Gala’s RheOx System to Treat Chronic Bronchitis Receives CE Mark for Health and Safety in EU

Gala’s RheOx System to Treat Chronic Bronchitis Receives CE Mark for Health and Safety in EU

The RheOx system for the treatment of chronic bronchitis has received the CE mark, an indication that it has met high health, safety, and environmental protection requirements, in the European Union.

Developed by Gala Therapeutics, the RheOx system is a minimally invasive tool used to perform a procedure called bronchial rheoplasty. In this procedure, a series of electrical pulses are delivered to cells in the lungs in an attempt to kill off cells that are producing excessive mucus and clear the way for normal cells to grow in their place.

The procedure is being investigated as a therapeutic intervention in chronic bronchitis, a disease characterized by ongoing inflammation in the lungs. Chronic bronchitis is diagnosed when a person has experienced a persistent cough that produces mucus and phlegm for at least three months per year in two consecutive years.

Chronic bronchitis can develop in people who do not have a history of lung disease, and is particularly common among people with chronic obstructive pulmonary disease (COPD). Risk factors for developing this condition include smoking, and regular exposure to pollutants and other lung-damaging chemicals.

“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,” Jonathan Waldstreicher, MD, CEO of Gala, said in a news release.

Preliminary analyses of bronchial rheoplasties on people with chronic bronchitis suggested that the procedure was reasonably safe and improved symptoms. In one study, participants with chronic bronchitis saw their average scores on the St. George’s Respiratory Questionnaire decrease by 16.9 points one year after treatment, indicating fewer/less severe respiratory symptoms.

“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,” Waldstreicher said.

In the future, Gala plans to launch a post-market study at top European respiratory centers to expand clinician experience on its RheOx system to perform bronchial rheoplasty, and to give patient access.

Currently, the RheOx system is still an investigational product in the United States, where an ongoing clinical trial (NCT03631472) is investigating its use in people with chronic bronchitis.

Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.
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One comment

  1. fred stehle says:

    I am totaly confused between NUVAIRA’s Targeted Lung Denervation and GAlA’s Rheox procedure. Are they both atempting to reduce the excess production of mucus? If they are, then are they aimed at the same physical location of the lungs and/or bronchial tubes? Also if from what I have read about both of the procedures being not very invasive, then do they qualify for “right to try” exemption? Obviously, I have a very selfish reason for making inquiries. thanks

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