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MGRM Monogram Technologies Inc

2.00
-0.07 (-3.38%)
28 Nov 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Monogram Technologies Inc NASDAQ:MGRM NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -0.07 -3.38% 2.00 1.99 2.12 2.10 2.00 2.06 25,549 01:00:00

Form 8-K - Current report

02/10/2024 10:20pm

Edgar (US Regulatory)


false 0001769759 0001769759 2024-09-30 2024-09-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): October 2, 2024 (September 30, 2024)

 

Monogram Technologies Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41707   81-3777260
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification Number)

 

3919 Todd Lane, Austin, TX 78744

(Address of principal executive offices, including zip code)

 

Registrant’s telephone number, including area code: (512399-2656

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s)
  Name of each exchange
on which registered
Common Stock, par value $0.001 per share   MGRM   The Nasdaq Stock Market

  

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

ITEM 7.01 REGULATION FD DISCLOSURE

 

Closing of Series D Preferred Offering

 

On October 2, 2024, Monogram Technologies Inc. (the “Company”) issued a press release announcing that the Company’s 8.00% Series D Convertible Cumulative Preferred Stock (the “Series D Preferred Stock”) continuous offering (the “Offering”) closed on October 1, 2024.

 

FDA Correspondence

 

On October 2, 2024, the Company issued a press release announcing that it received an Additional Information Request (“AIR”) from the U.S. Food and Drug Administration (“FDA”) related to the Company’s submission K242121 for marketing clearance for the Company’s mBôs (Monogram mBôs TKA System) (the “Application”). 

 

In each case, the foregoing disclosure is qualified in its entirety by the full text of the respective Press Releases.

 

A copy of the press releases are attached as Exhibits 99.1 and 99.2, respectively, and are hereby incorporated by reference into this Item 7.01. The information contained in this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing, except to the extent expressly stated in such filing.

 

ITEM 8.01 OTHER EVENTS

 

Closing of Series D Preferred Offering

 

The Company’s Series D Preferred Stock Offering closed 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 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 issue and sell the Series D Preferred Stock through, but not including, October 15, 2024.

 

The net proceeds of the offering of Series D Preferred Stock was approximately $11.7 million (after deducting the selling agent fees and excluding offering expenses)

 

The legal opinion of Duane Morris LLP relating to the securities that were offered and sold in this Offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

 

FDA Correspondence

 

On September 30, 2024, the Company received an Additional Information Request (“AIR”) from the U.S. Food and Drug Administration (“FDA”) related to the Company’s submission K242121 for marketing clearance for the Company’s mBôs (Monogram mBôs TKA System) (the “Application”).  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.  The Company’s management team believes the FDA communications reiterated an accommodative posture toward clinical data obtained from Indian trials. Regulatory strategy can be dynamic as new facts and opportunities emerge. The Company’s goal is to obtain FDA clearance as quickly and economically as possible. As the Company works to respond to the AIR, the Company, in parallel, will pursue a submission for its active modality with OUS. clinical data as it continues to work through the AIR for its semi-active system.  

 

2

 

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K, including the press releases, contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements.

 

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the Company’s lack of profitability and need for additional capital to grow its business; the Company’s dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of the Company’s latest annual and quarterly reports and other filings with the SEC.

 

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The Company undertakes no obligation to revise or update any forward-looking statements made in this Current Report on Form 8-K to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

 

  (d) Exhibits:

 

Exhibit No.   Description
5.1   Opinion of Duane Morris LLP dated October 2, 2024
99.1   Press Release dated October 2, 2024
99.2   Press Release dated October 2, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101).

 

3

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  MONOGRAM TECHNOLOGIES INC.
   
