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Devices Regulatory

 News Release - September 4, 2019

Gala Therapeutics Receives CE Mark for its Minimally Invasive RheOx(TM) System for Chronic Bronchitis

First-of-its-kind RheOx device designed to reduce mucus-producing cells and improve quality of life

MENLO PARK, Calif., Sept. 4, 2019 -- (Healthcare Sales & Marketing Network) -- Gala Therapeutics, Inc. (Gala) today announced that its RheOx™ system has received CE Mark in the European Union. In a minimally invasive procedure called Bronchial Rheoplasty™, RheOx delivers non-thermal energy to the airways to reduce mucus-producing cells in patients with Chronic Bronchitis.

Following CE marking, Gala Therapeutics plans to launch a post-market study at key European respiratory centers of excellence to expand clinician experience and patient access to Bronchial Rheoplasty using RheOx.

"Cough and excess sputum can be debilitating in patients diagnosed with Chronic Bronchitis, and until now, no therapy has been available to target these symptoms," said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. "We are pleased to achieve CE Mark, which allows us to market the first interventional therapy for Chronic Bronchitis. This milestone is a tremendous achievement in our journey to help improve quality of life and outcomes for people with Chronic Bronchitis around the world."

Chronic Bronchitis a chronic inflammation of the air passages in the lungs, in which a persistent cough produces phlegm and mucus for at least three months per year in two consecutive years. Chronic Bronchitis affects over 9 million people in the U.S., occurring in people with chronic obstructive pulmonary disease (COPD) and in individuals with normal lung function. Risk factors for Chronic Bronchitis include tobacco smoke, indoor and outdoor air pollution and occupational exposures.

About RheOx™

RheOx is a bronchoscopic system designed to reduce mucus-producing cells in patients with Chronic Bronchitis. The revolutionary technology includes an electrosurgical generator and a single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, making way for new normal cells to redevelop. Currently under evaluation in an early feasibility study in the United States, RheOx is limited by federal (or United States) law to investigational use.

About Gala Therapeutics

Gala Therapeutics is a privately held medical device company based in Menlo Park, CA, that is dedicated to developing disease-modifying therapies that improve survival, quality of life, and outcomes for patients with pulmonary diseases. Formed by Apple Tree Partners, a healthcare-focused venture capital firm based in New York, Gala is building a portfolio of technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.


Source: Gala Therapeutics

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