Monogram Provides Regulatory Update Following Meeting with FDA - Seite 2

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 Q2 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.

"Our team has been actively executing extensive, highly rigorous internal and external testing while diligently incorporating feedback from the FDA," said Ben Sexson, Chief Executive Officer of Monogram. "We continue to expect verification and validation to be largely complete in H1 2024, with a planned FDA 510(k) submission in H2 2024. We believe an OUS clinical data strategy could become valuable for ongoing research, development, and commercialization efforts."