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Monogram Granted Regulatory Approval to Import mBôs TKA System for Clinical Investigation
Patient Enrollment will Begin Shortly; First Live Patient Surgeries are Anticipated within 90 Business Days
Critical Milestone Achieved for Multi-Center Clinical Trial in India with Strategic Partner Shalby Hospitals for the mBȏs TKA System
Monogram May Market the Monogram mBôs™ TKA System, Subject to the Requirements of the Federal Food, Drug, and Cosmetic Act (the Act).
The Company is Preparing for Commercialization and Evaluating Strategies to Support the Adoption of its Robotic-Assisted Technology
Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)
Management to Host Business Update Conference Call on Wednesday, March 12, 2025, at 4:30 p.m. Eastern Time
Company has Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)
Investigator Meeting and Clinical Trial Training Held at the Shalby Hospital in Ahmedabad, India
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
Closed an Upsized and Oversubscribed $13 Million Public Offering to Fund Near-term Commercialization Milestones
Management to Host Business Update Conference Call on Tuesday, November 19, 2024 at 4:30 p.m. Eastern Time
Award from Medical Tech Outlook Highlights Monogram's mBôs TKA System
Submitted FDA 510(k) Application and Passed FDA Administrative Review for the mBôs TKA System
Secured Initial Strategic Multicenter Clinical Trial Collaboration with Shalby Limited
Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time
Clinical Trial Collaboration Follows 510(k) Submission and Passing of FDA Administrative Review; Preludes Planned International Launch for the mBȏs TKA System
Strategic Partner Shalby is Recognized as one of the Leading Institutions for Orthopedic Surgeries Worldwide, Performing Over 14,000 Annual Knee Replacement Surgeries Globally
Application was Submitted on July 19, 2024, Passed the FDA Administrative Review, and is Now Under Substantive Review
FDA Decision is Expected Within 90 Days of Initial Submission; However, the Process May be Paused if Additional Information is Requested
Management to Showcase Product Demonstration of mBôs Precision Robotic Surgical System and mVision Technologies
New Name Reflects Continued Evolution as an AI-Driven Robotics Company with a Strong IP Position
Verification and Validation Testing Expected to be Largely Complete in Q2 2024; 510(k) Submission with FDA Accelerated for Second Half of 2024
Engaged Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S.
Management to Host Business Update Conference Call on Wednesday, May 22 at 4:30 p.m. Eastern Time
CRO Expands Clinical Capabilities, Accelerating Product Pipeline Development and Commercialization Opportunities
510(k) Submission with FDA Accelerated for Early Second Half of 2024