Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device.
The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD and asthma.
The system is designed to reduce the risk of worsening moderate-to-severe chronic obstructive pulmonary disease (COPD) in patients on optimal medical care, according to Minneapolis-based Nuvaira. In March, the FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s Airflow-3 pivotal trial resulted in FDA investigational device approval for the company to complete the 400-patient study, Nuvaira noted. In April, the Centers for Medicare & Medicaid Services (CMS) approved Medicare coverage of the Airflow-3 trial.
Nuvaira also announced the appointment of medtech veteran Karen Peterson as VP Clinical, Regulatory & Quality. Peterson’s 30-year track record includes successful execution of multiple IDE clinical trials and PMA approvals. She joins Nuvaira from Stryker ENT (formerly Entellus Medical). Nuvaira also named Inspire Medical System CEO Tim Herbert to its board of directors.
“Despite the challenges of the COVID pandemic, we are thrilled about these additions to our leadership team and the positive announcements from FDA and CMS,” said Nuvaira CEO Dr. Dennis Wahr in a news release. “We support our global pulmonary thought-leaders who are working hard to ensure patient access to routine care and to important clinical trials like Airflow-3, while simultaneously adapting to the new reality of COVID-19.”