Menlo Park, CA, Sept. 9, 2020 – Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, today announced that a live case featuring its RheOxTM Bronchial Rheoplasty System was performed during the virtual European Respiratory Society (ERS) International Congress 2020.
The session showcased the endoscopic technique of Bronchial Rheoplasty with RheOx which delivers non-thermal energy to the airways to reduce mucus-producing cells in patients with chronic bronchitis. Prof. Dr. med. Felix Herth and Prof. Dr. med. Ralf Eberhardt of Thoraxklinik at the University of Heidelberg in Heidelberg, Germany, performed the procedure and described the clinical outcomes including:
- Safe and well-tolerated procedure with no device-related serious adverse events;
- Clinically meaningful improvements in patient quality of life at 12 months, based upon a 15.2-point mean reduction (p=0.0002) in the St. George’s Respiratory Questionnaire (SGRQ) and an 7.0-point mean reduction (p=0.0002) in the COPD Assessment Test (CAT);
- Significantly reduced goblet cell hyperplasia (P<0.001).
“At Thoraxklinik we have a long history of advancing research and treatments for lung disease to improve the lives of the patients we treat, including an increasing focus on new endoscopic approaches. We are excited to have treated the first patients in Germany with Bronchial Rheoplasty this week,” said Univ. Prof. Dr. med. Felix Herth, Medical Director of the Department for Internal Medicine and Pneumology at Thoraxklinik in Heidelberg. “There are no good treatment options for chronic bronchitis so we are very hopeful that Bronchial Rheoplasty will make a meaningful difference in quality-of-life for these patients.”
The case was part of the Gala Therapeutics post-market study, which aims to collect real-world clinical experience in up to 20 European centers on the performance, safety and efficacy of Bronchial Rheoplasty in up to 100 adult patients with moderate to severe chronic bronchitis.
“We are honored to spotlight Bronchial Rheoplasty at ERS, one of the world’s largest medical congresses for respiratory disease, and to engage additional caregivers in our post-market study,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “We look forward to continuing to build the clinical evidence for this therapy.”
View live case session https://ers.conference2web.com/#!resources/rheoplasty-bronchitis
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. Patients treated with RheOx have reported improvements in symptoms and quality of life (https://galatherapeutics.com/patient-stories/). Currently under evaluation in an early feasibility study in the United States, RheOx is limited by federal (or United States) law to investigational use. RheOx received CE certification in 2019.
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.