Monogram Technologies: FDA Meeting Boosts Confidence in 510(k) Submission

Monogram Technologies Inc. (NASDAQ:MGRM), an AI-driven robotics company focused on improving human health, recently provided an update on its 510(k) premarket filing submission for the mBôs TKA System. The company's Submission Issue Request (SIR) meeting with the U.S. Food and Drug Administration (FDA) on December 17, 2024, yielded positive results, boosting management's confidence in addressing the Additional Information Request (AIR) and potentially avoiding a clinical data request.

The mBôs TKA System, a precision robotic surgical system designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants, is Monogram's initial focus. The company submitted its 510(k) application on July 19, 2024, and passed the initial FDA Administrative Review. However, on September 30, 2024, Monogram received an AIR from the FDA, placing the application on hold pending a complete response.

In response to the AIR, Monogram submitted written responses and requested a SIR meeting with the FDA. The critical focus for the company was to demonstrate that its proposed nonclinical testing effectively mitigates FDA concerns, potentially avoiding the need for clinical data. The SIR meeting provided valuable feedback and guidance, validating the robustness of Monogram's approach and affirming that the proposed testing plans are well aligned with the FDA's expectations.



Monogram anticipates providing a comprehensive AIR response in Q1 2025, focusing on nonclinical testing to demonstrate the safety and effectiveness of its mBôs TKA System. This strategy aims to validate the proposed testing plans and align with the FDA's expectations, further reinforcing the submission. Obtaining clearance would be a significant milestone for Monogram's mission to advance the standard of care in orthopedic medicine.

The company's multigenerational product strategy is a key component of its long-term roadmap and commercialization plans. By submitting the mBôs TKA System for FDA clearance on an accelerated timeline, Monogram aims to commercialize its initial product while simultaneously working on the next-generation version. This approach allows the company to maintain a competitive edge in the orthopedic market by continually innovating and improving its technology.



Monogram's anticipated response to the FDA AIR in Q1 2025 is significant for the company's mission and market position. This response addresses the FDA's concerns, potentially mitigating the need for clinical data, and validates the robustness of Monogram's approach. Obtaining clearance would enable the company to commercialize its mBôs TKA System and advance the standard of care in orthopedic medicine, strengthening its market position as it seeks to obtain regulatory clearance for clinical trials in India and expand international relationships.

In conclusion, Monogram Technologies' positive SIR meeting with the FDA has boosted management's confidence in addressing the AIR and potentially avoiding a clinical data request. The company's multigenerational product strategy and commitment to obtaining FDA clearance as quickly as possible demonstrate its dedication to advancing the standard of care in orthopedic medicine. As Monogram continues to innovate and expand its international presence, investors should keep a close eye on this promising AI-driven robotics company.