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SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration Fort Lauderdale, FL.

Key Takeaway: SS Innovations International, Inc. has filed a pre-submission application with the FDA regarding its SSi MantraTM Surgical Robotic System. This follows acknowledgment from the CDRH on January 17, 2024. The SSi Mantra is notable for being the first surgical robotic system made in India and has already obtained regulatory approval in India and Guatemala. The company is now focusing on achieving further regulatory approvals in the United States and Europe, with a goal to make robotic surgery more affordable and widely accessible.
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Market Sentiment Analysis

POSITIVE FACTORS

  • Filing of the pre-submission application is a pivotal step for SS Innovations.
  • The SSi MantraTM Surgical Robotic System has received regulatory approval in India and Guatemala.
  • The system aims to make robotic surgery more affordable and accessible globally.
  • The technology offers broad-spectrum surgical applications including cardiac surgery.

Full Press Release Details

SS Innovations Announces Filing of Pre-Submission
Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration
Fort Lauderdale, FL., January 26, 2024 - SS
Innovations International, Inc. (the "Company" or "SS Innovations") (OTC: SSII), a developer of innovative surgical
robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that it has
filed a pre-submission application with the U.S. Food and Drug Administration (FDA) requesting feedback on its SSi MantraTM
Surgical Robotic System.
SS Innovations received acknowledgement of this
pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.
The CDRH is responsible for regulating firms who
manufacture, repackage, relabel, or import medical devices sold in the United States. In addition, CDRH regulates medical and non-medical
radiation-emitting electronic products such as lasers, x-ray systems and ultrasound equipment.
SS Innovations Founder, Chairman and Chief Executive
Officer, Dr. Sudhir Srivastava, commented, "The filing of our pre-submission application with the CDRH is a pivotal step for SS
Innovations, and provides an opportunity for us to gather feedback in an interactive meeting with the FDA prior to our planned 510(k)
premarket submission for the SSi MantraTM Surgical Robotic System. We are very pleased to have obtained regulatory approval
for the SSi MantraTM in India and Guatemala, and we are working towards obtaining approvals in the United States and Europe."
Surgical Robotic System is the first surgical system to be made in India, and one of the only systems in the world to be distinctly cost-effective
with broad-spectrum surgical applications, including cardiac surgery.
About SS Innovations International, Inc.
International, Inc. (OTC: SSII) is a developer of innovative surgical robotic technologies with a vision to make the benefits of robotic
surgery affordable and accessible to a larger part of the global population. SSII's product range includes its proprietary "SSi
MantraTM" surgical robotic system, and "SSi Mudra", its wide
range of surgical instruments capable of supporting a variety of surgical procedures including robotic cardiac surgery. SSII's business
operations are headquartered in India and SSII has plans to expand the presence of its technologically advanced, user-friendly, and cost-effective
surgical robotic solutions, globally. For more information, visit SSII's website at ssinnovations.com or LinkedIn for updates.
Supporting advanced, affordable, and accessible
robotic surgery, the SSi Mantra Surgical Robotic System provides the capabilities for multi-specialty usage including cardiothoracic,
head and neck, gynecology, urology, general surgery and more. With its modular, 3D 4K vision open-console design and superior ergonomics,
the system engages machine learning models to improve safety and efficiency during procedures. The
SSi Mantra system has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 40
different surgical procedures. The SSi Mantra has also received regulatory approval in Guatemala. The company expects to seek regulatory
approvals from the US Food and Drug Administration (FDA) and CE Mark in Europe in 2024 and 2025.
Forward-Looking Statements
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
For more information:

Frequently Asked Questions

What recent application did SS Innovations file with the FDA?

SS Innovations filed a pre-submission application for the SSi MantraTM Surgical Robotic System.

When did SS Innovations receive FDA acknowledgement for the filing?

The company received FDA acknowledgment of its filing on January 17, 2024.

What is the SSi Mantra Surgical Robotic System designed for?

The SSi Mantra is designed for multi-specialty surgical procedures, including cardiac surgery.

In which countries has the SSi Mantra received regulatory approval?

The system is approved in India and Guatemala.

When does SS Innovations plan to seek further regulatory approval?

The company plans to seek FDA and CE Mark approvals in 2024 and 2025.

Last updated: Jan 26, 2024