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.
“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.”
Asthma is among the most prevalent chronic respiratory diseases, estimated to affect over 300 million people globally. 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,. 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.
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.
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*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.
 G John Gibson, Robert Leddenkemper, Yves Sibille, Bo Lundback. European Lung White Book: Respiratory Health and Disease in Europe. European Respiratory Society, 2013.
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