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SS Innovations Receives Regulatory Approvals from the Guatemala Ministry of Health

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SS Innovations receives approval for clinical use of Mantra Surgical Robotic System in Guatemala
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  • SS Innovations has received approval from the Government of Guatemala Ministry of Health to make the SSi Mantra surgical robotic system available for clinical use in Guatemala. This marks the company's first regulatory approval in Central America. The Mantra System is the first surgical system made in India and is cost-effective with broad-spectrum surgical applications. It has already been granted regulatory approval in India, the United Arab Emirates, and now Guatemala. SS Innovations expects to secure regulatory approvals in the United States and Europe in the future.
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The Mantra Surgical Robotic System has been given the approval to be used for clinical use in Guatemala, marking the Company’s first regulatory approval in Central America

FORT LAUDERDALE, FL, Oct. 10, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - 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 announces receiving approvals from the Government of Guatemala Ministry of Health to make available the SSi Mantra surgical robotic system for clinical use in Guatemala.

This will be the first country in Central America to have gained official access to the innovative and cost-effective surgical platform since its official launch in India last year.  When asked of the potential benefit for the region, Dr. Sergio Acajabon, a General Surgeon from Houston, Texas, who is currently leading the campaign to bring robotic surgery to Guatemala, emphasized, “Because it is important for Guatemala to have robotic surgery technology, it quickly comes to mind that I have always wanted to offer the people of my country the opportunity to receive the same quality of medical care that people in other, more developed countries receive with better quality surgery.  This is not due to the capacity of our surgeons, but rather because of the lack of access to high-tech tools that can help us do more exact surgeries, with better vision as if we were directly inside of the patient’s body performing the surgery.”

Dr. Vishwa Pascual Srivastava, President, and Chief Operating Officer – South Asia for SS Innovations, said, “After traveling to Guatemala in July 2023, and giving multiple presentations to both the Social Security Hospital and Military Hospital, the largest institutions in the region, I was met with great enthusiasm and support for the mission we had started on the other side of the world in India.  Keeping in mind that India is not the only price sensitive market when it comes to providing gold standard healthcare at an affordable cost, Guatemala would serve as yet another example of how the vision at SS Innovations falls in line with much of the ‘forgotten world’ today.  I feel that Guatemala will also geographically be an ideal training center for surgeons from throughout Central America once the Guatemalan clinical programs have been successfully launched in the months to follow.”

Dr. Jorge Guerrero, Surgical Specialist from the Guatemalan Social Security Hospital, added, “As part of the innovations and advances in technology at a global level, it is important to be at the forefront, updating on new technologies.  Robotic assisted surgery complies with providing patient care, bringing numerous benefits to both the patient and the surgeon.”

The SSi Mantra 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. The Mantra System has been granted regulatory approval in India, the United Arab Emirates and now, Guatemala.  The Mantra Surgical Robotic System is clinically validated in more than 40 different types of surgical procedures wherein approximately 400 surgical procedures have been performed to date.  SS Innovations expects to secure regulatory approvals in the United States and Europe in 2024 and 2025.

About SS Innovations International, Inc.
SS Innovations 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 Mantra” 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.

About SSi Mantra

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 arm configuration, 3D 4K vision open-console design and superior ergonomics, the system engages with the surgeon and surgical teams 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 types of surgical procedures. The company expects to seek regulatory approvals from the US Food and Drug Administration (FDA) and CE Mark in Europe in 2023 and 2024.

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.

For more information:

PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341


FAQ

What is the approval received by SS Innovations?

SS Innovations has received approval from the Government of Guatemala Ministry of Health to make the SSi Mantra surgical robotic system available for clinical use in Guatemala.

Where has the Mantra Surgical Robotic System been approved?

The Mantra System has been granted regulatory approval in India, the United Arab Emirates, and now Guatemala.

What are the future plans for regulatory approvals?

SS Innovations expects to secure regulatory approvals in the United States and Europe in the future.

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