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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 8, 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 8, 2024, we issued a press release
providing shareholders and the investment community with a review of the significant milestones the Company achieved in 2023.
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 8, 2024 |
SS INNOVATIONS INTERNATIONAL, INC. |
|
|
|
|
By: |
/s/ Sudhir Srivastava |
|
|
Sudhir Srivastava, M.D.
Chairman and Chief Executive Officer |
2
Exhibit
99.1
SS Innovations Achieves Significant Milestones in 2023
-Company’s award winning SSi Mantra surgical
robotic system has completed over 550 surgeries and is clinically validated to perform more than 40 different types of surgical procedures-
-Company Builds Strong Foundation for Future
Growth-
FORT LAUDERDALE, FL, January 8, 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 provided shareholders and the
investment community with a review of the significant milestones the Company achieved in 2023.
Dr. Sudhir Srivastava, Chairman of the Board and
Chief Executive Officer of SS Innovations, and a pioneer in robotic cardiothoracic surgery, stated, “SS Innovations built a strong
foundation in 2023 and has laid the groundwork to achieve significant milestones in the years ahead. Since we completed our merger transaction
with publicly held AVRA Medical Robotics and began trading in the U.S. on the OTC Market in April 2023 under our new name, SS Innovations
International, Inc. and our new trading symbol, “SSII,” our SSi Mantra robotic surgical system has been clinically validated
for additional surgical procedures across multiple specialties and is now being utilized in more than 40 different types including thoracic,
cardiac, pediatric, gynecologic, urologic, general surgery, and head and neck surgeries.
“In the past nine months we have achieved
many milestones that included placing our first system in a Central Government Institution in India and receiving regulatory approval
from the Guatemala Ministry of Health, our second approval in addition to that from CDSCO, the Indian Regulatory Body. We also recently
entered into a co-development partnership agreement with Johns Hopkins University, a memorandum of understanding with Surgical Lab, Ltd.,
for a strategic distribution partnership for placement across 27 countries in Africa and an exclusive partnership with MIMA, a prominent
distribution company based in Tbilisi, Georgia, for distribution
of the SSi Mantra throughout CIS countries in Central Asia such as the Republic of Georgia, Kazakhstan, Azerbaijan, Turkmenistan and
Moldova. With growing placements of our award-winning robotic surgical system, we are nearing achievement of our next surgical milestone
of 1,000 cases after surpassing 550 surgical procedures just several weeks ago.”
“Looking
ahead, we’re diligently working to secure regulatory approvals in the United States and Europe, which we expect to receive in the
2024 – 2025 timeframe. All of these initiatives have strengthened our foundation for future growth and our momentum is clearly
building. We are excited to be progressing forward in fulfilling our mission to make robotic surgery accessible to the large global population
in need of safe and affordable surgical services,” concluded Dr. Srivastava.
2023
Operational Highlights
| ● | In
December 2023, we announced a partnership with Surgical Lab, Ltd., a pan- African medical
device distributor, for distribution across the African Continent. Surgical Lab has already
begun the required registration of the SSi Mantra in 27 African countries. |
| ● | Additionally
in December 2023, a milestone of 200 surgeries performed with the SSi Mantra at a single
institution was achieved by the team at Rajiv Gandhi Cancer Institute and Research Centre
in New Delhi, one of India’s most prestigious cancer hospitals. |
| ● | Also
in December 2023, SS Innovations received the Best Company in Robotic Surgery award by the
Healthcare Planning and Infrastructure Expo Conference and Awards in New Delhi, India. |
| ● | Also
in December 2023, Dr. Sudhir Srivastava successfully performed a Totally Endoscopic Coronary
Artery Bypass on a beating heart at Aster CMI Bengaluru, following the successful launch
of their robotic cardiac program. |
| ● | In
November 2023, the Company marked another significant milestone by announcing the successful
completion of 500 robotic surgeries across India using SSi Mantra Surgical Robotic System. |
