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On Tue, 1 Oct, 4:03 PM UTC
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[1]
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, 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. 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.
[2]
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 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." 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. 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.
[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 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." 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. 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.
[4]
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% Series D Convertible Cumulative Preferred Stock (the "Series D Preferred Stock") continuous offering on October 1, 2024. The Company sold 5,790,479 units, with each unit consisting of (a) one share of the Company's Series D Preferred Stock and (b) one common stock purchase warrant to purchase one share of the Company's common stock, $0.001 par value per share (the "Common Stock"), for a total of 5,790,479 shares of the Company's Series D Preferred Stock and warrants to purchase an aggregate of 5,790,479 shares of the Company's Common Stock (and shares of Common Stock underlying shares of Series D Preferred Stock, PIK dividends on Series D Preferred Stock, and all such warrants). The Company received gross proceeds of approximately $13 million in connection with this offering. "We would like to thank the 3,023 investors that participated in funding and all those that have supported our vision to revolutionize orthopedic robotics, allowing safe and fast orthopedic surgeries to drive better patient outcomes," said Benjamin Sexson, CEO of Monogram Technologies. "These funds will provide us with ample cash runway to meet all near-term commercialization milestones over the next 12 months and resources to support key initiatives, including clinical trials and further development of our technology. We are also working to obtain FDA clearance of our 510(k) submission, which would be a major de-risking event for the Company, and with this oversubscribed offering, investors have voted their confidence." Monogram intends to use the net proceeds of the offering of Series D Preferred Stock of approximately $11.7 million (after deducting the selling agent fees and excluding offering expenses) to fund general corporate and business purposes, operational needs, and various strategic initiatives, including among other things, new technology development and potential acquisitions. Dividends on the Series D Preferred Stock are payable quarterly in arrears to Series D Preferred stockholders of the record, on or about the 15 day of January, April, July and October, beginning on or about October 15, 2024. The first dividend, which is scheduled to be paid on October 15, 2024 will be $0.033 per share of Series D Preferred Stock and will cover the period from, and including, August 9, 2024, the first date we initially issued the Series D Preferred Stock through, but not including, October 15, 2024. Digital Offering, LLC acted as lead selling agent of the offering. The offering of Series D Preferred Stock was made pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC). The offering of Series D Preferred Stock was made only by means of a prospectus and related prospectus supplement meeting the requirements of Section 10 of the Securities Act of 1933, as amended. A copy of the prospectus supplement and accompanying base prospectus meeting such requirements related to the offering may be obtained free of charge from the SEC's website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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. 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.
[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% Series D Convertible Cumulative Preferred Stock (the "Series D Preferred Stock") continuous offering on October 1, 2024. The Company sold 5,790,479 units, with each unit consisting of (a) one share of the Company's Series D Preferred Stock and (b) one common stock purchase warrant to purchase one share of the Company's common stock, $0.001 par value per share (the "Common Stock"), for a total of 5,790,479 shares of the Company's Series D Preferred Stock and warrants to purchase an aggregate of 5,790,479 shares of the Company's Common Stock (and shares of Common Stock underlying shares of Series D Preferred Stock, PIK dividends on Series D Preferred Stock, and all such warrants). The Company received gross proceeds of approximately $13 million in connection with this offering. "We would like to thank the 3,023 investors that participated in funding and all those that have supported our vision to revolutionize orthopedic robotics, allowing safe and fast orthopedic surgeries to drive better patient outcomes," said Benjamin Sexson, CEO of Monogram Technologies. "These funds will provide us with ample cash runway to meet all near-term commercialization milestones over the next 12 months and resources to support key initiatives, including clinical trials and further development of our technology. We are also working to obtain FDA clearance of our 510(k) submission, which would be a major de-risking event for the Company, and with this oversubscribed offering, investors have voted their confidence." Monogram intends to use the net proceeds of the offering of Series D Preferred Stock of approximately $11.7 million (after deducting the selling agent fees and excluding offering expenses) to fund general corporate and business purposes, operational needs, and various strategic initiatives, including among other things, new technology development and potential acquisitions. Dividends on the Series D Preferred Stock are payable quarterly in arrears to Series D Preferred stockholders of the record, on or about the 15 day of January, April, July and October, beginning on or about October 15, 2024. The first dividend, which is scheduled to be paid on October 15, 2024 will be $0.033 per share of Series D Preferred Stock and will cover the period from, and including, August 9, 2024, the first date we initially issued the Series D Preferred Stock through, but not including, October 15, 2024. Digital Offering, LLC acted as lead selling agent of the offering. The offering of Series D Preferred Stock was made pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC). The offering of Series D Preferred Stock was made only by means of a prospectus and related prospectus supplement meeting the requirements of Section 10 of the Securities Act of 1933, as amended. A copy of the prospectus supplement and accompanying base prospectus meeting such requirements related to the offering may be obtained free of charge from the SEC's website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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. 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.
[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 payable to holders of record of shares of the Company's 8.00% Series D Convertible Cumulative Preferred Stock (the "Series D Preferred Stock") at the close of business on October 1, 2024. In addition, the Company announced that it will be paying the dividend in kind based on the closing price of its common stock, par value $0.001 per share on September 30, 2024. Holders of record will receive the dividend on October 15, 2024. Dividends on the Series D Preferred Stock are payable quarterly in arrears to Series D Preferred Stockholders of the record, on or about the 15 day of January, April, July and October, beginning on or about October 15, 2024. 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.
[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 declaration of a dividend of $0.0255 per share payable to holders of record of shares of the Company's 8.00% Series D Convertible Cumulative Preferred Stock (the "Series D Preferred Stock") at the close of business on October 1, 2024. In addition, the Company announced that it will be paying the dividend in kind based on the closing price of its common stock, par value $0.001 per share on September 30, 2024. Holders of record will receive the dividend on October 15, 2024. Dividends on the Series D Preferred Stock are payable quarterly in arrears to Series D Preferred Stockholders of the record, on or about the 15 day of January, April, July and October, beginning on or about October 15, 2024. 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. 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.
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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.
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 1.
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 2.
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 3.
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 4.
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 5.
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 1.
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 3.
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 2.
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Monogram Technologies, an AI-driven robotics company focusing on orthopedic surgery, announces $1 million in open market stock purchases by management, demonstrating confidence in their strategy and future milestones.
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Monogram Technologies, an AI-driven robotics company focusing on orthopedic surgery, has been recognized as the Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook. The award highlights the company's innovative mBôs TKA System and its potential to revolutionize knee replacement procedures.
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Monogram Technologies, an AI-driven robotics company focused on orthopedic surgery, will present its innovative mBôs precision robotic surgical system at the upcoming LD Micro Main Event XVII Conference in Los Angeles.
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Metagenomi presents its innovative SMART gene editing platform at the AIChE 7th International Conference on CRISPR Technologies, showcasing compact adenine base editors that fit into a single AAV vector, potentially revolutionizing in vivo gene editing for neuromuscular diseases.
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Tevogen Bio's CEO Ryan Saadi expresses confidence in the company's growth strategy and reaffirms commitment to advancing precision T cell technology. The biotech firm aims to address large and underserved global health challenges.
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