Lungpacer Medical has commenced subject enrolment in its Phase II STimulation to Activate RespIration (STARI) trial, assessing the feasibility, effectiveness and safety of the AeroNova system.
The company has initially enrolled six patients in the trial.
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The system provides sustained temporary transvenous diaphragm neurostimulation for those who need mechanical ventilation.
The prospective, open-label, multi-centre, randomised controlled trial’s main objective is to compare the system combined with standard care against standard care alone.
It will focus on reducing multi-organ injury associated with ventilator use in subjects experiencing acute hypoxemic respiratory failure (AHRF).
Subject enrolment is taking place across several sites in Canada and the US. Earlier feasibility data indicated that ongoing neurostimulation could benefit diaphragm, lung, heart and brain function.
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By GlobalDataAdditional study sites include Cleveland Clinic, Temple University Hospital, Prisma Health Richland and the University of California San Diego.
In March 2025, the company received investigational device exemption (IDE) approval from the US regulator to proceed with the STARI trial.
Lungpacer Medical CEO Doug Evans said: “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.
“We are deeply grateful to the patients, investigators, and research teams whose dedication makes this important study possible.”
The company’s another product, AeroPace, holds approval from the US Food and Drug Administration (FDA) for strengthening the diaphragm and supporting faster weaning from mechanical ventilation.
AeroPace is approved for use in individuals aged 18 years and above who have been on mechanical ventilation for a minimum of 96 hours but have not yet weaned.
Both AeroNova and AeroPace systems aim to reduce ventilator-related complications and improving patient recovery during the weaning process following respiratory failure.
