Regentis生物材料公司扩大了美国对GelrinC的审判范围,GelrinC是无细胞体液凝胶,用于膝盖软体修补,以加快林业发展局的批准速度。
Regentis Biomaterials expands U.S. trial for GelrinC, a cell-free hydrogel for knee cartilage repair, to speed FDA approval.
Regentis生物材料公司扩大了其美国临床试验网络,以进行第三阶段的GelrinC研究。 GelrinC是用于膝盖软骨修理的无细胞体液凝胶,并增加了包括NYU Langone和俄亥俄州立大学在内的主要矫形中心。
Regentis Biomaterials has expanded its U.S. clinical trial network for its Phase III study of GelrinC®, a cell-free hydrogel for knee cartilage repair, adding major orthopedic centers including NYU Langone and Ohio State University.
此举旨在加快患者入学率,已超过50%,利用手术修理和体育医学方面的专家团队。
The move aims to accelerate patient enrollment, which has passed 50%, leveraging expert teams in cartilage repair and sports medicine.
已在欧盟获得批准的GelrinC在以前的研究中表现出持久的疼痛缓解和功能改善。
GelrinC, already approved in the EU, has shown lasting pain relief and function improvement in prior studies.
该公司最近对外公开,寻求林业发展局批准首次对膝盖软骨缺陷进行现成治疗,每年影响超过470 000人。
The company, which recently went public, seeks FDA approval for the first off-the-shelf treatment for knee cartilage defects, affecting over 470,000 annually.