Medical device and MedTech insights, news, tips and more
Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
June 8, 2020
Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that its Nuvaira® Lung Denervation System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). This program creates an expedited pathway for prioritized FDA review of devices that have potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Nuvaira’s lung denervation system is designed to reduce the risk of moderate-to-severe COPD exacerbations in patients on optimal medical care. In March, FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s AIRFLOW-3 pivotal trial resulted in full IDE approval for completion of the 400-patient study, and in April, the Centers for Medicare & Medicaid Services (CMS) approved the AIRFLOW-3 trial for the purposes of Medicare coverage (42 CFR 405 Subpart B). These decisions are expected to support rapid FDA approval and positive reimbursement access in the U.S. market.
Nuvaira also announces appointment of Tim Herbert, President & CEO of Minneapolis-based Inspire Medical Systems to its Board of Directors. Tim has led Inspire through FDA approval of the first interventional device for treatment of obstructive sleep apnea (OSA) in 2010, followed by a string of positive reimbursement coverage decisions in the U.S. and the company’s successful IPO in 2018. In addition, Nuvaira has added medtech veteran Karen Peterson as VP Clinical, Regulatory & Quality to its executive team. Karen’s 30-year track record includes successful execution of multiple IDE clinical trials and PMA approvals. She joins Nuvaira from Stryker ENT (formerly Entellus Medical Inc.).
“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, M.D., CEO of Nuvaira Inc. “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”.
See Full Press Release: Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
Written by: Nuvaira
Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.
Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.