Dated: October 2, 2024 /s/ Benjamin Sexson
  Benjamin Sexson
  Chief Executive Officer

 

4

 

Exhibit 5.1

 

NEW YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
SILICON VALLEY
SAN DIEGO
SHANGHAI
BOSTON
HOUSTON
LOS ANGELES
HANOI
HO CHI MINH CITY

 

FIRM and AFFILIATE OFFICES

 

 

 

www.duanemorris.com

ATLANTA
BALTIMORE
WILMINGTON
MIAMI
BOCA RATON
PITTSBURGH
NEWARK
LAS VEGAS
CHERRY HILL
LAKE TAHOE
MYANMAR
OMAN
A GCC REPRESENTATIVE OFFICE
OF DUANE MORRIS

MEXICO CITY
ALLIANCE WITH
MIRANDA & ESTAVILLO

SRI LANKA
ALLIANCE WITH
GOWERS INTERNATIONAL

 

October 2, 2024

 

Monogram Technologies Inc.
3913 Todd Lane

Austin, TX 78744

 

Re: Monogram Technologies Inc. Offering of units consisting of one share Series D Preferred Stock and one Warrant -- Registration Statement on Form S-3 (File No. 333-279927)

 

Ladies and Gentlemen: 

 

We have examined the Registration Statement on Form S-3, File No. 333-279927 (as amended from time to time prior to the date hereof, the “Registration Statement”), of Monogram Technologies Inc., a Delaware corporation (the “Company”), filed with the Securities and Exchange Commission (the “Commission”) pursuant to the Securities Act of 1933, as amended (the “Securities Act”), and the prospectus and prospectus supplement with respect thereto, dated June 14, 2024 and July 9, 2024, as amended on September 11, 2024 and October 2, 2024 (collectively, the “Prospectus”), respectively, in connection with the continuous offering by the Company pursuant to Rule 415 under the Securities Act of up to 5,790,479 units, each unit consisting of (a) one share of the Company’s 8.00% Series D Convertible Cumulative Preferred Stock (the “Series D Preferred Stock”) and (b) one common stock purchase warrant (the “Warrant”) to purchase one share of our common stock, $0.001 par value per share (the “Warrant Shares”). The units were sold pursuant to that certain Selling Agent Agreement, dated as of July 9, 2024 (the “Selling Agent Agreement”) between the Company and Digital Offering LLC. Each share of the Series D Preferred Stock shall be convertible into one share of common stock of the Company (the “Conversion Shares”), $0.001 par value, in accordance with the terms of the Certificate of Designations as defined below. Dividends on the Series D Preferred Stock may be paid by the Company in cash or in kind in the form of common stock of the Company issued in an amount equal to the closing price of common stock on the last trading day of the most recent fiscal quarter at the Company’s discretion (the “PIK Dividend Shares”) in accordance with the Certificate of Designations.

 

In arriving at the opinions expressed below, we have examined and relied upon the Registration Statement, the Prospectus, the form of Selling Agent Agreement, the form of Common Stock Purchase Warrant, which will be issued in connection with the Warrant Agency Agreement (the “WAA”), to be entered into by the Company with Equity Stock Transfer, LLC (the “Warrant Agent”), the Company’s Sixth Amended and Restated Certificate of Incorporation, the Certificate Of Designation Of Preferences, Rights And Limitations of 8.00% Series D Convertible Cumulative Preferred Stock as filed with the Secretary of State of the State of Delaware on July 12, 2024 (the “Certificate of Designations”), and the Company’s Amended and Restated Bylaws, each as currently in effect, and the originals or copies, certified or otherwise identified to our satisfaction, of such documents, resolutions, certificates and other instruments of the Company and such other instruments and documents as we have deemed necessary or appropriate as a basis for the opinions set forth below.

 

 

 

 

 

 

Monogram Technologies Inc.

October 2, 2024

Page 2

 

In our examination, we have assumed without independent investigation the genuineness of all signatures, the legal capacity and competency of all natural persons, the authenticity of all documents submitted to us as originals and the conformity to original documents of all documents submitted to us as copies.

 

Based upon the foregoing, and subject to the assumptions, exceptions, qualifications and limitations set forth herein, we are of the opinion that:

 

1.              The Series D Preferred Stock has been issued and delivered in accordance with the Selling Agent Agreement for the consideration provided for therein, and such Series D Preferred Stock has been validly issued, fully paid and non-assessable.

