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Monogram Orthopaedics Inc. is pleased to announce the completion of its first pre-submission meeting with the U.S. Food and Drug Administration

Monogram Orthopaedics Inc. is pleased to announce the completion of its first pre-submission meeting with the U.S. Food and Drug Administration (FDA) for its mBôs TKA System to assist surgeons in treating patients who require total knee replacement procedures. The pre-submission objectives included a system review with the FDA and obtaining feedback on our proposed regulatory pathway and nonclinical test plan. To assist the Company with this effort, the Company engaged MCRA, a leading Washington, DC-based provider of regulatory strategy and advice for orthopedic and musculoskeletal devices.

The FDA considered a number of questions related to the proposed indicated uses, nonclinical test plan, predicates, and clinical pathway. The next step will be for the Company to prepare a supplement that will provide the FDA with additional detail on the operation of certain functions of our system discussed with their panel. The Company anticipates it will submit this supplement in Q2 2023.

"This meeting was a significant regulatory milestone on our journey to bring the mBôs TKA System to market," said Benjamin Sexson, CEO of Monogram. "FDA provided a lot of valuable and thoughtful feedback on our system and clarifications that will be helpful as we progress. We appreciate the input from the panel and look forward to preparing additional documentation for review."

The Monogram robotic TKA system is a navigated cart-based robot arm designed to cut with a sagittal saw. The eventual hope in the future is to reduce surgical time and enable the next generation of 3D-printed press-fit orthopedic implants. With 20 patent filings and an aggressive development effort, the Company continues to push this mission.

"In the meeting, FDA officials provided supportive feedback related to some of the Company's underlying regulatory assumptions and strategies; for example, they concur that animal testing is likely unnecessary," said Kevin Posey, Director of Quality Assurance and Regulatory Affairs. "Monogram intends to utilize the FDA's guidance, and future expected guidance to move forward with our testing plan, 510(k) filing, and commercialization efforts."

The first-generation surgical robot will facilitate the placement of Monogram's FDA-approved mPress implant system, a press-fit total knee with improvements to FDA-approved implant designs the Company licensed in March 2020. The implants will feature an asymmetric tibia and anatomic patella options for robotic implantation or manual instrumentation.

This page may include ''forward-looking statements.'' To the extent that the information presented in this presentation discusses financial projections, information, or expectations about Monogram Orthopedics Inc.’s business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.'' Although Monogram Orthopedics Inc. believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading "Risk Factors" and elsewhere in the offering statement filed with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained, and Monogram Orthopedics Inc. does not undertake any duty to update any forward-looking statements except as may be required by law.

The offering will be made only by means of an offering circular. An offering statement on Form 1-A relating to these securities has been filed with the U.S. Securities and Exchange Commission and has become qualified. The securities offered by Monogram are highly speculative. Investing in shares of Monogram involves significant risks. The investment is suitable only for persons who can afford to lose their entire investment. Furthermore, investors must understand that such investment could be illiquid for an indefinite period of time. No public market currently exists for the securities, and if a public market develops following the offering, it may not continue.

Monogram intends to list its securities on a national exchange and doing so entails significant ongoing corporate obligations including but not limited to disclosure, filing and notification requirements, as well compliance with applicable continued quantitative and qualitative listing standards. For additional information on Monogram, the offering and any other related topics, please review the Form 1-A offering circular that can be found at the following location
EDGAR Entity Landing Page. Additional information concerning Risk Factors related to the offering, including those related to the business, government regulations, intellectual property and the offering in general, can be found in the risk factor section of the Form 1-A offering circular.

DealMaker Securities, LLC is being compensated a 4% commission from the lead Selling Agent engaged by Monogram Orthopaedics Inc. in regards to advertising of this investment. The Company has engaged Digital Offering, LLC (“Digital Offering”) to act as lead selling agent (which we sometimes refer to as the “Selling Agent”) to offer the shares of our common stock, par value $0.001 (the “Common Stock”) to prospective investors in this offering on a “best efforts” basis, which means that there is no guarantee that any minimum amount will be received by the Company in this offering. The Company will pay a cash commission of 7.00% to Digital Offering on sales of the shares of Common Stock. See “Plan of Distribution” in the Offering Circular for details of compensation payable to the Selling Agent in connection with the offering. DealMaker Securities, LLC is not affiliated with other companies mentioned herein.

*NASDAQ Ticker Reservation Tracking #ME9437IN. Our request to reserve the ticker symbol "MGRM" for Monogram Orthopaedics Inc has been approved and will be reserved until 20 September 2024.