Weimu Medical Successfully Holds First Investigator Meeting for PVA Embolic Microspheres Clinical Trial

On December 19, 2021, the inaugural investigator meeting for Weimu Medical’s “Prospective, Multicenter, Randomized Controlled Clinical Trial of Polyvinyl Alcohol Embolization Microspheres for Transcatheter Arterial Chemoembolization in the Treatment of Primary Liver Cancer” was successfully held at Hunan Provincial People’s Hospital.

The meeting was chaired by Professor Xiang Hua from Hunan Provincial People's Hospital. It was attended by experts from various clinical centers, including research teams from Hunan Cancer Hospital, the Third Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Anhui Provincial Hospital, the First Hospital of Jilin University, the Third Affiliated Hospital of Sun Yat-sen University, the Third Affiliated Hospital of Guangzhou Medical University, and Peking University First Hospital, as well as Shanghai Weimu Medical Technology Co., Ltd.

At the meeting, Professor Xiang Hua of Hunan Provincial People's Hospital delivered an opening address, stating that as the lead institution, Hunan Provincial People's Hospital attaches great importance to the clinical trial project on polyvinyl alcohol embolic microspheres. The hospital will provide full support for the implementation of this project and expressed its best wishes for the successful completion of the research work.

Mr. Xie Dang, General Manager of Shanghai Weimu Medical Technology Co., Ltd., delivered an opening address, expressing sincere gratitude to all clinical centers participating in this study. He stated that Weimu Medical, as the research and development entity, would closely collaborate with each research center to carry out clinical work, and sincerely hoped that Weimu Medical’s polyvinyl alcohol embolic microspheres would benefit patients and society.

The meeting also conducted in-depth discussions on detailed issues regarding Weimu Medical’s polyvinyl alcohol (PVA) embolization microspheres, including the product itself, the clinical trial protocol, and the development timeline. Many constructive suggestions were collected, laying a solid foundation for the smooth conduct of the clinical trials for the PVA embolization microspheres.

China is the country with the highest burden of liver cancer, accounting for half of the global patient population. In 2020, there were 910,000 new cases of liver cancer worldwide, with 410,000 of these occurring in China.

Liver cancer has an insidious onset, with most patients remaining asymptomatic in the early stages; by the time they seek medical evaluation, the disease has often progressed to intermediate or advanced stages. Currently, transarterial chemoembolization (TACE) is internationally recognized as the first-line treatment for unresectable intermediate-to-advanced hepatocellular carcinoma and can be combined with systemic therapy, radiofrequency ablation, and other modalities. Drug-eluting bead transarterial chemoembolization (D-TACE) enhances local drug concentration within the tumor region, achieving favorable therapeutic outcomes while reducing the systemic toxicity of chemotherapeutic agents, thereby ensuring controlled and safe drug release.

Weimu Medical’s embolic microspheres currently entering clinical trials are its newly developed polyvinyl alcohol (PVA) embolic microspheres. Manufactured using imported PVA as the raw material and synthesized via a simpler, more efficient one-pot method, these microspheres feature a deformable spherical design that achieves a compression ratio of 70% and a 40% reduction in particle size after drug loading, thereby striking a balance between rigidity and elasticity. To date, Weimu Medical’s latest PVA embolic microsphere product has completed type testing at the Jinan Medical Device Quality Supervision and Inspection Center under the National Medical Products Administration (NMPA), obtaining a certificate of compliance. Preclinical animal studies have demonstrated safety and efficacy, and the clinical trial protocol has passed ethical review by the lead institution and received regulatory approval for clinical trials. Preparatory work for the clinical trial is now mature. The launch of Weimu Medical’s newly developed PVA embolic microspheres and their associated clinical trials hold significant importance for advancing precision therapy in liver cancer.

Shanghai Weimu Medical Technology Co., Ltd. is China’s first high-end interventional medical device company based on innovative materials. The company’s R&D focuses on high-end interventional medical devices utilizing innovative materials, targeting areas such as oncology, medical aesthetics, and pan-vascular interventions. Its product portfolio includes various medical microspheres and delivery systems, liquid adhesives, hydrogels, and more. Committed to innovation-driven development, Weimu Medical specializes in the translation of innovative material technologies into clinical applications, striving to create maximum value for physicians and patients, deliver premium services, and become China’s most innovative medical device company.