Diaphragm Strength Improved by Over Three Hundred Percent Using the Lungpacer® System over Standard of Care in Multicenter, Randomized Controlled Trial

Patients Difficult to Wean From Invasive Mechanical Ventilation Showed Over Three Hundred Percent Greater Improvement in Maximal Inspiratory Pressure Using Novel Diaphragm Stimulation Therapy

Lungpacer^® Medical, Inc. today announced the results of the RESCUE 2 trial. The abstract was accepted as a "Top 30" abstract for presentation in the "Best Oral Presentation" session at the European Society of Intensive Care Medicine (ESICM) LIVES 2020 virtual congress. It was presented by Dr. Martin Dres from the Respiratory and Critical Care Department of Sorbonne University. RESCUE 2 was a 30-day multi-center, randomized, controlled feasibility trial (RCT) evaluating the Lungpacer System as a weaning therapy, and compared Standard of Care (SoC) to Lungpacer plus SoC for patients on long-term mechanical ventilation. The study was designed to provide an initial assessment of device safety and effectiveness for weaning success and diaphragm strengthening in support of a pivotal RCT. Data from the RESCUE 2 study modified intent to treat (mITT) population was previously presented in September at the virtual European Respiratory Society (ERS) conference.

In the "per protocol" subset of the RESCUE 2 data, which included patients who received at least 50 percent of the protocol required Lungpacer therapy, average improvement in inspiratory muscle strength, as measured by Maximal Inspiratory Pressure (MIP), in the Lungpacer therapy group was 308 percent greater than the improvement in the SoC group. Rapid Shallow Breathing Index (RSBI) improvement was 167 percent greater as compared to SoC.¹ Improvement in MIP and RSBI has been shown to correlate with weaning success in mechanical ventilation patients^2,3 and MIP improvement has been associated with lower mortality.⁴ Selected centers also used ultrasound to evaluate direct changes in diaphragm thickening fraction. Compared to baseline, diaphragm thickening fraction improved by 35 percent and 30 percent more for the right and left hemidiaphragms, respectively, in the Lungpacer therapy group compared to SoC. The Lungpacer therapy group also showed a strong positive trend in the proportion of patients weaned and reduction in average duration of mechanical ventilation by Day 30, as compared to SoC group.¹

While mechanical ventilation is a life-saving therapy, it comes with unwanted side effects. Ventilators use positive pressure to force air into the lungs, leaving the diaphragm unused and causing it to weaken quickly. The Lungpacer System is designed to stimulate the diaphragm during mechanical ventilation to strengthen the muscle, so that the patient can be weaned from mechanical ventilation and resume natural breathing. The Lungpacer System is in the midst of clinical studies in the U.S. and Europe. There are currently no FDA-approved products to assist patients in weaning from mechanical ventilation.

"Mechanically ventilated patients can struggle to wean from invasive ventilation," noted Dr. Martin Dres, Respiratory and Critical Care Department, APHP, Sorbonne University. "Our findings have demonstrated a significant improvement in maximal inspiratory pressure, which is an indicator of diaphragm strengthening induced by the stimulation therapy. Importantly, we did not observe any safety alert. We are encouraged by the potential for the Lungpacer therapy to provide our patients with a better chance at being safely and promptly liberated from the ventilator. Further studies are currently ongoing to demonstrate the clinical benefit of the technology."

"This RESCUE 2 per protocol data set continues to expand on the compelling benefits of Lungpacer therapy for mechanically ventilated patients, which are currently being evaluated in an ongoing pivotal trial RESCUE 3," said Doug Evans, CEO of Lungpacer Medical, Inc. "We look forward to validating the safety and efficacy of Lungpacer therapy for improved clinical outcomes. This technology has great promise for decreasing healthcare costs and improving the quality of life for patients on invasive mechanical ventilation."

About the Lungpacer^® System

The Lungpacer System is a novel, first-in-class, temporary transvenous diaphragm neurostimulation system, FDA-designated as a breakthrough device and under investigational use in the US and EU.⁵ The Lungpacer System was also granted FDA Emergency Use Authorization (EUA) during the COVID-19 pandemic.⁶ The Lungpacer System operates using the following main components: Lungpacer IntraVenous Electrode - LIVE Catheter^®, Lungpacer Control Unit, and Intermediate Cable. The LIVE Catheter is a minimally invasive, central venous catheter used to deliver fluids and medications and to activate the diaphragm muscle via transvenous phrenic-nerve stimulation. The Lungpacer Control Unit is a mobile, portable unit that is used with the LIVE Catheter and Intermediate Cable to provide temporary transvenous diaphragmatic neurostimulation.

For more information on the Lungpacer System, please visit: www.lungpacer.com

1. Dres et al. Temporary transvenous diaphragm neurostimulation in mechanically ventilated patients – preliminary results from a randomized controlled trial. Presented at ESICM International Congress 2020 - Virtual, December 2020.
2. Supinski et al. Correlation of maximal inspiratory pressure to transdiaphragmatic twitch pressure in intensive care unit patients Crit Care. 2016 DOI: 10.1186/s13054-016-1247-z
3. Yang, KL, Tobin, MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med, May 1991. DOI: 10.1056/NEJM199105233242101
4. Medrinal et al. Respiratory weakness after mechanical ventilation is associated with one-year mortality - a prospective study. Crit Care. Jul 2016 DOI: 10.1186/s13054-016-1418-y
5. A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation (RESCUE 3): NCT03783884
6. FDA Emergency Use Authorization Letter (April 14, 2020).

CAUTION: INVESTIGATIONAL DEVICE. Limited by Federal law (United States) to investigational use. Used exclusively for clinical investigations.

IMPORTANT SAFETY AND EFFECTIVENESS INFORMATION:
Lungpacer DPTS treatment is for a maximum of 30 days. The LIVE Catheter component of the Lungpacer System has not been evaluated for safety when used with cardiac pacemakers or defibrillators and should be removed prior to Magnetic Resonance (MR) imaging. The LIVE catheter should not be placed into or allowed to remain in the right atrium or right ventricle. The most frequently reported SAE in the RESCUE 2 trial was septic shock (treatment group incidence 7.0% vs. control group incidence 7.3%). Device and procedure related SAEs most frequent in RESCUE 2 were respiratory thoracic and mediastinal disorders (10.5% vs. 5.5%, in the treatment and control groups, respectively). Device-related serious adverse events reported in a feasibility trial of 11 patients were single events of pneumothorax and mucus plug liberation. There were no unanticipated adverse device effects.

EMERGENCY USE AUTHORIZATION INFORMATION: The Lungpacer DPTS is available under an Emergency Use Authorization for the duration of the COVID-19 pandemic. For more information visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.

This Diaphragmatic Pacing Stimulator has not been FDA cleared or approved. This Diaphragmatic Pacing Stimulator has been authorized by FDA under an Emergency Use Authorization (EUA). This Diaphragmatic Pacing Stimulator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Diaphragmatic Pacing Stimulator Systems under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Lungpacer^®, Weaning Solution^®, Lungpacer DPT System™, Lungpacer DPT™, LIVE Catheter^® are registered trademarks of Lungpacer Medical.

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