Lungpacer Medical Initiates STARI Trial for Next-Generation Diaphragm Neurostimulation in Critically Ill Patients
Key Insights
Lungpacer Medical (search) has enrolled the first six patients in the STARI clinical trial, evaluating their next-generation AeroNova (search) system for continual diaphragm neurostimulation in mechanically ventilated patients.
The multi-center phase 2 trial aims to compare AeroNova (search) therapy plus standard care versus standard care alone in patients with acute hypoxemic respiratory failure to prevent ventilator-induced multi-organ injury.
Earlier feasibility data presented at THT 2025 demonstrated clinical improvements in lung, diaphragm, cardiac and brain function with continual neurostimulation therapy.
Lungpacer Medical (search) has achieved a significant milestone in critical care medicine with the enrollment of the first six patients in the STARI (STimulation to Activate RespIration) clinical trial. The groundbreaking study is evaluating the company's next-generation AeroNova (search) system, designed to deliver continual temporary transvenous diaphragm neurostimulation in patients requiring mechanical ventilatory support.
Trial Design and Objectives
STARI is structured 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 study aims to compare AeroNova (search) 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).
The trial represents an evolution from Lungpacer's current-generation AeroPace (search) intermittent neurostimulation therapy, which is FDA-approved to improve diaphragm strength and accelerate weaning from mechanical ventilation. The new AeroNova (search) system is designed to provide continual stimulation at the earliest stages of mechanical ventilation, potentially preventing complications before they develop.
Clinical Sites and Leadership
The first patients were randomized at University Health Network (UHN), with the first United States patient enrolled by Dr. Jonathan Eaton and Dr. Taylor Conrad at Louisiana State University (LSU). Additional clinical trial sites include Temple University Hospital (search), Cleveland Clinic, Prisma Health Richland and University of California San Diego.
"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."
Promising Early Data
Earlier feasibility data on continual neurostimulation therapy presented at THT 2025 demonstrated clinical improvements in lung, diaphragm, cardiac and brain function. This preliminary evidence supports the rationale for investigating continual stimulation as a means to improve multiple organ systems affected by mechanical ventilation.
Company Perspective
"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 (search). "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."
Regulatory Status
The AeroNova (search) system remains an investigational device, limited by United States law to investigational use exclusively for clinical investigations. In contrast, Lungpacer's current AeroPace (search) System has received FDA approval to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation for at least 96 hours who have not weaned.
The STARI trial represents a significant step forward in addressing the complex challenges faced by critically ill patients requiring mechanical ventilation, with the potential to prevent multi-organ complications rather than simply treating them after they develop.