Lungpacer Medical today announced positive results from a Phase 1 clinical study evaluating its neurostimulation technology platform.
The STIMULUS trial investigated the application of diaphragm neurostimulation to improve hemodynamic performance in patients on invasive mechanical ventilation. Results demonstrated improvement in hemodynamic performance, according to a news release. Investigators presented findings at the 2025 Transcatheter Heart Therapies (THT) conference.
Exton, Pennsylvania-based Lungpacer Medical’s trial evaluated its investigational AeroNova system. The company already offers the FDA-approved AeroPace system that delivers neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and strengthens the diaphragm in patients on mechanical ventilation.
The investigational AeroNova system comprises a cardiovascular catheter embedded with stimulating electrodes. It features a software-controlled system that contracts the diaphragm through transvenous prenic nerve neurostimulation. The company designed AeroNova to achieve ventilation using lower positive pressures from the ventilator. This mitigates ventilator-induced injury to the lung, diaphragm, heart and brain of patients on mechanical ventilation.
LungPacer said STIMULUS marks a significant milestone in advancing medtech designed to optimize patient care in the ICU. The single-center study aimed to evaluate AeroNova’s safety and effectiveness in patients with acute hypoxemic respiratory failure or post-thoracic surgery respiratory failure.
A key outcome focused on measuring how diaphragm activation, when synchronized with mechanical ventilation, could improve cardiovascular function and mitigate the negative hemodynamic effects commonly seen with invasive mechanical ventilation.
A look at the Lungpacer study results
Lungpacer’s study enrolled 19 patients. Of those, 16 underwent a stimulation titration procedure. The majority of patients (12/16, 75%) had pre-existing cardiac dysfunction and exhibited a high incidence of right ventricular dysfunction and/or pulmonary hypertension.
Using the AeroPace catheter, investigators safely delivered transvenous bilateral neurostimulation. They used stimulation levels titrated to achieve diaphragm activation, resulting in increasing levels of expiratory occlusion pressure. The study evaluated a range of cardiac outcomes at baseline compared to after treatment.
Increasing levels of diaphragm neurostimulation led to a significant increase in cardiac index and stroke volume. Lungpacer said this indicates better heart performance and enhanced blood flow. The company also reported overall hemodynamic stability and decreased pulmonary artery pressure.
“The study results indicate that diaphragm neurostimulation merits further exploration as a novel therapy to counteract the harmful cardiovascular effects associated with positive pressure ventilation by improving cardiac function and pulmonary hemodynamics,” Lungpacer said. “The study suggests a dose-response relationship, where increasing stimulation correlates with further improvements in cardiac and pulmonary parameters, providing a strong foundation for future investigation.”
