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 has received regulatory approval from India's CDSCO to begin clinical trials of its mBȏs TKA System for knee replacement surgery. The company will conduct a 102-patient, multi-center study in partnership with Shalby Hospitals, one of the world's largest orthopedic hospital groups.
The trial will evaluate the safety and effectiveness of the Monogram TKA System with the Consensus CKS implant. Patient enrollment is expected to begin shortly, with first surgeries anticipated within 90 business days. The company has already delivered training systems and hosted investigator meetings in Ahmedabad, India.
The clinical investigation is supported by Reliance Life Sciences, which manages regulatory submissions in India. Dr. Vikram I. Shah, Shalby Hospitals' Founder and Chairman, recently featured in TIME Magazine Asia Edition, endorsed the mBȏs System as the most advanced robotic technology in orthopedic medicine.
Monogram Technologies has received regulatory approval from India's CDSCO to import its mBôs TKA System for a clinical trial. The study, conducted with Shalby Hospitals, will evaluate the safety and effectiveness of their robotic knee replacement system across multiple centers in India.
Key highlights:
- 102 total knee replacement procedures planned
- Three-month clinical follow-up period
- First surgeries expected within 90 business days
- Training version already delivered in January
- Full-time employees will be deployed to India for support
The partnership with Shalby, one of the world's largest orthopedic hospital groups, and support from Reliance Life Sciences marks a significant step in advancing orthopedic innovation globally. The trial aims to demonstrate the system's performance in real surgical settings, including technically demanding cases, as Monogram progresses toward commercial launch.
Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company specializing in orthopedic surgery, has announced a strategic partnership with Urvin to launch an exclusive, verified shareholder communication platform.
The new platform creates a private message board exclusively for verified, active Monogram shareholders, enabling direct communication between investors while providing the company with an efficient channel for important updates. Access to the community is contingent on maintaining active share ownership, ensuring discussions remain focused among those with current investments.
Shareholders can join the platform by registering at urvin.finance using their transfer agent-registered email address and accessing the Verified Shareholder Communities section. This initiative aims to enhance shareholder engagement and streamline corporate communications, particularly during key company events.
Monogram Technologies (NASDAQ:MGRM) has received FDA 510(k) clearance for its Monogram mBôs TKA System, a robotic-assisted technology for total knee arthroplasty. The system is designed to deliver enhanced safety, efficiency, and accuracy in knee replacement procedures.
The clearance allows Monogram to market the device under the Federal Food, Drug, and Cosmetic Act's provisions. The company plans to integrate recent upgrades to the cutting system and other enhancements to strengthen its market competitiveness.
Monogram's commercialization strategy includes:
- Initial placements with key surgeon KOLs in strategic locations
- System demonstrations in real-world surgical settings
- Potential international expansion, including clinical trials in India with Shalby
- Development of additional clinical applications to establish it as a multi-application platform
Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company focused on orthopedic surgery, has reported its financial results for Q4 and full-year 2024. Key highlights include:
The company completed supplemental testing and submitted its response to the FDA's Additional Information Request (AIR) for their mBȏs™ Total Knee Arthroplasty System. They are awaiting FDA clearance for commercialization in the US.
Financial highlights for 2024:
- R&D expenses decreased 17% to $8.8 million
- Marketing expenses reduced 30% to $2.1 million
- G&A expenses increased 9% to $4.4 million
- Net loss of $16.3 million
- Cash position of $15.7 million as of December 31, 2024
Notable achievements include:
- Closed an oversubscribed $13 million public offering
- Advanced partnership with Shalby for clinical trials in India
- Named Orthopedic Joint Replacement Company of the Year 2024
- Management completed $1 million in open market stock purchases
Monogram Technologies (NASDAQ:MGRM) has reported its financial results for Q4 and full year 2024. The company completed supplemental testing and submitted its response to the FDA's Additional Information Request (AIR) for its mBȏs™ TKA System. Key highlights include:
- Closed an oversubscribed $13M public offering
- Management purchased $1M of common stock in open market
- Named Orthopedic Joint Replacement Company of the Year 2024
Financial results for FY2024:
- R&D expenses: $8.8M (down 17% YoY)
- Marketing expenses: $2.1M (down 30% YoY)
- G&A expenses: $4.4M (up 9% YoY)
- Net loss: $16.3M (vs $13.7M in 2023)
- Cash position: $15.7M as of December 31, 2024
The company is advancing its collaboration with Shalby for clinical trials in India and awaiting FDA clearance decision for U.S. commercialization.
Monogram Technologies (NASDAQ: MGRM), an AI-driven robotics company specializing in orthopedic surgery solutions, has announced its participation in the upcoming 37th Annual ROTH Conference. The event will take place from March 16-18, 2025, at the Laguna Cliffs Marriott Resort & Spa in Dana Point, California.
The company will be represented by CEO Ben Sexson and CFO Noel Knape, who will conduct one-on-one meetings with institutional investors during this invitation-only event. Interested investors can schedule meetings through their conference representatives or by contacting MGRM@mzgroup.us or Chris Tyson at (949) 491-8235.
Monogram Technologies (NASDAQ:MGRM), an AI-driven robotics company specializing in orthopedic surgery, has scheduled its Q4 and Full Year 2024 financial results conference call for March 12, 2025, at 4:30 p.m. Eastern Time. The event will feature CEO Ben Sexson and CFO Noel Knape, who will present the company's financial performance for the period ending December 31, 2024, along with regulatory updates and key milestones.
A detailed press release will be issued before the call, and the presentation will be accessible through the company's investor relations website. Participants can join the webcast through the provided StreamYard link, with a Q&A session following the main presentation.
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.
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