Lungpacer Medical Announces Premarket Approval for AeroPace® System

AeroPace is a minimally invasive transvenous diaphragm strengthening neurostimulation therapy for quicker patient liberation from mechanical ventilation

EXTON, Pa., Dec. 05, 2024 (GLOBE NEWSWIRE) — Lungpacer Medical, a neurostimulation company dedicated to developing innovative interventional therapies to free patients from mechanical ventilation (MV) and improve diaphragm, lung, heart, and brain health, today announced premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Company’s flagship AeroPace^® System.

Lungpacer Medical’s AeroPace System uses neurostimulation via an electrode-containing cardiovascular-catheter and software-controlled system to contract and strengthen the diaphragm in patients on mechanical ventilation. The AeroPace System’s FDA approved indication is 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. It is the first device of this kind approved by FDA.

The AeroPace System offers patients several clinical advantages compared with current standard of care including:

• More patients weaned, reducing their risk of remaining on mechanical ventilation at 30 days by up to 37%;
• Faster weaning by nearly 3 days; and
• Reduced risk for reintubation at 30 days by up to 60%.

“Today’s approval of our AeroPace System, an FDA designated Breakthrough Device, is transformative for respiratory care and represents a new era in which clinicians will now have a treatment option for critical care patients who have failed to wean from mechanical ventilation,” commented Doug Evans, Chief Executive Officer. “We expect that the AeroPace System will improve the standard of care and transform the future care of mechanically ventilated patients by helping them recover durable independent breathing. In memory of my son, Cameron, who endured the challenges of mechanical ventilation, we are all grateful to the dedicated physicians who conducted our three clinical trials and to the brave patients who participated in them such that their efforts will help many more patients to wean more quickly.”

A Step Forward in Ventilator Weaning
“The majority of patients requiring mechanical ventilation develop significant diaphragm muscle weakness. This seriously impairs their ability to recover spontaneous breathing which is known to be associated with poor clinical outcomes,” commented Ewan Goligher, MD PhD, Associate Professor of Medicine and Physiology, University of Toronto. “These data indicate that Lungpacer diaphragm pacing technology can accelerate recovery for patients who have difficulty weaning from mechanical ventilation.”

“Over the last decade the importance of maintaining diaphragmatic integrity during mechanical ventilation has become clear. Liberation of a patient from ventilatory support demands adequate diaphragmatic strength. Unfortunately, common techniques of mechanical ventilation tend to ignore or disadvantage the diaphragm,” commented Richard Branson, Professor University of Cincinnati. “To date, alterations in ventilator settings and patient monitoring can aid in limiting diaphragmatic injury and myopathy, but there are no therapeutic treatments. Clinicians utilize daily assessments and trials of spontaneous breathing to determine when the patient is ‘ready’ for ventilator liberation. This process requires close monitoring of the patient’s breathing and often needs to be repeated daily for several days. These spontaneous breathing trials can be stressful for the patient, resulting in anxiety and discomfort. Diaphragmatic pacing using AeroPace therapy is the first approved intervention proven to shorten the liberation process. This is a novel, effective step forward reducing patient time spent on the ventilator.”

“As a major WeanNet center in Germany, our facility is dedicated to weaning patients who have been on prolonged mechanical ventilation. The AeroPace therapy provides an incredibly important new tool to help these difficult to wean patients and is seamlessly integrated into the workflow of our clinic,” noted Prof. Dr. med. Ralf Ewert at Universität Greifswald in Germany, the leading enroller in the RESCUE 3 study. “We look forward to using this leading-edge therapy to more quickly wean our patients which is a key step towards freeing them from the negative effects of prolonged ventilation.”

The AeroPace System Strengthens the Diaphragm, Accelerating Recovery and Weaning from Ventilator Dependence
“By delivering periodic phrenic nerve stimulation using a venous catheter, the AeroPace System, strengthens the primary respiratory muscle, the diaphragm, to help patients to regain independent breathing faster. This is a great achievement for the patients exposed to invasive mechanical ventilation, with clinically significant benefits in terms of patient centered outcomes that should also benefit at the collective level in terms of healthcare resources,” said Martin Dres, MD, PhD, Professor of Critical Care Medicine at Sorbonne University, Paris, France, and country PI for the RESCUE 2 and RESCUE 3 clinical studies.

“We have used AeroPace Therapy in two clinical studies, and also during the pandemic under Emergency Use Authorization, to help wean ventilator dependent patients at our institution,” commented 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 top enroller in the RESCUE 3 clinical study. “The AeroPace System’s targeted phrenic nerve stimulation activates the diaphragm, acting as a ‘personal trainer’ for the diaphragm muscle. In our research, these daily, periodic stimulations improved diaphragm strength and empowered independent breathing, freeing patients from the trauma associated with mechanical ventilation.”

Joseph Shrager, MD, Professor and Chief of the Division of Thoracic Surgery at Stanford University School of Medicine and one of the top US enrollers in the RESCUE 3 study, added, “In our experience, the AeroPace Catheter is easily placed at the bedside using standard catheterization techniques. The AeroPace System provides a novel and pioneering therapy for a greatly underserved patient population who have few other options to address diaphragm weakness. We look forward to incorporating the AeroPace Therapy into our clinical care pathway to help to more effectively wean ventilator-dependent patients at our institution.”

The AeroPace System is indicated 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. The AeroPace System is contraindicated in patients with active implanted cardiac pacemakers, defibrillators or other implantable electronics within proximity to the device, having not been clinically evaluated for safety with these implantable devices.

Expansive Clinical Evidence and Extensive Patent Portfolio
Lungpacer is committed to advancing the treatment of patients who are critically ill and dependent on mechanical ventilation. With the approval of the AeroPace System, the company is set to bring a new standard of care to hospitals across the United States, helping clinicians improve patient outcomes and reduce the healthcare administration burden and patient suffering from extended mechanical ventilation.

A growing body of research including more than 100 scientific presentations, 30 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 now FDA approved AeroPace System and the investigational AeroNova^® System currently in clinical trials. Together these therapies can address approximately 2.5 million mechanically ventilated critical care patients in the U.S. A several billion dollar market is possible for the AeroPace and AeroNova Systems due to the potential transformational nature of these therapies to critical care.

Lungpacer’s products are protected by a broad and comprehensive portfolio of 154 U.S. and International Patents.

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, improving diaphragm strength and weaning from MV. 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 achieve physiological breathing intended to 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

The AeroPace System is approved by the United States Food and Drug Administration to improve weaning success in adult patients 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. Use exclusively for clinical investigations.