Form 8-K

8-K — SS Innovations International, Inc.

Accession: 0001213900-26-036006

Filed: 2026-03-30

Period: 2026-03-30

CIK: 0001676163

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0283970-8k_ssinnova.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED MARCH 30, 2026 (ea028397001ex99-1.htm)

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8-K — CURRENT REPORT

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

Pursuant to Section 13 or 15(d) of The Securities

Exchange Act of 1934

Date of report (Date of earliest event reported):

March 30, 2026

SS INNOVATIONS INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

Florida

001-42615

47-3478854

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

405, 3rd Floor, iLabs Info Technology Centre

Udyog Vihar, Phase III

Gurugram, Haryana India

122016

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including

area code: +91 73375 53469

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General

Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title of each Class

Trading Symbol

Name of each exchange on which registered

Common Stock

SSII

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the

Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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)

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

EX-99.1 — PRESS RELEASE, DATED MARCH 30, 2026

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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

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