Monogram Technologies (NASDAQ:MGRM) CEO Benjamin Sexson joined Steve Darling from Proactive to announce a strategic collaboration with Shalby Limited, a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups. This partnership will focus on conducting a multicenter clinical trial aimed at demonstrating the safety and effectiveness of Monogram's mBȏs TKA System for joint replacement. Sexson explained that under this collaboration, Shalby will enroll patients across various sites in India, where surgeons will evaluate the mBȏs TKA System in conjunction with the Consensus CKS implant.
The Consensus CKS implant is considered substantially equivalent to Monogram's mPress implants for regulatory purposes. Monogram has been actively engaged with the FDA, receiving feedback on their Clinical Investigational Plan during February 2024 Presubmission Communications. The company has incorporated this feedback into its 510(k) application, which has successfully passed the FDA Administrative Review. An interesting aspect of this collaboration is the potential post-trial transfer of a robot to the Shalby hospital system under specific conditions, as both companies explore further opportunities for collaboration.