COPD Patients Treated in First Sham Controlled Trial of Targeted Lung Denervation
London, Sept. 5, 2016 – Holaira, Inc., a developer of medical devices to treat obstructive lung diseases, announced it will host an educational symposium on the use of Targeted Lung Denervation* (TLD) in obstructive lung disease during the European Respiratory Society International Congress, Sept. 6, in London.
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. In addition, three medical experts will present their findings on topics including: Cholinergic Pathways and the Limitations of Inhaled Therapeutics; Mechanism of Action and the Holaira™ Lung Denervation System; early results from the AIRFLOW-1 Trial on TLD in COPD patients; and discussion of the Asthma RELIEF-1 study, a new TLD indication.
“The data from the evaluation of TLD in COPD patients using Holaira’s Lung Denervation system is very promising, as the procedure was well tolerated by patients and it demonstrates feasibility and safety,” said Professor Herth. “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 alternative methods of treatment that may provide lasting, whole lung improvement.
“We are encouraged by this new COPD technology, which will now be evaluated in asthma patients as well. In addition, I am looking forward to the symposium panel discussion to learn about recent clinical experiences utilizing this exciting new technique,” continued Professor Herth.
During the symposium Holaira will also be discussing the initiation of treatments in the AIRFLOW-2 Clinical Trial for patients with moderate to severe chronic obstructive pulmonary disease (COPD) using TLD. The first patients were treated using the Holaira™ Lung Denervation System under the direction of investigators, Christophe Pison, M.D., Ph.D., and Amandine Briault, M.D., at the Grenoble University Hospital Centre (CHUG) in France.
The AIRFLOW-2 (NCT#02058459) clinical trial is a randomized interventional study of bronchoscopic Targeted Lung Denervation using the Holaira Lung Denervation System, a catheter-based system developed to treat patients with moderate to severe COPD. The system’s proprietary technology delivers targeted energy to disrupt nerve signals to the lungs using a process known as denervation. The AIRFLOW-2 trial follows completion of the AIRFLOW-1 trial earlier this year and is currently underway at 16 institutions throughout Western Europe. It is the first randomized clinical trial with a sham control for TLD.
According to Professor Pison, “The minimally invasive procedure was performed in about an hour on the first patient with no procedural complications. TLD is the first medical procedure that targets the whole lung by disrupting overactive nerves into the lungs, which opens up the airways making it easier to breathe. It would be a true breakthrough for our patients to provide a lasting clinical improvement from this one-time procedure.”
COPD is one of the leading, yet under-recognized, causes of morbidity and mortality. It is characterized by a persistent airflow limitation due to a progressive narrowing of the airways interfering with normal breathing, resulting in shortness of breath (dyspnea), wheezing, chest tightness, and a productive cough. A progressive disease, it is estimated that COPD affects 4 to
10 percent of all adults in European countries. Worldwide, nearly 190 million people have COPD, and the World Health Organization estimates it will be the 3rd leading cause of death by 2020.
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. In the United States, COPD costs are estimated to be $50 billion annually.
About Holaira – Holaira, Inc., a privately-held lung denervation company headquartered in Minneapolis, Minn., is developing minimally invasive products to make breathing easier for patients suffering from obstructive lung diseases. Founded in 2008, Holaira is currently working on a novel catheter-based system that has the potential to improve lung function, exercise capacity and quality of life for patients with COPD. The company received CE Mark approval in Feb. 2016 for its Holaira Lung Denervation System for use during TLD, the one-time ablative therapy procedure that opens obstructed airways to improve breathing and has the potential to provide lasting, whole lung improvement for COPD sufferers. More information can be found by visiting www.holaira.com.
Targeted Lung Denervation in Obstructive Lung Disease: Concept to Clinic
Program Chairs: Alvar Agustí & Felix Herth
06 September 2016
Room ICC Capital Suite 9
*Targeted Lung Denervation (TLD) is currently under clinical investigation for chronic obstructive pulmonary disease and is not yet commercially available.
Holaira is a trademark of Holaira, Inc.
 COPD, May 2013, TDR, Inc.
 EFA 2015 COPD
 American Lung Association, COPD Fact Sheet, Feb. 2011