Full Press Release Details
Monogram Technologies
Announces FDA 510(k) Clearance for the Monogram mB s TKA System
Monogram May Market the Monogram mB s TKA System, Subject to the Requirements of the Federal Food, Drug, and Cosmetic
Preparing for Commercialization and Evaluating Strategies to Support the Adoption of its Robotic-Assisted Technology
March 17, 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 announced that the U.S. Food and
Drug Administration (FDA) has granted 510(k) clearance for its Monogram mB s TKA System. This determination means that Monogram
may market the device, subject to the general controls provisions of the Act.
Ben Sexson, Monogram Chief Executive Officer,
commented, "This FDA 510(k) clearance is a defining moment for Monogram. It marks the culmination of years of relentless effort,
innovation, and teamwork. Bringing a new technology to market in the medical field is an immense challenge, and this milestone is a testament
to the dedication and resilience of our entire team. We have navigated obstacles, refined our technology, and remained steadfast in our
mission to advance orthopedic robotics. Today, we take a significant step forward.
"Securing clearance for the Monogram mB s
TKA System was a rigorous process due to the complexity and sophistication of the technology. We are particularly excited about the system's
performance and its potential to advance robotics in orthopedic medicine. We believe we will have strong product-market fit and are well-positioned
to make a meaningful impact.
"I want to personally thank Kamran Shamaei
and Dr. Douglas Unis for their vision, dedication, and contributions to this achievement. Their expertise and commitment have been invaluable
in bringing this technology to life. Advancing a system like this from concept to clearance requires perseverance and collaboration, and
I'm incredibly proud of what we've accomplished together. We appreciate the FDA's engagement throughout this process.
"We anticipate this clearance will open
new opportunities for Monogram. As we move toward commercialization, we will continue refining our strategy and engaging in discussions
to support broader adoption. The journey has been long, but this is just the beginning."
The Monogram mB s TKA System is designed to deliver uncompromised safety, efficiency, and accuracy in robotic-assisted total knee
arthroplasty. Engineered with scalability in mind, the system is architected to eventually support multiple orthopedic applications beyond
knee replacement, positioning it as a platform for future expansion. Despite the increasing role of robotics in joint reconstruction,
the market remains underpenetrated and highly consolidated, leaving significant room for innovation and growth.
Monogram believes in the benefits of personalized
robotic surgery, enabled by patient-specific imaging (CT-based) and accurate predictive navigation tools. We see an opportunity to be
part of the ongoing adoption of robotic-assisted procedures.
"I've used nearly every robotic
system on the market, and I truly believe the Monogram mB s has the potential to be the best. It's slick. The precision, efficiency,
versatility, and safety considerations set it apart from anything I've seen. I'm incredibly impressed and confident that surgeons
will recognize the impact of this system," said Dr. Douglas Unis, Founder and Chief Medical Officer of Monogram.
"Navigating a regulatory submission of
this complexity is no small feat, and I'm extremely impressed by our management team's strategic approach and execution. Bringing
a system of this sophistication through clearance requires immense effort and careful planning. Monogram has achieved this with such a
small, highly focused, and motivated team. The dedication and commitment to the mission that our leadership has fostered is inspiring.
Now that we're cleared, I'm confident that when surgeons experience the mB s TKA System firsthand-especially given
the responses I've seen in multiple live demos-they will want to use it."
Now that the Monogram mB s TKA System has received FDA clearance, it opens significant opportunities for the Company both domestically
and internationally. Over the coming months, Monogram will integrate recent upgrades to the cutting system and other system enhancements
into the cleared mB s TKA System to further strengthen its competitiveness. The Company is focused on initial placements with key
surgeon KOLs in strategic geographies to establish clinical experience and demonstrate the system's advantages in real-world surgical
Monogram remains committed to a disciplined, long-term
commercialization strategy and will take a measured and strategic approach to market adoption. While the orthopedic robotics market operates
on a long sales cycle, this milestone significantly de-risks the platform and validates the Company's technology, positioning Monogram
for new strategic opportunities as it executes its growth strategy.
"At Monogram, we've built a small but incredibly dedicated and highly technical team. It has been an incredible experience
working alongside such talented and motivated individuals. We run lean, but I believe our commitment is second to none. Every day, we
push ourselves to develop what we hope will be the safest, fastest, and most accurate robotic system on the market," commented Kamran
Shamaei, Chief Technology Officer of Monogram.
"This work is deeply personal to us. We
imagine this system being used on our loved ones, and that drives us to hold ourselves to the highest standards of performance and excellence.
We work hard together because we believe in what we're building and the impact it can have on patient care.
"This achievement is dedicated to my
beloved sister, Ladan."
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 510(k) clearance for
its mB s TKA System and FDA clearance for its mPress implants. The Company is required to obtain FDA clearance before it can market
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 Company's 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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