Holaira Receives CE Mark for Lung Denervation System
Minneapolis, Minn., Aug. 3, 2016 – Holaira, a developer of medical devices to treat obstructive lung diseases, announced the initiation of treatments in the AIRFLOW-2 Clinical Trial for patients with moderate to severe chronic obstructive pulmonary disease (COPD) in a procedure called Targeted Lung Denervation* (TLD). Under the direction of principal investigator, Christophe Pison, M.D., Ph.D., the first patient was treated at the Grenoble University Hospital Centre (CHUG) in Grenoble, France, using the Holaira™ Lung Denervation System.
“The first patient treated, a 50-year-old female with COPD, tolerated the therapeutic treatment extremely well,” said pulmonary specialists, Professor Pison and Dr. Amandine Briault. “The minimally invasive procedure was performed in about an hour 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.”
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.
“Earlier studies of TLD now have three-year data demonstrating the procedure is feasible, safe and well tolerated in patients,” said Martin Mayse, M.D., founder and chief technology officer at Holaira. “Conducting a sham-controlled trial is an important control step to assure the integrity of the scientific data as we work to make this new technology a treatment option for COPD patients.”
The company also announced that it has received CE Mark approval for its 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.
“The CE Mark approval is an important regulatory milestone for our Lung Denervation System,” said Dennis Wahr, M.D., chief executive officer for Holaira. “This certification recognizes that the product complies with allEuropean health, safety and environmental product directives.
“From the onset, it has been our goal to develop a lung denervation system that meets the needs of patients suffering from obstructive lung disease while positively impacting their ability to breathe, exercise, and overall quality of life for the long-term. With the treatment of the first patient in the AIRFLOW-2 trial and receiving CE, we’re that much closer to making this a reality,” continued Dr. Wahr.
COPD is a progressive disease that is one of the leading causes of morbidity and mortality, yet it remains widely unrecognized. COPD 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. It is estimated that COPD affects 4 to 10 percent of all adults in European countries, and that nearly 190 million people have COPD worldwide, with more than 15 million adults diagnosed in the United States.
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.
Founded in 2008, Holaira, Inc., of Minneapolis, Minn., is a privately held company developing the Holaira™ Lung Denervation System to address chronic obstructive pulmonary disease (COPD) by treating the overactive airway nerves during Targeted Lung Denervation (TLD). TLD is a minimally invasive procedure that targets the parasympathetic innervation of the lungs. This one-time bronchoscopic procedure provides an ablative therapy that opens obstructed airways to improve breathing. TLD is currently under clinical investigation for COPD and is not yet commercially available. More information may be found at www.holaira.com.
*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.
 CDC MMWR, Nov 23 2012, Vol 51, No.46
 EFA 2015 COPD
 American Lung Association, COPD Fact Sheet, Feb. 2011
 Belmonte K. Cholinergic Pathways in the Lungs and Anticholinergic Therapy for Chronic Obstructive Pulmonary Disease.
Proc Am Thor Soc 2005; 2: 297-305.