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Monogram Technologies Inc. Common Stock (NASDAQ: MGRM) is a forward-thinking medical technology company specializing in the development of AI-driven robotic systems and patient-specific orthopedic implants. Formerly known as Monogram Orthopaedics Inc., the company aims to revolutionize reconstructive joint procedures through the integration of 3D printing, advanced machine vision, and next-generation robotics.
Monogram Technologies' flagship product, the mBŏs precision robotic surgical system, is designed to autonomously perform high-precision insertions of FDA-cleared press-fit implants. The system integrates automated digital image analysis algorithms and machine learning to deliver scalable, patient-specific load-bearing joint replacements. Their innovations are set to transform knee replacement surgeries by offering minimally invasive procedures that promise better-fitting and bone-sparing implants.
The company’s current and upcoming product lines include robotic surgical equipment, related software, orthopedic implants, tissue ablation tools, and navigation consumables. They are also in the verification and validation phase for their robotic products, aiming for a 510(k) submission to the FDA in the second half of 2024.
Recently, Monogram achieved significant milestones, including the delivery of their first surgical robot to a major global distributor, marking their entry into commercial revenues. The company's mBŏs robot addresses a major gap in the $19.4 billion knee replacement market, which still relies heavily on manual procedures for approximately 88% of surgeries.
Monogram Technologies continues to advance its commercialization roadmap while exploring new applications for its technology. Their mVision navigation system, aimed at eliminating cart-based tracking and minimizing surgical time, represents another leap forward in orthopedic robotics. As part of their growth strategy, Monogram is also actively seeking partnerships with independent distributors to further expand its market reach.
Visit www.monogramorthopedics.com for more information and the latest updates on their developments.
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.
Monogram Technologies announced a continuous public offering of up to $10 million in units, priced at $2.25 per unit. Each unit includes one share of 8.00% Series D Redeemable Convertible Cumulative Preferred Stock and a warrant to purchase one share of common stock at $3.375 per share. The offering is expected to result in net proceeds of approximately $9.25 million if all units are sold, after estimated commissions and expenses. The Series D Preferred Stock pays an annual dividend of $0.18 per share and is convertible into common stock. The company may redeem the preferred stock at a premium, which declines over time. Digital Offering, is acting as the sole managing selling agent, with the offering being conducted on a "reasonable best efforts" basis.
Monogram Technologies will host an investor and analyst day on June 20, 2024, at its headquarters in Austin, Texas. The event will feature a presentation and Q&A session by CEO Ben Sexson, Founder & Chief Medical Officer Dr. Douglas Unis, CTO Dr. Kamran Shamaei, and CFO Noel Knape. Attendees will see a product demonstration of the mBôs Precision Robotic Surgical System, designed to enhance orthopedic surgeries. The company plans to complete Verification and Validation testing for the mBôs TKA System by Q2 2024 and aims for a 510(k) submission in the second half of 2024. Monogram is also preparing for clinical trials outside the U.S. The event will include tours of the headquarters and cadaver lab, and the company recently shared its Q1 2024 financial results.
Monogram Orthopaedics announced a corporate name change to Monogram Technologies effective May 15, 2024. The AI-driven robotics company, focused on orthopedic surgery, is merging its subsidiary, Monogram Technologies, into the parent company. The ticker symbol will remain 'MGRM'. CEO Benjamin Sexson stated that the new name reflects the company’s evolution and broadening technological applications. Monogram is progressing towards a 510(k) submission for its robotic surgical system, Monogram mBôs™ TKA System, and is developing mVision navigation. The company aims to leverage its robust IP portfolio to drive growth and long-term shareholder value.
Monogram Orthopaedics (NASDAQ:MGRM) reported its Q1 2024 financial results and operational highlights. The company is advancing towards completing Verification and Validation (V&V) testing for its mBôs robot, anticipating a 510(k) submission to the FDA in the second half of 2024. They introduced mVision technology and engaged CRO for OUS clinical trials. Q1 R&D expenses rose to $2.4M from $1.9M in Q1 2023, while G&A expenses increased to $1.1M from $0.8M. Net loss improved to $3.5M from $3.9M. Cash reserves stood at $10.1M on March 31, 2024.
Monogram Orthopaedics Inc. has engaged a global Contract Research Organization (CRO) to oversee its clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System outside the U.S., aiming to accelerate its product pipeline development and commercialization opportunities. The CRO will submit the clinical trial data to local regulators and has experience with successful FDA submissions. Monogram plans to conduct a multi-center TKA clinical trial with the mBôs TKA System using the cemented version of its FDA-cleared mPress TKA implant. The company expects to complete enrollment and study execution expeditiously, leveraging the clinical data for post-launch marketing and international clearance. The clinical trial design follows FDA guidance and regulations for investigations conducted outside the U.S., ensuring compliance with GCP guidelines and other regulatory requirements.