Form 8-K - Current report

 

 

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): June 11, 2024

 

SS INNOVATIONS INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 

Florida		333-216054		47-3478854
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

1600 SE 15th Street, #512 Fort Lauderdale, Florida		33316
(Address of Principal Executive Offices)		(Zip Code)

 

Registrant’s telephone number, including area code: [phone]

 

 

(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
None		N/A		N/A

 

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 “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 June 11, 2024, we issued a press release announcing that the Company’s SSi Mantra Surgical Robotic System has received regulatory approval from the Indonesian Ministry of Health for clinical use in the Republic of Indonesia.

 

A copy of the press release is included as Exhibit 99.1 to this Report.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release, dated June 11, 2024
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: June 11, 2024	SS INNOVATIONS INTERNATIONAL, INC.
	By:	/s/ Sudhir Srivastava
		Sudhir Srivastava, M.D. Chairman and Chief Executive Officer

 

 

2

 

Exhibit 99.1

 

SS Innovations’ SSi Mantra Surgical Robotic System Approved for Use in Indonesia

 

Fort Lauderdale, FL., June 11, 2024 – Globe Newswire - SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today announced that its SSi Mantra Surgical Robotic System has received regulatory approval from the Indonesian Ministry of Health for clinical use in the Republic of Indonesia.

 

With more than 279 million people, Indonesia is the world’s fourth-most-populous country. However, robotic surgery has been slow to reach the island nation. Indonesia’s Bunda Hospital in Jakarta acquired its first robotic surgical system in 2012 and has only completed about 700 surgeries in the past 12 years.

 

“With the entry of the SSi Mantra to the Indonesian market, we believe that we can be instrumental in increasing access to and decreasing costs of robotic surgery options,” said Dr. Sudhir Srivastava, SS Innovation’s Chairman and CEO. “We look forward to broadening surgical horizons for Indonesians and continuing to expand our innovative surgical services and options across the globe.”

 

“I have been in the healthcare business for the past 30 years, and this is the first time I have seen such an impressive technology,” said Mohammad Ridwan, CEO of Neuro Medika Sejahtera, the distributor of the SSi Mantra in Indonesia. “I was very satisfied to see the quality of the SSi Mantra and the advancement offered by the SSi Maya, the Company’s mixed-reality software application. I believe that SS Innovations offers a practical and cost-effective solution to help expand robotic surgery access in Indonesia.”

 

Last month, SS Innovations announced that it had completed 100 robotic cardiac surgery cases in just over a year, utilizing the SSi Mantra Surgical Robotic System. It is the first surgical robotic system made in India, and one of the only systems in the world designed to be cost-effective with broad-spectrum surgical applications. The SSi Mantra is clinically validated in more than 70 different types of surgical procedures. SS Innovations has commenced the regulatory approval process in the United States and the European Union and anticipates receiving FDA approval to market and CE Mark approval in 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. SS Innovations has partnered with Johns Hopkins University, installing the SSi Mantra at the University's Minimally Invasive Surgical Training and Innovation Center (MISTIC) in Baltimore, MD. This installation is actively training new surgeons and promoting the global dissemination of advancements in medical robotics. The SSi Mantra system has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 70 different types of surgical procedures. SS Innovations has commenced the regulatory approval process in the United States and the European Union and anticipates receiving FDA approval to market and CE Mark approval in 2025.

 

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

Jeff Ramson


[e-mail]

Cover	Jun. 11, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jun. 11, 2024
Entity File Number	333-216054
Entity Registrant Name	SS INNOVATIONS INTERNATIONAL, INC.
Entity Central Index Key	0001676163
Entity Tax Identification Number	47-3478854
Entity Incorporation, State or Country Code	FL
Entity Address, Address Line One	1600 SE 15th Street
Entity Address, Address Line Two	#512
Entity Address, City or Town	Fort Lauderdale
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33316
City Area Code	954
Local Phone Number	478-1410
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false

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