Monogram Orthopaedics announces collaboration with Shalby Limited

Monogram Technologies announced its strategic collaboration with Shalby Limited to conduct a multicenter clinical trial to demonstrate the safety and effectiveness of the mBs TKA System.Shalby is the largest orthopedic hospital chain in the world employing over 4,000 people at 14 hospitals in 13 cities and more than 3 million patients treated. Shalby represents approximately 15% of the organized arthroplasty market in India, which has an approximate market size of 200,000 TKAs per year. Shalby, which has been growing at a 20% fifteen-year CAGR, currently operates in 8 countries with aggressive multi-continent international expansion plans. In May 2021, Shalby purchased California-based Consensus Orthopedics and established a US presence. Under the collaboration, Shalby will enroll patients at various sites in India for surgeons to evaluate the safety and effectiveness of the mBs 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 Presubmission Communications with the FDA and has incorporated feedback into its 510(k) application submitted to the FDA on July 19, 2024 and which passed the FDA Administrative Review. Notably, the strategic collaboration 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 trial, Monogram will be provided access to a network of highly experienced knee replacement surgeons under the guidance of Dr. Vikram Shah.