"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 (COPD) patients," said Dennis Wahr, M.D., 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 Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma in a procedure called Targeted Lung Denervation (TLD). Nuvaira's proprietary technology has demonstrated safety and feasibility in three clinical studies: IPS-I/II, AIRFLOW-1, and, most recently, the AIRFLOW-2 sham controlled randomized clinical trial, which was presented at the European Respiratory Society conference in September 2018.
Nuvaira is the first interventional pulmonary company to pursue and report one-year randomized, double-blinded and sham-controlled clinical evidence in COPD patients from a Phase 2b trial. "The rigor of the AIRFLOW-2 trial has set a high standard for the field," said Dr. Frank Sciurba, Professor of Medicine at UPMC in Pittsburgh, PA and U.S. principal investigator of Nuvaira's AIRFLOW-3 trial. "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 company also announced that Lisa Rogan has joined its executive team as senior vice president of market development, bringing with her over 20 years of medical device industry expertise in commercializing disruptive diagnostic and therapeutic technologies, including ten years of experience with interventional pulmonary devices targeting treatment of severe COPD.
"We are extremely excited to have Lisa Rogan join our executive team at Nuvaira," said Dr. Wahr. "She has a deep understanding and knowledge of the pulmonary field having spent the past decade in it, and she brings with her great business acumen and expertise in accessing new markets."
About Nuvaira Nuvaira is a privately held company headquartered in Minneapolis, Minn. The company has developed the Nuvaira Lung Denervation System to address chronic lung diseases by treating the overactive airway nerves with Targeted Lung Denervation (TLD). The Nuvaira Lung Denervation System is CE Mark approved. The Nuvaira Lung Denervation System is under clinical investigation and is not commercially available in the USA. Nuvaira and dNerva are registered trademarks of Nuvaira, Inc. Please visit us at www.Nuvaira.com.