FDA approves bronchoscopic therapy for COPD and Asthma

MINNEAPOLIS-The U.S. Food and Drug Administration (FDA) has granted approval to Nuvaira® Lung Denervation System for has been designation as a Breakthrough Device .

Targeted Lung Denervation (TLD) is a bronchoscopic therapy that ablates parasympathetic pulmonary nerves to induce anticholinergic action in COPD.

Targeted Lung Denervation is feasible and safe using esophageal visualization and demonstrates improvement in symptoms and health related quality of life in patients with COPD compared to inhaled anticholinergic maintenance therapy. TLD shows similar lung function improvements compared to tiotropium, confirming the anticholinergic mechanism of action.

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.

The Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases has received approval.This program creates an expedited pathway for prioritized Food and Drug Administration review of devices that have potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Nuvaira's lung denervation system is designed to reduce the risk of moderate-to-severe COPD exacerbations in patients on optimal medical care. In March review of Food and Drug Administration 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 U.S. market.

"Despite the challenges of the COVID pandemic, we are thrilled about these additions to our leadership team and the positive announcements from Food and Drug Administration and CMS." said Dennis Wahr, M.D., 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'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.

For further reference log on to: www.Nuvaira.com.