Energenx Medical Secures Exclusive License for Global Leading Pulsed Electric Field Technology to Accelerate Expansion in Respiratory and Oncology Therapies
Shanghai Shuneng Medical Technology Co., Ltd. (Energenx Medical Ltd.) inMay 202330Day andGalvanize Therapeutics Inc. (formerly Gala Therapeutics Inc.) jointly announced in China and the United States the signing of an “Exclusive License Agreement.” Shuneng Medical has obtained the exclusive license for Galvanize’s globally leading Pulsed Electric Field (PEF) technology in the China region, enabling it to develop, register, manufacture, and commercialize related products in therapeutic areas such as respiratory diseases and oncology.
As Galvanize’s exclusive strategic partner in China, Shuneng Medical will conduct independent research and development tailored to the needs of Chinese physicians and patients, thereby establishing proprietary intellectual property rights; through deep innovation, it will expand its future product pipeline.
On January 4, 2023, Shuneng Medical submitted an application for RheOx, a therapy indicated for the treatment of chronic obstructive pulmonary disease (COPD) accompanied by symptoms of airway hypersecretion due to chronic airway inflammation.®The Pulsed Electric Field Therapy System has been approved by the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration and entered the Special Review Procedure for Innovative Medical Devices, also known as the “Green Channel.”
On May 18, 2023, under the leadership of Professor Wang Guangfa, Director of the Department of Respiratory and Critical Care Medicine at Peking University First Hospital, China’s first bronchial rheoplasty was successfully performed, marking the launch of RheOx®The Dawn of Multicenter Clinical Trials in China.
RheOx, the first product of the strategic partnership between Shuneng Medical and Galvanize®It is currently the only respiratory interventional therapy product for COPD/chronic bronchitis that has entered China’s Green Channel special review process, received the U.S. FDA Breakthrough Device designation, and obtained EU CE certification for market launch. With its recent approval to enter the “Green Channel” and rapid initiation of clinical studies, RheOx is poised to...®Pulsed Electric Field Therapy System to Benefit Chinese COPD Patients More Rapidly.
Dr. Jonathan Waldstreicher, Founder and CEO of Galvanize, stated, “We are delighted to partner with the Shuneng team to bring RheOx®Introduce it to the Chinese market and rapidly implement it, providing this innovative therapy for patients with chronic bronchitis/COPD. Both companies share a consistent strategic vision: to improve the quality of life for patients burdened by respiratory diseases. Meanwhile, they will leverage core platform technologies to expand innovative therapies and jointly promote the development of Aliya™ soft tissue ablation technology in China.
Dr. Zhou Zhengrong, Founder and CEO of Shuneng Medical, stated, “Shuneng Medical will collaborate with Galvanize and leading experts both in China and abroad to advance the development of innovative therapies in respiratory and oncological interventions. With RheOx®Seize the first strategic cooperation opportunity to establish a leading position for the subsequent airway intervention product pipeline in China and globally. Looking forward to RheOx®"Poised to become the first commercially viable pulsed electric field therapy for respiratory interventional treatment of COPD in China, benefiting a broad patient population."
In recent years, the incidence of chronic obstructive pulmonary disease (COPD) in China has remained high due to factors such as smoking, indoor and outdoor air pollution, and dust exposure. In 2018, The Lancet published the results of the "China Pulmonary Health Study," led by Academician Wang Chen, which showed that the prevalence of COPD among adults aged 20 years and older was 8.6%, rising to 13.7% among those aged 40 and above, and exceeding 27% in individuals aged 60 and older. The number of COPD patients in China has reached 100 million, with nearly one million deaths attributed to COPD annually, making it the third leading cause of death in the country.
Clinically, chronic bronchitis and emphysema are closely associated with the development of chronic obstructive pulmonary disease (COPD). Chronic bronchitis is a chronic airway disease characterized significantly by hyperplasia of mucus-producing cells in the airways and mucus hypersecretion, clinically manifesting as prominent cough and sputum production. Most cases of chronic bronchitis are accompanied by airflow limitation, which corresponds to the COPD phenotype of chronic bronchitis.
COPD with a chronic bronchitis phenotype characterized by airway hypersecretion is associated with poorer clinical prognosis, increased frequency and severity of acute exacerbations, reduced quality of life, and higher mortality risk.
