• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI Executive AssistantNEW
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI Executive AssistantNEW
  • Settings
  • RSS Feeds
PublishGo to AppAI Helper
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI employees for your businessNEW
    Legal
    Terms of usePrivacy policyCookie policy

    Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA

    12/18/24 8:31:00 AM ET
    $MGRM
    Medical/Dental Instruments
    Health Care
    Get the next $MGRM alert in real time by email

    Management Anticipates That it has Sufficiently Addressed the FDA's Concerns to Mitigate the Need for a Clinical Data Request

    Management Anticipates a Comprehensive AIR Response in Q1 2025

    AUSTIN, TEXAS / ACCESSWIRE / December 18, 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 provided an update from its Submission Issue Request (SIR) meeting with the U.S. Food and Drug Administration ("FDA") on December 17, 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. On September 30, 2024, Monogram received an Additional Information Request ("AIR") from the FDA. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR. The FDA informed the Company that the Company had 180 days from the date of the AIR to provide a complete response to the AIR, or the FDA would consider the Application withdrawn.

    On November 20, the Company submitted written responses, including planned remediations where applicable for all deficiencies noted in the AIR, and requested a Submission Issue Request (SIR) meeting with the FDA to review select responses. A critical focus for the Company has been whether the proposed nonclinical testing effectively mitigates FDA concerns that could necessitate clinical data. On December 11, 2024, the Company received a Submission Issue Request (SIR) review letter that provided preliminary written comments on particular topics of interest before the SIR meeting scheduled for December 17, 2024. On December 17, 2024, the Company conducted a Submission Issue Request (SIR) meeting with the FDA.

    Management believes its comprehensive plans to address the Additional Information Request (AIR) could effectively satisfy the agency and anticipates that in light of its proposed testing, it will be unlikely that the FDA will request clinical data as part of its submission. The Company is actively executing the additional testing and anticipates that it will provide a comprehensive AIR response in the first quarter of 2025. Obtaining clearance would be a significant milestone for its mission to advance the standard of care in orthopedic medicine. The Company is already working on the next-generation version of the mBôs TKA System.

    "This meeting reaffirmed our strategic decision to effectuate a multigenerational product strategy and submit the mBôs TKA System for FDA clearance on an accelerated timeline," said Ben Sexson, CEO of Monogram Technologies. "This meeting resolved outstanding questions and was a significant step forward in our path toward commercialization of the mBôs TKA System and execution of our long-term road map. The feedback and guidance provided by the FDA during the Submission Issue Request meeting validate the robustness of our approach. Importantly, the absence of a requirement for clinical data further underscores the confidence we have in the strength of our submission. The Agency's comments provided valuable clarity and affirmed that the proposed testing plans are well aligned with their expectations. We are optimistic that the additional data we are generating will comprehensively address the outstanding items and further reinforce our submission. We remain committed to achieving FDA clearance as quickly as possible, driven by our mission to advance the standard of care in orthopedic medicine."

    Upcoming Milestones

    • The Company anticipates it will respond to the FDA AIR with supplemental data in Q1 2025.

    • The Company is seeking to obtain regulatory clearance to conduct clinical trials in India with strategic partner Shalby Hospitals.

    • The Company anticipates shipping a robot to India to initiate clinical trial training by January 2025.

    • The Company is seeking to obtain FDA clearance for the mBôs™ TKA System.

    • Continue exploring domestic relationships.

    • Seek to 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 www.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
    [email protected]

    SOURCE: Monogram Technologies Inc.



    View the original press release on accesswire.com

    Get the next $MGRM alert in real time by email

    Crush Q3 2025 with the Best AI Executive Assistant

    Stay ahead of the competition with Tailforce.ai - your AI-powered business intelligence partner.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Tailforce.ai

    Recent Analyst Ratings for
    $MGRM

    DatePrice TargetRatingAnalyst
    12/9/2024$4.00Buy
    ROTH MKM
    More analyst ratings

    $MGRM
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Chief Financial Officer Knape Noel was granted 288,461 shares (SEC Form 4)

      4 - Monogram Technologies Inc. (0001769759) (Issuer)

      11/26/24 8:52:37 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • SEC Form 4 filed by Knape Noel

      4 - MONOGRAM ORTHOPAEDICS INC (0001769759) (Issuer)

      4/26/24 3:28:17 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care

    $MGRM
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Monogram Technologies Reports First Quarter 2025 Financial Results

