Shalby Limited partners with Monogram Technologies for AI-driven robotic knee replacement trial

New Delhi: Shalby Limited has entered into a strategic clinical trial agreement with Monogram Technologies Inc. The partnership aims to conduct a multicenter clinical trial across India to evaluate the safety and effectiveness of Monogram’s mBôs TKA System, a precision robotic surgical solution designed for knee replacement surgeries.

Under the new agreement, Shalby Limited will enroll patients across various sites in India to test the mBôs TKA System with the Consensus CKS implant, a counterpart to Monogram’s mPress implants. This trial is crucial for providing real-world data that will support the international launch and commercialization of the mBôs TKA System. 

Monogram incorporated feedback from the U.S. Food and Drug Administration (FDA) after receiving comments on its Clinical Investigational Plan during pre-submission communications in February 2024. In a notable aspect of the agreement, the clinical trial also includes a post-trial provision that could see the transfer of a robotic system to Shalby under specific conditions, setting the stage for potential ongoing collaboration between the two companies.

Dr. Vikram Shah, Chairman of Shalby Limited, commented “We have seen the mBȏs TKA System and next gen pipeline firsthand and can say definitively that what they are working on will change the face of orthopedic medicine forever. We are excited to partner with Monogram and believe the market potential in the United States and globally for their system is very significant and could scale very quickly. We look forward to working with the Monogram team and broadening our relationship over the months to come.”

Monogram Technologies focuses on advancing orthopedic surgery through AI, machine vision, and robotics. Their mBôs TKA System is engineered to autonomously perform high-precision knee replacements using AI-guided navigation. The system works with FDA-cleared mPress press-fit implants, ensuring well-balanced, better-fitting, and bone-sparing knee replacements. 

Monogram’s broader product lineup includes robotic surgical equipment, software, orthopedic implants, tissue ablation tools, navigation consumables, and other essential instrumentation for joint replacement procedures. The company is also exploring additional clinical and commercial applications for the mBôs System and its advanced mVision navigation.

Ben Sexson, CEO of Monogram Technologies, highlighted, “With over 200,000 TKAs annually India represents a massive market potential driven by a large population and demographic tailwinds. India is underpenetrated for robotics but rapidly growing, and we believe the market potential is likely in the hundreds of systems.”

“Shalby is a world-class organization and we have been nothing but impressed by the calibre of their surgeons and standard of care. We resonate with Shalby’s ambitions growth plans globally including in the United States and look forward to validating the value proposition of the mBȏs TKA System with real world data. Our recent 510(k) submission is a catalyst for strategic synergies,” he added.

Monogram plans to use the clinical data generated from this trial to support the system’s commercialization and international regulatory clearance. Both companies anticipate that this partnership will lead to further studies on next-generation solutions like Monogram’s mVision navigation, potentially expanding the scope of the collaboration in the future.

“Shalby aspires to become a top 5 player in orthopedics globally within the next decade,” said Dr. Vikram Shah of Shalby. “Many markets around the globe are completely underserved. We recognize the importance of advanced technologies to realize this ambitious goal.”