SS Innovations International, Inc. (Nasdaq: SSII) announced plans to submit a De Novo Classification Request to the U.S. Food and Drug Administration (FDA) for its SSi Mantra 3 surgical robotic system in July 2025, seeking clearance to market the device in the United States.
The application will request approval for multiple surgical specialties, including urology, gynecology, general surgery, and thoracic and cardiac procedures. If approved, the SSi Mantra 3 would become a new option in the U.S. surgical robotics market, though the company notes that submission does not guarantee FDA approval.
Clinical Experience and Safety Profile
Since launching in August 2022, SS Innovations has installed 80 SSi Mantra robotic surgical systems across 75 hospitals globally. Surgeons have performed over 3,800 procedures with these systems, including more than 200 robotic cardiac surgeries.
The newer SSi Mantra 3 version, released in June 2024, has already been installed at 37 locations where it has been used in over 750 multispecialty procedures, including 70 cardiac cases. According to the company, real-world clinical data validated by a contract research organization demonstrates the system's safety record with no device-related mortality, injuries, or complications reported.
"We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion," said Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations. "We are taking important steps, including the planned De Novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market."
Technology Specifications
The SSi Mantra Surgical Robotic System features a modular design with 3 to 5 robotic arms and an open-faced ergonomic surgeon command center. The system includes advanced visualization with a 3D 4K monitor and supports over 40 different types of robotic endo-surgical instruments designed for various specialties.
Technical highlights include a touch panel monitor displaying patient information, virtual real-time imaging of the robotic patient side arm carts, and capabilities for superimposition of 3D diagnostic imaging models. The vision cart provides the surgical team with the same magnified 3D 4K view as the surgeon, designed to enhance safety and efficiency.
Global Expansion and Financial Growth
SS Innovations recently achieved a significant milestone with its listing on NASDAQ under the ticker symbol 'SSII' in April 2025. The company reported substantial financial growth for the year ending December 31, 2024, with revenues reaching $20.6 million—a 3.5-fold increase from the previous year's $5.9 million. Gross margins improved to 40.9% from 12.3% in 2023.
Beyond India, the company has expanded its footprint to include installations in Nepal, Ecuador, Guatemala, the Philippines, Indonesia, Sri Lanka, and Ukraine. In parallel with its FDA submission plans, SS Innovations is pursuing European Union CE Mark approval.
"The timing of our uplisting coincides with our global expansion beyond India into multiple countries worldwide," Dr. Srivastava noted. "We are pursuing the EU CE Mark and US FDA approval for our SSi Mantra surgical robotic system, which we expect to receive in late 2025 and early 2026, respectively."
Telesurgery Capabilities
SS Innovations has also pioneered telesurgery applications, becoming the first company in India to receive regulatory approval from the Central Drugs Standard Control Organization (CDSCO) for telesurgery and tele-proctoring procedures.
The company reports having successfully conducted 16 telesurgeries using the SSi Mantra system, including what it describes as the world's first robotic cardiac telesurgery and a landmark cardiac procedure performed across a distance of 2,000 kilometers within India.
This "Made in India for the world" technology represents a significant advancement in making robotic surgery more accessible and affordable globally, according to company leadership. With its focus on cost-effectiveness and clinical versatility, SS Innovations aims to expand the reach of robotic surgical capabilities to a broader patient population worldwide.
