Nuvaira Announces Four Clinical Abstracts Accepted for Presentation at ERS International Congress

Treating COPD and Asthma with Targeted Lung Denervation is Focus of Mini-Symposium

MILAN, Italy, Sept. 07, 2017 (GLOBE NEWSWIRE) -- Nuvaira, a developer of medical devices to treat obstructive lung diseases, today announced that four scientific abstracts featuring the Nuvaira(TM) Lung Denervation System have been accepted for presentation at the upcoming 27^th European Respiratory Society (ERS) International Congress, to be held Sept. 9-13, 2017, in Milan, Italy. The abstracts may be viewed through the ERS 2017 website.

Scientific experts will present their findings from studies on the safety and efficacy of Targeted Lung Denervation* (TLD), a bronchoscopic procedure developed to relieve obstructive airway disease, during a Thematic Poster session on "Endoscopic Lung Volume Reduction and TLD" taking place Sunday afternoon, Sept. 10. The abstracts will share some of the important preclinical work on the physiological response to lung denervation as well as clinical work on health related quality-of-life improvements.

In addition, Nuvaira announced it will host an evening mini-symposium at ERS on the use of TLD for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. The program will be co-chaired by Alvar Agustí, M.D., Ph.D., director of the Thorax Institute at Hospital Clinic in Barcelona, and Professor Felix Herth, M.D., Ph.D., FCCP, chairman, Division of Pulmonology and Respiratory Care Medicine, Thoarxklink, at the University of Heidelberg. Five medical experts will present their findings on topics including: Neural Control of Airway Smooth Muscle, TLD Mechanism of Action, the AIRFLOW-1 and AIRFLOW-2 trials on TLD for COPD patients, and the RELIEF-1 trial on TLD for severe asthma patients.

"I am very encouraged by the one-year data from the randomized AIRFLOW-1 Trial of TLD using the Nuvaira Lung Denervation System in patients with COPD," said Dirk-Jan Slebos, M.D., Ph.D., study principal investigator, University Medical Center, Groningen, The Netherlands. "As with earlier feasibility studies, the AIRFLOW-1 data provides strong evidence that TLD is feasible, provides a sustained treatment effect, and has evolved into a safe treatment. I look forward to discussing the findings in further detail during the evening session.

"TLD is the first medical procedure that targets the whole lung by bronchoscopically disrupting overactive parasympathetic nerves to promote airway dilatation and make it easier for patients to breathe. This one-time procedure may provide an important tool for long-term clinical improvement in COPD patients," continued Dr. Slebos.

Nuvaira recently announced completion of patient enrollment in the AIRFLOW-2 trial, the first sham-controlled clinical trial of TLD using the Nuvaira System in patients with moderate to severe COPD. The AIRFLOW-2 (NCT#02058459) trial, designed to assess safety and efficacy of TLD in patients suffering from moderate to severe COPD, has been conducted at 16 institutions throughout Western Europe and includes 82 patients. 

"We are excited to share new outcomes data and to be featured in four clinical abstracts at ERS 2017, the largest meeting of respiratory professionals in the world," said Shane Gleason, chief commercial officer at Nuvaira. "We are equally pleased with the positive feedback from the institutions participating in the AIRFLOW-2 Trial, which will build upon the discoveries and data already collected regarding the treatment of overactive airways nerves during TLD, and the potential to provide lasting, whole-lung improvement."

About COPD
COPD is the umbrella term used to describe a group of diseases such as small airway disease (chronic bronchitis) and emphysema, characterized by chronic and incompletely reversible airway obstruction that interferes with normal breathing. It is estimated that COPD affects 4 to 10 percent of all adults in European countries and more than 300 million people globally^{1 ,2}.

Pharmacological treatment is the approach for most patients today. Inhaled drugs are used once or twice daily to relax and temporarily open airways. Other forms of treatment include pulmonary rehabilitation, oxygen administration and surgical intervention. These treatments provide temporary relief. The annual financial burden of lung disease in Europe is €141 billion and COPD accounts for almost half³. In the United States, COPD costs are estimated to be more than $50 billion annually⁴.

About Nuvaira
Nuvaira (formerly known as Holaira) is a privately held company headquartered in Minneapolis, Minn. The company is developing the Nuvaira(TM) Lung Denervation System to address chronic obstructive pulmonary disease (COPD) and asthma by treating the overactive airway nerves during Targeted Lung Denervation* (TLD). Nuvaira received CE Mark approval for its Nuvaira Lung Denervation System for use during TLD in January 2016. More information may be found at www.Nuvaira.com.

Note to Media : The evening mini-symposium will take place on Sept. 12, at 17:30 in Room Blue 2, MiCo- Milano Congressi.

*Targeted Lung Denervation (TLD) is currently under clinical investigation for chronic obstructive pulmonary disease and is not yet commercially available.

Nuvaira is a trademark of Nuvaira, Inc.

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¹ Global Chronic Obstructive Pulmonary Disease Epidemiology and Patient Flow - 2017. Fore Pharma.
² http://www.efanet.org/get-advice/copd
³ http://www.efanet.org/get-advice/copd
⁴ Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Report

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