Research & Clinical Trials
Lungpacer Medical Begins AERO-PAS Study of AeroPace at Sutter Health Site
By News Desk ·
Key takeaways
- Lungpacer Medical enrolled the first patient in AERO-PAS, a post-approval study of the AeroPace System, at Sutter Health's California Pacific Medical Center in San Francisco.
- AERO-PAS will enroll up to 120 adults on mechanical ventilation for at least 96 hours who have not weaned, with enrollment completion anticipated in 2028.
- Doug Evans said the RESCUE-3 trial showed 43% faster weaning and a three-day average reduction of ventilator time in the ICU per patient.
Lungpacer Medical announced on November 12, 2026 the first patient enrollment in AERO-PAS, a post-approval multicenter study of its AeroPace System, at Sutter Health's California Pacific Medical Center in San Francisco. The Exton, Pennsylvania-based company said the study will enroll up to 120 adults on mechanical ventilation for at least 96 hours who have not weaned, with enrollment completion anticipated in 2028, according to GlobeNewswire.
How the AERO-PAS Study Will Work
AERO-PAS is a prospective, single-arm, multicenter study led at the first site by George S. Horng, MD, Medical Director of Critical Care Services at CPMC. The study will capture additional safety and effectiveness data on AeroPace through 30 days in routine clinical practice, building on the randomized RESCUE-3 pivotal trial that supported the therapy's FDA premarket approval. AeroPace is delivered through a catheter placed in a central vein that stimulates the phrenic nerves to contract and exercise the diaphragm, helping patients wean from mechanical ventilation.
"Patients who fail to wean after several days on the ventilator are some of the most challenging we care for, and every additional ventilator day adds risk for the patient and strain on the ICU," Horng said. Doug Evans, President and CEO of Lungpacer Medical, said RESCUE-3 showed diaphragm neurostimulation can help patients struggling to come off the ventilator, demonstrating 43% faster weaning and a three-day average reduction of ventilator time in the ICU per patient. Additional sites are expected to be activated in the coming months.
Lungpacer's Funding and Regulatory Record
Lungpacer Medical is a Vancouver-based medical device company founded in 2009 that develops FDA-approved temporary transvenous diaphragm neurostimulation systems and sells directly to U.S. hospital ICUs, according to akta.pro company records. The same records list total funding of $157.2 million across 10 funding rounds, including a $19.8 million convertible note in April 2026. The records also show CMS approved a New Technology Add-on Payment for AeroPace under the FY2026 IPPS Final Rule, enabling hospitals to receive up to $23,650.90 in additional Medicare reimbursement per case effective October 1, 2025.
Earlier AeroPace Milestones
Lungpacer Medical announced in July 2026 that the American Medical Association granted Category III CPT codes for AeroPace, effective July 1, 2026, according to GlobeNewswire. That same month, the AeroPace system was deployed at Temple Hospital in Philadelphia, and the company said it intends to raise an additional $75 million later this year to expand its sales force and develop a second product, according to American City Business Journals. In August 2026, Lungpacer Medical announced that AeroPace was nominated for the 2026 Prix Galien USA Award for Best Medical Technology, according to Financial Post.
What Comes Next for AERO-PAS
Additional AERO-PAS sites are expected to be activated in the coming months, and study enrollment completion is anticipated in 2028, the company said.