Nuvaira Announces Oral Presentation at ERS International Congress Discussing Significance of Targeted Lung Denervation to Treat COPD

Results from AIRFLOW-2 Trial Reveal Reduction in Exacerbations and other Respiratory Adverse Events

PARIS, Sept. 18, 2018 – Nuvaira, a developer of medical devices to treat obstructive lung diseases, announced the acceptance of a clinical abstract by the European Respiratory Society (ERS) for oral presentation at the 28th International Congress 2018 in Paris. Co-principal Investigator, Dirk-Jan Slebos, M.D., Ph.D., from the University Medical Center Groningen in the Netherlands, today will make the first public presentation of results from the AIRFLOW-2 clinical trial (NCT#02058459), the first multi-center, double-blind, randomized, sham-controlled study of Targeted Lung Denervation (TLD) using the Nuvaira™ Lung Denervation System to treat patients with moderate to severe COPD.

“Results from this phase II trial demonstrate a significant reduction in respiratory adverse events such as COPD exacerbations and hospitalizations of greater than 50 percent,” said Dr. Slebos. “I believe these results may have important implications for COPD sufferers and their overall quality of life, as well as for healthcare costs, as there is significant expense associated with exacerbations and hospitalizations.

“TLD is a one-time medical procedure, and it’s the first to target the whole lung by bronchoscopically disrupting parasympathetic nerves to promote airway dilation to make it easier for patients to breathe,” continued Dr. Slebos. “This novel lung denervation system may offer patients who suffer from COPD a long-term treatment that has added effect on top of medical management.”

The oral presentation entitled, “A double-blind, randomized, sham-controlled study of Targeted Lung Denervation in patients with moderate to severe COPD,” by Dr. Slebos et al., takes place today at 15:00 CEST in room 7.3Z2 as part of the session on “Interventional pulmonology highlights in 2018: ELVR, TLD and BT” (Session 496, Abstract no. OA4929) at the Paris Expo Porte de Versailles.

“We are gratified to have had a clinical abstract on results of the AIRFLOW-2 trial accepted for oral presentation at the ERS International Congress, the largest worldwide meeting of leaders in respiratory medicine,” said Martin Mayse, M.D., co-founder and chief technology officer of Nuvaira. “After proving safety and feasibility of TLD in earlier trials, this sham-controlled trial was the logical next step to further study the potential effectiveness of TLD for patients.”

Nuvaira also hosted an industry mini-symposium at the ERS Congress on Monday evening, which focused on TLD as a one-time treatment for COPD and asthma. The program was co-chaired by Alvar Agustí, M.D., Ph.D., director of the Thorax Clinic Institute at Hospital Clinic in Barcelona, and Professor Felix Herth, M.D., Ph.D., chairman of the Division of Pulmonology and Respiratory Care Medicine at the Thoraxklinik in Heidelberg.

Five medical experts presented clinical findings at the mini-symposium on topics that included: neural control of airway smooth muscle, mechanism of action and the Nuvaira Lung Denervation System, TLD in COPD and data from the AIRFLOW-1 and AIRFLOW-2 trials, TLD in severe asthma, and information regarding the upcoming AIRFLOW-3 pivotal trial, which is planned for sites in Europe, Canada and the U.S.

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 more than 300 million people globally[1][2].

[i] Global Chronic Obstructive Pulmonary Disease Epidemiology and Patient Flow – 2017. Fore Pharma.

[ii] http://www.efanet.org/get-advice/copd

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. 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 AIRFLOW-2

The AIRFLOW-2 (NCT#02058459) sham-controlled trial was designed to assess the safety of TLD in patients suffering from moderate to severe COPD. The trial included 82 patients at 15 institutions throughout Western Europe. Enrollment has been completed and long-term follow-up is ongoing. The principal investigators are Dirk-Jan Slebos, M.D., Ph.D., University Medical Center, Groningen, The Netherlands and Arschang Valipour, M.D., Ph.D., Otto Wagner Spital, Vienna, Austria.

About Nuvaira

Nuvaira is a privately held company headquartered in Minneapolis, Minn. The company has developed the Nuvaira™ 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.

