Shalby Limited announces strategic clinical trial agreement with Monogram Technologies. Monogram Technologies is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery.
Ahmedabad, Gujarat, India, September 2, 2024: Shalby Limited, a leading multispecialty hospital in India, announced a strategic partnership with Monogram Technologies Inc., (NASDAQ: MGRM) an AI-driven robotics company specializing in orthopedic surgery. This collaboration will focus on conducting a multicenter clinical trial in India to demonstrate the safety and effectiveness of Monogram’s mBȏs TKA System, a precision robotic surgical system designed for knee replacements.
Monograms 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 well balanced better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.
The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.
Under the agreement, Shalby will enroll up to patients at various sites in India for surgeons to evaluate the safety and effectiveness of the mBȏs TKA System with the Consensus CKS implant, which is substantially equivalent to the Monogram mPress implants for regulatory purposes. Monogram received comments on the Clinical Investigational Plan during its February 2024 Pre submission Communications with the FDA and has incorporated feedback. Notably, the strategic Clinical Trial Agreement contemplates the post-trial transfer of a robot to the hospital system under certain conditions following the trial as the companies contemplate 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 largest orthopedic hospital group in the world we have the privilege with our esteemed surgeons of evaluating the leading robots and advanced technologies on the market including pipeline products” said Dr. Vikram Shah, Chairman of Shalby Limited. “We have seen the mBȏs TKA System and next gen pipeline firsthand and can say definitively that what they are working on will change the face of orthopedic medicine forever. We are excited to partner with Monogram and believe the market potential in the United States and globally for their system is very significant and could scale very quickly. We look forward to working with the Monogram team and broadening our relationship over the months to come.”
“With over 200,000 TKAs annually India represents a massive market potential driven by a large population and demographic tailwinds. India is underpenetrated for robotics but rapidly growing, and we believe the market potential is likely in the hundreds of systems,” said Ben Sexson, CEO of Monogram Technologies Inc. “Shalby is a world class organization and we have been nothing but impressed by the caliber of their surgeons and standard of care. We resonate with Shalby’s ambitions growth plans globally including in the United States and look forward to validating the value proposition of the mBȏs TKA System with real world data. Our recent 510(k) submission is a catalyst for strategic synergies.”
“Shalby aspires to become a top 5 player in orthopedics globally within the next decade,” said Dr. Vikram Shah of Shalby. “Many markets around the globe are completely underserved. We recognize the importance of advanced technologies to realize this ambitious goal.”
Monogram plans to leverage the clinical data from the US study for post-launch marketing and to support international clearance and commercialization. Both Companies see a significant clinical need for a highly intuitive, safe, and accurate multi-application robotic platform. The Companies expect the relationship to extend, with additional studies on next-generation solutions like mVision to follow.
