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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):
January 26, 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: (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. and its subsidiaries.
Item 8.01 Other Events.
On January 26, 2024, we issued a press release
announcing that SSII had filed a pre-submission application with the U.S. Food and Drug Administration (FDA) requesting feedback on its
SSi MantraTM Surgical Robotic System.
A copy of the press release is included as Exhibit
99.1 to this Report.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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: January 26, 2024 |
SS INNOVATIONS INTERNATIONAL, INC. |
|
|
|
|
By: |
/s/ Sudhir Srivastava |
|
|
Sudhir Srivastava, M.D.
Chairman and Chief Executive Officer |
2
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1676163/000121390024006717/ex99-1_001.jpg)
SS Innovations Announces Filing of Pre-Submission
Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration
Fort Lauderdale, FL., January 26, 2024 - 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, today announced that it has
filed a pre-submission application with the U.S. Food and Drug Administration (FDA) requesting feedback on its SSi MantraTM
Surgical Robotic System.
SS Innovations received acknowledgement of this
pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.
The CDRH is responsible for regulating firms who
manufacture, repackage, relabel, or import medical devices sold in the United States. In addition, CDRH regulates medical and non-medical
radiation-emitting electronic products such as lasers, x-ray systems and ultrasound equipment.
SS Innovations Founder, Chairman and Chief Executive
Officer, Dr. Sudhir Srivastava, commented, “The filing of our pre-submission application with the CDRH is a pivotal step for SS
Innovations, and provides an opportunity for us to gather feedback in an interactive meeting with the FDA prior to our planned 510(k)
premarket submission for the SSi MantraTM Surgical Robotic System. We are very pleased to have obtained regulatory approval
for the SSi MantraTM in India and Guatemala, and we are working towards obtaining approvals in the United States and Europe.”
The SSi MantraTM
Surgical Robotic System is the first surgical system to be made in India, and one of the only systems in the world to be distinctly cost-effective
with broad-spectrum surgical applications, including cardiac surgery.
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
MantraTM” 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 4K 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 SSi Mantra has also received regulatory approval in Guatemala. The company expects to seek regulatory
approvals from the US Food and Drug Administration (FDA) and CE Mark in Europe in 2024 and 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
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341
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