Monogram Technologies (MGRM) Provides Regulatory Update on mBôs TKA System

Company has Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)

Investigator Meeting and Clinical Trial Training Held at the Shalby Hospital in Ahmedabad, India

Monogram Technologies Inc. (NASDAQ: MGRM) today provided an update regarding its 510(k) premarket filing submission to the U.S. Food and Drug Administration ("FDA") for the Company's mBôs TKA System. The Company has completed all supplemental testing and submitted its formal response to the U.S. Food and Drug Administration (FDA) regarding the Additional Information Request (AIR) 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 mBôs™ Total Knee Arthroplasty (TKA) 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 Limited (NSE:SHALBY) ("Shalby"), a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups, to conduct a multicenter clinical trial to evaluate the safety and effectiveness of the mBôs TKA System. In January 2025, the Company shipped a robot to support clinical trial training. The robot was successfully 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, a subsidiary of Reliance Industries, 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, a Reliance Group company-one of India's largest private sector companies-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. While regulatory timelines can be variable, the Company remains confident in its submission and the strength of its strategic partnerships with Reliance Life Sciences and Shalby to support the process.

"The Investigator Meeting was a successful milestone in the preparation for Monogram's clinical trial," said Dr. Ajaykumar Yadav, Associate Vice President and Group Head of Clinical Research at Reliance Life Sciences. "Bringing together key stakeholders, the meeting provided an opportunity for in-depth discussions on study protocols and a demonstration of the mBôs technology, reinforcing the collaborative approach to this clinical trial. Monogram has submitted a strong and comprehensive application, and we continue to support the regulatory process as expected. Reliance Life Sciences remains committed to advancing innovation in healthcare and looks forward to contributing to the successful execution of this study."

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