SS Innovations Expands Global Opportunity with Regulatory Approval of the SSi Mantra Surgical Robotic System in Colombia, Oman, Sri Lanka and Kenya

Rhea-AI Summary

SS Innovations (Nasdaq: SSII) received regulatory approvals for the SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka and Kenya.

The approvals were granted by INVIMA (Colombia, Nov 2025), DGPA&DC (Oman, Nov 2025), NMRA (Sri Lanka, Jan 2026) and PPB (Kenya, Jan 2026). The SSi Mantra now has approval in eleven countries and a cumulative installed base of 168 systems with 7,885 surgeries through Dec 31, 2025.

Positive

• Regulatory approvals in Colombia, Oman, Sri Lanka and Kenya
• Approved in 11 countries, expanding global market access
• Installed base 168 systems as of Dec 31, 2025
• 7,885 cumulative surgeries performed through Dec 31, 2025
• 150+ telesurgeries demonstrating remote-use capability

Negative

• U.S. FDA 510(k) review is still pending with mid-2026 target
• European Union CE marking remains pending in 2026
• Relatively small installed base of 168 systems limits near-term revenue scale

Key Figures

Countries with approval: 11 countries Installed base: 168 systems Cumulative surgeries: 7,885 surgeries +5 more

8 metrics

Countries with approval 11 countries Total regulatory approvals for SSi Mantra to date

Installed base 168 systems SSi Mantra cumulative installed base as of Dec 31, 2025

Cumulative surgeries 7,885 surgeries Total SSi Mantra surgeries as of Dec 31, 2025

Cardiac procedures 390 procedures Cumulative SSi Mantra cardiac surgeries

Pediatric surgeries 121 surgeries Cumulative SSi Mantra pediatric procedures

Telesurgeries performed more than 150 Cumulative telesurgeries performed with SSi Mantra

FDA review timing mid-2026 Anticipated completion of 510(k) review for SSi Mantra

EU CE marking goal 2026 Company’s target timing for CE marking certification

Market Reality Check

Price: $4.91 Vol: Volume 35,071 is below 20...

low vol

$4.91 Last Close

Volume Volume 35,071 is below 20-day average of 65,219 (relative volume 0.54). low

Technical Shares at $4.91, trading 78.1% below 52-week high of $22.42 and below 200-day MA at $6.

Peers on Argus

Key medical device peers like IART, AHCO, BBNX, ESTA and NVCR show price decline...

Key medical device peers like IART, AHCO, BBNX, ESTA and NVCR show price declines between -1.23% and -7.64%, while SSII is down -0.41%. Scanner data does not flag a coordinated sector momentum move.

Historical Context

5 past events · Latest: Mar 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 18	Telesurgery approvals	Positive	+7.2%	Regulatory approval for telesurgeries in Indonesia and the Philippines with >150 cases.
Mar 10	Earnings results	Positive	-5.6%	Reported 2025 revenue of $42.5M, up 105.7%, and margin expansion.
Mar 09	Private placement	Positive	+5.4%	Closed $18.6M private placement of 5,774,839 shares to fund growth initiatives.
Jan 13	Prelim revenue	Positive	+10.8%	Preliminary 2025 revenue of $43.0M and 168 installed SSi Mantra systems.
Jan 08	Exec appointment	Positive	-1.4%	Appointment of Milan Rao as Global COO and CFO to support scaling.

Pattern Detected

Recent company news has often led to positive price reactions, but strong financial results in March showed a negative divergence.

Recent Company History

Over the past few months, SS Innovations has combined rapid commercial expansion with capital raising and leadership changes. On Jan 13, 2026, preliminary 2025 revenue growth and an installed base of 168 systems drove a +10.84% move. A management appointment on Jan 8 saw a modest decline. In March, the company reported full-year 2025 results with revenue of $42.5M and completed an $18.6M private placement, with mixed price reactions. The Mar 18 telesurgery approvals in Indonesia and the Philippines were followed by a +7.16% gain, underscoring sensitivity to regulatory and adoption milestones.

Market Pulse Summary

This announcement expands SSi Mantra’s footprint with regulatory approvals in Colombia, Oman, Sri La...

