Monogram advances in FDA process for robotic surgery system

AUSTIN, TX - Monogram Technologies Inc. (NASDAQ:MGRM), a company specializing in AI-driven robotics for orthopedic surgery with a market capitalization of $74.8 million, has recently completed additional testing and submitted a formal response to the U.S. Food and Drug Administration (FDA) regarding a request for more information about its mBôs Total (EPA:TTEF) Knee Arthroplasty (TKA) System. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 7.31, indicating robust short-term financial stability despite recent market challenges. The response, addressing the Additional Information Request (AIR) received on September 30, 2024, potentially moves the company closer to FDA clearance for commercial sale in the United States.

Earlier, Monogram announced a partnership with Shalby Limited (NSE:SHALBY), an Indian orthopedic hospital group, to conduct a multicenter clinical trial for the mBôs TKA System. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates a rapid cash burn rate that investors should monitor. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with InvestingPro. This January, a robot was dispatched to Shalby Hospital in Ahmedabad, India, to facilitate clinical trial training, followed by an Investigator Meeting held from January 31 to February 1, 2025. The meeting, managed by Reliance Life Sciences, gathered principal investigators and surgeons to discuss study protocols and demonstrate the mBôs technology.

Dr. Ajaykumar Yadav of Reliance Life Sciences highlighted the Investigator Meeting as a significant step in preparing for the upcoming clinical trial, emphasizing the strong application submitted by Monogram and the continuous support provided by Reliance Life Sciences in the regulatory process.

Monogram is also enhancing its robotic technology, notably improving the cutting system to achieve a 300% increase in feed rate, which positions its performance closer to manual surgery while maintaining robotic precision. Dr. Douglas Unis, Monogram’s Chief Medical (TASE:BLWV) Officer, described the advancements as transformative for the autonomous system, aiming to deliver a competitive robotic solution in the market.

Ben Sexson, CEO of Monogram, expressed confidence in the system’s potential to revolutionize the market, emphasizing the importance of speed and accuracy for surgeons. The company, despite its small team, has pursued rigorous testing and development to meet high standards of safety and performance.

Monogram, which has previously obtained FDA clearance for its mPress implants, is seeking 510(k) clearance for its robotic products. The company is committed to developing a multi-application robotic system that competes with manual surgery times without compromising on precision or safety. With the stock trading 56% below its 52-week high of $4.90, and analysts setting price targets between $4 and $6, investors seeking detailed valuation analysis can access comprehensive insights through InvestingPro’s advanced metrics and Fair Value calculations.

The information in this article is based on a press release statement from Monogram Technologies Inc.

In other recent news, Monogram Technologies Inc. announced the results of its Annual Meeting of Stockholders, where all agenda items were approved. This included the election of directors Rick Van Kirk and Colleen Gray, and the appointment of Fruci & Associates II, PLLC as the independent registered public accounting firm for 2024. The stockholders also approved an amendment to the company’s 2019 Stock Option and Grant Plan, as well as executive compensation. Meanwhile, Roth/MKM has given Monogram Technologies a new Buy rating, citing the potential of the company’s mBōs robotics platform in knee surgeries. The platform is expected to compete with Stryker (NYSE:SYK)’s MAKO system, which currently dominates the robotic total knee arthroplasty market. Monogram Technologies has submitted for 510k approval and plans to launch its product in the United States and India by late 2025 or early 2026. The analyst from Roth/MKM highlighted the opportunity for Monogram Technologies to capture market share in a field projected to see increased robotic adoption. These developments indicate significant strategic and operational activities within the company.

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