Monogram Technologies Receives Regulatory Approval for mBôs TKA System in India, Patient Enrollment to Begin Shortly

Monogram Technologies has obtained regulatory approval from India's CDSCO to import its mBôs TKA system for a 102-patient clinical investigation. The trial will evaluate the safety and effectiveness of the Monogram TKA System in collaboration with Shalby Hospitals. Patient enrollment is expected to begin shortly, with the first surgeries within 90 business days.

Monogram Technologies Inc. (NASDAQ: MGRM) has achieved a significant milestone by obtaining regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to import its mBôs Total Knee Arthroplasty (TKA) system for a clinical investigation. The approval marks a critical step in the company's efforts to evaluate the safety and effectiveness of the Monogram TKA System in a real-world surgical setting.

The clinical trial, conducted in collaboration with Shalby Hospitals, will involve 102 patients across multiple sites in India. The study will assess the safety and effectiveness of the Monogram TKA System, which combines AI-driven robotics with advanced navigation methods. The trial is expected to commence patient enrollment shortly, with the first live patient surgeries anticipated within 90 business days [1].

Monogram Technologies, an AI-driven robotics company focused on improving human health, particularly in orthopedic surgery, has been working closely with Shalby Limited, one of the world's largest orthopedic hospital groups. The partnership aims to evaluate the Monogram TKA System's performance, using the Consensus CKS implant, which is substantially equivalent to Monogram's FDA-cleared mPress implants for regulatory purposes [1].

The approval from CDSCO is a significant advancement for Monogram Technologies, demonstrating the company's commitment to innovation and its potential to bring cutting-edge surgical technology to patients in India and beyond. The clinical trial is part of the company's broader strategy to commercialize its robotic surgical systems and orthopedic implants [1].

Monogram Technologies' Chief Executive Officer, Benjamin Sexson, expressed pride in the achievement, stating, "This trial will allow us to demonstrate performance in real surgical settings, including technically demanding cases. Initiating this trial is an important step in building clinical confidence and proving our value proposition" [1].

The collaboration with Shalby Hospitals, which has a strong reputation for clinical innovation, underscores the potential of the Monogram TKA System to redefine standards of care in orthopedic medicine. Dr. Ajaykumar Yadav, Associate Vice President and Head of Clinical Research at Reliance Life Sciences, emphasized the significance of the approval, highlighting the transformative potential of MedTech solutions in the Indian healthcare market [1].

Monogram Technologies' mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is to provide well-balanced, better-fitting bone-sparing knee replacements. The company is also exploring other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation system [1].

As the trial progresses, investors and financial professionals should closely monitor Monogram Technologies' developments, as the successful completion of this clinical investigation could pave the way for broader market acceptance and commercialization of the company's innovative orthopedic solutions.

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