AUSTIN, TX - Monogram Technologies Inc. (NASDAQ:MGRM), an AI-driven robotics company, has announced the submission of a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for its mBôs TKA System, aimed at enhancing orthopedic surgeries.
The application, which was submitted on July 19, 2024, has passed the administrative review phase and is now under substantive review, with an FDA decision anticipated within 90 days, barring any requests for additional information.
The filing, consisting of 28,214 pages, is the result of over eight years of development, including extensive testing and simulated surgeries by fifteen surgeons. Ben Sexson, CEO of Monogram Technologies, highlighted the milestone as a potential catalyst for institutional engagement.
The FDA submission follows feedback from the agency and a teleconference regarding the mBôs TKA System verification test plan and a proposed clinical trial protocol. Monogram's management believes this feedback will contribute to a successful submission.
Several surgeons who have been involved in the system's testing have expressed high expectations for the mBôs TKA System's impact on orthopedic surgery, emphasizing its potential for accuracy, efficiency, and safety. Dr. Fabio Orozco and Dr. Robert Jamieson, both experienced in robotic surgery, plan to support Monogram's commercial launch post-clearance.
Monogram's CFO, Noel Knape, anticipates that the submission will facilitate funding opportunities and interest from institutional investors as the company progresses toward its milestones.
The mBôs precision robotic surgical system is designed to autonomously execute optimized surgical paths for inserting the company's FDA-cleared mPress press-fit implants. The goal is to achieve well-balanced, better-fitting, and bone-sparing knee replacements. Monogram is exploring additional clinical and commercial applications for its mBôs system with mVision navigation.
While Monogram has previously obtained FDA clearance for mPress implants, it must secure clearance for its robotic products before entering the market. The company's forward-looking statements, including those regarding the use of proceeds and future performance, are subject to risks and uncertainties.
This news article is based on a press release statement from Monogram Technologies Inc.
InvestingPro Insights
As Monogram Technologies Inc. (NASDAQ:MGRM) awaits a pivotal decision from the FDA on its mBós TKA System, the company's financial health and market performance provide additional context for investors monitoring the situation. InvestingPro data reveals a market capitalization of $71.89 million for Monogram, underscoring a modest size within the tech-driven medical devices sector. While the company's P/E ratio stands at a negative -4.22, reflecting its current lack of profitability, the high Price / Book ratio of 7.03 suggests a market that values the company's assets quite optimistically relative to its book value.
An InvestingPro Tip highlights that Monogram holds more cash than debt on its balance sheet, which is a reassuring sign for investors concerned about the company's financial resilience during this crucial regulatory phase. Another tip indicates that analysts expect sales growth in the current year, which could be a harbinger of improved financial performance, especially if the FDA clearance is granted.
However, it is worth noting that Monogram is not yet profitable, with analysts not anticipating profitability this year, and the company is quickly burning through cash. This reinforces the importance of the FDA's upcoming decision on the company's future prospects.
Despite these challenges, Monogram has experienced a strong return over the last three months, with a 19.47% price total return, demonstrating recent investor confidence. For those interested in deeper analysis, there are additional InvestingPro Tips available, which provide further insights into Monogram's financial and market performance (https://www.investing.com/pro/MGRM).
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.