      Receives FDA Clearance for the mBôs™ TKA System Groundbreaking Trial Set to Deliver one of the World's First Autonomous Saw-Based Robotic TKA Surgeries on Live Patients Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time AUSTIN, Texas, May 14, 2025 (GLOBE NEWSWIRE) -- 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, has reported its financial and operational results for the first quarter ended March 31, 2025. First Quarter 2025 and Subsequent Operational Highlights The U.S. Food and Drug Administration ("FDA") granted 510(k)

      5/14/25 4:01:00 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA

      Management Anticipates That it has Sufficiently Addressed the FDA's Concerns to Mitigate the Need for a Clinical Data RequestManagement Anticipates a Comprehensive AIR Response in Q1 2025 AUSTIN, TEXAS / ACCESSWIRE / December 18, 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 provided an update from its Submission Issue Request (SIR) meeting with the U.S. Food and Drug Administration ("FDA") on December 17, 2024, regarding its 510(k) premarket filing submission for the Company's mBôs TKA System (the "Application").The Application was submitted on

      12/18/24 8:31:00 AM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • Monogram Technologies Announces Management and Related Parties Complete Open Market Purchases of MGRM Common Stock Totaling $1 Million

      AUSTIN, TEXAS / ACCESSWIRE / December 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 completed purchases of MGRM common stock on the open market by certain related parties including Chief Financial Officer Noel Knape, totaling approximately $1 million. Additional details can be found on the Form 8-K filed today by the Company under Item 8.01 Other Events."Our senior management team has purchased shares in the open market, reflecting high confidence in our strategy and expectation to create long-term shareholder value," said Ben Sexson

      12/2/24 4:05:00 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care

    $MGRM
    Leadership Updates

    Live Leadership Updates

    See more
    • Monogram Accepted to NVIDIA Inception Program

      Collaboration to Provide Monogram with Technical Resources to Drive Development and Commercialization of mBôs SystemAUSTIN, TX / ACCESSWIRE / April 11, 2024 / Monogram Orthopaedics Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), a medical technology company focused on reconstructive joint procedures and surgical robotics, today announced it has joined NVIDIA Inception, a program designed to help companies evolve faster through cutting-edge technology and access to the latest technical resources from NVIDIA.NVIDIA Inception will help drive Monogram to help drive development of its mBôs robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation co

      4/11/24 1:20:00 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care

    $MGRM
    SEC Filings

    See more
    • SEC Form 10-Q filed by Monogram Technologies Inc.

      10-Q - Monogram Technologies Inc. (0001769759) (Filer)

      5/14/25 3:59:51 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • Monogram Technologies Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

      8-K - Monogram Technologies Inc. (0001769759) (Filer)

      4/29/25 6:05:28 AM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • SEC Form S-8 filed by Monogram Technologies Inc.

      S-8 - Monogram Technologies Inc. (0001769759) (Filer)

      4/17/25 3:12:04 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care

    $MGRM
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • ROTH MKM initiated coverage on Monogram Technologies with a new price target

      ROTH MKM initiated coverage of Monogram Technologies with a rating of Buy and set a new price target of $4.00

      12/9/24 7:59:36 AM ET
      $MGRM
      Medical/Dental Instruments
      Health Care

    $MGRM
    Financials

    Live finance-specific insights

    See more
    • Monogram Technologies Reports First Quarter 2025 Financial Results

      Receives FDA Clearance for the mBôs™ TKA System Groundbreaking Trial Set to Deliver one of the World's First Autonomous Saw-Based Robotic TKA Surgeries on Live Patients Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time AUSTIN, Texas, May 14, 2025 (GLOBE NEWSWIRE) -- 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, has reported its financial and operational results for the first quarter ended March 31, 2025. First Quarter 2025 and Subsequent Operational Highlights The U.S. Food and Drug Administration ("FDA") granted 510(k)

      5/14/25 4:01:00 PM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • Monogram Technologies to Host Third Quarter 2024 Results Conference Call on Tuesday, November 19, 2024 at 4:30 p.m. Eastern Time

      AUSTIN, TX / ACCESSWIRE / November 12, 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, will hold a conference call on Tuesday, November 19, 2024 at 4:30 p.m. Eastern Time in conjunction with its reported financial results for the third quarter ended September 30, 2024 and to discuss key milestones. A press release detailing these results will be issued prior to the call.Monogram CEO Ben Sexson and CFO Noel Knape will host the conference call, followed by a question-and-answer session. The conference call will be accompanied by a presentation, which can b

      11/12/24 8:31:00 AM ET
      $MGRM
      Medical/Dental Instruments
      Health Care
    • Monogram Technologies Announces Preferred Stock Dividends

      AUSTIN, TX / ACCESSWIRE / October 1, 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

      10/1/24 8:31:00 AM ET
      $MGRM
      Medical/Dental Instruments
      Health Care