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, 2018 – 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 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