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By Gerelyn Terzo, Benzinga
The robotic orthopedics industry just took a step forward. Monogram Technologies (NASDAQ: MGRM), which is behind a futuristic surgical robot, has announced a strategic partnership with Shalby Limited (NSE: SHALBY), one of India’s leading orthopedic hospital groups. The venture adds to Monogram’s momentum as its latest technological breakthroughs proceed through the proper regulatory channels.
As part of the collaboration, the companies will embark on a multicenter clinical trial campaign in which they demonstrate the safety and effectiveness of Monogram’s flagship mBȏs TKA System for robotic orthopedic surgery and implants. Monogram’s technology solution comprises over 750 precision parts, nearly two-dozen patent applications and 1.5 million-plus lines of code. Its robotics tech is deemed more advanced than that of legacy companies, and it is one of only a couple of autonomous players.
Led by founder Vikram I. Shah, a world-renowned joint replacement surgeon, Shalby says it is the biggest orthopedic hospital chain on the planet. The company sits atop the rankings for arthroplasty based on volume, commanding 15% of India’s organized arthroplasty market share. With over a dozen hospitals sprinkled across 13 cities, Shalby seems uniquely positioned to capitalize on this market’s CAGR of about 20% amid India’s booming population of 1.4 billion people, the most populous nation in the world as of 2023, according to Pew Research.
Monogram Technologies CEO Ben Sexson said of the collaboration, “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. India is underpenetrated for robotics but is rapidly growing, and we believe the market potential is likely in the hundreds of systems.”
Following the clinical trial, the partners will examine the post-trial transfer of Monogram’s robot to Shalby’s hospital system amid the potential for future collaborations. The trial will provide Monogram with access to Shalby’s network of seasoned knee replacement surgeons who are under the tutelage of Dr. Shah.
Orthopedic Landscape
Following a slowdown on the heels of the pandemic, orthopedic surgical volumes have been on the rise once again. In 2023, the global orthopedic surgery market expanded by 6.3% to $59 billion, outpacing its historical average.
Research shows nearly 6 million lives are lost globally each year due to traumatic injuries, half of which could be preventable. However, legacy orthopedic surgery is in many ways inefficient and lacking in precision, with 88% of surgeries performed manually and most implants taking the form of one-size-fits-all, described as “one-size-fits-none” by some. While there are surgical robots in the industry, they are considered price-prohibitive and are quickly becoming obsolete.
Monogram’s vision involves the use of one surgical robot to perform safe and quick orthopedic surgeries. When combined with best-fit implants, there is an expectation for better patient outcomes so desperately needed around the world.
Through the partnership, Shalby will begin enrolling patients throughout India for surgeons to assess the success of Monogram’s mBȏs TKA System with the hospital group’s Consensus Knee System (CKS) implant, which is at a similar regulatory stage to Monogram’s mPress implants.
On July 19th Monogram submitted it’s 510(k) application for mBôs TKA System Clearance. The application passed the Administrative Review and is under Substantive Review. According to MDUFA Performance Goals and Procedures, Fiscal Years 2023 through 2027, U.S. Food and Drug Administration, "For 510(k) submissions received in FY 2024, the average Total Time to Decision goal for FDA and industry is 124 calendar days.“ The company is pushing to conduct its first live inpatient OUS surgeries with Shalby pending regulatory approvals.
Alignment Of Interests
Shalby has seen continued growth, including a 20% 15-year CAGR in volume, with a footprint that covers eight countries and aggressive multi-continent international expansion plans. The company made its debut in the U.S. market several years ago when it acquired Sacramento, California-based Consensus Orthopedics. Shalby has set its sights on further expanding its footprint globally within the coming decade. “We believe many markets around the globe are completely underserved. We recognize the importance of advanced technologies to realize this ambitious goal,” stated Dr. Shah.
Monogram’s Sexson shared how his company and Shalby are aligned in areas such as the caliber of surgeons and standard of care, while they are inspired by Shalby’s ambitious growth plans, including in the United States. Monogram intends to validate the value proposition of its mBȏs TKA System with real-world data, enabled by its recent regulatory submission coupled with a green light from its FDA Administrative Review, which Sexson describes as a “catalyst for strategic synergies” among the new partners.
Investors who are interested in becoming a part of Monogram’s groundbreaking surgical robot technology as the company gears up to expand its reach globally can learn more about investment opportunities here.
Read More About the Latest Developments At Monogram Orthopedics:
Monogram Orthopedics (NASDAQ: MGRM) Aims To Overcome Robot Shortcomings With Its Advanced Solution
AI In Orthopedic Surgery: How Leveraging AI Could Improve Surgical Outcomes
Featured photo by GrumpyBeere on Pixabay.
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