SS Innovations (Nasdaq: SSII) gains SSi Mantra approvals across 4 countries
Rhea-AI Filing Summary
SS Innovations International, Inc. reported new regulatory approvals for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka and Kenya, expanding its addressable markets in Latin America, the Middle East, Africa and South Asia. The system now has regulatory clearance in eleven countries, including India and the United Arab Emirates. As of December 31, 2025, SSi Mantra’s installed base totaled 168 systems across ten countries, with 7,885 cumulative surgeries performed, including 390 cardiac procedures and 121 pediatric surgeries, plus more than 150 telesurgeries. The company also stated it anticipates U.S. FDA review of its 510(k) submission to be completed by mid‑2026 and believes it can obtain European Union CE marking in 2026.
Positive
- Expanded regulatory footprint: SSi Mantra now has regulatory approval in eleven countries, including new approvals in Colombia, Oman, Sri Lanka and Kenya, materially broadening SS Innovations’ global market access.
- Demonstrated clinical utilization: As of December 31, 2025, 168 installed systems supported 7,885 surgeries, including cardiac and pediatric procedures and over 150 telesurgeries, indicating growing adoption and clinical validation.
Negative
- None.
Insights
Multiple country approvals broaden SSi Mantra’s commercial footprint and validate clinical adoption.
SS Innovations highlighted regulatory approval for the SSi Mantra system in Colombia, Oman, Sri Lanka and Kenya, bringing total approved countries to eleven. This widens potential demand across several underpenetrated regions for a lower-cost robotic surgery platform.
The disclosure that 168 systems were installed across ten countries and 7,885 surgeries completed by December 31, 2025 shows growing real‑world usage, including cardiac and pediatric procedures. More than 150 telesurgeries demonstrate operational capability in remote or distributed care settings.
Management said it anticipates completion of U.S. FDA 510(k) review by mid‑2026 and believes EU CE marking is achievable in 2026. Future filings describing actual clearances and commercial traction in these major markets will be important to understand the next phase of growth.
8-K Event Classification
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As used in this Current Report on Form 8-K (this “Current Report”), the terms “SSi,” “the Company,” “we,” “us” and “our” refer to SS Innovations International, Inc. and its subsidiaries.
Item 8.01 Other Events.
On March 30, 2026, the Company issued a press release announcing that it had received regulatory approval for the SSi Mantra surgical robotic system for multiple indications in Colombia, Oman, Sri Lanka and Kenya.
A copy of the press release is included as Exhibit 99.1 to this Current Report.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated March 30, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 30, 2026 | SS INNOVATIONS INTERNATIONAL, INC. | |
| By: | /s/ Sudhir Srivastava | |
| Sudhir Srivastava, M.D. | ||
| Chairman and Chief Executive Officer | ||
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Exhibit 99.1
SS Innovations Expands Global Opportunity with Regulatory Approval of the SSi Mantra Surgical Robotic System in Colombia, Oman, Sri Lanka and Kenya
Fort Lauderdale, FL – March 30, 2026 – 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 has received regulatory approval for the SSi Mantra surgical robotic system (the “SSi Mantra”), for multiple indications in Colombia, Oman, Sri Lanka and Kenya.
The Company received regulatory approval for the SSi Mantra from the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (“INVIMA”) in Colombia in November 2025, from the Directorate General of Pharmaceutical Affairs and Drug Control (“DGPA&DC”) in Oman in November 2025, from the National Medicines Regulatory Authority (“NMRA”) in Sri Lanka in January 2026, and from the Pharmacy and Poisons Board (“PPB”) in Kenya in January 2026. SS Innovations believes that it is favorably positioned to address these underpenetrated markets given the SSi Mantra’s cost advantages combined with its advanced technology, differentiated features, ease of training, and user-friendliness.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We continue to expand SS Innovations’ global opportunity with an eye on democratizing access to cutting-edge robotic surgery for patients in underserved regions of the world. Over the past few months, our advanced, cost-efficient SSi Mantra surgical robotic system has received regulatory approval in Colombia, Oman, Sri Lanka, and Kenya. We are committed to decentralizing excellence in surgical robotic care in these new jurisdictions, among others, while pursuing the established United States and Europe Union markets. We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) premarket notification for the SSi Mantra by mid-2026. Separately, we continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can obtain in 2026.”
To date, the SSi Mantra has been granted regulatory approval in eleven countries, including India and the following:
| ● | Colombia | ● | Oman | |
| ● | Ecuador | ● | Philippines | |
| ● | Guatemala | ● | Sri Lanka | |
| ● | Indonesia | ● | Ukraine | |
| ● | Kenya | ● | United Arab Emirates |
As of December 31, 2025, the SSi Mantra cumulative installed base totaled 168 across ten countries and cumulative surgeries reached 7,885, including 390 cardiac procedures and 121 pediatric surgeries.
To date, more than 150 telesurgeries have been performed with the SSi Mantra.
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 robotic surgical procedures including 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 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. The optional SSi MantrAsana Tele Surgeon Console is a portable, compact alternative to the SSi Mantra’s standard surgeon command center that provides equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. 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 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’ 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@theequitygroup.com
Devin Sullivan, Managing Director
T: (212) 836-9608
dsullivan@theequitygroup.com
Media Contact:
RooneyPartners LLC
Kate Barrette
T: (212) 223-0561
kbarrette@rooneypartners.com
FAQ
What did SS Innovations (SSII) announce about the SSi Mantra system?
In how many countries is SSi Mantra now approved according to SSII’s filing?
How widely is SSi Mantra deployed and used based on SSII’s data?
What are SS Innovations’ U.S. and EU regulatory plans for SSi Mantra?
What differentiating features does the SSi Mantra surgical robot offer?
How does SS Innovations position SSi Mantra in underpenetrated markets?
Filing Exhibits & Attachments
4 documents