SSII SS Innovations International Inc (PK)

 

 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): September 11, 2024

 

SS INNOVATIONS INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 

Florida		000-56608		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: (954) 478-1410

 

 

(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 September 11, 2024 we issued a press release updating SSi’s progress and timeline in obtaining U.S. Food and Drug Administration approvals to market our SSi Mantra Surgical Robotic System in the United States. 

 

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, September 11, 2024
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: September 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 Conducts Interactive Meeting with the Center for Devices and Radiological
Health (CDRH) of the Food and Drug Administration (FDA) and Updates its Expected FDA Approval Timeline

 

Fort Lauderdale, FL., September 11, 2024 - SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today issued an update on its progress and timeline in obtaining U.S. Food and Drug Administration (“FDA”) approvals to market the SSi Mantra Surgical Robotic System (“SSi Mantra”) in the United States.

 

Early this year, the Company completed its first interactive pre submission meeting with the FDA for the SSi Mantra. The Company received valuable feedback from the FDA regarding its planned regulatory strategy, biocompatibility assessment, reprocessing validation, and clinical data requirements and, based on this feedback, will proceed with a de novo pathway for the pre-market submission of the SSi Mantra for numerous indications in parallel.

 

The Company plans to have follow-on pre-submission meetings in the upcoming months and anticipates submitting the SSi Mantra for an investigational device exemption (IDE) application in the first quarter of 2025 to initiate clinical trials.

 

The Company is planning to simultaneously conduct clinical trials for various indications including abdominal, pelvis, thoracic and cardiac.

 

The Company believes that it will be able to meet the clinical trial requirements relatively quickly because (i) the SSi Mantra’s safety, efficacy, and performance has already been demonstrated in ongoing clinical  use in India, where it has performed all the types of surgical procedures for which approval is being applied for; and (ii) under applicable FDA protocols, procedures performed in India can be included in the clinical trials. The Company plans to also conduct some of the clinical trials in the United States, particularly for Cardiac, where it has already identified potential testing sites.

 

The Company estimates that, barring any unanticipated developments, it should be able to secure its pre-market approvals by the end of 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. SS Innovation’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. SS Innovations’ business operations are headquartered in India and the Company has plans to expand the distribution of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit SS Innovation’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 80 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 the latter half of 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’ 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.

 

Follow us on:

 

LinkedIn: https://www.linkedin.com/company/ssinnovationsgroup/

YouTube: https://www.youtube.com/@ssinnovations

 

For media inquiries, please contact:

 

press@ssinnovations.org

+1-212-739-0300

 

 

 

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Cover	Sep. 11, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Sep. 11, 2024
Entity File Number	000-56608
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
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Pre-commencement Issuer Tender Offer	false
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