Nuvaira Announces Enrollment Completion in First Sham-Controlled Clinical Trial of Targeted Lung Denervation for COPD

Minneapolis, Minn., June 27, 2017 – Nuvaira (formerly known as Holaira), a developer of medical devices to treat obstructive lung diseases, today announced completion of patient enrollment in the AIRFLOW-2 trial, the first sham-controlled clinical trial of Targeted Lung Denervation* (TLD) using the Nuvaira™ Lung Denervation System in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The AIRFLOW-2 (NCT#02058459) trial, designed to assess the safety of TLD in patients suffering from moderate to severe COPD at 16 institutions throughout Western Europe, included 82 patients.

COPD is one of the leading causes of morbidity and mortality worldwide. It is characterized by a persistent airflow limitation due to a progressive narrowing of the airways interfering with normal breathing that results in shortness of breath (dyspnea), wheezing, chest tightness, and a productive cough.

“Completing the first randomized, sham-controlled clinical trial of Targeted Lung Denervation is an important milestone to ensure the integrity of scientific data as Nuvaira works to develop a new treatment option for COPD patients,” said Jim Pavliska, vice president of Clinical Affairs at Nuvaira. “We are very pleased with the ongoing feedback from the 16 institutions participating in the AIRFLOW-2 trial, as it is providing key insights into optimizing patient selection and procedure workflow for our upcoming pivotal trial, AIRFLOW-3.”

The Nuvaira Lung Denervation System is a catheter-based system used to treat the overactive airway nerves during TLD. It is a one-time bronchoscopic procedure that uses the dNerva™ Dual Cooled Radiofrequency catheter to provide ablative therapy that opens obstructed airways to improve breathing, and has the potential to provide lasting, whole-lung improvement in patients with moderate to severe COPD.

“We are encouraged by our experience in the AIRFLOW-2 trial using the Nuvaira System,” said Professor Felix Herth, M.D., Ph.D., FCCP, chairman, Division of Pulmonology and Respiratory Care Medicine, Thoraxklink, University of Heidelberg. “Because COPD is a progressive disease that affects millions of people and places a significant financial burden on the system, it is imperative that we find better methods of treatment. This new COPD technology may offer a true breakthrough for patients by providing long-term clinical improvement from a one-time procedure,” continued Professor Herth.

“TLD is the first medical procedure that targets the whole lung by bronchoscopically disrupting overactive parasympathetic nerves to promote airway dilatation to make it easier to breathe,” said Dirk-Jan Slebos, M.D., Ph.D., study principal investigator, University Medical Center, Groningen, The Netherlands. “Our previous research indicates that using Nuvaira’s Lung Denervation System is feasible and safe, and there is evidence for a working therapy. In the current study we compared two groups of COPD patients in a sham-controlled manner to show safety and feasibility while separating treatment effect from any placebo effect. Details of the study will be discussed during the September ERS meeting in Milan, Italy.”

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 half[3]. In the United States, COPD costs are estimated to be more than $50 billion annually[4].

About Nuvaira

Nuvaira (formerly known as Holaira) is a privately held company headquartered in Minneapolis, Minn. The company is developing the Nuvaira™ Lung Denervation System to address chronic obstructive pulmonary disease (COPD) 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.

Institutions Participating in the AIRFLOW-2 Clinical Trial:

Institution Principal Investigator at Site Country
1.       AKH Linz Bernd Lamprecht, MD Austria
2.       Otto Wagner Spital Arschang Valipour, MD* Austria
3.       CHRU de Lille-Hôpital Calmette Thierry Perez, MD France
4.       CHU de Grenoble – Hôpital Michallon Christoph Pison, MD France
5.       CHU de Paris – Hôpital Bichat Claude Bernard Armelle Marceau, MD France
6.       CHU de Reims – Hôpital Maison Blanche Gaetan Deslee, MD France
7.       CHU de Strasbourg – Nouvel Hôpital Civil Romain Kessler, MD France
8.       Asklepios-Fachkliniken Munchen Gauting Wolfgang Gesierich, MD Germany
9.       Charite-Universitatsmedizin Berlin Ralf-Harto Huebner, MD Germany
10.    Klinikverbund Kempten Oberallgäu Christian Schumann, MD Germany
11.    Ruhrlandklinik Essen Kaid Darwiche, MD Germany
12.    Thoraxklinik Heidelberg Felix Herth, MD Germany
13.    Universitätsklinikum Bonn Dirk Skowasch, MD Germany
14.    Academic Medical Center Peter Bonta, MD The Netherlands
15.    University Medical Center Groningen Dirk-Jan Slebos, MD* The Netherlands
16.    Royal Brompton & Harefield NHS Foundation Trust Pallav Shah, MD United Kingdom

 

* AIRFLOW-2 Trial Principal Investigators

# # #

Media Contact:

Shane Gleason
Nuvaira
+1 (703) 772-3035
sgleason@Nuvaira.com

*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.

[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