Lungpacer Medical Announces Investigational Device Exemption (IDE) for STARI, Phase 2 Feasibility Clinical Trial

EXTON, Pa., March 10, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical, a leading neurostimulation company committed to advancing therapies that assist patients in overcoming the negative effects of mechanical ventilation (MV), is excited to announce approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the STARI (STimulation to Activate RespIration) clinical trial. This trial will evaluate the feasibility of the company's investigational AeroNova^® System in patients suffering from moderate to severe Acute Hypoxemic Respiratory Failure (AHRF).

The AeroNova System is a novel, minimally invasive medical device designed to deliver continuous diaphragm neurostimulation in tandem with mechanical ventilation. The investigational device aims to mitigate the harmful effects of positive-pressure mechanical ventilation and reduce the risk of multi-organ ventilator-induced injury. This approach has the potential to minimize ventilator-associated injuries across multiple organ systems, including the diaphragm, heart, brain, and lungs. 

The STARI trial (NCT06832306), a Phase 2 feasibility study, will explore the potential of transvenous diaphragm neurostimulation-assisted ventilation (DNAV) in mechanically ventilated patients with moderate-to-severe AHRF. Through DNAV, the AeroNova System will provide bilateral diaphragm activity that allows reduced positive pressure from the ventilator while maintaining patient respiration.

"This is an important step in advancing our AeroNova System, which represents a new frontier in ventilator therapy," said Doug Evans, CEO of Lungpacer Medical. "The STARI trial will provide critical insights into how diaphragm neurostimulation can benefit patients with AHRF and may ultimately reshape the way we treat patients requiring mechanical ventilation."

Lungpacer's AeroNova System, along with its FDA-approved AeroPace System, has the potential to change the landscape of mechanical ventilation treatment, offering significant benefits to the nearly 2.5 million U.S. patients who are mechanically ventilated each year. These therapies aim to decrease ventilator-associated injury and ultimately improve the weaning process for patients recovering from respiratory failure.

In addition, injury or insult to the lung resulting from a national health security threat can lead to AHRF or more severe outcomes, and solutions to support diaphragm stimulation may help patients recover from mechanical ventilation.

The study is being funded in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00021.

About Lungpacer Medical, AeroPace and AeroNova 
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 used to stimulate the nerves that activate and exercise the diaphragm twice daily to strengthen the diaphragm and facilitate weaning from MV. The AeroPace System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in December 2024 to improve weaning success ? increase weaning, reduce ventilator days, and reduce reintubation - in patients ages 18 years or older on mechanical ventilation ? 96 hours and who have not weaned.

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 mitigate multi-organ ventilator-induced injury to patients on mechanical ventilation. AeroPace and AeroNova have the potential to help the nearly 2.5 million US patients who require mechanical ventilation every year, accounting for up to $96 billion annually in direct care costs.

Learn more at Lungpacer.com and connect on LinkedIn. 

Contact: [email protected] 

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. The AeroPace System is not approved in any other country.

CAUTION: The AeroNova System is limited by Federal law (United States) to investigational use. Used exclusively for clinical investigations. 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8a951a39-72ea-41da-adb0-d4e0e1727e69