Monogram Technologies Receives FDA Response for mBôs TKA System and Closes $13 Million Public Offering
7 Sources
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CORRECTION FROM SOURCE: Monogram Technologies Issues Correction to Press Release Announcing it Received an FDA Response for its mBôs TKA System
AUSTIN, TX, October 3, 2024 (Newswire.com) - Company Has 180 Days From Receipt to Produce Additional Information 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,
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Monogram Technologies Receives FDA Response for mBôs TKA System
AUSTIN, TX, October 2, 2024 (Newswire.com) - Company to Conduct Clinical Trial to Produce Additional Information Within 180 Days Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on
[3]
Monogram Technologies Receives FDA Response for mBôs TKA System By Investing.com
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
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Monogram Technologies Announces Closing of Upsized and Oversubscribed $13 Million Public Offering
AUSTIN, TX, October 2, 2024 (Newswire.com) - 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, announced today that the Company closed the previously announced 8.00%
[5]
Monogram Technologies Announces Closing of Upsized and Oversubscribed $13 Million Public Offering By Investing.com
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, announced today that the Company closed the previously announced 8.00%
[6]
Monogram Technologies Announces Preferred Stock Dividends
AUSTIN, TX, October 1, 2024 (Newswire.com) - 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, announced today the declaration of a dividend of $0.0255 per share
[7]
Monogram Technologies : Announces Preferred Stock Dividends Form 8 K
Monogram Technologies Announces Preferred Stock Dividends AUSTIN, TX - September 30, 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, announced today the
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Monogram Technologies, an AI-driven robotics company focusing on orthopedic surgery, receives an Additional Information Request from the FDA for its mBôs TKA System and successfully closes an oversubscribed $13 million public offering.
FDA Response for mBôs TKA System
Monogram Technologies Inc. (NASDAQ:MGRM), an AI-driven robotics company focused on orthopedic surgery, announced that it 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
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.The FDA has placed the application on hold pending a complete response to the AIR. Monogram has 180 days from the date of the AIR to provide a complete response, or the FDA will consider the application withdrawn
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.Correction to Press Release
On October 3, 2024, Monogram issued a correction to its initial press release, clarifying that the company has 180 days from receipt to produce additional information, rather than conducting a clinical trial within that timeframe
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.$13 Million Public Offering
Monogram Technologies announced the closing of its previously announced 8% Series D Convertible Cumulative Preferred Stock offering on October 1, 2024. The company sold 5,790,479 units, each consisting of one share of Series D Preferred Stock and one common stock purchase warrant, raising gross proceeds of approximately $13 million
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.Use of Proceeds and Future Plans
The company intends to use the net proceeds of approximately $11.7 million to fund general corporate and business purposes, operational needs, and various strategic initiatives, including new technology development and potential acquisitions
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.Company's Response and Strategy
Ben Sexson, CEO of Monogram Technologies, stated that the FDA response provides more transparency for the company's path forward toward obtaining clearance and commercialization. The company will continue to execute its strategic objectives, with the highest priority being obtaining FDA clearance as quickly and economically as possible
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.Related Stories
Product Development and Market Potential
Monogram's 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 company believes that its technology will enable more personalized knee implants for patients, resulting in well-balanced, better-fitting knee replacements with bone-sparing implants
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.Future Outlook
While Monogram works to respond to the AIR for its semi-active system, the company will also pursue a submission for its active modality with Outside the United States (OUS) clinical data. The company remains confident in its thesis for orthopedic robotics and the value proposition of its proposed active robotic system
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