FDA Grants Breakthrough Device Designation to Gala Therapeutics'... - Medical Tech Outlook

Posted: 29 Sep 2019 10:19 PM PDT

By MedTech Outlook | Monday, September 30, 2019

Jonathan Waldstreicher, MD, CEO

The breakthrough device designation will accelerate the regulatory pathway for the device, facilitating seamless access to the patients.

FREMONT, CA: Gala Therapeutics specializes in the development of robust medical devices for the treatment of pulmonary diseases. The company recently received a Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its RheOx Bronchial Rheoplasty system. The RheOx leverages a minimally invasive procedure to deliver non-thermal energy to the airways, reducing mucus-producing cells in patients with chronic bronchitis.

Jonathan Waldstreicher, MD, CEO of Gala Therapeutics, said, "The US Food and Drug Administration's decision to grant Breakthrough Device Designation status for the RheOxTMsystem enables Gala Therapeutics to work with FDA on an accelerated timeline towards US approval. "We are hopeful to offer to patients with Chronic Bronchitis the first therapy designed to reduce mucus-producing cells, and thereby provide them with a better day-to-day quality of life."

The revolutionary technology of the RheOx bronchoscopic system utilizes an electrosurgical generator and a single-use catheter to deliver non-thermal energy to the airways and reduce the number of abnormal mucus-producing cells in the lungs and pave the way for the development of new cells. The system is engaged in an early feasibility study in the US and is limited by federal law to investigational use. The RheOx also received CE certification earlier this year.

"Today there are no treatments to address the debilitating symptoms impacting the quality of life in patients with Chronic Bronchitis," Waldstreicher said. "We are excited by the FDA's decision to designate RheOx as a breakthrough device, underscoring the significant unmet need for these patients. We look forward to working with the FDA to bring a solution that improves the lives of these patients."

The Breakthrough Device Designation will streamline the regulatory pathway for the state-of-the-art medical device, enabling the facilitation of effective treatment for the intended patients suffering from life-threatening and irreversibly debilitating diseases. It also ensures that the patients are given timely access to necessary treatments.

Chronic bronchitis affects over 9 million people in the US and mostly occurs in people with Chronic Obstructive Pulmonary Disease (COPD), and individuals with normal lung function. Its symptoms include persistent cough, production of excess mucus, and impaired quality of life. It also causes an increased risk of exacerbations and mortality. The conventional treatments are mostly directed at bronchodilation and reduction in inflammation and fail to address the overproduction of mucus.

"Today, more than 9 million Americans suffer from Chronic Bronchitis, with significant quality of life issues, including cough, excessive phlegm and shortness of breath, even when they use inhalers," Waldstreicher said. "Our clinical studies aim to show that the minimally invasive RheOxTM technology provides meaningful quality-of-life improvements for these patients by reducing cough and mucus levels."

Gala Therapeutics aims to develop innovative and disease-modifying therapies to enhance survival, quality of life, and patient outcomes. The privately-held medical device company is backed by Apple Tree Partners, a healthcare-focused venture capital firm based in New York. The company is developing a suite of robust technologies designed to address the evolving requirements of interventional pulmonologists, thoracic surgeons, and physicians.

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