Nuvaira
Nuvaira is a medical technology company based in Minneapolis, Minnesota, specializing in innovative therapies for obstructive lung diseases, including the development of the dNerva Lung Denervation System.
Company Overview
Nuvaira is a medical technology company that develops innovative therapies for obstructive lung diseases. The company is headquartered in Minneapolis, Minnesota, USA. Nuvaira has positioned itself at the forefront of medical innovations with a strong intellectual property portfolio, holding over 70 patents issued and pending worldwide.
Products
Nuvaira's primary product is the dNerva Lung Denervation System, a novel, catheter-based system designed to treat overactive airway nerves. The dNerva system is currently under clinical investigation and is not yet commercially available in the USA. The system aims to provide relief through a one-time, outpatient procedure known as Targeted Lung Denervation (TLD), intended to reduce the frequency of exacerbations in chronic obstructive pulmonary disease (COPD) patients.
Clinical Trials
Nuvaira is actively participating in the AIRFLOW-3 Clinical Trial, which focuses on reducing exacerbation risk in COPD patients. Clinical studies involving Nuvaira's technologies have already treated over 500 patients. The outcomes of these trials are pivotal in gaining regulatory approval and moving towards commercial availability.
Funding and Financials
In 2019, Nuvaira successfully raised $79 million in a financing round. This financial support is instrumental in advancing their clinical trials, research, and development activities. Achieving this level of funding underscores the confidence investors have in Nuvaira's innovative approaches and their potential impact on treating obstructive lung diseases.
FDA Breakthrough Device Designation
The US Food and Drug Administration (FDA) has designated the dNerva Lung Denervation System as a Breakthrough Device. This designation is granted to medical technologies that have the potential to offer more effective treatment for life-threatening or irreversibly debilitating diseases. Being classified as a Breakthrough Device helps Nuvaira expedite the development, assessment, and review process to ensure patients receive timely access to transformative therapies.