First patients successfully treated in the Nuvaira AIRFLOW-3 COPD pivotal trial

A first for Temple University Hospital and U.S. Patients

MINNEAPOLIS, June 10, 2019 – Nuvaira, developer of novel therapeutic strategies to treat obstructive lung diseases, announced the first treatments in the AIRFLOW-3 pivotal trial, the first interventional COPD trial to target reduction in COPD exacerbations as a primary endpoint. Two U.S. patients were successfully treated with Nuvaira’s Targeted Lung Denervation (TLD) therapy at the Temple Lung Center at Temple University Hospital in Philadelphia, and both returned home the same day.

TLD is a bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity. Mechanistically similar to anticholinergics (the principal class of drugs for treatment of COPD) which must be taken daily to manage symptoms, the one-time TLD procedure has the potential to durably reduce exacerbation risk, improve symptoms, and stabilize lung function.

Prior to randomization, the first three patients at each of the 40 participating centers in the U.S., Canada and Europe will be treated with TLD therapy, as part of Nuvaira’s comprehensive physician training and education program. 400 patients will be randomized into the AIRFLOW-3 pivotal trial.

Dr. Gerard J. Criner, Chair and Professor, Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center, performed TLD treatment in the first two patients with moderate-to-severe COPD, high symptom burden, and a history of COPD exacerbation despite optimal medical management.

“Many of our COPD patients experience exacerbations which cannot be controlled with their maintenance medications,” said Dr. Criner. “As a pulmonary community, we need to embrace the development of interventional therapies which may stabilize these patients and reduce their risk of exacerbation. Based on the existing evidence, we are enthusiastic about the potential of TLD to meet a true unmet medical need, and are proud that Temple has treated the first patients in the AIRFLOW-3 pivotal trial.”

About Nuvaira
Nuvaira is a privately held company headquartered in Minneapolis, MN. The company’s proprietary dNerva® Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, in a procedure called Targeted Lung Denervation (TLD). Nuvaira has three completed clinical studies: IPS-I/II, AIRFLOW-1, and most recently, the AIRFLOW-2 randomized, sham-controlled double-blind clinical trial.

The dNerva® lung denervation system is CE Mark approved. The dNerva® lung denervation system is under clinical investigation and is not commercially available in the USA. Nuvaira and dNerva are registered trademarks of Nuvaira, Inc. Please visit www.airflowtrial.com and www.Nuvaira.com.

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