Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device

Inspire Medical Systems CEO Tim Herbert has joined Nuvaira Board of Directors

MINNEAPOLIS, 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”.

The Nuvaira Lung Denervation System is a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma. Nuvaira’s proprietary technology has demonstrated safety and feasibility in three peer-reviewed published clinical studies in COPD patients. A growing body of literature supports the therapeutic potential of Targeted Lung Denervation (TLD) to meet a significant unmet medical need in patients at risk of COPD exacerbations, also called “lung attacks”, which represent the major driver of healthcare cost and poor clinical prognosis.

About Nuvaira

Nuvaira is a privately held company headquartered in Minneapolis, MN. The company’s proprietary Nuvaira Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, in a procedure called Targeted Lung Denervation (TLD). The Nuvaira Lung Denervation System is under clinical investigation and is not commercially available in the USA, and is CE Mark approved. Nuvaira and dNerva are registered trademarks of Nuvaira, Inc.

Please visit our website and publication bibliographies at www.Nuvaira.com.

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Media Inquiries:

Amy Wolter

+1 (763) 450-5676

info@nuvaira.com

Nuvaira Announces Chief Financial Officer and Pivotal Study Milestone

Seasoned Veteran Tom Griffin Joins Nuvaira’s Executive Team

MINNEAPOLIS, Feb. 4, 2020 – Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that Tom Griffin has joined Nuvaira as Chief Financial Officer.

Tom Griffin has a 30-year track record of strong leadership guiding high-growth companies through investment financing, rapid commercialization growth and initial public offering stages.  Tom was most recently Chief Financial Officer of Avedro, Inc. (NASDAQ: AVDR) a leading hybrid ophthalmic pharmaceutical and medical technology company. Avedro completed its initial public offering in February 2019 and was acquired by Glaukos Corporation (NYSE: GKOS) in November 2019.  Prior to joining Avedro, Tom served as the Chief Financial Officer of Entellus Medical, Inc., (NASDAQ: ENTL) from 2007 to May 2016, guiding the company through its initial public offering in 2015.  Entellus was acquired by Stryker Corporation in February 2018.

“We are thrilled that Tom has joined our team,” said Dennis Wahr, M.D., chief executive officer at Nuvaira. “His experience guiding start-up medical device companies through the critical clinical development phase with successful transition to commercial growth and public market offerings will be critical to Nuvaira’s continued progress and success.”

“Joining Nuvaira represents an extraordinary opportunity for me to be part of a dynamic and pioneering company that is deploying truly disruptive technologies that will benefit patients and provide value to physicians and the healthcare system,” said Mr. Griffin.  “The company has an exciting vision for development of its therapy and I am looking forward to working with the team to achieve Nuvaira’s strategic and financial growth objectives.”

The company’s dNerva® 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 completed clinical studies: IPS-I/II, AIRFLOW-1, and most recently, the AIRFLOW-2 sham controlled randomized clinical trial (RCT), which was recently published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), a top-tier global medical journal.  Nuvaira’s pivotal AIRFLOW-3 trial is currently enrolling patients in the US, Canada and Europe, and has just reached the 50-patient enrollment milestone.  Nearly 200 patients have now been treated with targeted lung denervation in clinical trials since 2012.

About Nuvaira

Nuvaira is a privately held company headquartered in Minneapolis, Minn. The company has developed the dNerva® Lung Denervation System to address chronic obstructive pulmonary disease (COPD) and asthma by treating the overactive airway nerves with Targeted Lung Denervation (TLD). The dNerva® Lung Denervation system is CE Mark approved.  The dNerva® 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.

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Media Inquiries:

Amy Wolter

+1 (763) 450-5676

info@nuvaira.com

Nuvaira Receives French Innovation Funding for AIRFLOW-3 Pivotal Trial

Novel program provides reimbursement for TLD therapy in France

MINNEAPOLIS, April 28, 2019 – Nuvaira, developer of novel therapeutic strategies to treat obstructive lung diseases, has received acceptance from the Haute Autorité de Santé (HAS, the French health technology assessment agency) into its Forfait Innovation program. The program is designed to fast-track novel medical devices with significant potential to improve clinical outcomes, with the objective of expediting access to important new therapies.

The Forfait Innovation is a unique program which finances national access to breakthrough innovative therapies during continued collection of clinical and/or health economic data to allow the HAS to fully evaluate the therapy’s performance and clinical value. Strict program requirements include novelty, pre-commercial status, demonstrated safety, and clinical potential to satisfy an unmet medical need. The program also requires a robust, prospective clinical trial designed to confirm safety and efficacy in a well-characterized patient population. Nuvaira’s AIRFLOW-3 randomized, sham-controlled double-blinded pivotal trial (NCT03639051) is the first interventional COPD study to target a reduction in COPD exacerbations as a primary endpoint.

In February, Nuvaira, working with reimbursement consultancy MediTech Access and key opinion leaders from University Medical Centers in Grenoble and Reims, submitted a dossier of pre-clinical and clinical data, including one-year outcomes from its randomized sham-controlled AIRFLOW-2. HAS considers that AIRFLOW-3 can provide adequate confirmatory evidence of TLD safety and efficacy. Under the Forfait Innovation program, costs for the French patients enrolled in AIRFLOW-3 at 8 university medical centers across France, including costs of the TLD catheters, will be reimbursed. Centers may continue treating patients with TLD therapy after the completion of trial enrollment, with continued reimbursement, until results of the AIRFLOW-3 trial are available.

“We are thrilled that our AIRFLOW-2 trial outcomes have resulted in reimbursement under this novel program” said Dennis Wahr, M.D., chief executive officer at Nuvaira. “We anticipate that results from our AIRFLOW-3 trial will allow us to transition into permanent, national reimbursement.”

“Vagal nerve input to the lung is a significant contributor to symptoms and exacerbations in COPD patients.” said Bruno Degano, MD, Ph.D., director of pulmonary medicine at CHU Grenoble. “University Hospital Grenoble is pleased to lead our country’s education and recruitment efforts in AIRFLOW-3.”

About Nuvaira
Nuvaira is a privately held company headquartered in Minneapolis, MN. The company’s proprietary dNerva® Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, in a procedure called Targeted Lung Denervation (TLD). Nuvaira has three completed clinical studies: IPS-I/II, AIRFLOW-1, and most recently, the AIRFLOW-2 randomized, sham-controlled double-blind clinical trial.

The dNerva® lung denervation system is CE Mark approved. The dNerva® 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 www.Nuvaira.com.

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Media Inquiries:
Amy Wolter
+1 (763) 450-5676
info@nuvaira.com

Nuvaira Announces a $79 Million Financing Round to Pursue Groundbreaking Treatment of COPD

Market Development Veteran Lisa Rogan Joins Nuvaira’s Executive Team

MINNEAPOLIS, Feb 11, 2019 – Nuvaira, a developer of novel therapeutic medical devices  to treat obstructive lung diseases, announced today it has closed a $79 million  equity financing led by U.S. Venture Partners, with Endeavour Vision, Qiming Venture Partners, Lightstone Ventures and Richard King Mellon Foundation joining the round, along with all of Nuvaira’s existing investors: Advanced Technology Ventures; Morgenthaler Ventures, Split Rock Partners, Versant Ventures, Vertex Ventures HC, Vertex Growth Fund and Windham Venture Partners.

“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),” 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.