Analysis

This announcement expands SSi Mantra’s footprint with regulatory approvals in Colombia, Oman, Sri Lanka and Kenya, bringing total approvals to 11 countries. The company reported an installed base of 168 systems and 7,885 cumulative surgeries, including 390 cardiac and 121 pediatric procedures, plus more than 150 telesurgeries. Investors may track progress toward the anticipated mid-2026 FDA 510(k) decision and targeted 2026 EU CE marking, and how new-country approvals translate into additional installations and procedure volumes.

Key Terms

regulatory approval, surgical robotic system, telesurgeries, 510(k) premarket notification, +1 more

5 terms

regulatory approval regulatory

"announced that the Company has received regulatory approval for the SSi Mantra"

Regulatory approval is the official permission given by government agencies or authorities that allows a product, service, or business activity to be legally operated or sold. It is important to investors because receiving approval often indicates that a product has been reviewed for safety and compliance, which can influence its success and the company’s prospects in the market. Without this approval, launching or selling certain products may be restricted or prohibited.

surgical robotic system medical

"regulatory approval for the SSi Mantra surgical robotic system"

A surgical robotic system is a hospital-grade machine that combines robotic arms, high-resolution cameras and control software to help surgeons perform operations with smaller cuts, steadier movements and better views. Investors care because these systems can change how often and how profitably procedures are done: hospitals buy expensive equipment, pay ongoing fees for instruments and service, and may attract more patients, making adoption, approvals and recurring revenue important signals of financial upside.

telesurgeries medical

"To date, more than 150 telesurgeries have been performed with the SSi Mantra."

Surgery performed by a clinician who is physically distant from the patient, using robotic instruments, real‑time video and sensors controlled over high‑speed networks; think of a surgeon using a precise game controller to operate tools in another location. Investors care because telesurgeries can expand patient access, shift where care happens, and create new markets for medical robots, software and communications, while also carrying regulatory, reimbursement and liability uncertainties that affect adoption and returns.

510(k) premarket notification regulatory

"review of our 510(k) premarket notification for the SSi Mantra by mid-2026."

A 510(k) premarket notification is a regulatory submission to the U.S. Food and Drug Administration that shows a new medical device is as safe and effective as an existing, legally marketed device. Think of it like demonstrating your new model performs like a trusted older model so it can be sold; for investors, 510(k) clearance is a key hurdle that affects how quickly a device can reach market, development cost, and the level of regulatory risk in a medical-device investment.

ce marking regulatory

"pathway towards a European Union CE marking certification for the SSi Mantra"

CE marking is a symbol placed on certain products showing they meet European Union safety, health and environmental rules required to sell them in the EU/EEA. For investors, it signals that a product has cleared a common regulatory hurdle—like a passport for market access—reducing legal and market-entry risk and often widening sales opportunities across European markets.

AI-generated analysis. Not financial advice.

FORT LAUDERDALE, Fla., March 30, 2026 (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 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

Which countries granted SS Innovations (SSII) approval for the SSi Mantra in early 2026?

The SSi Mantra received approvals in Sri Lanka and Kenya in January 2026. According to the company, Colombia and Oman received approvals in November 2025, bringing total approved countries to eleven.

How many SSi Mantra systems were installed and surgeries performed as of Dec 31, 2025 for SSII?

As of Dec 31, 2025, the SSi Mantra had a cumulative installed base of 168 systems. According to the company, those systems recorded 7,885 cumulative surgeries, including 390 cardiac and 121 pediatric procedures.

What is the timeline for the SSII SSi Mantra U.S. FDA 510(k) review?

SS Innovations expects the FDA 510(k) review of the SSi Mantra to complete by mid-2026. According to the company, this timeline represents the current target but remains subject to regulatory review outcomes.

Has SS Innovations obtained CE marking for the SSi Mantra and what is the expected timing?

The company is pursuing CE marking and believes it can obtain certification in 2026. According to the company, CE marking remains in progress and is not yet finalized as of the announcement.

How many telesurgeries and pediatric procedures has SSII reported for the SSi Mantra?

The SSi Mantra has performed more than 150 telesurgeries to date. According to the company, cumulative procedures include 121 pediatric surgeries among the 7,885 total reported.