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Shalby Limited: Shalby Limited, India's leading multispecialty hospital, has entered into a strategic partnership with Monogram Technologies Inc., NASDAQ: MGRM, an AI-powered robotics company specializing in orthopedic surgery. The collaboration will focus on conducting a multicenter clinical trial in India to demonstrate the safety and efficacy of Monogram's MBS TKA System, a robotic surgical system designed for knee replacement.
The Monogram Môs Precision Robotic Surgical System is designed to autonomously navigate a customized path through the precise insertion of FDA-cleared mPress press-fit implants. It is intended for balanced-fitting bone sparing replacements. The company intends to initially manufacture and market robotic surgical instruments and associated software, orthopedic implants, tissue resection tools, navigation consumables and many other devices needed for joint replacement procedures. Other clinical and commercial applications for mVision navigation with the Môs are also being explored.
The company believes that their mBôs robotic surgical assistant, which combines AI and innovative navigation methods (mVision), will enable more appropriate knee-replacements for patients, resulting in knee-replacements with balanced fitting through bone grafts. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.
Under the agreement, Shelby will enroll patients at various locations in India for surgeons to evaluate the safety and efficacy of the MBS TKA system with the Consensus CKS implant, which is equivalent to the Monogram MPress implant for regulatory purposes. Monogram received comments on the clinical investigation plan during a pre-submission communication with the FDA in February 2024, and the feedback has been incorporated. Notably, the strategic clinical trial agreement contemplates transferring the robot to the hospital system under certain conditions following the trial, as the companies consider further collaboration.
Through this clinical agreement, Monogram will be provided access to a network of highly experienced knee replacement surgeons under the guidance of Dr. Vikram Shah.
“As the world’s largest orthopedic hospital group, we have had the privilege of working with our esteemed surgeons to evaluate market-leading robots and advanced technologies, including pipeline products,” said Dr. Vikram Shah, Chairman, Shalby Ltd. “We can see that what they are working on will revolutionize orthopedics.”
We are excited to partner with Monogram and believe the market potential for their systems in the United States and globally is very significant, and can be evaluated very quickly. We look forward to working with the Monogram team and expanding our relationship in the coming months.
Ben Saxon, CEO of Monogram Technologies Inc., said that with 200,000 TKAs annually, India represents a large population and enormous market potential. India is underdeveloped for robotics but is growing rapidly and we believe the market potential is in the hundreds of systems. Shelby is a world-class institution and we are impressed with the caliber of their surgeons and the standard of care. We agree with Shelby's ambitious growth plans globally, including the United States, and look forward to validating the value proposition of the MBS TKA system with real-world data. Our recent 510(k) submission is a catalyst for strategic synergies.
Dr. Vikram Shah of Shelby said, “Shelby aspires to be among the top 5 in orthopedics globally over the next decade. While many markets around the world are underserved, we recognize the importance of advanced technologies to realize this ambitious goal.”
Monogram plans to leverage clinical data from the U.S. study for marketing after launch and to support international approval and commercialization. Both companies see a significant medical need for a highly intuitive, safe, and accurate multi-application robotic platform. The companies hope to grow the relationship with additional studies on next-generation solutions such as MVision.