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Media Inquiries:

Amy Wolter

+1 (763) 450-5676

info@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

Nuvaira Announces 1st Patient Treated in RELIEF-1 Study Evaluating New Approach for Asthma Treatment

Clinical Trial Assesses First-of-its-Kind, One-Time Medical Procedure in Patients with Severe Asthma

Minneapolis, Minn., March 27, 2018 – Nuvaira, a developer of medical devices to treat obstructive lung diseases, today announced treatment of the first patient in the RELIEF-1 Clinical Study in Europe. The RELIEF-1 trial (NCT02872298) is a prospective, multi-center, single-arm (non-randomized) study designed to evaluate the safety and technical feasibility of a procedure called Targeted Lung Denervation (TLD) using the Nuvaira™ Lung Denervation System for the treatment of severe asthma.

The feasibility study is slated to treat a total of 30 patients at facilities in France, Germany, the Netherlands and the United Kingdom, with patient follow-up planned out to three years. Principal Investigators of RELIEF-1 are Nick ten Hacken, M.D., Ph.D., at the University Medical Center Groningen (UMCG), the Netherlands, and Professor Pallav Shah, M.D., at Royal Brompton & Harefield NHS Foundation Trust and Chelsea and Westminster Hospital NHS Foundation Trust in London. Dirk- Jan Slebos, M.D., Ph.D., performed the first patient treatment in the Department of Pulmonary Diseases at UMCG.

“The first patient tolerated the minimally invasive therapeutic treatment very well and there were no procedural complications,” according to Dr. ten Hacken. “TLD is the first medical procedure that targets the whole lung by disrupting the overactive   nerves into the lungs, thereby opening up the airways and making it easier to breathe. We are encouraged by how well the   first patient responded to TLD and we look forward to treating additional asthma patients utilizing this innovative, one-time procedure.”

The Nuvaira Lung Denervation System is a catheter-based system developed to treat patients with obstructive lung disease, specifically severe asthma and chronic obstructive pulmonary disease (COPD). The system’s proprietary technology delivers targeted energy to disrupt nerve signals to the lungs using a process known as denervation. The simple, one-time bronchoscopic treatment has the potential to provide lasting whole lung improvement for severe asthma patients by opening obstructed airways to make breathing easier. Currently, there is no cure for asthma, but there are treatment plans that can   help patients manage the disease. Approximately three quarters of asthma sufferers are adults, with 10 percent suffering from severe asthma, which is difficult to treat[1].

“The first patient treatment in our RELIEF-1 Clinical Trial is an important milestone in our quest to develop a safe and effective treatment for asthma patients worldwide,” said Dennis Wahr, M.D., chief executive officer at Nuvaira. “Earlier trials evaluating TLD in COPD patients have demonstrated feasibility and promising long-term, sustained treatment results. We look forward to the completion of this important study.”

About Asthma

Asthma is among the most prevalent chronic respiratory diseases, estimated to affect over 300 million people globally[2]. Asthma sufferers have difficulty moving air in and out of the lungs, due to airway narrowing (bronchoconstriction), airway wall thickening (inflammation), and elevated mucus production. The ongoing burden of this serious and costly disease is estimated at more than $50 billion per year with more than 5,000 emergency department visits per day in the US alone[3],[4]. Severe asthma often requires multiple medications to maintain or achieve control of symptoms and the risk of flare-ups. Severe   asthma may also be refractory, or insensitive to currently available medications. This means that despite use of their medications, these patients still cannot achieve asthma control or avoid flare-ups, which may result in an overall reduction in their quality of life.

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) 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 the treatment of COPD in January 2016. More information may be found at www.Nuvaira.com.

# # #

Media Inquiries:

Amy Wolter

+1 (763) 450-5676

info@nuvaira.com

*Targeted Lung Denervation (TLD) is currently under clinical investigation for asthma and COPD and is not yet commercially available. Nuvaira is a trademark of Nuvaira, Inc.

[1] G John Gibson, Robert Leddenkemper, Yves Sibille, Bo Lundback. European Lung White Book: Respiratory Health and Disease in Europe. European Respiratory Society, 2013.

[2] Global, regional prevalence for COPD and asthma 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. www.the

lancert.com/respiratory. Online Aug. 16, 2017.

[3] Wang, Emergency department charges for asthma-related outpatient visits. J Health Care Poor Underserved. 2014 February; 25(1):396-405 [4] Barnett, Costs of Asthma in the United States:2002-2007. J Allergy Clin Immunol January 2011.

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, Sept. 7, 2017 – Nuvaira, a developer of medical devices to treat obstructive lung diseases, today announced that four scientific abstracts featuring the Nuvaira™ Lung Denervation System have been accepted for presentation at the upcoming 27th 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 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) 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.

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

Media Inquiries:

Amy Wolter

+1 (763) 450-5676

info@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

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

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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