Shalby & Monogram Technologies Partner to Advance Knee Replacement Surgery

The companies expect their relationship to extend beyond the initial trial, with additional studies on next-generation solutions to follow.

Shalby Limited, one of India’s leading multispecialty hospital chains, has announced a strategic partnership with Monogram Technologies, an AI-driven robotics company specializing in orthopedic surgery.

This collaboration aims to conduct a multicenter clinical trial in India to assess the safety and effectiveness of Monogram’s mBȏs TKA System, a precision robotic surgical system designed for knee replacement surgeries.

Monogram Technologies' mBȏs precision robotic surgical system is designed to autonomously execute optimized paths for the high-precision insertion of FDA-cleared mPress press-fit implants.

The system aims to facilitate well-balanced, better-fitting, and bone-sparing knee replacements.

Monogram's goal is to produce and market a range of robotic surgical equipment and related software, including orthopedic implants, tissue ablation tools, navigation consumables, and other necessary instruments for reconstructive joint replacement procedures.

The mBȏs system, combined with Monogram’s mVision navigation technology, utilizes AI and novel navigation methods to create personalized knee implants for patients.

This approach is expected to improve the precision and effectiveness of knee replacements while preserving bone integrity.

Monogram is also exploring additional clinical and commercial applications for its navigated precision robot and mVision navigation technology.

The Partnership Agenda

Under the agreement, Shalby will enroll patients at various sites across India to evaluate the safety and effectiveness of the mBȏs TKA System.

This will be in combination with the Consensus CKS implant, which is considered substantially equivalent to the Monogram mPress implants for regulatory purposes.

Reportedly, the trial will be conducted under the guidance of Dr Vikram Shah, Chairman of Shalby Limited, who has expressed confidence in the potential impact of this technology.

"As the largest orthopedic hospital group in the world, we have the opportunity to evaluate leading robots and advanced technologies on the market, including pipeline products. We have seen the mBȏs TKA System and next-gen pipeline firsthand and believe that what they are working on will significantly impact orthopedic medicine. We are excited to partner with Monogram and see considerable market potential in the United States and globally for their system," Chairman Shah noted.

Monogram Technologies received feedback on the Clinical Investigational Plan during its February 2024 Pre-Submission Communications with the US Food and Drug Administration (FDA). It has incorporated the feedback into the trial design, as claimed by the company.

The strategic Clinical Trial Agreement also includes a provision for the post-trial transfer of a robot to Shalby Limited under certain conditions, indicating the potential for further collaboration between the two companies.

Ben Sexson, CEO of Monogram Technologies, said, "With over 200,000 TKAs annually, India represents a significant market potential driven by a large population and demographic trends. India is underpenetrated for robotics but rapidly growing, and we believe the market potential is likely in the hundreds of systems. Shalby is a world-class organization, and we have been impressed by the caliber of their surgeons and standard of care."

Plans for Global Expansion

Monogram Technologies plans to use the clinical data from the US study for post-launch marketing and to support international clearance and commercialization.

Both Shalby Limited and Monogram Technologies recognize the need for a highly intuitive, safe, and accurate multi-application robotic platform.

The companies expect their relationship to extend beyond the initial trial, with additional studies on next-generation solutions like mVision to follow.

Dr Vikram Shah expressed Shalby Limited’s vision for growth, stating, "Shalby aims to become a top 5 player in orthopedics globally within the next decade. Many markets around the globe are underserved. We recognize the importance of advanced technologies to achieve this goal."