Monogram Provides Regulatory Update Following Meeting with FDA

510(k) Submission with FDA Accelerated for Early Second Half of 2024

AUSTIN, TX / ACCESSWIRE / May 1, 2024 / Monogram Orthopaedics 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 related to the regulatory and commercialization path for its mBôs surgical system following its meeting with the U.S. Food and Drug Administration (the "FDA").

On April 19, 2024, Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission request. Subsequently, Monogram conducted a teleconference meeting with the FDA on April 24, 2024, to discuss the written feedback further and obtain feedback on the Monogram mBôs 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 preparing a successful 510(k) submission to obtain clearance.

The Company shared with the FDA various test protocols essential for establishing the safety and effectiveness of the Monogram mBôs TKA System and a synopsis of its proposed OUS clinical investigation plan.

Based on the feedback, management assesses that: 1) the proposed testing plan generally appears acceptable to address the technical differences identified with the proposed predicate device, and 2) for the active (also autonomous) embodiment of its product, a clinical testing plan that includes approximately 100 knee surgeries conducted on an OUS population at three sites with three months of follow-up should generally be sufficient for evaluating the safety and effectiveness of the Monogram mBôs TKA System. Notably, on March 21st, the Company announced that it had modified the Monogram mBôs TKA System to reduce the likelihood of an FDA clinical data request with its submission.

In their written response the FDA indicated they support a least burdensome approach to acquiring clinical data. Management anticipates running an OUS clinical trial could save the Company significant cost and time. Currently, management estimates the cost to run an OUS clinical trial as proposed to be approximately $1.5M. The Company plans to run a clinical trial to support post-launch marketing irrespective of whether it will be needed for obtaining regulatory clearance with the FDA.