Monogram Technologies Submits 510(k) Application for mB s TKA System Clearance Application was Submitted on

Monogram Technologies Submits 510(k) Application

for mB s TKA System Clearance

Application was Submitted on July 19, 2024,

Passed the FDA Administrative Review, and is Now Under Substantive Review

FDA Decision is Expected Within 90 Days of

Initial Submission; However, the Process May be Paused if Additional Information is Requested

AUSTIN, TX - August 8, 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 announced that it has submitted a 510(k) premarket filing to the U.S.

Food and Drug Administration (FDA) for the Company's mB s TKA System. The application was submitted on July 19, 2024, and

passed the FDA Administrative Review. An FDA decision is expected within 90 days of the initial submission; however, the process may be

paused if additional information is requested.

"The 28,214-page submission is the culmination

of over eight years and thousands of hours, comprising verification and validation from numerous, extremely rigorous tests including

simulated cadaveric surgeries by fifteen surgeons," said Ben Sexson, CEO of Monogram Technologies. "This FDA submission for

the mB s TKA System represents a significant milestone for Monogram in our journey to improve human health with our precision robotic

surgical system and should be an essential catalyst for institutional engagement.

"I would like to thank our entire team for

their incredible hard work and dedication, including Kamran Shamaei and engineering leadership, Muhammad Afnan, Pedro Alfonso, Gerardo

Gonzalez, Daniel Grunden, Ani Nayak, and Nisha Patel. I would also like to thank our founder and Chief Medical Officer, Dr. Doug Unis,

for starting this vision many years ago. The work undertaken by such a small group is a true testament to our incredible teamwork. No

task was too small, and the team worked extremely hard to get this done in a timely manner, driven by our mission to advance the standard

of care for orthopedic patients," concluded Sexson.

Dave McGurl, Vice President of Regulatory Affairs at MCRA, said, "We believe that this is a very strong application. The team did

a thorough job, with strong support for their arguments and thorough testing based on FDA feedback. The quality of the documentation is

high, and I'm confident it will be evident to the FDA how much work went into developing this system."

The submission follows recent FDA written

feedback regarding Monogram's pre-submission request and a teleconference meeting to discuss further the Monogram

mB s TKA System verification test plan, including a proposed clinical trial protocol on an outside the U.S. (OUS)

target population. Management believes the feedback was comprehensive and will be advantageous for a successful 510(k) submission to

obtain clearance, commercialization, and marketing for the mB s TKA System.

Kamran Shamaei, Chief Technology Officer at Monogram,

added, "We are more committed than ever to see this vision materialize. The team is already pushing the next-gen technology and other

clinical applications. We believe our system will fit a unique market opportunity we intend to exploit. Robots on the market today have

limitations, including the inability to scale to other applications. We believe AI-driven computer vision and high-efficiency surgeon-assisted

robotics with an uncompromised focus on safety and accuracy will become the de facto choice in the future."

"I do approximately 1,000 knees per year,

and all robotically," said Dr. Fabio Orozco. "The Monogram mB s prioritizes patient safety and accuracy with uncompromised

efficiency and ease of use. I demand only the best for my patients and feel the mB s is a significant step forward for the orthopedic

market. After having done robotic surgery for ten years, I genuinely believe that Monogram's will be the most advanced technology

and will have the biggest impact on orthopedic surgery once it is released. After clearance, I plan to support Monogram's commercial

launch. Dr. Orozco is the president of Orozco Orthopaedics in South Jersey and is the Director of orthopedic surgery and robotics

at AtlantiCare Regional Medical Center. Dr. Orozco did his residency and fellowship at Thomas Jefferson University Hospital, where he

serves as an associate professor.

"I have done thousands of Total Knee

Replacements and used many of the most advanced technologies on the market," said Dr. Robert Jamieson. "I have helped

support Monogram's development of the mB s and also participated in the Verification and Validation testing for the FDA.

In my opinion, Monogram's mB s is like the most recent iPhone, and the competition is still the first generation iPhone.

What excites me the most about Monogram and the mB s is its potential for the future. A high-efficiency robot with high

autonomy has the potential to be transformative for the orthopedic market. Monogram's leadership is dedicated to advancing the

state of the art in orthopedic medicine. Management is highly dedicated to patient safety in all aspects of their product design,

and it shows. After clearance, I plan to support Monogram's commercial launch. Dr. Robert Jamieson recently left private

practice in Northern California and is now joining Intermountain Health in St. George, UT. Dr. Jamieson completed his

fellowship at the Joint Replacement Institute in Los Angeles.

"My team performs approximately 300

total knee replacement surgeries annually, and 95% are completed using robotic arm-assisted surgery," said Dr. Joey Romero.

"I am dedicated to technological advancement in arthroplasty surgery with a special focus on using robotic-assisted surgery to

improve patient care. I want only the best for my patients and firmly believe the accuracy, precision, and patient-specific

customization of robotic-assisted surgery is paramount in improving reproducible, successful surgical outcomes. I supported Monogram

Technologies during its development and participated in the formal verification and validation testing for the mB s TKA System

FDA submission. The Monogram team has impressed me from the start. They have listened to my feedback, their management is highly

engaged, and it's obvious they have placed the highest importance on patient safety. Post commercialization, I plan to support

Monogram's commercial launch." Dr. Joey Romero practiced at St. David's Center for Hip and Knee Replacement Medical

Center in Austin, TX. He completed his arthroplasty fellowship residency at the Hospital for Special Surgery in New York

"Our 510(k) submission marks another major milestone on the road to building the next generation of

orthopedic robotics," said Dr. Doug Unis, founder and Chief Medical Officer. "Thanks to the tireless work of our

incredible team, the day I can use the mB s in my operating room continues to grow closer."

Monogram's Chief Financial Officer Noel Knape

said, "We anticipate this submission will open up funding opportunities, and we are seeing continued traction with institutional

players as we execute our milestones."

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 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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