Lungpacer Medical Announces Positive Results from STIMULUS Trial: Diaphragm Neurostimulation Improves Hemodynamic Performance During Mechanical Ventilation
Lungpacer Medical, the award-winning medical device company founded by BPK professor Andy Hoffer in 2009 and spun out from the SFU Neurokinesiology Lab in 2014, achieved a key milestone on December 5, 2024 when the FDA granted Premarket Approval to its first product, AeroPace™. Designed as a personal trainer for the diaphragm muscle of critically ill patients who are unable to wean from mechanical ventilation, the AeroPace system uses an intravenous catheter to rhythmically stimulate the phrenic nerves in order to rebuild diaphragm strength and empower natural, independent breathing. Read More
Most recently, on February 20, 2025 Lungpacer announced the latest progress with a phase 1 clinical study undertaken in collaboration with Toronto General Hospital on a second product, AeroNova, intended for ICU patients who are likely to require more than a day or two of mechanical ventilation. The AeroNova system is designed to electrically activate the phrenic nerves over the first 24 hours and for up to seven days in order to protect their diaphragm muscle from rapid and profound, ventilator-induced, disuse atrophy. This study was led by Thiago Bassi, MD, PhD (from BPK, SFU) and demonstrated that pacing the diaphragm in ICU patients benefits the heart by improving hemodynamic performance. For details, see https://lungpacer.com/lungpacer-medical-announces-positive-results-from-stimulus-trial-diaphragm-neurostimulation-improves-hemodynamic-performance-during-mechanical-ventilation/
These results are significant because they help demonstrate that phrenic nerve pacing in critically ill, mechanically ventilated patients can benefit the diaphragm muscle (by countering its rapid atrophy in response to disuse), the lungs (by reducing injurious positive ventilator pressure and reducing atelectasis), the brain (by increasing neural connectivity in deeply sedated mechanically ventilated patients) and now also the heart.
Notably, in addition to Dr. Bassi, two other recent graduates from the BPK PhD program, Elizabeth Rohrs, RT, PhD and Karl Fernandez, RT, PhD, are first authors in publications demonstrating the beneficial effects of phrenic nerve pacing on the lungs, the diaphragm muscle and the brain of mechanically ventilated patients:
Diaphragm neurostimulation during mechanical ventilation reduces atelectasis and transpulmonary plateau pressure, preserving lung homogeneity and PaO2/FiO2. Elizabeth Rohrs, Thiago Bassi et al. J Appl Physiol 2021 Jul 1;131(1):290-301. doi: 10.1152/japplphysiol.00119.2021. Epub 2021 Jun 10.
Transvenous stimulation yields exposure-dependent protection from ventilator-induced diaphragm atrophy. Fernandez KC, Rohrs EC, Bassi TG, et al. J Appl Physiol 2023 Jul 1;135(1):15-25. doi: 10.1152/japplphysiol.00547.2022. Epub 2023 May 25.
Restoring brain connectivity by phrenic nerve stimulation in sedated and mechanically ventilated patients. Thiago Bassi, Elizabeth Rohrs et al. Commun Med (Lond). 2024 Nov 18;4(1):235. doi: 10.1038/s43856-024-00662-0.
