Monogram Technologies Receives FDA Response for mBôs TKA System

Rhea-AI Summary

Monogram Technologies (NASDAQ:MGRM) has received an Additional Information Request (AIR) from the FDA regarding its 510(k) premarket filing for the mBôs TKA System. The company has 180 days to respond or the application will be considered withdrawn. Monogram plans to conduct clinical trials to produce the required information.

CEO Ben Sexson stated that this response provides more clarity on the path to clearance and commercialization. The company recently closed a $13 million public offering and will continue executing its strategic objectives. Monogram will pursue a submission for its active modality with Outside the United States (OUS) clinical data while addressing the AIR for its semi-active system.

Upcoming milestones include obtaining regulatory clearance for clinical trials in India, conducting OUS live-patient surgery trials, and seeking clearance for the mBôs TKA System. The company also plans to explore domestic and international relationships, including exhibiting at Arab Health in January 2025.

Positive

• Recently closed an upsized and oversubscribed $13 million public offering
• Growing surgeon support and market interest for the orthopedic robotics system
• Plans to conduct clinical trials in India with strategic partner Shalby Hospitals
• Pursuing submission for active modality with OUS clinical data

Negative

• FDA placed the 510(k) premarket filing submission on hold pending response to Additional Information Request
• Company has 180 days to respond to AIR or application will be considered withdrawn
• Delay in obtaining FDA clearance for the mBôs TKA System

Insights

Medical Device Regulatory Expert

The FDA's Additional Information Request (AIR) for Monogram's mBôs TKA System is a significant development. This 180-day response window is standard but crucial. The company's plan to conduct clinical trials in India is a strategic move to gather necessary data efficiently.

The FDA's comprehensive feedback provides a clear roadmap for Monogram. Their dual-track approach - responding to the AIR for the semi-active system while pursuing submission for the active modality with OUS data - is a smart strategy to expedite the process.

The planned 92 total knee replacement procedures with a 3-month follow-up should provide robust clinical evidence. However, the timeline extending into early 2025 for Indian regulatory clearance suggests a longer path to FDA approval than initially anticipated. This could impact the company's cash runway and commercialization timeline.

Investors should closely monitor Monogram's progress in meeting these regulatory milestones and its ability to maintain sufficient funding throughout this extended development phase.

Orthopedic Surgeon

Monogram's mBôs TKA System, particularly its fully active, hands-free version, could indeed be a game-changer in orthopedic robotics. The positive surgeon feedback from cadaveric demos is encouraging, suggesting strong market potential upon approval.

The system's value proposition likely lies in improved precision and potentially reduced operative times. However, the delay in FDA clearance puts Monogram at risk of falling behind competitors in this rapidly evolving field.

The planned clinical trials in India with Shalby Hospitals are a smart move. Indian orthopedic expertise is well-regarded and this collaboration could provide valuable data. However, the FDA may scrutinize this data more closely than U.S.-based trials.

The company's focus on both domestic and international relationships is prudent, especially given the regulatory hurdles in the U.S. Exhibiting at Arab Health could open doors in the lucrative Middle Eastern market, potentially providing alternative revenue streams while navigating FDA approval.

Company to Conduct Clinical Trial to Produce Additional Information Within 180 Days

AUSTIN, TX / ACCESSWIRE / October 2, 2024 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today announced that it has received an Additional Information Request ("AIR") from the U.S. Food and Drug Administration ("FDA") on September 30, 2024, regarding its 510(k) premarket filing submission for the Company's mBôs TKA System (the "Application").

The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR. The FDA has informed the Company that the Company has 180 days from the date of the AIR to provide a complete response to the AIR or the FDA will consider the Application withdrawn.

"We believe this response provides more transparency for Monogram's path forward toward obtaining clearance and ultimately commercialization," said Ben Sexson, CEO of Monogram Technologies. "We feel the increased clarity regarding the potential suitability of Indian clinical data is de-risking. Having just closed our upsized and oversubscribed $13 million public offering, Monogram will continue to execute on our strategic objectives. With growing surgeon support and market interest, we continue to believe in our thesis for orthopedic robotics and the value proposition of our proposed active robotic system. The highest priority for the Company remains obtaining FDA clearance as quickly and economically as possible. Management believes the FDA feedback was comprehensive and provides a framework to execute."

As the Company works to respond to the AIR, the Company, in parallel, will pursue a submission for its active modality with Outside the United States ("OUS") clinical data as it continues to work through the AIR for its semi-active system.

"The Company has committed considerable resources to cadaveric system demos this quarter. We feel the surgeon feedback and market interest is greatest for our hands-free, fully active system. We are increasingly confident such system could be a game-changing advancement for the industry. This response provides more transparency for Monogram's path forward toward obtaining clearance and ultimately commercialization," Mr. Sexson continued."

Upcoming Milestones

• Obtain regulatory clearance to conduct clinical trials in India with strategic partner Shalby Hospitals, with clearance expected in early Q1 2025.

• Conduct OUS live-patient surgery trials and submit clinical trial data to FDA, with clinical trials expected to include 92 total knee replacement procedures with a 3 month clinical follow-up.

• Seek to obtain clearance for the mBôs™ TKA System.

• Continue exploring domestic relationships.

• Continue expanding international relationships (the Company will be exhibiting at Arab Health in January 2025).

About Monogram Technologies Inc.

Monogram Technologies (NASDAQ: MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.

Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.

Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.

The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.

To learn more, visit monogramtechnologies.com.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties. For example, the Company's statement regarding the Company's proposed use of net proceeds is a forward-looking statement. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the prospectus and the Company's other filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.

Investor Relations

Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us

Contact Information

Chris Tyson
Executive Vice President
mgrm@mzgroup.us
949-491-8235

SOURCE: Monogram Technologies Inc.

View the original press release on accesswire.com

FAQ

What is the status of Monogram Technologies' (MGRM) FDA application for the mBôs TKA System?

Monogram Technologies received an Additional Information Request (AIR) from the FDA on September 30, 2024, regarding its 510(k) premarket filing for the mBôs TKA System. The application is on hold pending a complete response to the AIR within 180 days.

How much time does Monogram Technologies (MGRM) have to respond to the FDA's Additional Information Request?

Monogram Technologies has 180 days from September 30, 2024, to provide a complete response to the FDA's Additional Information Request for the mBôs TKA System.

What are Monogram Technologies' (MGRM) plans for clinical trials of the mBôs TKA System?

Monogram Technologies plans to conduct clinical trials in India with strategic partner Shalby Hospitals, expecting clearance in early Q1 2025. The trials are expected to include 92 total knee replacement procedures with a 3-month clinical follow-up.

How much funding did Monogram Technologies (MGRM) recently secure through a public offering?

Monogram Technologies recently closed an upsized and oversubscribed $13 million public offering to support its strategic objectives and development of the mBôs TKA System.