Monogram Technologies Secures Initial Strategic Clinical Trial Collaboration

Clinical Trial Collaboration Follows 510(k) Submission and Passing of FDA Administrative Review; Preludes Planned International Launch for the mBȏs TKA System

Strategic Partner Shalby is Recognized as one of the Leading Institutions for Orthopedic Surgeries Worldwide, Performing Over 14,000 Annual Knee Replacement Surgeries Globally

AUSTIN, TX / ACCESSWIRE / August 12, 2024 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today announced its strategic collaboration with Shalby Limited (NSE:SHALBY) ("Shalby"), a global muti-specialty hospital chain and one of India's leading orthopedic hospital groups, to conduct a multicenter clinical trial to demonstrate the safety and effectiveness of the mBȏs TKA System.Shalby is the largest (ranked #1 in arthroplasty by volume) 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 (with a compound annual growth rate of approximately 20% and a population of 1.4 billion people). 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.

"Shalby Advanced Technologies, Inc., aspires to become a top 10 player in orthopedics globally within the next decade," said Dr. Vikram Shah, Chairman of Shalby. "We believe many markets around the globe are completely underserved. We recognize the importance of advanced technologies to realize this ambitious goal."

Under the collaboration, Shalby will enroll 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 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.