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Nuvaira Announces AIRFLOW-3 COPD Pivotal Trial Milestone

Nuvaira Announces AIRFLOW-3 COPD Pivotal Trial Milestone

100 Randomized Patients; Inspire’s CEO Tim Herbert appointed Chairman of the Board

MINNEAPOLISAugust 11, 2021 – Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that 100 patients have been randomized in the FDA pivotal AIRFLOW-3 Clinical Trial.  This COPD trial is evaluating the safety and effectiveness of the Nuvaira Lung Denervation System to reduce the risk of COPD exacerbations in patients on optimal medical care.

Nuvaira also announces that Tim Herbert, President & CEO of Minneapolis-based Inspire Medical Systems has been appointed Chairman of the Board of Directors.

“Despite the healthcare system challenges of the COVID pandemic, treatment of COPD exacerbations remains a critical unmet need” said Dennis Wahr, M.D., CEO of Nuvaira Inc.  “We applaud our trial investigators for their unwavering support of the AIRFLOW-3 trial and their commitment to enrollment.”  Over 250 patients have been randomized or treated with TLD in Nuvaira clinical trials, including over 50 patients in the United States.

Prof. Pallav Shah (Royal Brompton Hospital, London) randomized the 100th patient in the AIRFLOW-3 trial on August 11.  “We are thrilled to be part of AIRFLOW-3, and to build on the knowledge and experience with the therapy which has the potential to alter the clinical trajectory for COPD patients with persistent exacerbations.” Prof. Shah said.  “We are proud to help Nuvaira and our colleagues celebrate this milestone and look forward to offering TLD as a therapeutic option for many of our COPD patients who struggle to maintain clinical stability on routine pharmacotherapy.”  Professor Shah and his team have randomized or treated over 40 patients in TLD clinical trials, and currently are ranked #1 globally across AIRFLOW-3 trial centers.

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 a positive safety profile 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.

About Nuvaira

Nuvaira is a privately held company headquartered in Minneapolis, MN. The company’s proprietary Nuvaira Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, in a procedure called Targeted Lung Denervation (TLD).  The Nuvaira Lung Denervation System is under clinical investigation and is not commercially available in the USA, and is CE Mark approved. Nuvaira and dNerva are registered trademarks of Nuvaira, Inc.

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