Monogram Technologies Receives Approval for Robotic Knee Replacement Trial in India

Monogram Technologies (NASDAQ: MGRM), an AI-driven robotics company transforming orthopedic surgery, has received approval from India's Central Drugs Standard Control Organization to import its mBôs TKA system and begin a 102-patient, multi-center clinical trial in partnership with Shalby Limited (NSE: SHALBY). The study will evaluate the safety and effectiveness of Monogram's robotic total knee replacement system using a Consensus CKS implant and include three-month clinical follow-up across multiple Indian sites. This regulatory clearance represents a crucial advancement in bringing AI-enhanced orthopedic solutions to international markets, potentially improving surgical outcomes for patients requiring knee replacements.

The clinical trial partnership with Shalby Limited, a prominent healthcare provider, demonstrates the growing global interest in robotic-assisted orthopedic procedures. Monogram will deploy full-time staff to support training and execution, with surgeries expected to begin within 90 business days. The mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants, aiming to achieve well-balanced, better-fitting bone-sparing knee replacements. This technology combines 3D printing, advanced machine vision, AI, and next-generation robotics to enable patient-optimized orthopedic implants at scale.

CEO Benjamin Sexson called the approval a major milestone toward commercial launch, highlighting the significance of expanding into the Indian healthcare market. Partners from Reliance Life Sciences and Shalby praised the trial's potential to elevate global orthopedic standards, recognizing the importance of international validation for medical technologies. The trial's success could pave the way for broader adoption of AI-driven surgical systems in emerging markets, addressing the growing demand for advanced orthopedic care worldwide. For more information about the company's technology, visit https://www.monogramtechnologies.com.

The approval comes as Monogram continues to pursue regulatory clearances for its robotic products, having already obtained FDA clearance for mPress implants. The company's approach represents the convergence of multiple advanced technologies in medical device innovation, potentially setting new benchmarks for precision in joint replacement procedures. The Indian clinical trial will provide valuable data on the system's performance in diverse patient populations, contributing to the global body of evidence supporting robotic-assisted orthopedic surgery. This development underscores the increasing role of AI and robotics in transforming surgical practices and improving patient outcomes in orthopedics.