200th Treatment Milestone for AIRFLOW-3 COPD Trial

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300 Patients Treated Worldwide with dNerva® Targeted Lung Denervation therapy

MINNEAPOLIS, Jan. 25, 2022 /PRNewswire/ -- Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, announces two treatment milestones. 200 patients have been treated in the AIRFLOW-3 pivotal trial, the first interventional COPD trial to target reduction in COPD exacerbations as a primary endpoint. Worldwide, 300 patients have received dNerva® Targeted Lung Denervation (TLD) therapy across five clinical trials.

dNerva® 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 COPD drugs) taken daily to manage symptoms, the one-time dNerva procedure has the potential to reduce exacerbation risk, improve symptoms, and stabilize lung function.

The 300^th dNerva TLD treatment occurred this month. Dr. Gerard Criner, Chair and Professor, Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University has treated 20 patients in the AIRFLOW-3 trial. "If we can help patients stabilize their COPD symptoms and keep them out of the hospital, that will benefit patients, their caregivers, and reduce burden on the healthcare system as well" he said. COPD exacerbations represent approximately two-thirds of the total cost of COPD care, estimated at $49B annually in the U.S.

This month also marks a critical treatment milestone in the AIRFLOW-3 trial. Prof. Pallav Shah, Consultant Physician at the Chelsea & Westminster and Royal Brompton Hospitals in London and Professor of Respiratory Medicine at Imperial College is the leading enroller in the trial. He performed the 200^th AIRFLOW-3 procedure in a patient with moderate-to-severe COPD, high symptom burden, and a history of COPD exacerbations despite optimal medical management. "Many COPD patients suffer from poor quality of life due to repeated COPD exacerbations" he said. "The AIRFLOW-3 trial is an exciting opportunity to evaluate a one-time outpatient procedure that may durably reduce COPD exacerbations and improve clinical stability."

The Company recently secured an additional $50 million commitment of debt and equity financing with Innovatus Capital Partners, LLC, which will be used to complete the AIRFLOW-3 trial and achieve U.S. FDA approval.

About Nuvaira
Nuvaira is a privately held company headquartered in Minneapolis, MN. The company's proprietary dNerva® Targeted Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, with a one-time, outpatient bronchoscopic procedure designed to reduce the frequency and severity of COPD exacerbations.

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

Innovatus Capital Partners, LLC
Innovatus Capital Partners, LLC, is an independent adviser and portfolio management firm with approximately $1.7B in assets under management. Innovatus adheres to an investment strategy that identifies disruptive and growth opportunities across multiple asset categories with a unifying theme of capital preservation, income generation, and upside optionality. The firm has a dedicated team of life sciences investment professionals with deep experience in healthcare, including life sciences. Innovatus and its principals have significant experience providing debt financing to medical device, diagnostics, and biotechnology companies that address unmet medical needs, improve patient outcomes, and reduce overall healthcare expenditures. Further information can be found at www.innovatuscp.com.

SOURCE Nuvaira