Monogram Orthopaedics Inc. announced the Company executed a conditional purchase order to initiate a pilot program with a global distributor. Monogram will update its system software to facilitate robotic surgery with the distributor's implants for comprehensive evaluation. Notably, the Company anticipates testing may include robotic surgeries on live patients.

The distributor will conduct its evaluation outside of the United States. As Monogram continues to pursue a 510(k) clearance in the United States, the Company anticipates that this development could help bolster those efforts. The Company anticipates that following a successful evaluation, an Outside the United States (OUS) commercialization strategy could also help establish the commercial viability of the system and provide clinical data helpful for a US regulatory submission.

The Company is currently performing rigorous testing at its Austin facility and expects to ship the first system in the fourth quarter of 2023, provided developments proceed as expected. The conditional purchase order provides for the sale of the Company's surgical robot system to an international healthcare provider and shipment to be made by November 30, 2023. The provider reserves the right to reject or cancel the order.

The Company plans to continue executing its multi-generational product release strategy by first establishing a market presence, achieving regulatory clearance, and then introducing increasingly differentiated technologies. The Company is pushing to demo the next generation of its product pipeline later this year.