Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function.

Nuvaira is conducting a pivotal clinical trial to assess the Dnerva system’s effectiveness in reducing COPD exacerbations, defined as a combination of two or more of symptoms – cough, sputum, wheezing, dyspnea or chest tightness – with at least one symptom persisting for more than three days, requiring treatment with antibiotics, steroids or hospitalization. The FDA cleared the way for the international, multicenter, randomized, sham-controlled AIRFLOW-3 investigational device exemption (IDE) study in 2018.

New director, VP named

In conjunction with the breakthrough status, the company announced the appointment of Tim Herbert, president and CEO of Minneapolis-based Inspire Medical Systems Inc., to its board of directors, citing his track record in obtaining FDA approval of the first interventional device to treat obstructive sleep apnea. Nuvaira has also named Karen Peterson as vice president of clinical, regulatory and quality. Peterson previously worked at Stryker ENT.

“Despite the challenges of the COVID pandemic, we are thrilled about these additions to our leadership team and the positive announcements from FDA and CMS,” said Dennis Wahr, Nuvaira’s CEO. “We support our global pulmonary thought leaders who are working hard to ensure patient access to routine care and to important clinical trials like AIRFLOW-3, while simultaneously adapting to the new reality of COVID-19.”

The breakthrough device designation is the latest in a series of positive events for the privately held company, and brings with it benefits such as increased communications with FDA staff and priority review. In March, the agency granted Nuvaira full IDE approval to complete the 400-patient study, following a review of safety data from the first 50 patients. In April, the company secured Medicare coverage for the AIRFLOW-3 study from CMS. The trial is slated for completion in November 2021.

It is estimated that more than 300 million people worldwide have COPD. Among U.S. adults, the prevalence exceeds 19 million U.S. adults, at an annual cost of about $50 billion. Current treatment consists of self-care, such as exercise and quitting smoking, and use of bronchodilators and rescue inhalers. However, failure to take these medications regularly and out-of-pocket costs for some patients can lead to lead to COPD exacerbations.

Clinical evidence

In a trio of peer-reviewed studies published last summer, the Dnerva console and dual-cooled radiofrequency (RF) catheter provided safe and effective targeted lung denervation (TLD) therapy by interrupting vagus nerve signaling to and from the lung. In a single-center substudy of Nuvaira’s IPS-II trial, published in Respiration, the lungs of TLD-treated patients were successfully denervated through monitoring of an established neural link between breathing and heart rate. A second study, also published in Respiration, confirmed 12-month safety and feasibility of TLD in patients with moderate-to-severe COPD. Results of AIRFLOW-2, published in the American Journal of Respiratory and Critical Care Medicine, found the risk of severe COPD exacerbation requiring hospitalization was significantly lower in TLD-treated patients, compared with the sham treatment arm through 12.5 months of randomization, with no hemoptysis or pneumothorax in the TLD group.

The nonsurgical procedure is performed under general anesthesia, with most patients going on home the same day. The TLD catheter is introduced via a bronchoscope through the mouth and down to the airways, where energy ablates the vagal pulmonary nerves while cooling and protecting the outer airways. The entire procedure takes about an hour to treat both lungs and leaves no foreign material in the body.

Founded in 2008, Nuvaira has raised a total of $151 million in private equity funding, most recently in a $79 million round led by U.S. Venture Partners. The funds were earmarked for the AIRFLOW-3 to support FDA approval and to launch a clinical development strategy in targeted European markets. The Dnerva system won CE mark approval in 2016.

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