Currently, the mainstay of treatment for COPD is pharmacological therapy, including inhaled bronchodilators or inhaled corticosteroids (ICS), as well as oral PDE-4 inhibitors and mucolytic/expectorant agents. However, these interventions cannot eliminate the already hyperplastic mucus-producing cells. Meanwhile, surgical or interventional treatments such as lung volume reduction surgery, endobronchial valve implantation, and thermal vapor ablation are primarily targeted at the emphysema phenotype. There is a lack of effective clinical therapies to control airway hypersecretion.
RheOx, led by Shuneng Medical and approved for entry into the “Green Channel”®Pulsed field ablation systems fill this therapeutic gap, with their efficacy and safety validated through extensive clinical use overseas.
RheOx®Pulsed Field Ablation Treatment Video
Bronchial Rheoplasty is an innovative bronchoscopic interventional therapy pioneered by Galvanize for the treatment of COPD with chronic bronchitis.
This therapeutic approach involves advancing a disposable treatment catheter electrode via bronchoscopy into the proximal bronchi of the lungs, delivering preset pulsed electric field energy to the surface of the bronchial mucosa. This achieves targeted ablation of the superficial mucosa, inducing necrosis of mucus-producing goblet cells. Meanwhile, the "non-thermal" pulsed energy preserves the extracellular matrix and avoids damage to adjacent tissues.
Bronchial Rheoplasty Therapy Demonstration
Bronchial rheoplasty controls the ablation depth within the bronchial mucosal epithelium and submucosa, resulting in minimal trauma and sparing the deeper, regenerative-capable basal cells. As the airway mucosa heals, normal ciliated cells can regenerate.
The left image shows the patient's bronchoscopic view before treatment, and the right image shows RheOx.®Bronchoscopic images of the patient after one month of treatment. Image source: GalvanizeTx official website
Notably, bronchial rheoplasty is cited in the newly released 2023 Global Strategy for the Diagnosis, Treatment, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD 2023 Report), underscoring its endorsement by global authoritative experts.
Shuneng Medical, established in 2021, is a medical technology company rooted in the Chinese market that integrates advanced global medical technologies and talent resources. The company focuses on globally leading respiratory and oncology interventional technologies, accelerating the implementation, iteration, and re-innovation of innovative therapies through a dual-track approach combining overseas introduction and independent R&D. While rapidly establishing the clinical value of its therapies, Shuneng Medical also prioritizes product usability, accessibility, and therapeutic expansion to better address unmet clinical needs in the market, providing trustworthy clinical solutions for physicians and patients. Guided by its mission, “Technology Illuminates Life,” the company is committed to becoming a leader in therapies for pulmonary diseases and oncology interventions.
Dr. Zhou Zhengrong, the founder, has dedicated seventeen years to the medical field, gaining hands-on experience in R&D and commercial operations across China and the United States with internationally leading medical device companies. In 2011, as Medtronic’s first employee in this initiative, he established the Shanghai Innovation Center, Medtronic’s first cross-business R&D center outside of Europe and the United States. He was subsequently named a Medtronic Global Technical Fellow. In 2018, he successfully transitioned into a leadership role within Medtronic’s Greater China business unit, where he led his team in driving initiatives from concept to commercialization to better meet the needs of local Chinese customers.
Founder: Dr. Zhou Zhengrong
In an interview with VCBeat, Dr. Zhou Zhengrong, founder of Shuneng Medical, emphasized that Shuneng Medical is a disease-oriented, innovative medical technology company rooted in the Chinese market and adept at leveraging international resources. Shuneng Medical was jointly established by Galvanize, a globally leading medical technology company, and ATP (Apple Tree Partners), a renowned life sciences venture capital fund.
Shuneng Medical aims to rapidly deploy RheOx, a globally innovative respiratory interventional product that has received preliminary clinical validation, through its strategic partnership with Galvanize.®Respiratory interventions represent a high-potential sector, requiring forward-thinking companies to collaborate with domestic experts in developing innovative therapies and cultivating the market. Shuneng Medical aims to enhance awareness of new therapies among physicians and patients through further collaboration with Chinese experts in new product development, basic research, and clinical trials, thereby promoting the establishment of future domestic consensus based on robust clinical evidence. Meanwhile, the company is proactively warming up the market to prepare for the successful commercialization of its pulsed electric field product pipeline and pulmonary disease-focused product portfolio, ultimately benefiting patients in China.
In the future, Shuneng Medical will continue to focus on the fields of respiratory medicine and oncology, leveraging its core competencies in “needs-product-market,” along with licensed and independently developed patented technologies, to provide Chinese physicians and patients with clinical solutions centered around disease management. Shuneng Medical will also fully utilize Galvanize’s overseas presence to reverse-export China-based innovations to the international market, sharing Chinese wisdom with the world.