Galvanize Announces License Agreement and Partnership with Energenx Medical for its Technologies in China
License will maximize the availability of Pulsed Electric Field therapies for the population
Energenx has obtained Green Channel approval for RheOx, Galvanize's proprietary Pulsed Electric Field (PEF) system for the treatment of Chronic Bronchitis
First patient was enrolled in the China RheOx clinical trial for Chronic Bronchitis
REDWOOD CITY, Calif, and SHANGHAI, May 30, 2023 /PRNewswire/ -- Galvanize Therapeutics, Inc., a leader in developing pulsed electric field therapies for COPD, solid tumors and cardiac arrhythmias, announced today that the company has signed an exclusive license agreement with Energenx Medical, Ltd to develop and commercialize its products in Mainland China, Hong Kong, Taiwan, and Macau.
Recognizing the potential for its technologies in China, Galvanize worked with its founding investor Apple Tree Partners (ATP) to form Energenx in 2021. Headquartered in Shanghai, the company is led by Founder & CEO Zhengrong Zhou, Ph.D., a veteran of the medical device industry in the United States and China who most recently spent a decade in leadership positions at Medtronic China. Energenx will further develop and manufacture Galvanize's RheOx and Aliya systems in China, according to the needs of local physicians and patients, and will conduct clinical trials to seek local regulatory approval. In January 2023, Energenx received approval from the Medical Device Technical Evaluation Center (CMDE) of the China National Medical Products Administration (NMPA) for RheOx to enter the "Green Channel Special Review Process," under which regulatory review times may be accelerated.
Jonathan Waldstreicher, M.D., Founder & CEO of Galvanize, commented: "We are thrilled to partner with Energenx to bring access to the RheOx therapy to more patients to treat the symptoms of chronic bronchitis. Zhengrong has built a world class team that has worked hand-in-hand with our Galvanize employees to launch this treatment, which we believe promises to greatly improve health and quality of life for those people living with chronic bronchitis. We are also excited to advance our Aliya soft tissue ablation system in China through our relationship with Energenx."
Dr. Zhengrong Zhou said: "We are very excited to work with Galvanize to promote the development of innovative therapies for lung disease and oncology with top experts at home and abroad. Using RheOx as the first collaboration opportunity, together, we are establishing leadership in interventional pulmonology with continued pipelines in China and globally. RheOx is expected to become the first commercially available pulsed electric field respiratory intervention technology to treat the symptoms of chronic bronchitis in China, benefiting a broad base of COPD patients."
On May 18, 2023, Professor Guangfa Wang, Director of the Department of Respiratory and Critical Care Medicine at Peking University 1st Hospital in Beijing, treated the first COPD patient as part of the RheOx China Study for patients with chronic bronchitis. The procedure was performed using a minimally-invasive approach through a bronchoscope and the patient was discharged soon after without complications.
RheOx is designed to reduce mucus-producing cells in patients with chronic bronchitis through a minimally invasive bronchoscopic procedure called bronchial rheoplasty. The revolutionary RheOx 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, making way for new normal cells to redevelop. In 2019, RheOx received CE Mark in the European Union and U.S. Food and Drug Administration Breakthrough Device Designation. RheOx is limited by U.S. federal law to investigational use only.
The Aliya PEF system delivers high-voltage, high-frequency electrical currents through a single monopolar electrode placed in the target tissue. The PEF energy destabilizes the cells via electric fields, resulting in non-thermal cell death.
The non-thermal modality of the Aliya PEF system preserves surrounding healthy tissue, enabling non-thermal ablation near critical structures, such as nerves and blood vessels. The Aliya waveform and electrode are designed to maximize the potential for releasing tumor antigens and may stimulate an immune response, potentially disrupting the immunosuppressive tumor microenvironment.
The Aliya System is 510(k) cleared in the United States for the surgical ablation of soft tissue. It is not currently commercially available in any other geography.
About Galvanize Therapeutics™
Galvanize Therapeutics aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, starting with treating chronic bronchitis symptoms, cardiac arrhythmias, and solid tumors. Formed by ATP (Apple Tree Partners), Galvanize is based in San Carlos, Calif., and is researching and commercializing its revolutionary Aliya Pulsed Electric Field (PEF) energy platform in the United States and Europe. For more information, please visit www.galvanizetx.com.
About Energenx Medical
Energenx Medical Ltd. (Energenx Medical) is a disease-focused medical technology company based in Shanghai, China. The company, with a mission of "Innovation Illuminating Life", is committed to developing and commercializing world-leading interventional pulmonology and oncology solutions to serve unmet clinical needs, and to becoming a trusted partner and leader in therapeutic areas.