BioGend Therapeutics reported a significant increase in monthly procedures for its single-use autologous cartilage repair product, RevoCart, and achieved profitability in July. Looking ahead to the second half of the year, the company expects to receive the full report of its Osteogenic Inductive Factor (OIF) Phase II clinical data in August. Following this, BioGend plans to communicate with regulatory authorities regarding its Phase III clinical trial program, with an anticipated official launch in the second half of next year. Meanwhile, RevoCart is scheduled to be introduced to four major teaching hospitals in the latter half of the year. Combined with reduced impact from antibiotic production line maintenance, revenue contributions from both products are expected to achieve double-digit growth next year.

In July, RevoCart procedures reached 50 cases in a single month, exceeding the usual 30–40 cases. The company attributes the increase partly to seasonal effects during the summer. Thanks to the strong monthly performance, BioGend surpassed its breakeven point. The company emphasized that, despite achieving short-term profitability, its focus remains on continuous R&D investment and expanding its product line rather than short-term gains.

For the second half of the year, BioGend will prioritize the advancement of OIF clinical trials. Phase II studies are currently ongoing in Taiwan for tibial fractures and in Japan with a partner company for fracture healing. The company expects to receive complete reports for these trials after August and will evaluate potential markets and clinical scale to discuss Phase III trial plans with the TFDA. BioGend intends to lead the Phase III trials independently, with the first indications to be determined in consultation with regulatory authorities.

Additionally, RevoCart is expected to enter four teaching hospitals, including National Taiwan University Hospital and Chang Gung Memorial Hospital, in the second half of the year. This expansion effectively covers all teaching centers, supporting double-digit growth in procedures and patient usage next year.

Resource: 博晟推進OIF朝三期臨床邁進；愛膝康進藥醫院續增