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 multi-centre clinical trial.
Conducted in partnership with the orthopaedic hospital group, Shalby Limited, the clinical investigation will assess the system’s effectiveness and safety.
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It will involve 102 total knee replacement procedures with a three-month follow-up period.
The trial sites are spread across India, aiming to evaluate the Monogram TKA system alongside the Consensus Knee System (CKS) implant.
Monogram delivered a training version of the system earlier this year while an investigator meeting was held in Ahmedabad, India, from 31 January to 1 February.
The company is now focused on training hospital staff and surgeons for the upcoming trial, with full-time employees being deployed to support these efforts.
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By GlobalDataSubject enrolment for the trial is expected to begin soon, with the initial surgical procedures projected to occur within 90 business days.
Reliance Life Sciences, part of India’s Reliance Group, will manage the regulatory aspects of the clinical trial in the country.
Monogram Technologies CEO Benjamin Sexson said: “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.
“Initiating this trial is an important step in building clinical confidence and proving our value proposition. As we continue our ongoing efforts toward commercial launch, we remain focused on creating long-term value and will continue to thoughtfully evaluate opportunities that align with the best interests of our shareholders.”
An AI-driven robotics company, Monogram, is developing a product solution architecture that integrates 3D printing, AI, robotics, and machine vision to produce orthopaedic implants.
Its 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.
