SMAIO has announced that it has received FDA 510(k) clearance for the customized surgery planning software co-developed with NuVasive1.
Obtaining FDA 510(k) clearance for this customized version of the surgery planning software represents a key milestone in the partnership and licensing agreement signed in Q1 2022 between SMAIO and NuVasive, a global leader in spine technology innovation. This customized surgery planning software is based on SMAIO’s previously released vertebral realignment planning technology, “Balance Analyzer 3D”.
Philippe ROUSSOULY, CEO of SMAIO, stated: “This 510(k) clearance represents a major step towards the commercialization of our joint planning platform and innovative services to NuVasive customers. We believe that with our technology, surgeons will soon benefit from our cutting-edge solution for planning and performing spine surgery, considering individual morphological specificities and ultimately, for improving patient outcomes”.
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.
1 On February 9, 2023, Globus Medical, a U.S.-based company that manufactures and markets a full range of spinal devices and implants, signed an agreement to acquire NuVasive in an all-stock transaction valued at approximately $3.1 billion. As of the date of the publication of the annual financial report and the information available to SMAIO, NuVasive owns 15.55% of the Company’s share capital.