Edge Medical® announced that its independently developed MP1000 multiport robotic surgical system, SP1000 single-port robotic surgical system, and MSP2000 single-port multiport super robotic surgical system have simultaneously received clearance from the Therapeutic Goods Administration (TGA) of Australia and are now formally listed on the Australian Register of Therapeutic Goods (ARTG). The cleared products are indicated for endoscopic surgical procedures in urology, gynecology, general surgery, and thoracic surgery. This milestone marks the official market entry of all three robotic surgical platforms — multiport, single-port, and integrated single-multiport — into Australia, laying a critical foundation for the Company to further expand across Australia and the broader Asia-Pacific region and to advance the global clinical adoption of premium Chinese surgical robotics.

Three Platforms Cleared Simultaneously

Entering Australia with a Complete Product Portfolio

The three cleared products represent Edge Medical's® core innovations across the multiport, single-port, and integrated robotic surgery domains. The MP1000 multiport robotic surgical system addresses multi-disciplinary, multi-procedure clinical needs; the SP1000 single-port robotic surgical system is designed for single-incision minimally invasive surgery; and the MSP2000 single-port multiport super robotic surgical system leverages a platform-based architecture to extend adaptability across diverse surgical approaches and clinical settings.

Australia features a mature healthcare system, advanced surgical capabilities, and a rigorous medical device regulatory framework, making it a representative high-end medical device market in the Asia-Pacific region. Robot-assisted surgery was adopted early in Australia, with an established clinical foundation in urology, gynecology, and general surgery. Driven by an aging population, growing demand for oncologic and chronic disease treatment, and sustained institutional emphasis on precision minimally invasive surgery, enhanced recovery, and the ability to manage complex procedures, the Australian laparoscopic surgical robot market offers substantial growth potential. As an innovative enterprise with a complete product portfolio spanning multiport, single-port, and integrated platforms alongside global service capabilities, Edge Medical® is well-positioned to leverage its platform-based product strategy and deepen collaboration with local healthcare institutions and clinical experts.

The simultaneous TGA clearance of all three products underscores that Edge Medical® has established a comprehensive product architecture spanning multiport, single-port, and integrated single-multiport platforms — capable of delivering richer, more flexible robotic minimally invasive surgical solutions tailored to different specialties, procedures, and institutional needs. From single-product overseas certification to the synchronized entry of multiple platforms and models into international markets, Edge Medical's® globalization is evolving from "product export" to "platform export."

Aligning with Global Regulatory Frameworks

Continued Validation of International Product Capability

This Australian TGA clearance follows prior regulatory milestones, including approval by China's National Medical Products Administration (NMPA), CE marking in the European Union, and registration with Brazil's National Health Surveillance Agency (ANVISA), representing another significant international market access achievement for Edge Medical® robotic products.

Different countries and regions have established distinct regulatory frameworks governing medical device registration, quality management, clinical evaluation, and post-market surveillance. Sustained success in passing regulatory reviews across multiple major markets demonstrates Edge Medical's® continuously maturing comprehensive capabilities in product R&D, manufacturing, quality control, clinical validation, and international regulatory registration.

To date, the Edge Medical® multiport robotic surgical system has obtained market access in 68 countries and regions worldwide, covering major markets including China, Europe, Brazil, and Southeast Asia. The Edge Medical® single-port robotic surgical system and the Edge Medical® single-port multiport super robotic surgical system have secured market access in 43 and 42 countries and regions, respectively, including China, Europe, New Zealand, and Malaysia.

An ever-expanding international regulatory footprint signifies that Edge Medical's® product portfolio is being validated against the regulatory standards and clinical demands of an increasing number of countries and regions, providing a solid foundation for subsequent localized clinical deployment, surgeon training, academic exchange, and commercialization.

Australia as a New Foothold

Accelerating Penetration of the Asia-Pacific High-End Medical Market

Australia is one of the most influential medical device markets in the Asia-Pacific region and a vital node connecting Oceania with the broader Asia-Pacific healthcare innovation ecosystem. The simultaneous market entry of all three products will further strengthen Edge Medical's® operational footprint across Asia-Pacific, creating favorable conditions for deeper engagement with local healthcare institutions, clinical experts, and industry partners.

Looking ahead, Edge Medical® will use this TGA clearance as a catalyst to actively drive clinical adoption and commercial deployment in the Australian market. The Company will continue to build out localized training, clinical support, and after-sales service systems, and will engage in deeper collaboration with local healthcare institutions and clinical experts across key specialties including urology, gynecology, general surgery, and thoracic surgery.

At the same time, formal market access in Australia will synergize with Edge Medical's® existing presence across China, Europe, Latin America, and Southeast Asia, further enhancing the Company's brand influence, channel coverage, and international operational capabilities in the Asia-Pacific region. From indigenous R&D in China to market access across multiple major international markets; from the multiport system leading the global expansion to the accelerated international rollout of single-port and integrated platforms — Edge Medical® is driving premium Chinese medical equipment onto a broader global clinical stage through sustained technological innovation, a complete product matrix, and a systematic global strategy.