Nuvaira Announces Peer-Reviewed Publications of Targeted Lung Denervation Mechanisms of Action and Clinical Outcomes

AIRFLOW-2 randomized, sham-controlled one-year data accepted by AJRCCM

MINNEAPOLIS, Aug 19, 2019 – Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, announced today multiple peer-reviewed publications that provide further evidence of the safety, clinical effectiveness, and mechanisms of action of Targeted Lung Denervation (TLD) therapy in COPD.

The company’s dNerva® 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 TLD technology has demonstrated safety and feasibility in three completed clinical studies and the company is now enrolling patients in its FDA pivotal trial, AIRFLOW-3.

In a single-center substudy of Nuvaira’s IPS-II trial, Valipour and colleagues present physiologic evidence that the lungs of TLD treated patients were successfully denervated, through monitoring of an established neural link between breathing and heart rate. Slebos and colleagues reported one-year data from AIRFLOW-1, a dose and safety study which confirmed 12-month safety and feasibility of TLD in patients with moderate-to-severe COPD. Both manuscripts are accepted for publication in the journal Respiration.

AIRFLOW-2 is a double-blinded, sham controlled, multicenter randomized clinical trial (RCT) to assess respiratory adverse events in 82 moderate-to-severe COPD patients with high symptom burden despite optimal medical management. Shah, Slebos and colleagues found the risk of severe COPD exacerbation requiring hospitalization was significantly lower in the TLD treatment group compared to the sham treatment group through 12.5 months of randomization (p=0.0390). No hemoptysis or pneumothorax was found, consistent with longer-term follow-up of earlier trials. AIRFLOW-2 is accepted for publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).

These publications contribute to a growing body of literature supporting the therapeutic potential of Targeted Lung Denervation to meet a significant unmet medical need in patients with symptomatic COPD.

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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Media Inquiries:
Amy Wolter
+1 (763) 450-5676
info@nuvaira.com

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.

# # #
Media Inquiries:
Amy Wolter
+1 (763) 450-5676
info@nuvaira.com