The Nuvaira Lung Denervation System has been designated as a Breakthrough Device by the US FDA. Nuvaira’s lung denervation system is a bronchoscopic procedure designed to reduce the risk of moderate-to-severe COPD exacerbations.
In March, FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s AIRFLOW-3 pivotal trial resulted in full IDE approval for completion of the 400-patient study, and in April, the Centers for Medicare & Medicaid Services (CMS) approved the AIRFLOW-3 trial for the purposes of Medicare coverage (42 CFR 405 Subpart B). These decisions are expected to support rapid FDA approval and positive reimbursement access in the US market.
The Nuvaira Lung Denervation System is a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma. Nuvaira’s proprietary technology has demonstrated safety and feasibility in three peer-reviewed published clinical studies in COPD patients. A growing body of literature supports the therapeutic potential of Targeted Lung Denervation (TLD) to meet a significant unmet medical need in patients at risk of COPD exacerbations, also called “lung attacks”, which represent the major driver of healthcare cost and poor clinical prognosis.
“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 Dennis Wahr, MD, CEO of Nuvaira Inc. “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.”
Nuvaira also appointed Tim Herbert, president & CEO of Minneapolis-based Inspire Medical Systems, to its Board of Directors. Tim has led Inspire through FDA approval of the first interventional device for treatment of obstructive sleep apnea (OSA) in 2010, followed by a string of positive reimbursement coverage decisions in the US and the company’s successful IPO in 2018. In addition, Nuvaira has added medtech veteran Karen Peterson as VP Clinical, Regulatory & Quality to its executive team. Karen’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 Inc.).