New Milestone Trial for Patients with COPD

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 300th 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 200th 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.

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