SMAIO announced that it has received FDA 510(k) clearance for the customized surgery planning software co-developed with NuVasive. Obtaining FDA 510(k) approval for this customized version of the surgery planning software represents a key milestone in the partnership and licensing agreement signed in First Quarter 2022 between SMAIO and NuVasive. This customized surgery planning software is based on SMAIO's previously released vertebral realignment planning technology, "Balance Analyzer 3D".

The achievement of this first milestone, in line with the roadmap presented by SMAIO at the time of its IPO in April 2022, triggers a $3 million payment by NuVasive to SMAIO. As part of the previously announced partnership, an additional milestone payment will be triggered after further integration of the Balance Analyzer 3D into the NuVasive platform, as well as additional technical capabilities.