- Monogram Technologies (MGRM, Financial) has obtained regulatory approval from India's CDSCO for its mB™s TKA System clinical trial.
- The trial, in partnership with Shalby Hospitals, will involve 102 knee replacements across multiple centers in India.
- First surgeries are expected within 90 business days, with full-time staff deployed to support the initiative.
Monogram Technologies Inc. (MGRM) has received crucial regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) for the import and clinical trial of its innovative mB™s TKA System. This marks a significant milestone for the U.S.-based AI-driven robotics company, specializing in revolutionary orthopedic surgery solutions.
The clinical investigation will be conducted in collaboration with Shalby Limited, one of the world's largest orthopedic hospital groups. The trial aims to evaluate the safety and effectiveness of Monogram's robotic knee replacement system, deploying it through 102 total knee replacement procedures with a follow-up period of three months. The study will take place across multiple centers in India, leveraging Shalby's extensive healthcare framework.
In preparation, Monogram has already delivered a training version of the system, and the company plans to deploy full-time employees in India to ensure seamless training and execution support for the trial. Patient enrollment is anticipated to commence shortly, with the first surgeries expected within 90 business days from the announcement on April 29, 2025.
The strategic collaboration is bolstered by Reliance Life Sciences, part of one of India's largest private sector companies, which will manage the regulatory submissions. This partnership represents a step forward in advancing orthopedic innovation worldwide and aligns with Monogram's goal of commercializing personalized knee implants that offer better-fitting, bone-sparing solutions.
