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Monogram Technologies Receives FDA Response for mBôs TKA System
Monogram Technologies (NASDAQ:MGRM) has received an Additional Information Request (AIR) from the FDA regarding its 510(k) premarket filing for the mBôs TKA System. The company has 180 days to respond or the application will be considered withdrawn. Monogram plans to conduct clinical trials to produce the required information.
CEO Ben Sexson stated that this response provides more clarity on the path to clearance and commercialization. The company recently closed a $13 million public offering and will continue executing its strategic objectives. Monogram will pursue a submission for its active modality with Outside the United States (OUS) clinical data while addressing the AIR for its semi-active system.
Upcoming milestones include obtaining regulatory clearance for clinical trials in India, conducting OUS live-patient surgery trials, and seeking clearance for the mBôs TKA System. The company also plans to explore domestic and international relationships, including exhibiting at Arab Health in January 2025.
CEO Ben Sexson stated that this response provides more clarity on the path to clearance and commercialization. The company recently closed a $13 million public offering and will continue executing its strategic objectives. Monogram will pursue a submission for its active modality with Outside the United States (OUS) clinical data while addressing the AIR for its semi-active system.
Upcoming milestones include obtaining regulatory clearance for clinical trials in India, conducting OUS live-patient surgery trials, and seeking clearance for the mBôs TKA System. The company also plans to explore domestic and international relationships, including exhibiting at Arab Health in January 2025.
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