Lungpacer Announces CMS NTAP Approval for AeroPace® System in FY2026 IPPS Final Rule
Exton, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical Inc., a medical technology company focused on neurostimulation therapies for critically ill patients, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for the AeroPace® System under the Fiscal Year 2026 Inpatient Prospective Payment System (IPPS) Final Rule, effective October 1, 2025.
The AeroPace® System is an FDA-designated breakthrough device that uses periodic neurostimulation to exercise the diaphragm, helping mechanically ventilated patients to breathe independently faster. Clinical evidence shows that patients treated with the AeroPace System strengthened their diaphragm by 50%, reduced their risk of being on the ventilator for 30 days by 35%, and reduced ventilator time by 3 days when compared to standard of care.
Under the FY2026 IPPS Final Rule, NTAP approval allows for up to 65% reimbursement of the additional cost associated with the technology. Specifically, hospitals will be eligible to receive up to $23,650.90 in additional Medicare reimbursement per case using the AeroPace System. The NTAP is intended to offset the cost of innovative therapies that provide substantial clinical improvement over existing options.
“New Technology Add-On Payment (NTAP) approval from Centers for Medicare & Medicaid Services (CMS) for the AeroPace System recognizes its clinical value and the potential impact of this groundbreaking therapy to improve patient outcomes,” said Doug Evans, president and CEO of Lungpacer. “This milestone not only reduces financial barriers for hospital adoption but also brings us closer to delivering our technology to the patients who need it most.”
The NTAP designation supports early adoption of technologies that demonstrate newness, cost-effectiveness, and meaningful clinical advancement. The inclusion of AeroPace in the NTAP program highlights its potential to address a critical gap in care for patients requiring prolonged mechanical ventilation. For more information, view the CMS IPPS Final Rule here:
https://public-inspection.federalregister.gov/2025-14681.pdf.
About Lungpacer Medical, AeroPace and AeroNova
Lungpacer Medical is dedicated to developing minimally invasive technologies designed to reduce ventilator-induced injury and help patients wean off mechanical ventilation and breathe on their own. Lungpacer’s neurostimulation AeroPace System is used to stimulate the nerves that activate and exercise the diaphragm twice daily to strengthen the diaphragm and facilitate weaning from MV. The AeroPace System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in December 2024 to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation ≥ 96 hours and who have not weaned.
Lungpacer’s second product, currently in the investigational phase, the AeroNova® System, utilizes continual diaphragm neurostimulation in conjunction with mechanical ventilation at reduced positive pressures and is designed to mitigate multi-organ ventilator-induced injury in patients on mechanical ventilation. AeroPace and AeroNova have the potential to help the nearly 2.5 million US patients who require mechanical ventilation every year, accounting for up to $96 billion annually in direct care costs.
Learn more at Lungpacer.com and connect on LinkedIn.
Contact: media@lungpacer.com
The AeroPace System is approved by the United States Food and Drug Administration to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on MV at least 96 hours and who have not weaned. The AeroPace System is not approved in any other country.
CAUTION: The AeroNova System is limited by Federal law (United States) to investigational use. Used exclusively for clinical investigations.
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