Nuvaira, a medical device company, announced it has secured $79 million to support the AIRFLOW-3 clinical trial to assess the company’s new targeted lung denervation (TLD) system, a minimally invasive treatment for chronic obstructive pulmonary disease (COPD).
COPD includes a group of diseases characterized by chronic airway obstruction that interferes with breathing.
The stimulation of parasympathetic pulmonary nerves that run along the two main bronchi in the lungs causes bronchoconstriction and mucus secretion. They are the dominant neuronal pathway in the control of airway smooth muscle tone, and some bronchodilator medications act by interfering with this system.
TLD is a new treatment with the potential to provide lasting whole lung improvement for COPD patients by opening obstructed airways, making breathing easier.
TLD is a one-time, non-surgical procedure that involves passing a bronchoscope through the mouth and into the lungs. A special catheter containing an electrode is then passed through the bronchoscope, and delivers a type of electrical energy — called radiofrequency energy — to the nerves located just outside the airways. This interrupts overactive nerve signals and may reduce obstructive airway symptoms.
Treatment is delivered first to one lung, then to the other. Once the energy has been delivered, the catheter and bronchoscope are removed. According to the company’s website, the procedure takes about one hour.
“The rigor of the AIRFLOW-2 trial has set a high standard for the field,” Frank Sciurba, MD, professor of medicine at UPMC in Pittsburgh, Pennsylvania, and U.S. principal investigator of Nuvaira’s AIRFLOW-3 trial, said in a press release. “We are encouraged by the results of the AIRFLOW-2 trial, and we see TLD potentially filling an unmet need for our COPD patients who continue to have exacerbations while on maximal guideline-based pharmacologic therapy.”
The new AIRFLOW-3 trial (NCT03639051) will evaluate the efficacy and safety of TLD in addition to optimal medical care to reduce moderate or severe exacerbations and related hospitalizations in COPD patients, compared with optimal medical care alone. The team expects to enroll about 520 participants.
The financing round to support the trial was led by U.S. Venture Partners, together with new investors Endeavour Vision, Qiming Venture Partners, Lightstone Ventures, and Richard King Mellon Foundation, and previous Nuvaira investors.
“We are thrilled to have such a strong consortium of top-tier investors in this financing, as a clear vote of confidence in our work and the performance of our novel catheter-based system in our Phase 2b randomized, sham-controlled trial in patients with chronic obstructive pulmonary disease,” said Dennis Wahr, MD, chief executive officer of Nuvaira. “These funds will be used to support the pivotal AIRFLOW-3 clinical trial for FDA approval, and to implement a targeted clinical development strategy in key European markets.”
Nuvaira’s TLD is currently under clinical investigation, and is not yet commercially available in the U.S.