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): August 2, 2023

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: (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 “SSII,” “the Company,” “we,” “us” and “our” refer to SS Innovations International, Inc. f/k/a Avra Medical Robotics, Inc. and its subsidiaries.

Item 7.01 Regulation FD Disclosure.

On August 2, 2023, SSII issued a press release announcing that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic device, the SSi Mantra and that the Company had retained Elexes, a regulatory and quality compliance firm, to support the Company as it moves through the approval process. A copy of the press release is attached as Exhibit 99.1 to this Report.

The foregoing information, including the press release attached as Exhibit 99.1 to this Report, is being furnished pursuant to Item 7.01 of this Current Report and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended or incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1*		Press Release, dated August 2, 2023

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

*	Furnished but not filed.

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: August 2, 2023	SS INNOVATIONS INTERNATIONAL, INC.

	By:	/s/ Sudhir Srivastava
		Sudhir Srivastava, M.D. Chairman and Chief Executive Officer

Exhibit 99.1

SS Innovations Begins FDA and CE Regulatory Approval Processes for SSi Mantra Flagship Surgical Robotic Device

Company retains Elexes, a regulatory and quality compliance firm with deep experience, to advance approval process

FORT LAUDERDALE, FL / ACCESSWIRE /August 2, 2023 / SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC:SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, announced that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic device, the SSi Mantra. The Company has retained Elexes, a regulatory and quality compliance firm, to support the Company as it moves through the approval process.

The SSi Mantra is the first surgical system to be made in India, and one of the only systems in the world designed to be distinctly cost-effective with broad-spectrum surgical applications, including cardiac surgery. The device has been granted regulatory approval by the Indian Central Drugs Standard Control Organization (CDSCO) and is clinically validated in India in more than 40 different surgical procedures.

Elexes is a regulatory and quality compliance firm with a reputation for delivering excellent expert guidance and unbiased assistance. They offer services worldwide and assist clients in securing approvals for breakthrough innovations. Elexes has strong expertise in approval of and post market compliance for medical devices, pharmaceutical drugs, and biologics.

Dr. Sudhir Srivastava, CEO, Chairman and Founder of SS Innovations, said, “As SS Innovations prepares to pursue regulatory approvals for our SSi Mantra surgical robotic device in Europe and the United States, we are very pleased to have retained Elexes to facilitate the process.”

“Elexes has an excellent reputation and track record of success, and has previously worked with some of the foundational companies in the medical robotic field, including its key personnel’s experience with Intuitive Surgical and Stryker. We feel confident in the organization’s ability to guide us to achieving FDA and CE approvals as early as 2024 and 2025.”

About Elexes

Elexes helps companies prepare documentation, review reports, perform risk analysis, and secure regulatory approvals. The regulatory and quality compliance firm is ISO 13485 certified by BSI Group, and establishes GMP/ISO compliant pre- and post-market systems for its clients. Elexes leverages expertise, uses cutting-edge tools for project management and effective communication while preemptively informing clients about potential issues with an impact on cost and timeline. The company believes that safe and effective innovation should be aptly positioned to the regulators for timely approvals and continually made available to the patients and practitioners. For more information, please visit: https://elexes.com.

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, 3D vision open-console design and superior ergonomics, the system engages machine learning models 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 40 different surgical procedures. The company expects to seek regulatory approvals from the US Food and Drug Administration (FDA) and CE Mark in Europe in 2023 and 2024.

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
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341

Cover	Aug. 02, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 02, 2023
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	true
Elected Not To Use the Extended Transition Period	false