EXTON, Pa., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Lungpacer Medical, a neurostimulation company developing interventional therapies to free patients from mechanical ventilation (MV) and improve diaphragm, lung, heart, and brain health, today announced that the Company’s flagship AeroPace System is under Food and Drug Administration (FDA) review in a premarket approval (PMA) application.
The investigational AeroPace System provides periodic phrenic nerve neurostimulation to strengthen the primary respiratory muscle, the diaphragm, to help people with ventilator dependence regain independent breathing faster. The RESCUE 3 study submitted with the PMA is the third in a series of studies to support FDA and international regulatory approvals. Lungpacer’s AeroPace technology previously received FDA Breakthrough Device designation and during the COVID-19 pandemic had Emergency Use Authorization (EUA) for patients on MV.
Without a strong diaphragm it is impossible to breathe independently1. Artificial breathing support from a mechanical ventilator may weaken the diaphragm muscle more than 50% in one day and prevent liberation from MV2. By delivering targeted phrenic nerve stimulations which activate the diaphragm, the AeroPace System acts as a “personal trainer” for the diaphragm muscle. These daily, repetitive stimulations are designed to improve diaphragm strength and empower independent breathing, freeing patients from the trauma of mechanical ventilation.
A growing body of research including more than 92 scientific presentations, 24 peer reviewed publications, and clinical studies in over 400 patients at 50 international centers, is building evidence and data to demonstrate the value of Lungpacer’s AeroPace Therapy. “This emerging research underscores the clinical potential of AeroPace therapy in providing a new option to alleviate the negative impacts of mechanical ventilation by restoring diaphragm strength and expediting ventilator independence. The AeroPace System has the potential to positively improve the standard of care and transform the future care for ventilated patients,” Lungpacer Medical CEO Doug Evans stated.
Dr. Ali Ataya, Associate Professor of Medicine, and Director of the Pulmonary Hypertension and Rare Lung Disease Program at the University of Florida, Gainesville and a RESCUE 3 study Principal Investigator, noted: “We have used AeroPace Therapy in two clinical studies, and also during the pandemic under EUA, to help wean ventilator dependent patients at our institution. The AeroPace System provides a novel and exciting treatment therapy for an underserved patient population with no other options today. We look forward to incorporating AeroPace Therapy into our clinical care pathway upon PMA approval.”
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1 Jubran A, Tobin MJ. Pathophysiologic basis of acute respiratory distress in patients who fail a trial of weaning from mechanical ventilation. Am J Respir Crit Care Med. 1997-155:906-15. doi: 10.1164/ajrccm.155.3.9117025.PMID:9117025.
2 Levine S, et al. Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans. N Engl J Med. 2008 27 Mar: 358(13): 1327-35. doi: 10.1056/NEJMoa070447. PMID: 18367735.
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 designed to stimulate the nerves that activate and exercise the diaphragm to improve diaphragm strength and weaning from MV. Lungpacer’s second product, the AeroNova System, utilizes continual diaphragm stimulation in synchrony with mechanical ventilation and is designed to achieve physiological breathing and mitigate ventilator-induced injury to the lung, diaphragm, heart and brain of patients on ventilation. AeroPace and AeroNova may potentially 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: media@lungpacer.com
CAUTION: Investigational Device. Limited by Federal law (United States) to investigational use. Used exclusively for clinical investigations.
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