Core Viewpoint - The article highlights the significance of innovative medical devices in the treatment of cervical cancer, particularly focusing on the introduction of the absorbable protective hydrogel, Respacio®, developed by Shanghai Ruining Biotechnology Co., Ltd. This product aims to reduce radiation damage during cancer treatment, addressing a critical need in the healthcare sector [1][5][20]. R&D Background - Cervical cancer is a major public health issue for women globally, ranking as the fourth most common cancer among women, with approximately 604,000 new cases and 342,000 deaths reported in 2020 by WHO [3]. - In China, cervical cancer is the second most common malignant tumor in the female reproductive system, with around 110,000 new cases and 34,000 deaths annually as of 2022 [3]. - A significant percentage (70%) of cervical cancer patients are diagnosed at advanced stages (FIGO II-III), complicating treatment and increasing risks of side effects [3]. Product Introduction - Respacio® is the first domestic absorbable protective hydrogel specifically designed for tumor radiotherapy, particularly for cervical and prostate cancer treatments [5][20]. - The hydrogel forms a physical barrier between the tumor and surrounding healthy tissues, significantly reducing radiation exposure to healthy organs and enhancing treatment safety and efficacy [7][10]. Clinical Research and Data - A prospective Phase I clinical trial conducted by the radiotherapy team at Peking Union Medical College Hospital demonstrated the safety and effectiveness of Respacio® in cervical cancer patients, with no severe acute toxic reactions observed [16]. - The trial involved eight patients, all of whom did not experience grade 3 or higher acute toxicity reactions, and no late rectal toxicity was reported [16]. - The hydrogel showed a reduction in volume over a period of 24 to 36 weeks post-injection, indicating its effective absorption and degradation [16]. Competitive Landscape - Currently, there are no mature absorbable hydrogel products in the domestic radiotherapy protection market, making Respacio® the first to enter the registered clinical trial phase [20]. - Internationally, similar products include SpaceOAR® Hydrogel, which has a significant market presence with annual sales exceeding $200 million, demonstrating its effectiveness in reducing rectal radiation dose by approximately 70% [21][20]. Company Overview - Shanghai Ruining Biotechnology Co., Ltd., established in 2018, focuses on the research and industrialization of high-end biomedical materials [24]. - The company has developed a leading medical hydrogel technology platform and has a rich pipeline of innovative medical devices, including tumor embolization hydrogels and intrauterine adhesion prevention hydrogels [24].