Monogram Technologies Gains Regulatory Approval for Robotic Knee Surgery Trial in India

Monogram Technologies has secured regulatory approval from India's Central Drugs Standard Control Organization to initiate a comprehensive clinical trial for its robotic total knee replacement system. The multi-center study will involve 102 patients and evaluate the safety and effectiveness of the company's mBôs TKA system using a Consensus CKS implant.

The trial represents a critical milestone for Monogram's expansion into the global orthopedic surgery market. By partnering with Shalby Limited, the company aims to demonstrate the precision and potential benefits of its AI-driven robotic surgical technology. The study will include a three-month clinical follow-up across multiple Indian medical sites.

CEO Benjamin Sexson characterized the regulatory approval as a significant advancement toward commercial launch. The company will deploy full-time staff to support training and execution, with surgical procedures expected to commence within 90 business days.

This clinical trial could have broader implications for orthopedic surgical techniques, potentially offering more personalized and precise knee replacement procedures. The mBôs system integrates advanced technologies including AI, machine vision, and robotics to potentially improve surgical outcomes and patient recovery.

The study underscores Monogram's commitment to transforming orthopedic surgery through technological innovation, with the potential to set new standards in surgical precision and patient care.