Nuvaira Announces Published Two-Year Results in COPD Patients treated with Targeted Lung Denervation

AIRFLOW-2 two-year data confirm sustained reduction of severe COPD exacerbation risk vs. a control group.

MINNEAPOLISNov. 23, 2020 /PRNewswire/ — Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, announced today publication of two-year follow-up data from its randomized, sham-controlled, double-blinded trial (AIRFLOW-2) that confirms long-term safety and durable effect of Targeted Lung Denervation (TLD) therapy in COPD patients.

TLD, a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung, has been developed to reduce the clinical consequences of neural hyperactivity, including airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma. Nuvaira’s proprietary TLD technology has demonstrated safety and feasibility in three completed clinical studies, and physician and patient interest in the therapy has enabled continued enrollment in Nuvaira’s FDA pivotal trial (AIRFLOW-3).

AIRFLOW-2 was a double-blinded, sham controlled, multicenter randomized clinical trial (RCT) to assess respiratory adverse events in 82 moderate-to-severe COPD patients with high symptom burden despite optimal drug therapy.  COPD exacerbations represent the highest proportion of COPD costs to the healthcare system and are associated with decreased lung function and poor quality of life.  Valipour and colleagues (Int J COPD 2020:15 2807-2816) confirmed that the risk of severe COPD exacerbation requiring hospitalization was significantly lower in the TLD treatment group compared to the control group through two years of follow-up (p=0.04).  Lung function and Quality of Life measures showed clinical stability in TLD-treated patients over two years of follow-up.

Five peer reviewed publications contribute to the growing body of evidence supporting the therapeutic potential of Targeted Lung Denervation to meet a significant unmet medical need in patients at risk of COPD exacerbation.

About Nuvaira
Nuvaira‘s proprietary 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 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 our clinical trial website www.airflowtrial.com and publication bibliographies at www.Nuvaira.com.

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

First patients successfully treated in the Nuvaira AIRFLOW-3 COPD pivotal trial

A first for Temple University Hospital and U.S. Patients

MINNEAPOLIS, June 10, 2019 – Nuvaira, developer of novel therapeutic strategies to treat obstructive lung diseases, announced the first treatments in the AIRFLOW-3 pivotal trial, the first interventional COPD trial to target reduction in COPD exacerbations as a primary endpoint. Two U.S. patients were successfully treated with Nuvaira’s Targeted Lung Denervation (TLD) therapy at the Temple Lung Center at Temple University Hospital in Philadelphia, and both returned home the same day.

TLD is a bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity. Mechanistically similar to anticholinergics (the principal class of drugs for treatment of COPD) which must be taken daily to manage symptoms, the one-time TLD procedure has the potential to durably reduce exacerbation risk, improve symptoms, and stabilize lung function.

Prior to randomization, the first three patients at each of the 40 participating centers in the U.S., Canada and Europe will be treated with TLD therapy, as part of Nuvaira’s comprehensive physician training and education program. 400 patients will be randomized into the AIRFLOW-3 pivotal trial.

Dr. Gerard J. Criner, Chair and Professor, Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center, performed TLD treatment in the first two patients with moderate-to-severe COPD, high symptom burden, and a history of COPD exacerbation despite optimal medical management.

“Many of our COPD patients experience exacerbations which cannot be controlled with their maintenance medications,” said Dr. Criner. “As a pulmonary community, we need to embrace the development of interventional therapies which may stabilize these patients and reduce their risk of exacerbation. Based on the existing evidence, we are enthusiastic about the potential of TLD to meet a true unmet medical need, and are proud that Temple has treated the first patients in the AIRFLOW-3 pivotal trial.”

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.airflowtrial.com and 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.

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