High-end orthopedic device manufacturer BioGend Therapeutics has officially received a Class II Medical Device License from the Taiwan FDA for its "Soft Tissue Processing System." * Regenerative Potential: The system is designed to process autologous adipose (fat) tissue to obtain Stromal Vascular Fraction (SVF), which contains a variety of regenerative cells. This breakthrough has immediate applications in soft tissue repair and aesthetic regenerative medicine.

• Financial Discipline: Chairman Chen Te-li reported that while the company recorded a net loss of NT$103 million in 2025, the deficit has narrowed by 19% year-on-year as revenue grew to NT$222 million (+33%). The current losses are primarily attributed to heavy R&D investment in its core Osteoinductive Factor (OIF), which is currently in Phase III clinical trials.
• Resilience Strategy: Management noted that despite global geopolitical uncertainties, BioGend Therapeutics is prepared to reach break-even by adjusting R&D pacing and expenditure structures if necessary, while maintaining its 18% revenue growth momentum seen in early 2026.

Resource: 博晟生醫「舒效切軟組織處理系統」，獲二類醫材許可證