 

2.              The Conversion Shares, issuable by the Company upon conversion of the Series D Preferred Stock, when issued and delivered by the Company in accordance with the terms of the Certificate of Designations, will be validly issued, fully paid and non-assessable

 

3.              The Warrants have been duly authorized by the Company, and as issued and sold in accordance with the Registration Statement the Prospectus, and the terms of the WAA, upon due authorization, execution, and delivery of such agreement by the parties thereto, with payment received by the Company in the manner described in the Selling Agent Agreement, are valid and binding obligations of the Company, enforceable against the Company in accordance with their terms except as such enforceability may be limited by (i) any applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally including, without limitation, fraudulent transfer or fraudulent conveyance laws; (ii) public policy considerations, statutes or court decisions that may limit rights to obtain exculpation, indemnification or contribution (including, without limitation, indemnification regarding violations of the securities laws and indemnification for losses resulting from a judgment for the payment of any amount other than in United States dollars); and (iii) general principles of equity (including, without limitation, concepts of materiality, reasonableness, good faith and fair dealing) and the availability of equitable remedies (including, without limitation, specific performance and equitable relief), regardless of whether considered in a proceeding in equity or at law.

 

4.              The Warrant Shares have been duly authorized by all necessary corporate action on the part of the Company and assuming sufficient authorized but unissued shares of common stock, $0.001 par value per share, of the Company are available for issuance when the Warrants are exercised, the Warrant Shares, when issued, delivered and paid for in accordance with the terms of the Warrants, will be validly issued, fully paid and nonassessable.

 

5.              The PIK Dividend Shares, when issued and delivered by the Company in accordance with the terms of the Certificate of Designations, such shares of common stock, $0.001 par value, will be validly issued, fully paid, and non-assessable.

  

 

 

 

 

Monogram Technologies Inc.

October 2, 2024

Page 3

 

The opinions expressed above are subject to the following exceptions, qualifications, limitations and assumptions:

 

A. The effectiveness of the Registration Statement under the Securities Act will not have been terminated or rescinded.
   
B. We render no opinion herein as to matters involving the laws of any jurisdictions other than the Delaware General Corporation Law (the “DGCL”) and the laws of the State of New York. This opinion is limited to the effect of the current state of the DGCL and the laws of the State of New York and the facts as they currently exist. We assume no obligation to revise or supplement this opinion in the event of future changes in such laws or the interpretations thereof or such facts.
   
C. The Board of Directors of the Company shall have duly established the terms of each such security and duly authorized the issuance and sale of such security and such authorization shall not have been modified or rescinded.
   
D. With regard to opinion paragraphs 3 and 4: (i) our opinion is subject to the qualification that the availability of specific performance, an injunction or other equitable remedies is subject to the discretion of the court before which the request is brought; (ii) we express no opinion as to any provision of the Warrants that (a) provides for liquidated damages, buy-in damages, monetary penalties, prepayment or make-whole payments or other economic remedies to the extent such provisions may constitute unlawful penalties, (b) relates to advance waivers of claims, defenses, rights granted by law, or notice, opportunity for hearing, evidentiary requirements, statutes of limitations, trial by jury, or procedural rights, (c) restricts non-written modifications and waivers, (d) provides for the payment of legal and other professional fees where such payment is contrary to law or public policy, (e) relates to exclusivity, election or accumulation of rights or remedies, (f) authorizes or validates conclusive or discretionary determinations, or (g) provides that provisions of the Warrants are severable to the extent an essential part of the agreed exchange is determined to be invalid and unenforceable; (iii) we express no opinion as to whether a state court outside of the State of Delaware or a federal court of the United States would give effect to the choice of Delaware law provided for in the Warrants; (iv) the WAA is a valid, binding, and enforceable agreement of each party thereto (other than expressly covered above in respect to the Company); and (v) the WAA will be governed by the laws of the State of Delaware.

 

 

 

 

 

 

Monogram Technologies Inc.

October 2, 2024

Page 4

 

We consent to the filing of this opinion as Exhibit 5.1 to the Registration Statement, and we further consent to the use of our name under the caption “Legal Matters” in the Registration Statement and the prospectus that forms a part thereof. In giving these consents, we do not thereby admit that we are within the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission promulgated thereunder.

 

  Very truly yours,
   
  /s/ Duane Morris LLP

 

 

 

 

 

 

Exhibit 99.1

 

 

Monogram Technologies Announces Closing of Upsized and Oversubscribed $13 Million Public Offering

 

AUSTIN, TX – 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 15th 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.

 

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

 

 

 

Exhibit 99.2

 

 

Monogram Technologies Receives FDA Response for mBôs TKA System

 

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

 

AUSTIN, TX – 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

 

 

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Entity Registrant Name Monogram Technologies Inc.
Entity Central Index Key 0001769759
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