Holaira Announces First Scientific Presentations on Targeted Lung Denervation for COPD

Six Abstracts Delivered during ERS International Congress 2014

Minneapolis, MN, September 08, 2014 – Holaira, Inc., a developer of medical devices to treat obstructive lung diseases, today announced the first scientific data presentations on the use of the Holaira™ Lung Denervation System in a procedure called Targeted Lung Denervation* (TLD), at the European Respiratory Society (ERS) International Congress 2014, Sept. 6-10, in Munich, Germany. Data presented included results of the first two multicenter feasibility studies of the Holaira System in patients with chronic obstructive pulmonary disease (COPD).

Holaira is developing a novel catheter-based system to address COPD by treating the overactive airway nerves during TLD, a one-time bronchoscopic procedure that provides an ablative therapy that opens obstructed airways to improve breathing, and has the potential to provide lasting whole lung improvement. 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.[1] Worldwide, nearly 190 million people have COPD[2], with more than 15 million adults diagnosed in the United States.[3]

The company’s innovative technology is the subject of six abstracts being presented at the ERS International Congress including oral presentations on the two multicenter feasibility studies of the Holaira System in patients with COPD.

“Our research indicates that using Holaira’s Lung Denervation System to perform TLD therapy is feasible and safe,” said Dirk-Jan Slebos, M.D., Ph.D., principal investigator, University Medical Center, Groningen, The Netherlands. “Furthermore, in this very early phase open label trial, there is evidence for a working therapy as our patients have experienced sustained improvements in their lung function, exercise tolerance and quality of life compared to their pre-procedure condition. We are encouraged about the potential for this new bronchoscopic therapy.”

The multicenter feasibility studies were conducted at six sites in Austria, France, The Netherlands and South Africa.

Thought-provoking research on the anti-inflammatory effects of TLD was also shown by Loes E.M. Kistemaker, Ph.D., at the Congress. According to Martin Mayse, M.D., chief technology officer and co-founder of Holaira, “The potential to inhibit airway inflammation in COPD patients is of clinical interest. Acetylcholine is the primary neurotransmitter in the airways. It is well known to induce bronchoconstriction and mucous secretion, but there is growing evidence it may play a role in airway inflammation as well. By targeting the parasympathetic innervation of the lungs, TLD may not only reduce the amount of bronchoconstriction and mucous secretion, but may decrease inflammation as well. Early findings suggest this, and we are planning to look at this in further detail in subsequent studies,” continued Dr. Mayse.

Concurrent with the Congress, Holaira will host its first educational symposium on TLD Monday evening, Sept. 8. Professor Marc Decramer, M.D., Ph.D., Chairman, University Hospitals Leuven, Belgium, and Professor Felix Herth, M.D., Ph.D., FCCP, Chairman, Division of Pulmonology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Germany, are chairing a panel of distinguished pulmonologists and scientists who will discuss the need for new COPD therapies, pre-clinical work with the Holaira System and TLD feasibility studies. The upcoming AIRFLOW-1 randomized, sham control multi-center clinical study will also be also reviewed with the audience.


Information about the abstracts referenced in this news release is listed below:

Anti-inflammatory effects of targeted lung denervation in patients with COPD
Loes E.M. Kistemaker, Dirk-Jan Slebos, Herman Meurs, Huib A.M. Kerstjens, Reinoud Gosens.

Bilateral targeted lung denervation in patients with COPD in a single procedure
Arschang Valipour, Christophe Pison, Romain Kessler, Gaetan Deslee.

Efficacy of targeted lung denervation on patients with moderate to severe COPD
Dirk-Jan Slebos, Karin Klooster, Coenraad F.N. Koegelenberg, Johan Theron, Dorothy Steyn, Martin Mayse.

Importance of surface cooling during targeted lung denervation for COPD
Martin Mayse, Philip Johnson, James Hummel.

Safety and feasibility of targeted lung denervation in patients with moderate to severe COPD
Dirk-Jan Slebos, Karin Klooster, Coenraad FN Koegelenberg, Johan Theron, Dorothy Steyn, Martin Mayse, Chris T. Bolliger.

Targeted lung denervation in the healthy sheep model – A potential treatment for COPD
Martin Mayse, Philip Johnson, John Streeter, Mark Deem, James Hummel.

About Holaira Holaira, Inc., is a privately held lung denervation company 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 chronic obstructive pulmonary disease. More information can be found by visiting www.holaira.com.

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*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.

[1] http://www.efanet.org/chronic-obstructive-pulmonary-disease/

[2] COPD, May 2013, TDR, Inc.

[3] CDC MMWR, Nov 23 2012, Vol 51, No.46