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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): April 29, 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 “SSi,” “the Company,”
“we,” “us” and “our” refer to SS Innovations International, Inc. and its subsidiaries.
Item
8.01 Other Events.
On
April 29, 2024, we issued a press release announcing the successful performance of the first infant pyeloplasty using our SSi Mantra
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:
April 29, 2024 |
SS
INNOVATIONS INTERNATIONAL, INC. |
|
|
|
|
By: |
/s/
Sudhir Srivastava |
|
|
Sudhir
Srivastava, M.D.
Chairman and Chief Executive Officer |
Exhibit 99.1
SS Innovations Achieves
Pediatric Milestone with First Infant Pyeloplasty Using SSi Mantra
Surgical Robotic System
Company’s flagship SSi Mantra surgical
device has now been used in more than 1000 procedures
Fort Lauderdale, FL., April 29, 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 the successful
performance of the first pyeloplasty procedure performed on an infant utilizing its flagship SSi Mantra Surgical Robotic System. The
successful surgery was performed by Dr. Chandra Mohan Vaddi at the Preeti Urology & Kidney Hospital in Hyderabad, India.
The pyeloplasty procedure, which involves the
surgical reconstruction of the renal pelvis to remove a blockage that prevents urine from properly draining into the bladder, was successfully
completed on a 12 month old baby weighing 8.5 kilograms (approximately 17.6 pounds).
“Words can hardly
express the overwhelming joy and pride we feel as we witness the SSi Mantra Surgical Robotic System changing the trajectory of children's
lives,” said Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations. “This milestone
is a testament to the precision and adaptability of the SSi Mantra in meeting the nuanced requirements of pediatric care. It underscores
our commitment to extending state-of-the-art surgical options to all patient demographics, including the most vulnerable. From the very
beginning, our vision for our surgical robotic system was to revolutionize healthcare for everyone, including children, ensuring that
even the most delicate surgeries are performed with unmatched precision and care.”
The SSi Mantra Surgical Robotic System is the
first surgical system to be made in India, and one of the only systems in the world to be cost-effective with broad-spectrum surgical
applications. It has been granted regulatory approval in India, Guatemala and Indonesia, and is clinically validated in more than 60
different types of surgical procedures, including pyeloplasty. More than 1000 surgical procedures have been performed using the system
to date including cardiothoracic, head and neck, gynecology, urology, and general surgeries in India. SS Innovations has commenced the
regulatory approval process in the United States and European Union, and anticipates receiving such approvals in the latter half of 2024
or-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. The SSi
Mantra has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 60 different
types of surgical procedures. The Company has initiated the regulatory approval process in the United States and the EU, with approval
anticipated in the latter half of 2024 or 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
jramson@pcgadvisory.com
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