Welcome to our dedicated page for Monogram Orthopaedics news (Ticker: MGRM), a resource for investors and traders seeking the latest updates and insights on Monogram Orthopaedics stock.
Monogram Technologies Inc (NASDAQ: MGRM) pioneers AI-driven orthopedic solutions combining surgical robotics, 3D printing, and machine vision. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's innovative approaches to joint replacement technology.
Access timely announcements including regulatory submissions, clinical trial progress, and strategic partnerships. Our curated collection features earnings reports, product development milestones, and analyses of the company's unique robotic surgical ecosystem designed for precision implant placement.
Key updates cover advancements in autonomous surgical systems, FDA clearance processes, and collaborations with medical institutions. Bookmark this page for verified information about Monogram's integration of digital imaging analytics, and bone-sparing surgical techniques that aim to redefine orthopedic care standards.
Monogram Technologies (NASDAQ:MGRM) has provided key updates on its mBôs TKA System. The company has completed supplemental testing and submitted its formal response to the FDA's Additional Information Request (AIR) from September 30, 2024, awaiting clearance decision for U.S. commercialization.
In partnership with Shalby , Monogram conducted an Investigator Meeting in Ahmedabad, India (January 31-February 1, 2025) to prepare for a multicenter clinical trial. The trial, managed by Reliance Life Sciences, aims to evaluate the system's safety and effectiveness.
Notable technological improvements include a 300% increase in feed rate for the cutting system. The company's autonomous robotic platform is being developed to be time-competitive with manual surgery while maintaining accuracy and safety, positioning itself as a potential market disruptor in orthopedic robotics.
Monogram Technologies (NASDAQ:MGRM) provided an update following its Submission Issue Request (SIR) meeting with the FDA regarding its 510(k) premarket filing for the mBôs TKA System. The company's July 2024 application received an Additional Information Request (AIR) on September 30, putting the application on hold. Following the December 17 SIR meeting, management believes its comprehensive plans will satisfy the FDA without requiring clinical data.
The company anticipates providing a complete AIR response in Q1 2025. Key upcoming milestones include seeking regulatory clearance for clinical trials in India with Shalby Hospitals, shipping a robot to India for trial training by January 2025, and pursuing FDA clearance for the mBôs TKA System while expanding domestic and international relationships.
Monogram Technologies (NASDAQ:MGRM) announced that management and related parties, including CFO Noel Knape, have completed approximately $1 million in open market purchases of MGRM common stock. CEO Ben Sexson stated this reflects high confidence in their strategy and expectation to create long-term shareholder value. The company outlined upcoming milestones including an FDA meeting by December 2024, seeking regulatory clearance for clinical trials in India with Shalby Hospitals, obtaining FDA clearance for the mBôs™ TKA System, and expanding domestic and international relationships.
Monogram Technologies (NASDAQ:MGRM) reported Q3 2024 financial results, highlighting an upsized and oversubscribed $13 million public offering. The company submitted a 510(k) premarket filing for its mBȏs TKA System and received an Additional Information Request from FDA. Key financials include R&D expenses of $2.2 million, marketing expenses of $1.8 million, and a net loss of $5.0 million. Cash position stood at $16.6 million as of September 30, 2024. The company secured a strategic collaboration with Shalby for multicenter clinical trials in India and was named Orthopedic Joint Replacement Company of the Year 2024.
Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company focused on orthopedic surgery, has announced its upcoming Third Quarter 2024 earnings conference call scheduled for Tuesday, November 19, 2024, at 4:30 p.m. Eastern Time. CEO Ben Sexson and CFO Noel Knape will host the call to discuss financial results for the quarter ended September 30, 2024, and key milestones. A presentation will accompany the webcast, accessible through the company's investor relations website. The call will be available for replay until February 19, 2025.
Monogram Technologies (NASDAQ:MGRM) has been named Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook. The award recognizes the company's stellar reputation and trust among customers and industry peers, particularly highlighting their mBôs TKA Precision Robotic Surgical System. The selection process involved an exhaustive evaluation by C-level executives, industry thought leaders, and the editorial board, following numerous nominations from Medical Tech Outlook's subscribers.
Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company focused on orthopedic surgery, will participate in the LD Micro Main Event XVII Conference on October 29-30, 2024 in Los Angeles. CFO Noel Knape will conduct one-on-one meetings and deliver a presentation on October 30 at 12:30 pm PT.
The company will showcase its mBôs precision robotic surgical system, designed to autonomously execute optimized paths for high-precision insertion of FDA-cleared mPress press-fit implants for total knee replacements. The presentation will be available via webcast and on Monogram's investor relations website.
Investors can schedule meetings with management by contacting their conference representative or emailing MGRM@mzgroup.us.
Monogram Technologies Inc. (NASDAQ:MGRM) has issued a correction to its October 2, 2024 press release regarding the FDA response for its mBôs TKA System. The company clarifies that it has 180 days from receipt to produce additional information, rather than conducting a clinical trial within that timeframe as previously stated. This correction affects only the subtitle of the original press release, with no other changes made to the content. Monogram Technologies, an AI-driven robotics company focusing on orthopedic surgery, remains committed to improving human health through its innovative technologies.
Monogram Technologies (NASDAQ:MGRM) has received an Additional Information Request (AIR) from the FDA regarding its 510(k) premarket filing for the mBôs TKA System. The company has 180 days to respond or the application will be considered withdrawn. Monogram plans to conduct clinical trials to produce the required information.
CEO Ben Sexson stated that this response provides more clarity on the path to clearance and commercialization. The company recently closed a $13 million public offering and will continue executing its strategic objectives. Monogram will pursue a submission for its active modality with Outside the United States (OUS) clinical data while addressing the AIR for its semi-active system.
Upcoming milestones include obtaining regulatory clearance for clinical trials in India, conducting OUS live-patient surgery trials, and seeking clearance for the mBôs TKA System. The company also plans to explore domestic and international relationships, including exhibiting at Arab Health in January 2025.
Monogram Technologies Inc. (NASDAQ:MGRM) has successfully closed its upsized and oversubscribed $13 million public offering of 8.00% Series D Convertible Cumulative Preferred Stock. The company sold 5,790,479 units, each comprising one share of Series D Preferred Stock and one common stock purchase warrant. The offering attracted 3,023 investors and provided Monogram with gross proceeds of approximately $13 million.
CEO Benjamin Sexson stated that the funds will provide ample cash runway for near-term commercialization milestones over the next 12 months, supporting key initiatives such as clinical trials and technology development. The company is also working on obtaining FDA clearance for its 510(k) submission. Monogram plans to use the net proceeds of approximately $11.7 million for general corporate purposes, operational needs, and strategic initiatives, including new technology development and potential acquisitions.
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