Monogram Technologies Updates Regulatory Filing on mBôs TKA System and Clinical Trial Progress in India

AUSTIN, TX, February 25, 2025 – Monogram Technologies Inc. (NASDAQ: MGRM) announced a regulatory update on its mBôs Total Knee Arthroplasty (TKA) System in a recent SEC Form 8-K filing. The disclosed information, including a detailed press release attached as Exhibit 99.1, outlines key developments regarding the company’s 510(k) premarket filing with the U.S. Food and Drug Administration (FDA) and preparations for a multicenter clinical trial in India.

According to the filing, Monogram has completed all supplemental testing and has submitted its formal response to the FDA’s Additional Information Request received on September 30, 2024. The company does not currently anticipate further information requests and expects that, subject to a favorable review, the next FDA communication will be a clearance decision. Approval would pave the way for commercialization of the mBôs TKA System in the United States.

In addition to its regulatory progress in the United States, Monogram detailed the advancement of its clinical trial preparations in India. In August 2024, the company announced a strategic collaboration with Shalby Limited, one of India’s leading orthopedic hospital chains, to conduct a multicenter trial evaluating the safety and effectiveness of the mBôs TKA platform. The clinical trial training, supported by a robot shipment in January 2025, was bolstered by an Investigator Meeting held at a Shalby Hospital in Ahmedabad. Organized by Reliance Life Sciences, a subsidiary of Reliance Industries managing the regulatory submission for the trial, the meeting brought together principal investigators, surgeons, and clinical staff to review study protocols and operational procedures.

The press release highlighted significant advancements in the mBôs system, notably a cutting system upgrade that has boosted feed rates by approximately 300%. Dr. Douglas Unis, Chief Medical Officer at Monogram, commented on the technology’s performance, noting that the new system delivers competitive cutting speeds with enhanced precision while maintaining the benefits inherent to a fully autonomous operation. Ben Sexson, Chief Executive Officer, emphasized the company’s commitment to developing a robotic platform that addresses surgeons’ priorities of safety and efficiency, with the team aiming to bring a disruptive technology to clinical practice.

Monogram Technologies, an AI-driven robotics company focused on advancing orthopedic surgery, continues to refine its next-generation platform. The company remains confident in its regulatory submissions both in the United States and India as it works toward commercializing its innovative robotic surgical system.

Forward-looking statements in the filing reflect management’s current expectations and are subject to risks and uncertainties, including regulatory and operational risks detailed in the company’s filings with the SEC.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Monogram Orthopaedics’s 8K filing here.

Monogram Orthopaedics Company Profile

Monogram Orthopaedics, Inc focuses on developing a product solution architecture to enable patient-optimized orthopaedic implants. The company intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation for use in reconstructive joint replacement procedures.