Monogram Orthopedics Partners with India's Shalby Limited for Robotic Surgery Clinical Trials

Monogram Orthopedics (NASDAQ: MGRM) has taken a significant step forward in advancing its robotic orthopedic surgery technology through a newly announced strategic partnership with Shalby Limited (NSE: SHALBY), one of India's leading orthopedic hospital groups. The collaboration will focus on conducting multicenter clinical trials to demonstrate the safety and effectiveness of Monogram's flagship mBȏs TKA System for robotic orthopedic surgery and implants.

This partnership comes at a crucial time for the orthopedic surgery market, which expanded by 6.3% to $59 billion in 2023. With nearly 6 million lives lost globally each year due to traumatic injuries, half of which could be preventable, there is a pressing need for more efficient and precise orthopedic surgical solutions.

Monogram's mBȏs TKA System represents a significant advancement in robotic orthopedic technology. The system comprises over 750 precision parts, nearly two-dozen patent applications, and more than 1.5 million lines of code. It is considered more advanced than legacy systems and is one of only a few autonomous players in the field.

Shalby Limited, led by renowned joint replacement surgeon Vikram I. Shah, commands 15% of India's organized arthroplasty market share. With over a dozen hospitals across 13 cities, Shalby is well-positioned to capitalize on India's growing orthopedic market, which has a compound annual growth rate of approximately 20%.

The clinical trial will provide Monogram with access to Shalby's network of experienced knee replacement surgeons. Following the trial, the partners will explore the potential transfer of Monogram's robot to Shalby's hospital system and consider future collaborations.

Monogram Technologies CEO Ben Sexson highlighted the significance of the Indian market, stating, "With over 200,000 total knee arthroplasties (TKAs) annually, we believe India represents a massive market potential driven by a large population and demographic tailwinds." He also noted that while India is currently underpenetrated for robotics, the market is rapidly growing with potential for hundreds of systems.

The partnership aims to address the limitations of legacy orthopedic surgery, which is often inefficient and lacking in precision. Currently, 88% of surgeries are performed manually, and most implants are one-size-fits-all. Monogram's vision involves using a single surgical robot to perform safe and quick orthopedic surgeries, combined with best-fit implants for improved patient outcomes.

As part of the collaboration, Shalby will begin enrolling patients throughout India for surgeons to assess the success of Monogram's mBȏs TKA System with Shalby's Consensus Knee System (CKS) implant. This trial is a crucial step in validating the value proposition of Monogram's technology with real-world data.

The timing of this partnership is particularly significant, as Monogram recently submitted its 510(k) application for mBȏs TKA System Clearance on July 19th. The application has passed the Administrative Review and is currently under Substantive Review. According to FDA performance goals, the average Total Time to Decision for 510(k) submissions received in FY 2024 is 124 calendar days.

This collaboration between Monogram Orthopedics and Shalby Limited represents a significant step forward in the advancement of robotic orthopedic surgery. As the global population continues to grow and age, the demand for more efficient and precise orthopedic surgical solutions is likely to increase. The success of this partnership could potentially lead to improved patient outcomes and a transformation in the field of orthopedic surgery worldwide.