EXTON, Pa., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical, a leader in innovative respiratory care neurostimulation technologies, today announced the first six patients enrolled in the groundbreaking STARI (STimulation to Activate RespIration) clinical trial. STARI is evaluating the safety, effectiveness, and feasibility of Lungpacer's next-generation AeroNova system designed to deliver continual temporary transvenous diaphragm neurostimulation in patients requiring mechanical ventilatory support. Lungpacer’s current-generation AeroPace intermittent neurostimulation therapy is FDA-approved to improve diaphragm strength and accelerate weaning from mechanical ventilation.
STARI is designed as a multi-center, prospective, randomized controlled open-label phase 2 feasibility trial enrolling patients across leading medical centers in the United States and Canada. The trial aims to compare AeroNova therapy in conjunction with standard of care versus standard of care alone to mitigate multi-organ ventilator-induced injury in patients suffering from acute hypoxemic respiratory failure (AHRF). Earlier feasibility data on continual neurostimulation therapy presented at THT 2025 demonstrated clinical improvements in lung, diaphragm, cardiac and brain function.
“We are delighted to have randomized the first several patients into the novel STARI study at University Health Network (UHN) and excited to have had the first United States patient enrolled by Dr. Jonathan Eaton and Dr. Taylor Conrad at Louisiana State University (LSU),” said Dr. Ewan Goligher, Associate Professor of Medicine and Physiology at the University of Toronto. “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.” Additional clinical trial sites include Temple University Hospital, Cleveland Clinic, Prisma Health Richland and University of California San Diego.
"We are excited to announce the first several patient enrollments in the STARI trial--a major milestone for Lungpacer and for the field of critical care medicine," said Doug Evans, CEO of Lungpacer Medical. "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."
About Lungpacer Medical
Lungpacer Medical is pioneering neurostimulation therapies designed to preserve and restore diaphragm function in mechanically ventilated patients. The company’s technologies aim to improve outcomes and accelerate recovery for critically ill patients who require mechanical ventilation. For more information, please visit www.lungpacer.com.
CAUTION: AeroNova is an investigational device. Limited by United States law to investigational use. Exclusively for clinical investigations.
The AeroPace System is approved by the United States Food and Drug Administration to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on MV at least 96 hours and who have not weaned.
Media Contact: media@lungpacer.com
