Monogram Orthopaedics Inc. provided an update related to the regulatory and commercialization path for its mBos 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 first quarter 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 mBos??

TKA System verification test plan, including a proposed clinical trial protocol on an outside the U.S. (OUS) target population. The Company shared with the FDA various test protocols essential for establishing the safety and effectiveness of the Monogram mBosTM 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 million. 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. Updated Key Objectives:Given the favorable FDA feedback for using OUS clinical data, Monogram management anticipates establishing an ongoing OUS clinical strategy to support its innovation strategy.

Access to an extensive OUS surgeon and hospital network and an accommodative FDA posture towards OUS data could accelerate the development and commercialization of its technology pipeline, including mVision, its novel tracking solution that aims to eliminate point based registration and tracking with large fiducial based arrays. The Company recently announced that the Verification and Validation testing will be largely complete in second quarter of 2024 and anticipates a 510(k) submission to follow in the second half of 2024. The Company's plan to aggressively accelerate 510(k) submission for its mBôs surgical system with design modifications that management believes reduce the risk of a clinical trial request is on track.

The Verification and Validation testing is underway, and the Company has largely completed various mandated packaging, biocompatibility, sterilization, and cleaning validations. Except for ongoing IEC testing, most tests that rely on outside vendors are on track or largely complete. For IEC testing, the Company has largely completed various mandated radiated emissions and immunity testing.

The paperwork reviews are largely complete, and various electromechanical and safety tests are starting soon. The Company believes the system will perform favorably in outstanding IEC testing based on completed internal testing and various design considerations. One of the most demanding test protocols is the Human Factors Evaluation and Design Validation, which requires at least 15 surgeons to use the system in a simulated surgery.

The Company is using much of the data from these labs to test other aspects of the system, such as system accuracy. The Company has completed six simulated surgeries, with a significant remaining portion planned in May 2024. Monogram has engaged MCRA, a US-based Contract Research Organization (CRO), to support its regulatory strategy for submission.