Full Press Release Details
Monogram Technologies Provides 510(k) Submission
Update Following Positive Meeting with FDA
Management Anticipates That it has Sufficiently
Addressed the FDA's Concerns to Mitigate the Need for a Clinical Data Request.
Management Anticipates a Comprehensive AIR Response in Q1 2025
AUSTIN, TX - December 18, 2024 -
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 from its Submission Issue Request (SIR) meeting with
the U.S. Food and Drug Administration ("FDA") on December 17, 2024, regarding its 510(k) premarket filing submission for the
Company's mB s TKA System (the "Application").
The Application was submitted on July 19, 2024,
and passed the initial FDA Administrative Review. On September 30, 2024, Monogram received an Additional Information Request ("AIR")
from the FDA. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR. The FDA
informed the Company that the Company had 180 days from the date of the AIR to provide a complete response to the AIR, or the FDA would
consider the Application withdrawn.
On November 20, the Company submitted written
responses, including planned remediations where applicable for all deficiencies noted in the AIR, and requested a Submission Issue Request
(SIR) meeting with the FDA to review select responses. A critical focus for the Company has been whether the proposed nonclinical testing
effectively mitigates FDA concerns that could necessitate clinical data. On December 11, 2024, the Company received a Submission Issue
Request (SIR) review letter that provided preliminary written comments on particular topics of interest before the SIR meeting scheduled
for December 17, 2024. On December 17, 2024, the Company conducted a Submission Issue Request (SIR) meeting with the FDA.
Management believes its comprehensive plans to
address the Additional Information Request (AIR) could effectively satisfy the agency and anticipates that in light of its proposed testing,
it will be unlikely that the FDA will request clinical data as part of its submission. The Company is actively executing the additional
testing and anticipates that it will provide a comprehensive AIR response in the first quarter of 2025. Obtaining clearance would be a
significant milestone for its mission to advance the standard of care in orthopedic medicine. The Company is already working on the next-generation
version of the mB s TKA System.
"This meeting reaffirmed our strategic
decision to effectuate a multigenerational product strategy and submit the mB s TKA System for FDA clearance on an accelerated
timeline," said Ben Sexson, CEO of Monogram Technologies. "This meeting resolved outstanding questions and was a
significant step forward in our path toward commercialization of the mB s TKA System and execution of our long-term road map.
The feedback and guidance provided by the FDA during the Submission Issue Request meeting validate the robustness of our approach.
Importantly, the absence of a requirement for clinical data further underscores the confidence we have in the strength of our
submission. The Agency's comments
provided valuable clarity and affirmed that the proposed testing plans are well aligned with their expectations. We are optimistic
that the additional data we are generating will comprehensively address the outstanding items and further reinforce our
submission. We remain committed to achieving FDA clearance as
quickly as possible, driven by our mission to advance the standard of care in orthopedic medicine."
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. For example, the Company's statement regarding the Company's proposed use of net proceeds
is a forward-looking statement. 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.
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