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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): November 27, 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. and its subsidiaries.
Item 8.01 Other Information.
On November 27, 2023, SSII issued a press release
announcing that the Company had reached a milestone by having 500 surgical procedures performed using its 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: November 27, 2023 |
SS INNOVATIONS INTERNATIONAL, INC. |
|
|
|
|
By: |
/s/ Sudhir Srivastava |
|
|
Sudhir Srivastava, M.D.
Chairman and Chief Executive Officer |
2
Exhibit 99.1
SS Innovations International SSi Mantra Robotic
Surgical System Crosses 500 Successful Procedure Milestone
Company Founder and Chairman, Dr. Sudhir P.
Srivastava performed complex heart surgery, while simultaneously, Dr. Sudhir K. Rawal, Medical Director for Rajiv Gandhi Cancer Institute,
performed complex Urology Oncology surgery, marking 500 surgery milestone using the SSi Mantra Surgical Robotic System
Fort Lauderdale, FL., November 27, 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, today announced the successful
completion of 500 robotic surgeries using the Company’s innovative SSi Mantra Surgical Robotic System, and marking another significant
milestone for the Company.
Dr. Sudhir K. Rawal, Medical Director and Chief
of the Urology-Oncology Department at the Rajiv Gandhi Cancer Institute and Research Center in New Delhi, was proud that it was his team
that achieved this significant milestone by successfully completing the 500th procedure using the SSi Mantra Surgical Robotic
System. He was assisted by Dr. Amitabh Singh, a renowned surgeon in the field of Urology Oncology and a distinguished surgeon from Dr.
Rawal’s team. This recognition is noteworthy given Dr. Rawal and the Rajiv Gandhi Cancer Institutes’ help in securing SS Innovations’
clinical validation, but also as the first healthcare institution in the Indian Subcontinent to acquire the system, and as a result, performing
the highest volume of clinical procedures with the SSi Mantra Robotic System within all of India to date.
Dr. Rawal stated, “This is great news that
the SSi Mantra has been used in 500 cases across India in diverse disciplines of surgery. I believe that this is the start of an affordable
robotic surgery solution in the country that can easily provide world class care. The SSi Mantra is the first affordable system and as
such, has the opportunity to be utilized in large metropolitan area hospitals as well as in tier 2 and tier 3 cities medical facilities.
It has been a big journey for Dr. Sudhir Srivastava and his team, and I am proud to have been associated right from the beginning and
during the various phases of the clinical trials where we used this robotic system in some very complex cancer surgery procedures. I believe
that the SSi Mantra has the potential to become the most used robotic surgical system in India over the next several years.”
After crossing the significant milestone mark,
the 501st surgery was performed by SS Innovations International Inc., Founder and Chairman, Dr. Sudhir P. Srivastava, and was
a bilateral internal mammary artery takedown procedure to be utilized in a heart surgery patient with significant coronary artery disease.
The two harvested internal mammary arteries were used to bypass blocked coronary arteries, restoring blood flow to previously diseased
areas of the heart, and resulting in improved functioning of the heart. This was a first of its kind procedure to be performed with the
SSi Mantra Robotic System. This surgery was done as part of the ongoing teaching curriculum at the Narayana Hrudalayala Institute of Cardiac
Sciences in Bengaluru, Karnataka, where Dr. Srivastava launched the robotic cardiac surgery program, along with the support of Dr. Devi
Shetty, Chairman of the prestigious healthcare institution, several months ago. Dr. Srivastava was assisted by Dr. Nitin Kumar Rajput,
a prominent surgeon in the field of minimally invasive cardiac surgery.
Commenting on this noteworthy milestone, Dr. Srivastava
said, “It is with great pleasure to realize that from humble beginnings as a company, and through the dedication and effort of our
team, along with enormous support from the community of surgeons from all corners of India and the globe, that we have collectively achieved
this milestone of 500 successful surgeries using our innovative SSi Mantra System. I am deeply grateful to all who have shared our vision
of making Gold Standard Healthcare an affordable and accessible right for the many patients in India who otherwise may not have had access
to this level of advanced care. I am thankful to all the doctors and hospitals throughout India who have joined us on this incredible
journey of innovation and service. Knowing that we have been able to successfully launch in India, we look forward to now serving as a
model to the many underserved jurisdictions globally. Although this milestone is very significant, more importantly, it reminds us of
how much more we have to accomplish in India and around the world.”
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 distinctly cost-effective
with broad-spectrum surgical applications, including cardiac surgery. The Ssi Mantra Robotic System has been
granted regulatory approval in India, the United Arab Emirates and most recently, Guatemala. The Ssi Mantra Surgical Robotic System is
clinically validated in more than 40 different types of surgical procedures and now, 500 surgical procedures have been performed to date.
SS Innovations expects to secure regulatory approvals in the United States and Europe in the 2024 – 2025 time frame.
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 system has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than
40 different types of surgical procedures. 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
3
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