Bonraybio Corp.  announced on October 7 that its consolidated revenue for September reached NT$26.215 million, representing a 36.02% increase compared with the same period last year. Cumulative consolidated revenue for the first three quarters of 2025 reached NT$224.075 million, up 40% year-on-year and exceeding the company’s total revenue for all of 2023. In addition to strong revenue growth, Bonraybio has also made significant progress in product certification this year.

The company noted that its next-generation Sperm Quality Analyzer obtained U.S. FDA clearance in May 2025. Notably, its Sperm DNA Fragmentation Test Kit became the world’s first FDA-cleared diagnostic assay utilizing AI-based analysis in this category—an achievement expected to accelerate market expansion and revenue growth in the United States.

Meanwhile, Bonraybio’s Sperm Selector, designed to select higher-quality sperm for intracytoplasmic sperm injection (ICSI) procedures and improve blastocyst success rates in assisted reproduction, successfully passed on-site inspection under the EU Medical Device Regulation (MDR) earlier this year and is currently under final review. The product has been a strong seller in non-EU markets for the past two years, and the company expects that MDR certification will further facilitate entry into the European market and boost revenue.

Bonraybio’s complete line of male infertility products is now marketed in over 70 countries worldwide, with continued expansion into new regions. The company recently obtained certification under the Medical Device Single Audit Program (MDSAP), meeting regulatory standards across Australia, Brazil, Canada, Japan, and the United States. In addition, product registration approval from Russian authorities will enable Bonraybio to further extend its global sales network.

Driven by strong demand across existing product lines and the launch of new certified products, Bonraybio reported outstanding revenue and profit performance in the first three quarters of 2025. With new markets opening and additional certifications expected, the company anticipates sustained growth momentum through the fourth quarter of this year and into 2026.

Resource: 邦睿9月營收2621萬元、年增36% 前三季營收年增40%超越去年全年