| ● | In
October 2023, SS Innovations entered into a co-development partnership agreement with Johns
Hopkins University to broaden procedural applications of medical robotics; they have also
installed an SSi Mantra system at the Johns Hopkins Hospital, Minimally Invasive and Surgical
Training Institute (MISTIC) in Baltimore, MD to support its progress. |
| ● | Also
in October 2023, the SSi Mantra Surgical Robotic System received approval for clinical use
in Guatemala, marking the Company’s first regulatory approval in Central America. |
| ● | In
August 2023, the first international sale of the SSi Mantra was announced. In July 2023,
the system was delivered to one of the premier hospitals in Dubai, United Arab Emirates,
which is part of a publicly traded multinational for-profit hospital and healthcare system
that operates 32 hospitals and a network of healthcare facilities in six countries, including
India. |
| ● | In
July 2023, the Company announced that it has begun the process of pursuing FDA and CE regulatory
approvals for the SSi Mantra surgical robotic system by retaining Elexes, a regulatory and
quality compliance firm that assists its clients in securing clinical approvals for breakthrough
innovations. The regulatory process is expected to be completed in the 2024 – 2025-time
frame. |
| ● | In
June 2023, the first successful surgical procedure using the SSi Mantra surgical robotic
system was performed at the National Institute of Tuberculosis and Respiratory Diseases (NITRD)
in New Delhi, India. NITRD is the first Central Government Institution in India to purchase
the SSi Mantra system, and the first Indian hospital with national status to conduct robotic
surgery using the indigenous SSi Mantra surgical robotic system. |
| ● | Also
in June 2023, the SSi Mantra was used to perform complex cardiac surgery and was successfully
utilized in internal mammary harvesting in two adult coronary artery bypass procedures in
India. Management believe that there is a significant opportunity for the SSi Mantra to address
the large unmet need for safe, timely, and affordable cardiac surgical care in India and
around the world. |
| ● | In
May 2023, thoracic surgeons conducted the first-ever lung surgeries using the SSi Mantra.
The surgeries, a lower left lobectomy and a pneumonectomy (complete removal of the lung),
pericardial window (removal of a portion of the pericardium), and a complex thymectomy (removal
of the thymus) were carried out successfully at the Narayana Hrudayalaya Health City in Bengaluru,
Karnataka, India. |
| ● | Also
in May 2023, the Company’s CEO and Chairman, Dr. Sudhir Srivastava, performed a world-first
robotic cardiac surgery using the SSi Mantra surgical robotic system at Continental Hospitals,
Hyderabad, Telangana, India. Additionally, Dr. Srivastava, a pioneer in robotic cardiac
surgery, performed two internal mammary takedowns which were utilized in bypass procedures
at the Narayana Hrudayalaya Institute of Cardiac Sciences which is well-known for performing
a high volume of cardiac surgeries. |
| ● | Also
in May 2023, surgeons at the Rajiv Gandhi Cancer Institute completed the center’s 100th
robotic surgery, a successful radical prostatectomy, using the SSi Mantra surgical robotic
system. |
| ● | In
April 2023, the SSi Mantra was utilized to successfully perform the first pediatric pyeloplasty
robotic surgery on a 5-year-old boy at Hindusthan Hospital, Coimbatore, Tamil Nadu, India. |
| ● | Also
in April 2023, surgeons performed the first head and neck surgery using the SSi Mantra at
Medanta the Medicity in Gurugram, Haryana. The Trans Oral Robotic Surgery (TORS) was performed
to remove a cancerous mouth lesion. |
| ● | In
April 2023, the Company completed the transaction with publicly held AVRA Medical Robotics
and began trading in the U.S. on the OTC Market under its new name, SS Innovations International,
Inc. and new trading symbol, “SSII.” |
| ● | In
March 2023, the SSi Mantra was utilized in a Thymectomy Surgery at Continental Hospitals,
Hyderabad. The robotic surgical procedure offered several advantages over traditional surgery
with minimal trauma and faster recovery. |
| ● | In
February 2023, the SSi Mantra surgical robotic system was awarded the prestigious Aegis Graham
Bell Award for being an Innovative Medical Device. |
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
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