Monogram Orthopaedics Inc Stock Price, News & Analysis

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 The company has 180 days to respond or the application will be considered withdrawn.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.

Monogram Technologies Inc. (NASDAQ:MGRM), an AI-driven robotics company focused on orthopedic surgery, has declared a dividend of $0.0255 per share for holders of its 8.00% Series D Convertible Cumulative Preferred Stock. The dividend will be paid in kind based on the closing price of Monogram's common stock on September 30, 2024. Shareholders of record as of October 1, 2024 will receive the dividend on October 15, 2024.

The company has established a quarterly dividend schedule for Series D Preferred Stockholders, with payments to be made on or about the 15th day of January, April, July, and October, starting from October 15, 2024.

Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company specializing in orthopedic surgery, announced an upsize to their continuous offering from $10 million to $12.5 million. Each unit comprises one share of 8.00% Series D Convertible Cumulative Preferred Stock and one warrant to purchase common stock at $3.375 per share. Warrants become exercisable 180 days post-July 9, 2024, through July 8, 2025. Series D Preferred Stock can convert into common stock at the holder's option. Proceeds will fund corporate and operational needs, technology development, and potential acquisitions. CEO Benjamin Sexson highlighted the strengthened capacity to support strategic initiatives. The offer closes on September 12, 2024, subject to standard conditions.

Monogram Technologies (NASDAQ:MGRM) reported its Q2 2024 financial results, highlighting key operational achievements. The company submitted a 510(k) premarket filing to the FDA for its mBôs TKA System, which passed the administrative review. Monogram also secured a strategic collaboration with Shalby for multicenter clinical trials in India. Financial results showed R&D expenses decreased to $2.4 million from $3.0 million year-over-year, while marketing expenses significantly dropped to $92,000 from $1.7 million. The net loss improved to $3.5 million compared to $5.2 million in the prior-year quarter. Cash and cash equivalents stood at $7.3 million as of June 30, 2024.

Monogram Technologies Inc. (NASDAQ:MGRM) has announced a strategic collaboration with Shalby (NSE:SHALBY) to conduct a multicenter clinical trial for its mBȏs TKA System. Shalby, the world's largest orthopedic hospital chain, will enroll patients at various sites in India to evaluate the system's safety and effectiveness. This collaboration follows Monogram's recent 510(k) submission to the FDA, which has passed the Administrative Review.

Key points:

• Shalby performs over 14,000 annual knee replacement surgeries globally
• The Indian TKA market size is approximately 200,000 per year, growing at a 20% CAGR
• The trial will use Consensus CKS implants, equivalent to Monogram's mPress implants
• Post-trial, Monogram may transfer a robot to Shalby's hospital system
• Both companies see potential for expanded collaboration and global market opportunities

Monogram Technologies (NASDAQ:MGRM) has submitted a 510(k) premarket filing to the FDA for its mBôs TKA System, an AI-driven robotic system for orthopedic surgery. The 28,214-page application, submitted on July 19, 2024, has passed the FDA Administrative Review. An FDA decision is expected within 90 days, though the process may be paused if additional information is requested.

The submission represents a significant milestone for Monogram and is expected to be a catalyst for institutional engagement. The company believes the application is strong, with thorough testing based on FDA feedback. Several orthopedic surgeons have expressed support for the mBôs system, praising its focus on patient safety, accuracy, and efficiency. Monogram anticipates that this submission will open up funding opportunities and increase traction with institutional players.

Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company focused on orthopedic surgery, has announced a business update conference call scheduled for August 14, 2024, at 4:30 p.m. Eastern Time. The call will coincide with the release of the company's financial results for Q2 2024, ending June 30. CEO Ben Sexson and CFO Noel Knape will host the call, which will include a presentation and a Q&A session.

Investors can access the call through a registration link provided by the company. The presentation will be available for viewing during the webcast and can also be accessed via Monogram's investor relations website. A press release detailing the financial results will be issued prior to the call.