Full Press Release Details
Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications
Clinical Data Validated by Leading Third-Party CRO for Safety, Feasibility and Efficacy
Lauderdale, FL - May 8, 2025 - 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.
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.
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.
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.
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 seven 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."
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.
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
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Sullivan, Managing Director