EXCLUSIVE: FDA Approves Monogram Technologies' mBôs TKA System For Knee Surgery

On Monday, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Monogram Technologies Inc.’s MGRM Monogram mBôs TKA System.

Ben Sexson, Monogram’s Chief Executive Officer, commented, “We are particularly excited about the system’s performance and its potential to advance robotics in orthopedic medicine. We believe we will have strong product-market fit and are well-positioned to make a meaningful impact.”

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Monogram Tech may Market the Monogram mBôs TKA System subject to the Federal Food, Drug, and Cosmetic Act requirements.

The Monogram mBôs TKA System is designed to deliver robotic-assisted total knee arthroplasty.

Monogram believes in the benefits of personalized robotic surgery, enabled by patient-specific imaging (CT-based) and accurate predictive navigation tools. The company sees an opportunity to be part of the ongoing adoption of robotic-assisted procedures.

The company is focused on initial placements with key surgeon KOLs in strategic geographies to establish clinical experience and demonstrate the system’s advantages in real-world surgical settings.

Upcoming Milestones include:

• Upgrade cleared system cutting system and other improvements to enhance competitiveness.
• Continues to refine and enhance its next-generation technology in parallel with regulatory and clinical trial preparations to improve future competitiveness and expand to new applications.
• The company is working to obtain regulatory clearance to initiate clinical trials in India in collaboration with its strategic partner, Shalby Limited, a hospital chain.
• The company is working to advance the submission of additional clinical applications to expand the robotic system’s capabilities and establish it as a versatile, multi-application platform.

Cash and cash equivalents totaled $15.7 million as of December 31, 2024. The company continues to direct its resources, focusing on commercializing the mBôs TKA System as capital efficiently as possible.

Price Action: MGRM stock closed at $2.33 on Friday.

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