CORRECTION FROM SOURCE: Monogram Technologies Issues Correction to Press Release Announcing it Received an FDA Response for its mBôs TKA System

Rhea-AI Summary

Monogram Technologies Inc. (NASDAQ:MGRM) has issued a correction to its October 2, 2024 press release regarding the FDA response for its mBôs TKA System. The company clarifies that it has 180 days from receipt to produce additional information, rather than conducting a clinical trial within that timeframe as previously stated. This correction affects only the subtitle of the original press release, with no other changes made to the content. Monogram Technologies, an AI-driven robotics company focusing on orthopedic surgery, remains committed to improving human health through its innovative technologies.

Positive

• FDA has responded to Monogram's mBôs TKA System submission
• Company has a defined timeframe (180 days) to provide additional information

Negative

• Additional information required by FDA, potentially delaying approval process
• Correction to previous press release may cause investor confusion

Insights

Medical Device Regulatory Expert

This FDA response for Monogram's mBôs TKA System is a significant development, but it's important to understand its implications. The 180-day timeline to provide additional information is standard in the FDA review process for medical devices. It doesn't necessarily indicate approval or rejection but suggests the FDA needs more data to complete their evaluation. This could involve various requests, from additional clinical data to manufacturing process details. For Monogram, this period is critical. They must efficiently gather and present the required information to keep the review process moving. The correction from "conduct clinical trial" to "produce additional information" is notable, as it broadens the scope of potential FDA requests beyond just clinical trials. This clarification might affect the company's near-term strategy and resource allocation.

Financial Analyst

The correction in Monogram's press release, while seemingly minor, could have significant financial implications. The original statement suggesting a need for a clinical trial within 180 days implied a more defined and potentially costly path forward. The corrected version, indicating a broader requirement to "produce additional information," introduces more uncertainty but also flexibility. For a company with a market cap of $77.67 million, the difference could be substantial in terms of cash burn and timeline to potential approval. Investors should closely monitor how Monogram approaches this 180-day period. The company's ability to efficiently address FDA's requests without needing extensive new studies could significantly impact its financial position and timeline to market. This situation underscores the importance of clear communication in the highly regulated medical device sector, where nuances in regulatory interactions can sway investor sentiment and company valuation.

Company Has 180 Days From Receipt to Produce Additional Information

AUSTIN, TX / ACCESSWIRE / October 3, 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 a correction to its press release issued on Wednesday, October 2, 2024, entitled "Monogram Technologies Receives FDA Response for mBôs TKA System" (the "Prior Press Release").

In yesterday's prior press release, dated October 2, 2024, it was stated in the subtitle that: "Company to Conduct Clinical Trial to Produce Additional Information Within 180 Days." The Company now clarifies the subtitle should state: "Company Has 180 Days From Receipt to Produce Additional Information." Other than this correction, there are no other changes to the previous press release.

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

SOURCE: Monogram Technologies Inc.

View the original press release on accesswire.com

FAQ

What is the correction Monogram Technologies (MGRM) made to its October 2, 2024 press release?

Monogram Technologies corrected the subtitle of its October 2, 2024 press release. The company clarified that it has 180 days from receipt to produce additional information for the FDA, rather than conducting a clinical trial within that timeframe as previously stated.

How long does Monogram Technologies (MGRM) have to respond to the FDA regarding its mBôs TKA System?

Monogram Technologies has 180 days from receipt of the FDA response to produce additional information regarding its mBôs TKA System.

What product is Monogram Technologies (MGRM) seeking FDA approval for?

Monogram Technologies is seeking FDA approval for its mBôs TKA System, which is likely related to their focus on AI-driven robotics for orthopedic surgery.

When did Monogram Technologies (MGRM) receive the FDA response for its mBôs TKA System?

The exact date of receipt is not specified in the press release. However, Monogram Technologies announced receiving the FDA response in a press release dated October 2, 2024.