SS Innovations plans to submit a De Novo request to the FDA for its SSi Mantra 3 surgical robotic system in July 2025.
Quiver AI Summary
SS Innovations International, Inc. announced plans to submit a De Novo Classification Request to the U.S. Food and Drug Administration (FDA) in July 2025 for their SSi Mantra 3 surgical robotic system, aiming for FDA market clearance in the U.S. Since launching their original system in August 2022, SS Innovations has installed 80 units across 75 hospitals, performing over 3,800 surgeries with no reported complications. The SSi Mantra 3, which was launched in June 2024, has already been used in more than 750 procedures, including cardiac surgeries. The FDA submission will seek approval for various surgical specialties. The company, which markets its system in six countries and is also pursuing CE Mark approval in the European Union, is committed to making advanced robotic surgery technology both affordable and accessible globally.
Potential Positives
- The planned submission of the SSi Mantra 3 for FDA De Novo Classification could lead to U.S. market approval, significantly expanding the company's market presence.
- Since launch, the SSi Mantra systems have been successfully utilized in over 3,800 surgeries, showcasing the system's effectiveness and safety in various surgical procedures.
- The company has already secured approval to market its system in six countries, indicating strong international demand and potential for further global expansion.
- Real-world clinical data has validated the safety of the SSi Mantra 3 for a wide range of surgical procedures, enhancing the company’s credibility in the surgical robotics space.
Potential Negatives
- Submission of the De Novo Classification Request does not guarantee FDA approval, which could delay or prevent the U.S. market entry of the SSi Mantra 3.
- The need for FDA approval indicates that the company may still be in early stages of gaining regulatory acceptance for its product in the U.S., which could affect its competitive position.
- The press release highlights a reliance on a single product (SSi Mantra 3) for future growth, raising concerns about potential risks if this product does not meet market expectations or regulatory criteria.
FAQ
What is the SSi Mantra 3 surgical robotic system?
The SSi Mantra 3 is an innovative surgical robotic system designed for multispecialty surgical procedures, including cardiac surgeries.
When will SS Innovations submit the De Novo Classification Request?
The Company plans to submit the De Novo Classification Request to the FDA in July 2025.
What are the benefits of the SSi Mantra surgical system?
The SSi Mantra offers user-friendly features, including modular robotic arms and advanced 3D visualization technology for enhanced surgical precision.
How many surgeries have been performed using the SSi Mantra system?
Over 3,800 surgeries, including more than 200 robotic cardiac surgeries, have been performed using the SSi Mantra system since 2022.
Is the SSi Mantra approved for use in any countries?
Yes, the SSi Mantra surgical robotic system is currently approved for marketing in six countries worldwide.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SSII Insider Trading Activity
$SSII insiders have traded $SSII stock on the open market 44 times in the past 6 months. Of those trades, 36 have been purchases and 8 have been sales.
Here’s a breakdown of recent trading of $SSII stock by insiders over the last 6 months:
- SUDHIR SRIVASTAVA (Chairman and CEO) has made 0 purchases and 8 sales selling 16,683,050 shares for an estimated $23,016,601.
- FREDERIC H MOLL has made 3 purchases buying 8,747,265 shares for an estimated $12,001,247 and 0 sales.
- TIMOTHY P. ADAMS has made 2 purchases buying 2,650,620 shares for an estimated $3,764,107 and 0 sales.
- BARRY F COHEN (COO - Americas) has made 31 purchases buying 6,604 shares for an estimated $58,111 and 0 sales.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
Full Release
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:
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T: (303) 953-9878
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T: (212) 836-9608
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