For more than 15 years, Lungpacer Medical has developed neurostimulation technologies for critical care, including the AeroPace temporary transvenous system that activates the diaphragm to help mechanically ventilated patients regain independent breathing. The company’s work spans clinical research and engineering, with its first human diaphragm-pacing use in 2015 and FDA premarket approval for AeroPace in 2024. Based in Vancouver with U.S. operations in Exton, Pennsylvania, Lungpacer is also studying continual diaphragm stimulation through its investigational AeroNova system.
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FDA Premarket Approval (PMA)
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CMS New Technology Add-On Payment (NTAP)
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Avery Biomedical Devices, IncFounded by Roger Avery in the late 1960s, Avery Biomedical Devices makes implanted diaphragm pacemaker systems that stimulate the phrenic nerves to support breathing. The company’s predecessor introduced the first commercially distributed diaphragm pacemaker in 1971, and Avery has since manufactured more than 10,000 neurostimulators implanted in over 50 countries. Renamed in 2005, the Long Island manufacturer’s Spirit system has full FDA approval for adult and pediatric use and is produced under an ISO 13485 quality system.COMMACK, NY
Respair, IncBorn from University of Pittsburgh clinical research, Pittsburgh-based Respair develops airway devices for ventilated patients, beginning with RelianceET, a breathing tube designed to replace the conventional inflatable cuff with soft baffles that seal the airway without added pressure. Founded by physicians Carl Snyderman and Garrett Coyan, the company brings surgeons, engineers, and entrepreneurs together to address ventilator-associated complications. Respair completed hundreds of benchtop tests and received a Phase I SBIR award from the NIH while advancing the device toward regulatory submission.PITTSBURGH, PA
Synapse Biomedical IncFounded in 2002, Oberlin-based Synapse Biomedical develops and manufactures neurostimulation medical devices that help patients breathe and recover movement. Its FDA-approved NeuRx Diaphragm Pacing System supports diaphragm conditioning for people with spinal cord injuries and ALS, while the company’s TransAeris system is designed to address ventilator-induced diaphragm dysfunction. Synapse says its NeuRx products are manufactured in Ohio at an ISO 13485-certified facility and have been used to treat more than 2,000 patients.OBERLIN, OH
VENTSAFESan Francisco-based VENTSAFE develops mechanical ventilation devices for intensive care units, with a focus on improving respiratory support for patients in critical condition. Its ongoing development work incorporates adaptive technology, artificial intelligence and clinician feedback as the company advances its ventilation platform.