Udaipur : Shalby Limited, a leading multispecialtyhospital in India, announced a strategic partnership with Monogram Technologies Inc.,(NASDAQ: MGRM) an AI-driven robotics company specializing in orthopedic surgery. Thiscollaboration will focus on conducting a multicenter clinical trial in India to demonstrate the safetyand effectiveness of Monogram’s mBȏs TKA System, a precision robotic surgical system designedforknee replacements.
“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 pipelineproducts” said Dr. Vikram Shah, Chairman of Shalby Limited. “We have seen the mBȏs TKA Systemand next gen pipeline firsthand and can say definitively that what they are workingon will change theface of orthopedic medicine forever. We are excited to partner with Monogram and believe the marketpotential in the United States and globally for their system is very significant and could scale veryquickly. We look forward to working with the Monogram teamand broadening our relationship overthe months to come.”
Monograms mBôs precision robotic surgical system is designed to autonomously execute optimizedpaths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goalis wellbalanced better-fitting bone sparing knee replacements. The Company initially intends to produce andmarket robotic surgical equipment and related software, orthopedic implants, tissue ablation tools,navigation consumables, and other miscellaneous instrumentation necessary for reconstructive jointreplacement procedures. Other clinical and commercial applications for themBôs with mVisionnavigation are also being explored.
The Company believes that its mBôs precision robotic surgical assistants, which combine AI andnovelnavigation methods (mVision), will enable more personalized knee implants for patients,resulting inwell balanced better-fitting knee replacements with bone sparing implants. Monogramanticipates thatthere may be other clinical and commercial applications for its navigated mBôsprecision robot andmVision navigation.
Under the agreement, Shalby will enroll up to patients at various sites in India for surgeons toevaluatethe safety and effectiveness of the mBȏs TKA System with the Consensus CKS implant,which issubstantially equivalent to the Monogram mPress implants for regulatory purposes.Monogramreceived comments on the Clinical Investigational Plan during its February 2024PresubmissionCommunications with the FDA and has incorporated feedback. Notably, the strategicClinical TrialAgreement contemplates the post-trial transfer of a robot to the hospital system undercertainconditions 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.
“With over 200,000 TKAs annually India represents a massive market potential driven by a largepopulation and demographic tailwinds. India is underpenetrated for robotics but rapidly growing,andwe believe the market potential is likely in the hundreds of systems,” said Ben Sexson, CEOofMonogram Technologies Inc. “Shalby is a world class organization and we have been nothingbutimpressed by the caliber of their surgeons and standard of care. We resonate with Shalby’sambitionsgrowth plans globally including in the United States and look forward to validating thevalueproposition of the mBȏs TKA System with real world data. Our recent 510(k) submission isa catalystfor 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. Werecognizethe 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 tosupport international clearance and commercialization. Both Companies see a significant clinicalneedfor a highly intuitive, safe, and accurate multi-application robotic platform. The Companiesexpect therelationship to extend, with additional studies on next-generation solutions like mVision to follow.
