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.

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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.

Nuvaira annonce un exposé oral lors du congrès international de l’ERS pour discuter de l’importance de la dénervation ciblée du poumon afin de traiter la BPCO

Les résultats de l’essai AIRFLOW-2 font apparaître une réduction des exacerbations et autres effets indésirables respiratoires

PARIS, le 18 septembre 2018 (GLOBE NEWSWIRE) — Nuvaira, un développeur de dispositifs médicaux pour traiter les maladies pulmonaires obstructives, a annoncé aujourd’hui l’acceptation par la European Respiratory Society (ERS) d’un extrait clinique en vue d’un exposé oral lors de son 28congrès international qui se tiendra à Paris. Co-investigateur principal de l’étude, Dirk-Jan Slebos, M.D., Ph.D., du University Medical Center Groningen aux Pays-Bas, fera aujourd’hui une première présentation publique des résultats de l’essai clinique AIRFLOW-2 (NCT#02058459), première étude sous contrôle simulé, aléatoire, en double aveugle et multicentrique de la dénervation pulmonaire ciblée (Targeted Lund Denervation – TLD) utilisant le Système de dénervation pulmonaire Nuvaira™ afin de traiter les patients souffrant de BPCO modérée à sévère.

« Les résultats de cet essai de phase II démontrent une importante réduction des effets indésirables respiratoires du type exacerbations de la BPCO et hospitalisations dans plus de 50 % des cas », a indiqué le Dr. Slebos. « Je suis convaincu que ces résultats peuvent avoir des retombées majeures pour les patients atteints de BPCO et sur leur qualité de vie en général, mais aussi en termes de coûts des soins, en effet on relève des dépenses conséquentes liées aux exacerbations et autres hospitalisations. »

« La dénervation ciblée du poumon est une procédure médicale administrée en une seule séance, qui est la première à cibler l’ensemble du poumon par la voie bronchiscopique en interrompant les nerfs parasympathiques afin de faciliter la dilation des voies aériennes ce qui facilite la respiration des patients », a poursuivi le Dr. Slebos. « Ce nouveau système de dénervation pulmonaire peut offrir aux patients qui souffrent de BPCO un traitement à long terme, avec un effet supplémentaire en plus de la gestion médicale ».

L’exposé oral, intitulé « A double-blind, randomized, sham-controlled study of Targeted Lung Denervation in patients with moderate to severe COPD », du Dr. Slebos et al. aura lieu ce jour à 15h00 (CEST) en salle 7.3Z2 dans le cadre de la session « Interventional pulmonology highlights in 2018: ELVR, TLD and BT » (Session 496, extrait n°OA4929) au parc Paris Expo de la Porte de Versailles.

« Nous sommes honorés que notre extrait clinique sur les résultats de l’essai AIRFLOW-2 ait été accepté pour un exposé oral lors du congrès international de l’ERS, la plus grande conférence qui réunit les plus grands spécialistes de la médecine respiratoire », a déclaré Martin Mayse, M.D., co-fondateur et Directeur technologique de Nuvaira. « Après avoir prouvé l’innocuité et la faisabilité de la TLD dans le cadre d’essais antérieurs, cet essai sous contrôle simulé correspondait en toute logique à l’étape suivante pour étudier plus en profondeur l’efficacité potentielle de la TLD pour les patients ».

Nuvaira a également organisé un mini-symposium sectoriel lors du congrès de l’ERS lundi soir, consacré à la TLD administrée en une séance pour le traitement de la BPCO et de l’asthme. Ce programme était présidé par Alvar Agustí, M.D., Ph.D., Directeur du Thorax Clinic Institute à l’Hospital Clinic de Barcelone, et par le professeur Felix Herth, M.D., Ph.D, Président de la division de pneumologie et de médecine respiratoire au Thoraxklinik de Heidelberg.

Cinq experts médicaux ont exposé des conclusions cliniques lors de ce mini-symposium sur des sujets tels que le contrôle neural des muscles lisses des voies aériennes, le mécanisme d’action et le Système de dénervation pulmonaire de Nuvaira, la TLD dans le traitement de la BPCO et les données extraites des essais AIRFLOW-1 et AIRFLOW-2, la TLD dans le traitement de l’asthme sévère ainsi que des informations concernant le prochain essai pivot AIRFLOW-3, prévu sur différents sites en Europe, au Canada et aux États-Unis.

À propos de la BPCO
La BPCO est le terme générique pour décrire un groupe de maladies comme le syndrome des petites voies respiratoires (bronchite chronique) et l’emphysème, caractérisé par une obstruction chronique et incomplètement réversible des voies respiratoires qui rend la respiration difficile. La BPCO toucherait à l’heure actuelle plus de 300 millions de personnes dans le monde1,2.

Aujourd’hui, la plupart des patients reçoivent un traitement pharmacologique. L’administration d’un bronchodilatateur par inhalation une ou deux fois par jour permet de décontracter et ouvrir temporairement les voies respiratoires. D’autres formes de traitement comprennent également la réadaptation pulmonaire, l’oxygénothérapie et une intervention chirurgicale. En Europe, les pathologies pulmonaires représentent une charge financière annuelle de 141 milliards d’euros et la BPCO représente à elle seule près de la moitié de cette dépense3. Aux États-Unis, on estime que les coûts liés à la BPCO s’élèvent à plus de 50 milliards de dollars par an4.

À propos d’AIRFLOW-2
L’essai sous contrôle simulé AIRFLOW-2 (NCT#02058459) est destiné à évaluer l’innocuité de la TLD sur des patients souffrant de BPCO modérée à sévère. L’essai a porté sur 82 patients répartis entre 15 établissements en Europe occidentale. Le recrutement est achevé et le suivi sur le long terme est en cours. Les principaux investigateurs sont Dirk-Jan Slebos, M.D., Ph.D., du University Medical Center de Groningen, aux Pays-Bas, et Arschang Valipour, M.D., Ph.D., du Otto Wagner Spital de Vienne, en Autriche.

À propos de Nuvaira
Nuvaira est une entreprise privée basée à Minneapolis (Minnesota). La société a développé le Système de dénervation pulmonaire (« Lung Denervation System ») Nuvaira™ pour lutter contre la bronchopneumopathie chronique obstructive (BPCO) et l’asthme en traitant les nerfs hyperactifs des voies respiratoires lors de la dénervation pulmonaire ciblée* (TLD ). Nuvaira a reçu l’approbation de la marque CE pour son Système de dénervation pulmonaire Nuvaira à utiliser pendant la TLD en janvier 2016. Pour en savoir plus :  www.Nuvaira.com.

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

* La dénervation pulmonaire ciblée (« Targeted Lung Denervation » – TLD) fait actuellement l’objet de recherches pour la bronchopneumopathie chronique obstructive (BPCO)  et n’est pas encore disponible dans le commerce.

Nuvaira est une marque déposée de 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

Une photo pour accompagner ce communiqué est disponible à l’adresse : http://www.globenewswire.com/NewsRoom/AttachmentNg/7a4d08f3-b50c-4544-bc2c-cf5b7041311a