TAIPEI, Taiwan, June 26, 2018 /PRNewswire/ — Recently, BioGend Therapeutics, a leading regenerative medicine company that focuses on bone and cartilage repair and regeneration, announced that BioGend Therapeutics completes enrollment for the pivotal clinical trial of one-step autologous knee cartilage repair/regeneration.
The company is led by an experienced management team in business operation, orthobiologic R/D, and clinical and regulatory affairs. The Biphasic Cartilage Repair Implant (BiCRI) technology, one of BioGend’s two major orthobiologic platforms, is a one-step autologous cartilage repair treatment for knee chondral or osteochondral defects (see Figure 1). During the surgery, a small amount of healthy cartilage tissue is harvested from the non-weight bearing area and mechanically reduced to small fragments followed by a brief enzymatic treatment to improve chondrocytes bioactivity and mobility. The cartilage tissue fragments are delivered using a bioabsorbable porous cylindrical biphasic plug to the defect site. The entire operation can be done arthroscopically in less than one hour. The pivotal clinical trial just completed enrollment of all 92 patients required to demonstrate non-inferiority at one-year follow-up. BioGend expects to receive TFDA approval in late 2019. A small cohort of 10 patients treated with the BiCRI device in a pilot study continues to demonstrate sustained good clinical performance at 5 years follow-up. The company is in the process of discussing with potential global strategic partners to develop markets in China, EU and the US for its one-step simple and effective autologous BiCRI cartilage technology.
Osteoinductive Factor (OIF) technology, another BioGend’s orthobiologic platform, has more than 10 years preclinical data demonstrating the safety and efficacy of OIF as a bone graft substitute. OIF is produced from E. coli bacteria by a BioGend’s sister company to assure consistent high quality. A pilot clinical trial to investigate the safety of OIF/TCP for open fracture management is expected to start in the 2H2018. A multicenter multinational spinal fusion pilot study of OIF/TCP is planned to begin in the 1H2020.
BioGend is preparing to list in Taipei Exchange next year to raise the fund required for launching the BiCRI product in Taiwan in early 2020. The company is also planning to bring knee cartilage patients from China and Southeaster Asia to Taiwan for surgery. BioGend welcome to discuss with potential strategic partners for global business collaboration, including investment in BioGend company.