The preliminary approval in Egypt will help the Company bring its technology to one of the largest markets in the Middle East, while the product registrations in Vietnam will enable Baird to expand the addressable patient population in this key Southeast Asian country. These milestones reflect the continued successful execution of the Company’s international growth and diversification strategy.
In Vietnam, Baird Medical received Class C medical device registration certificates for several products within its microwave ablation portfolio, including its J-series microwave ablation needles for benign thyroid nodules, G-series needles for liver tumors, and MTI-5AT and MTI-5ET microwave ablation generators. The certificates, which follow an initial product registration issued in January 2026, represent an important step in expanding the Company's footprint in Southeast Asia and supporting future commercialization opportunities in the region.
Additionally, the Egyptian Drug Authority (EDA) granted preliminary approval for Baird Medical's BD-GT Microwave Ablation System and related accessories in January 2026. The preliminary approval marks progress toward establishing a regulatory pathway for the Company's technology in the Egyptian market, in advance of a potential final registration of the system’s sterile accessories.
"Securing medical device registrations in Vietnam and advancing through the regulatory process in Egypt are important steps in expanding the presence of our microwave ablation technology in strategic markets beyond the U.S. and PRC," said Haimei Wu, Chairwoman and CEO of Baird Medical. "These developments demonstrate our ability to navigate regulatory requirements across different jurisdictions and expand the reach of our technology across multiple clinical applications, including thyroid nodules and liver tumors. At the same time, we are focused on continuing to translate our FDA clearance into accelerating commercial traction in the United States by strengthening our physician relationships and expanding adoption of microwave ablation technology. We see strong opportunities to build on our established international presence while establishing a larger foothold in the U.S. market."
The international regulatory developments build on Baird Medical's broader growth strategy, which includes expanding its presence in established markets while accelerating commercial activities in the United States following FDA 510(k) clearance for its microwave ablation technology in November 2023. Baird Medical continues to expand its international regulatory footprint across markets including Argentina, Vietnam, Indonesia, and Pakistan, while advancing the regulatory process in Egypt. The Company continues to focus on strengthening its commercial infrastructure, increasing physician engagement, and building awareness of microwave ablation as a minimally invasive treatment option for a range of indications.
As part of these efforts, Baird Medical will attend the American Thyroid Association (ATA) Annual Meeting, taking place November 4-7, 2026, in Philadelphia, Pennsylvania. The meeting will bring together clinicians, researchers, and industry leaders focused on advancing thyroid care, providing an opportunity for the Company to engage with the medical community and support awareness of microwave ablation technology for the treatment of benign thyroid nodules.