The company’s Motus device received breakthrough designation from the FDA in 2020, and it was assigned a CPT code in January, according to a March 15 news release emailed to Becker’s. Motus is used in the BalancedBack total joint replacement procedure.
A phase 2 clinical study of Motus aims to enroll 150 patients across 16 clinical sites in 11 states. The company expects to earn investigational device exemption approval later this year, the release said.
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