Monogram submits formal response to FDA Additional Information Request

Monogram Technologies provided an update regarding its 510(k) premarket filing submission to the U.S. Food and Drug Administration for the Company’s mBos TKA System. The Company has completed all supplemental testing and submitted its formal response to the U.S. Food and Drug Administration regarding the Additional Information Request received on September 30, 2024. The Company does not currently anticipate further requests for information from the agency. Assuming a favorable decision by the FDA following receipt of the AIR, the next communication from them is anticipated to be a clearance decision for the mBos Total Knee Arthroplasty System. If granted, that would enable commercialization and sales of the TKA system in the United States. In August 2024, Monogram announced a strategic collaboration with Shalby to conduct a multicenter clinical trial to evaluate the safety and effectiveness of the mBos TKA System. In January 2025, the Company shipped a robot to support clinical trial training. The robot was shipped as planned, and an Investigator Meeting was conducted at a Shalby Hospital in Ahmedabad, India, from January 31 to February 1, 2025. The meeting was organized by Reliance Life Sciences and attended by principal investigators, multiple surgeons, and staff. The purpose of the meeting was to review study protocols, regulatory requirements, and operational procedures. Reliance Life Sciences is responsible for managing the regulatory submission and communications for the clinical trial in India. As the regulatory sponsor, Reliance Life Sciences is overseeing the submission process and engagement with India’s regulatory authorities. Monogram has submitted its system for regulatory clearance to run the clinical trial and will provide updates as they occur.