SS Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications

Rhea-AI Summary

SS Innovations International (NASDAQ: SSII) announced plans to submit a De Novo Classification Request to the FDA for its SSi Mantra 3 surgical robotic system in July 2025. The company has demonstrated significant market traction with 80 SSi Mantra systems installed across 75 hospitals since August 2022, facilitating over 3,800 surgeries. The newer SSi Mantra 3 version, launched in June 2024, has 37 installations and has been used in more than 750 procedures, including 70 cardiac cases, with no device-related complications.

The FDA submission will seek approval for multiple surgical specialties including urology, gynecology, general surgery, and thoracic and cardiac surgery. The system is currently approved in six countries, and the company is simultaneously pursuing EU CE Mark approval.

Positive

• Successful track record with 80 systems installed and 3,800+ surgeries performed
• Strong safety profile with no device-related mortality, injury, or complications in 750+ procedures
• Clinical data validated by leading third-party CRO
• Already approved in 6 countries with EU approval in progress
• Multi-specialty application covering various surgical procedures

Negative

• FDA submission does not guarantee approval
• Relatively new product in market with limited track record compared to established competitors

All Clinical Data Validated by Leading Third-Party CRO for Safety, Feasibility and Efficacy

FORT LAUDERDALE, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company is planning to submit a De Novo Classification Request to the U.S. Food and Drug Administration (the “FDA”) for the SSi Mantra 3 surgical robotic system (the “SSi Mantra 3”) in July 2025.   

If approved by the FDA, the SSi Mantra 3 would be cleared to market in the United States. Submission of the De Novo Classification Request does not guarantee FDA approval.

Since the Company began the sale of its system in August 2022 it has installed a total of 80 SSi Mantra robotic surgical systems in 75 hospitals and over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries. The SSi Mantra 3 version was launched in June 2024, and the Company has already installed 37 systems that have been utilized to perform more than 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device related mortality, injury or complications.      

Real world clinical data, validated by a leading contract research organization (“CRO”), supports the ability of the SSi Mantra 3 to safely perform a wide variety of surgical procedures. The planned submission of the SSi Mantra 3 to the FDA will include an application for multispecialty indications including urology, gynecology, general surgery, and thoracic and cardiac surgery.

Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion. 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. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.”

About SS Innovations
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.

About the SSi Mantra
The SSi Mantra Surgical Robotic System is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures.

Forward Looking Statements
This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations International’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

Investor Contact:
The Equity Group        
Kalle Ahl, CFA                
T: (303) 953-9878        
kahl@equityny.com

Devin Sullivan, Managing Director
T: (212) 836-9608
dsullivan@equityny.com

Media Contact:
press@ssinnovations.org
T: (212) 739-0300

FAQ

When will SS Innovations (SSII) submit its FDA De Novo application for the SSi Mantra 3 robotic system?

SS Innovations plans to submit its De Novo Classification Request to the FDA for the SSi Mantra 3 surgical robotic system in July 2025.

How many SSi Mantra 3 systems has SSII installed and how many surgeries have been performed?

Since June 2024, SSII has installed 37 SSi Mantra 3 systems which have been used in more than 750 multispecialty procedures, including 70 cardiac cases.

What surgical specialties will be included in SS Innovations' FDA application?

The FDA application will include multispecialty indications for urology, gynecology, general surgery, and thoracic and cardiac surgery.

What is the safety record of SS Innovations' SSi Mantra 3 robotic system?

The SSi Mantra 3 has reported no device-related mortality, injury, or complications across more than 750 surgical procedures.

In how many countries is SS Innovations' robotic system currently approved?

The SSi Mantra surgical robotic system is currently approved for marketing in six countries, with EU CE Mark approval in progress.