device designation and premarket approval (PMA) to improve weaning success in mechanically ventilated patients. The Centers for Medicare & Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) status for the AeroPace System starting October 1, 2025, providing incremental reimbursement for eligible cases and facilitating adoption across hospitals.

About Lungpacer Medical
Lungpacer Medical is dedicated to developing minimally invasive technologies designed to reduce ventilator-induced injury and help patients wean off mechanical ventilation and breathe on their own. Learn more at Lungpacer and connect on LinkedIn.

About AeroPace
Lungpacer's AeroPace System stimulates the phrenic nerves that activate the diaphragm twice daily to strengthen the diaphragm and facilitate weaning from mechanical ventilation. The system is indicated to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation at least 96 hours and who have not weaned. The AeroPace System is not approved in any other country and is not for use in patients with active implanted cardiac pacemakers, defibrillators, or other implantable electronics within proximity to the neurostimulation catheter as it has not been clinically evaluated for safety with these implantable electronic devices.

Contact: ...

MENAFN09122025004107003653ID1110457290