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Provides Regulatory Update on mB s TKA System and Clinical Trial Preparation in India

Key Takeaway: Monogram Technologies Provides Regulatory Update on mB s TKA System and Clinical Trial Preparation in India Company has Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR) Meeting and Clinical Trial Traini

Full Press Release Details

Monogram Technologies
Provides Regulatory Update on mB s TKA System and Clinical Trial Preparation in India
Company has Completed
all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)
Meeting and Clinical Trial Training Held at the Shalby Hospital in Ahmedabad, India
February 25, 2025 - Monogram Technologies Inc. (NASDAQ: MGRM) ("Monogram" or the "Company"), an AI-driven
robotics company focused on improving human health with an initial focus on orthopedic surgery, today provided an update regarding its
510(k) premarket filing submission to the U.S. Food and Drug Administration ("FDA") for the Company's mB s TKA System. The
Company has completed all supplemental testing and submitted its formal response to the U.S. Food and Drug Administration (FDA) regarding
the Additional Information Request (AIR) received on September 30, 2024. The Company does not currently anticipate further requests
for information from the agency. Assuming a favorable decision by the FDA following receipt of the AIR, the next communication from them
is anticipated to be a clearance decision for the mB s Total Knee Arthroplasty (TKA) System. If granted, that would enable
commercialization and sales of the TKA system in the United States.
In August 2024, Monogram announced a strategic
collaboration with Shalby Limited (NSE: SHALBY) ("Shalby"), a global multi-specialty hospital chain and one of India's leading
orthopedic hospital groups, to conduct a multicenter clinical trial to evaluate the safety and effectiveness of the mB s TKA System.
In January 2025, the Company shipped a robot to support clinical trial training. The robot was successfully shipped as planned, and
an Investigator Meeting was conducted at a Shalby Hospital in Ahmedabad, India, from January 31 to February 1, 2025. The
meeting was organized by Reliance Life Sciences, a subsidiary of Reliance Industries, and attended by principal investigators, multiple
surgeons, and staff. The purpose of the meeting was to review study protocols, regulatory requirements, and operational procedures.
Reliance Life Sciences, a Reliance Group company-one
of India's largest private sector companies-is responsible for managing the regulatory submission and communications for the
clinical trial in India. As the regulatory sponsor, Reliance Life Sciences is overseeing the submission process and engagement with India's
regulatory authorities. Monogram has submitted its system for regulatory clearance to run the clinical trial and will provide updates
as they occur. While regulatory timelines can be variable, the Company remains confident in its submission and the strength of its strategic
partnerships with Reliance Life Sciences and Shalby to support the process.
"The Investigator Meeting was a successful
milestone in the preparation for Monogram's clinical trial," said Dr. Ajaykumar Yadav, Associate Vice President and
Group Head of Clinical Research at Reliance Life Sciences. "Bringing together key stakeholders, the meeting provided an opportunity
for in-depth discussions on study protocols and a demonstration of the mB s technology, reinforcing the collaborative approach
to this clinical trial. Monogram has submitted a strong and comprehensive application, and we continue to support the regulatory process
as expected. Reliance Life Sciences remains committed to advancing innovation in healthcare and looks forward to contributing to the
successful execution of this study."
Monogram team in Ahmedabad, India,
with various stakeholders for clinical trial Investigator Meeting from Jan 31 to Feb 1, 2025.
Monogram continues to refine and enhance its
next-gen technology in parallel with its regulatory and clinical trial preparations. The most significant advancement has been to the
cutting system, which has facilitated an approximately 300% increase in feed rate. A video demonstrating these next-gen improvements
Dr. Douglas Unis, Monogram's Chief Medical Officer, commented,
"The latest advancements in Monogram's robotic system are a game changer. The new cutting system enables cutting speeds that
are becoming competitive with manual surgery while maintaining the accuracy and functionality expected from robotic-assisted procedures.
The performance is truly remarkable for a completely hands-free, unconstrained autonomous system. With these improvements, we are on track
to deliver one of the most impressive robotic solutions on the market today."
The Company remains focused on developing a multi-application robotic system that is time-competitive with manual surgery without compromising
accuracy or safety. Monogram continues to refine its technology to improve system performance and usability as it progresses toward commercialization.
The Company believes its approach to active robotic cutting offers a unique value proposition and remains committed to innovation in orthopedic
"We have completed all proposed testing
with what we view to be favorable results and we remain focused on developing a robotic platform that surgeons will want to use,"
said Ben Sexson, CEO. "Our research shows that safety and uncompromised speed are the top priorities for surgeons. We have always
believed that an autonomous system could be optimized to be competitive with manual surgical times. I feel confident we are starting to
get there. Like our shareholders, we are eager to bring this vision to the operating room.
We have built a system that we believe has
the potential to disrupt the market. Our thesis is that fast, accurate, unconstrained autonomous cutting, eventually in many clinical
applications, will help drive continued adoption of robotics. Our technology has undergone rigorous and extensive testing, and we have
made every effort to try and ensure our system meets the highest standards.
What we have accomplished-with fewer
than 30 full-time employees-is a testament to the dedication and expertise of our team. I could not be prouder of what our small
and highly dedicated team has achieved."
About Monogram Technologies Inc.
Monogram Technologies (NASDAQ: MGRM) is an AI-driven
robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution
architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation
Monograms mB s precision robotic surgical
system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants.
The goal is well balanced, better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic
surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous
instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mB s
with mVision navigation are also being explored.
Monogram has obtained FDA clearance for mPress
implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can
market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.
The Company believes that its mB s precision
robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for
patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may
be other clinical and commercial applications for its navigated mB s precision robot and mVision navigation.
To learn more, visit www.monogramtechnologies.com.
Forward-Looking Statements
This press release may contain "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical
facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results
and involve a number of risks and uncertainties.. Forward-looking statements, other than statements of historical fact, are highly likely
to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control,
and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of
future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result
of a number of factors, including those described in the prospectus and the Company's other filings with the SEC. The Company undertakes
no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.
Executive Vice President
Direct: 949-491-8235
Last updated: Feb 25, 2025