American Journal of Respiratory and Critical Care Medicine Publishes Landmark Data on AeroPace® System's Breakthrough Results in Ventilator Weaning

International multi-center trial demonstrates AeroPace strengthens the diaphragm by 50%, weans more patients from ventilation, and reduces ventilator time by 3 days in patients difficult to wean from mechanical ventilation

EXTON, Pa., June 12, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical, Inc., a pioneering medical device company focused on neurostimulation therapies for critical care patients, today announced the publication of pivotal clinical trial results in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The comprehensive study provided clinical evidence that the company's FDA-approved AeroPace® System accelerates liberation from mechanical ventilation while strengthening diaphragm function in critically-ill patients.

The landmark findings were recently presented at the Critical Care Reviews Meeting 2025 in Belfast, Northern Ireland, where the RESCUE 3 Trial results were featured as one of only 12 major trial presentations at the world’s premier critical care research conference.

The international, multi-center randomized clinical trial was conducted across 48 centers in the United States and Europe and enrolled 223 adult patients who had been on mechanical ventilation for at least 96 hours and had failed two or more weaning attempts. Results showed that patients treated with the AeroPace System and standard of care experienced improvements across multiple clinical outcomes – including an average reduction of three ventilator days – at probabilities exceeding 97.5% compared to standard of care alone. The study results are highly clinically meaningful in a population for which each ventilator day increases the risk of complications and mortality.

Study Highlights:

• Greater Weaning Success: AeroPace demonstrated a higher rate of successful weaning from mechanical ventilation compared to standard of care (adjusted hazard ratio 1.34, 95% credible interval 1.01-1.78, 97.9% posterior probability of superiority)
• Reduced Ventilator Days: Patients treated with AeroPace had 2.5 fewer days on mechanical ventilation to weaning, and 2.8 fewer ventilator days to day 30
• Enhanced Diaphragm Strength: AeroPace patients experienced a 50% increase in maximum inspiratory pressure (MIP), an indicator of diaphragm strength
• Durable Weaning: Reintubation/reinstatement of mechanical ventilation was reduced by 50% in patients treated with AeroPace and fewer patients required tracheostomies over 30 days
• Safety Established: Well-tolerated therapy with negligible increase in perceived pain and discomfort (0.2 points on 10-point scale); adverse events as expected for critical care ICU patients
  

“This robust, international trial validates what we’ve long believed – that targeted diaphragm neurostimulation can fundamentally transform outcomes for patients having difficulty weaning from mechanical ventilation,” said Doug Evans, CEO of Lungpacer Medical. “The three-day reduction in ventilator time is highly meaningful for these patients who are struggling each day to breathe again on their own. Every day on the ventilator increases the risk of complications, inability to wean, and even death. We are proud to make this innovative breakthrough technology available to patients, physicians, and hospitals which we believe will be game-changing in critical care.”

International Recognition and Publication

The publication in the AJRCCM further validates the clinical significance of these breakthrough findings in the global critical care community. The publication, formally titled “Temporary Transvenous Diaphragm Neurostimulation for Weaning From Mechanical Ventilation (RESCUE-3),” was presented by leading researchers Dr. Ewan Goligher and Dr. Martin Dres.

“The RESCUE-3 trial represents a pivotal advancement in critical care, offering a novel approach to addressing diaphragm dysfunction in patients requiring prolonged mechanical ventilation,” said Dr. Martin Dres. “By evaluating the safety and efficacy of the AeroPace System, we aim to provide clinicians with a valuable tool to enhance patient outcomes and potentially reduce the duration of mechanical ventilation.”

“Improving outcomes in intensive care has long been challenging,” said Dr. Ewan Goligher. “Transvenous diaphragm neurostimulation is a groundbreaking new approach to treating critical respiratory failure, and emerging clinical trial data suggest it may accelerate recovery in patients requiring prolonged mechanical ventilation. Backed by a strong physiological rationale, this therapy represents an exciting and important advancement in intensive care medicine.”

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. Lungpacer’s AeroPace System is designed to stimulate the nerves that activate and exercise the diaphragm, improving diaphragm strength and weaning from MV. Lungpacer’s second product, currently in the investigational phase, the AeroNova® System, utilizes continual diaphragm stimulation in synchrony with mechanical ventilation and is designed to achieve physiological breathing intended to mitigate multiorgan ventilator-induced injury to patients on ventilation. AeroPace and AeroNova may potentially help nearly 2.5 million US patients who require mechanical ventilation every year, accounting for up to $96 billion annually in direct care costs.

Media Contact: media@lungpacer.com

FDA Approval
The AeroPace System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in December 2024, with an indication to improve weaning success—increase weaning, reduce ventilator days, and reduce reintubation—in patients 18 years or older on mechanical ventilation for at least 96 hours and who have not weaned. The AeroPace System is contraindicated in patients with active implanted devices within proximity to the device. The breakthrough technology is eligible for New Technology Add-on Payment with CMS.

Study Design and Methodology
The RESCUE 3 Trial was an international, multi-center, open-label, randomized clinical trial conducted between 2019 and 2023 across 48 centers in the United States and Europe (France, Spain, Germany). The study utilized a robust Bayesian statistical approach with borrowing of prior information from a phase II randomized trial (RESCUE-2). Of the 223 randomized patients, 109 were assigned to the AeroPace treatment group and standard of care and 114 to the control group receiving standard care alone.

The pre-specified primary analysis showed compelling evidence of AeroPace's superiority to standard of care, with high posterior probabilities demonstrating the treatment's effectiveness. Importantly, pre-specified subgroup analyses revealed consistent benefits across diverse patient populations, indicating broad applicability of the therapy to patients on mechanical ventilation having trouble weaning.

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