Monogram Technologies Advances mBôs TKA System Toward FDA Clearance
Key Insights
Monogram Technologies (search) anticipates addressing FDA concerns regarding its mBôs TKA System (search) without requiring clinical data, potentially accelerating the path to market.
The company plans to submit a comprehensive response to the FDA's Additional Information Request (AIR) in the first quarter of 2025.
Monogram is pursuing regulatory clearance for clinical trials in India with Shalby Hospitals (search), expanding its global market presence.
Monogram Technologies (search) Inc. (NASDAQ:MGRM) has made significant progress in its pursuit of FDA clearance for its mBôs TKA System (search), a robotic surgical system designed for total knee arthroplasty (TKA). Following a Submission Issue Request (SIR) meeting with the FDA on December 17, 2024, the company believes it can address the agency's concerns without the need for clinical data. This could potentially expedite the regulatory process and reduce associated costs.
The mBôs TKA System (search) leverages AI-driven robotics to optimize the precision and accuracy of knee implant placement. The system is designed to autonomously execute optimized paths for high-precision insertion of Monogram's FDA-cleared mPress (search) press-fit implants, with the goal of achieving well-balanced, better-fitting, bone-sparing knee replacements.
Addressing FDA Concerns
In July 2024, Monogram submitted its 510(k) premarket filing for the mBôs TKA System (search). On September 30, 2024, the FDA issued an Additional Information Request (AIR), placing the application on hold. Monogram responded with written remediations and requested the SIR meeting to address the FDA's concerns, particularly regarding the need for clinical data.
"This meeting reaffirmed our strategic decision to effectuate a multigenerational product strategy and submit the mBôs TKA System (search) for FDA clearance on an accelerated timeline," said Ben Sexson, CEO of Monogram Technologies (search). "The feedback and guidance provided by the FDA during the Submission Issue Request meeting validate the robustness of our approach."
Upcoming Milestones
Monogram anticipates providing a comprehensive response to the FDA's AIR in Q1 2025. The company is also seeking regulatory clearance to conduct clinical trials in India with Shalby Hospitals (search). A robot is expected to be shipped to India by January 2025 to initiate clinical trial training. Monogram will also be exhibiting at Arab Health in January 2025 to expand international relationships.
The mBôs TKA System
The mBôs system is designed to combine 3D printing, advanced machine vision, AI, and next-generation robotics to enable patient-optimized orthopedic implants at scale. The company believes its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants.
Monogram has already obtained FDA clearance for its mPress (search) implants and is now focused on securing clearance for its robotic products. The company believes that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.