EXTON, PA — Lungpacer Medical announced the enrollment of the first six patients in its landmark STARI (STimulation to Activate RespIration) clinical trial, a study evaluating the company’s next-generation AeroNova system for patients requiring mechanical ventilatory support.
The AeroNova device delivers continual temporary transvenous diaphragm neurostimulation—an advanced approach designed to support respiratory muscle activity during mechanical ventilation. Lungpacer’s current AeroPace system, which provides intermittent neurostimulation therapy, already holds FDA approval for improving diaphragm strength and accelerating weaning from ventilators.
The STARI trial is a multi-center, randomized, controlled, open-label phase 2 feasibility study being conducted across leading hospitals in the United States and Canada. It will compare AeroNova therapy combined with standard care against standard care alone in patients suffering from acute hypoxemic respiratory failure (AHRF). The study’s primary goal is to evaluate whether continuous diaphragm stimulation can help mitigate multi-organ ventilator-induced injury and improve overall patient recovery.
Dr. Ewan Goligher, Associate Professor of Medicine and Physiology at the University of Toronto and a lead investigator, noted that the first patients were randomized at University Health Network (UHN) in Toronto, with the first U.S. enrollment completed at Louisiana State University by Dr. Jonathan Eaton and Dr. Taylor Conrad. “By supporting diaphragm function and enhancing cardiopulmonary function at the earliest stages of ventilator support, diaphragm neurostimulation has the potential to prevent complications associated with mechanical ventilation and accelerate recovery, ultimately improving outcomes for some of our most critically ill patients,” Goligher said.
Additional sites participating in the trial include Temple University Hospital, Cleveland Clinic, Prisma Health Richland, and the University of California San Diego.
Doug Evans, CEO of Lungpacer Medical, described the milestone as a defining step in advancing critical care innovation. “Our next-generation neurostimulation technology holds the promise of transforming outcomes for critically ill patients by not only enabling more rapid recovery of independent breathing function but also improving lung, cardiac, and other organ function that we know to be negatively impacted during mechanical ventilation,” Evans said.
Early feasibility data presented at THT 2025 have already shown promising signs, demonstrating improvements in lung, diaphragm, cardiac, and brain function. With the STARI trial now underway, Lungpacer aims to further validate its technology’s potential to change the standard of care in mechanical ventilation.
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