Monogram Receives CDSCO Approval to Conduct TKA System Trial in India

Monogram Technologies has received approval from India's Central Drugs Standard Control Organization (CDSCO) to import the mBôs total knee arthroplasty (TKA) system for a clinical trial. The trial, conducted in partnership with Shalby Limited, will assess the system's effectiveness and safety in 102 total knee replacement procedures. Monogram is focused on training hospital staff and surgeons for the trial, with subject enrolment expected to begin soon. The company is developing a product solution architecture that integrates 3D printing, AI, robotics, and machine vision to produce orthopaedic implants.

Monogram Technologies Inc. (NASDAQ: MGRM) has received approval from India's Central Drugs Standard Control Organization (CDSCO) to import its mBôs total knee arthroplasty (TKA) system for a clinical trial. The trial, conducted in partnership with Shalby Limited, will assess the system's effectiveness and safety in 102 total knee replacement procedures. The study will involve a three-month clinical follow-up period and will be conducted across multiple sites in India.

Monogram Technologies, an AI-driven robotics company, has been focused on training hospital staff and surgeons for the upcoming trial. The company has already delivered a training version of the mBôs TKA system and held an investigator meeting in Ahmedabad, India, from January 31 to February 1. Subject enrolment for the trial is expected to begin shortly, with the initial surgical procedures projected to occur within 90 business days.

The clinical trial will evaluate the Monogram TKA system alongside the Consensus Knee System (CKS) implant, which is substantially equivalent to the Monogram mPress implants for regulatory purposes. Monogram Technologies CEO Benjamin Sexson stated, "The approval to begin clinical trial activities marks a major milestone for Monogram, further advancing our efforts to de-risk the value proposition of our technology."

Reliance Life Sciences, part of India's Reliance Group, will manage the regulatory aspects of the clinical trial in the country. Dr. Ajaykumar Yadav, Associate Vice President and Head of Clinical Research at Reliance Life Sciences, commented, "The approval to enable the clinical investigation in India is not only a major step for Monogram but also a meaningful milestone for the advancement of orthopedic innovation globally."

The trial is a critical milestone for Monogram Technologies, which is developing a product solution architecture that integrates 3D printing, AI, robotics, and machine vision to produce orthopaedic implants. The company's mBôs system claims to perform autonomous insertion of the company’s mPress press-fit implants. Monogram has already secured clearance from the US Food and Drug Administration (FDA) for its mPress implants and is pursuing 510(k) clearance for its robotic products.

References:
[1] https://finance.yahoo.com/news/monogram-gains-india-cdsco-approval-092352502.html
[2] https://www.stocktitan.net/news/MGRM/monogram-technologies-granted-regulatory-approval-to-import-m-bos-jodx2u2gk48i.html