Monogram Technologies Receives Regulatory Approval to Conduct Clinical Trials in India for mBôs TKA System.

Monogram Technologies has received regulatory approval from India's Central Drugs Standard Control Organization to conduct a 102-patient clinical trial for its mBôs TKA system. The trial will be conducted in collaboration with Shalby Limited and aims to evaluate the safety and effectiveness of the Monogram TKA System. Patient enrollment is expected to start shortly, with the first surgeries within 90 business days. The trial is a critical milestone for Monogram's efforts to de-risk its technology and build clinical confidence.

Monogram Technologies, an AI-driven robotics company, has received regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to conduct a 102-patient clinical trial for its mBôs TKA system. The trial, set to begin shortly, will evaluate the safety and effectiveness of the Monogram TKA System in collaboration with Shalby Limited, one of the world's largest orthopedic hospital groups.

The trial will involve 102 total knee replacement procedures across multiple centers in India, with a three-month clinical follow-up period. The first surgeries are anticipated within 90 business days. The study aims to generate crucial safety and effectiveness data for Monogram's AI-driven robotic orthopedic surgery system.

The clinical trial will utilize the Consensus CKS implant, which is substantially equivalent to Monogram's mPress implants for regulatory purposes. This approach could streamline the regulatory pathway by leveraging established implant equivalence.

The partnership with Shalby Limited provides Monogram with both medical expertise and potential access to key opinion leaders in orthopedic surgery. Dr. Vikram I. Shah, Founder and Chairman of Shalby Hospitals, has endorsed the technology, stating that it is the most advanced robotic technology available in the field today.

This regulatory approval represents a significant advancement in Monogram's clinical development pathway. The trial will allow the company to demonstrate the system's performance in real surgical settings, including technically demanding cases, further de-risking the technology and building clinical confidence.

For investors tracking Monogram's progress, this regulatory clearance provides a concrete milestone that enables progression to the clinical validation phase. While representing important advancement, this remains one step in the longer path toward potential commercialization, with execution of the trial and subsequent data analysis representing the next critical phases.

References:
[1] https://www.stocktitan.net/news/MGRM/monogram-technologies-granted-regulatory-approval-to-import-m-bos-jodx2u2gk48i.html