Lungpacer Medical
Lungpacer Medical, headquartered in Vancouver, Canada, develops the AeroPace™ system to stimulate the diaphragm and help patients wean off ventilators, with operations in Exton, Pennsylvania, and team members across Europe.
AeroPace System Features and Use
The AeroPace™ system by Lungpacer Medical is designed to stimulate the nerves activating the diaphragm, providing repetitive exercises for 10-20 minutes twice a day to rebuild diaphragm strength and empower natural, independent breathing. This system includes a neurostimulation console that sends a signal to electrodes on the AeroPace catheter to stimulate the phrenic nerve. The catheter can also be used to provide fluids and medications, resembling a typical catheter in size and shape.
Clinical Trials and Research
Lungpacer Medical is currently enrolling patients in the RESCUE 3 pivotal clinical study to evaluate the safety and efficacy of the AeroPace System. The company has conducted over five years of clinical research on its technology, yielding positive clinical outcomes. These include a 7.4% increase in ventilator weaning, a 7.9% increase in survival rates, and a reduction of 1.4 days of ventilator use compared to patients who did not receive the therapy.
Regulatory Milestones
The AeroPace™ system has received several significant regulatory designations. In May 2016, it was awarded the FDA Breakthrough Device designation. Later, in April 2020, the system received FDA Emergency Use Authorization (EUA). These recognitions facilitate testing and potential wide-scale adoption of this investigational device, which is currently only available for investigational use due to Federal Law limitations.
Global Operations
Lungpacer Medical is headquartered in Vancouver, Canada, with U.S. operations based in Exton, Pennsylvania. The company also has team members distributed throughout Europe, reflecting its global reach in advancing medical technology for ventilator-dependent patients.
Patent Holdings and Awards
Lungpacer Medical holds an extensive portfolio of 93 patents across the globe, underscoring its innovative approach in medical technologies. In recognition of its pioneering work, the company won the TCT 2021 Shark Tank Innovation Competition, highlighting its leading role in advancements for respiratory care solutions.