Monogram Technologies Inc. (Monogram) develops a product solution architecture with the long-term goal to enable patient-optimized orthopaedic implants economically at scale by linking 3D printing and robotics with advanced pre-operative imaging.
The company has a robot prototype that can autonomously execute optimized paths for high precision insertion of implants in simulated cadaveric surgeries. Monogram intends to produce and market robotic surgical equipment and related software, orthopaed...
Monogram Technologies Inc. (Monogram) develops a product solution architecture with the long-term goal to enable patient-optimized orthopaedic implants economically at scale by linking 3D printing and robotics with advanced pre-operative imaging.
The company has a robot prototype that can autonomously execute optimized paths for high precision insertion of implants in simulated cadaveric surgeries. Monogram intends to produce and market robotic surgical equipment and related software, orthopaedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. The company has obtained 510(k) clearances for certain implants but has not yet made 510(k) premarket notification submissions or obtained 510(k) premarket clearances for any of robotic products. FDA 510(k) premarket clearance is required to market the company’s robotic products.
Principal Products and Services
Monogram’s primary business will be to market orthopaedic implants insertable with the company’s orthopaedic robot (which it has named mBôs), if and when it obtains 510(k) premarket clearance. Monogram has licensed FDA cleared generic implants and the development and 510(k) premarket clearance of the company’s robotic system remains its focus. The company plans to execute an incremental, multi-generational product release strategy, starting with generic knee implants prepared with its robotic system.
Near-Term Product Focus
The company is executing a phased commercialization approach whereby it initially plans to launch its robotic system to prepare bone for Monogram’s generic implants with the intention of introducing and seeking 510(k) premarket clearance for more novel implants later. The company’s generic implants are based on licensed implants that it, with assistance from the licensor, has upgraded to be competitive with the current state of the art.
On July 1, 2020, the company entered into a non-exclusive licensing and distribution agreement with a medical technology company for an FDA-approved total knee system, FDA-approved partial knee system, and FDA-approved total hip system.
The company has successfully completed all required testing for this modified implant, and the licensor has submitted a Letter of File for the modifications made to the licensed implants, having determined that no regulatory submissions to FDA are required. The company intends for this modified implant to be Monogram’s first-generation press-fit implant to be used with its surgical robot, if and when the surgical robot receives clearance from the FDA.
In the first quarter of 2023, Monogram completed a pre-submission meeting with the FDA in relation to its planned 510(k) premarket notification submission for its robot to, among other things, determine whether clinical data will be required with the company’s 510(k) premarket notification submission for its robot. Monogram completed a pre-submission meeting with the FDA in December 2023 and anticipates an additional pre-submission meeting with the FDA in Q2 2024. The company has presented the FDA with significant portions of its Verification and Validation test plans, including a synopsis of its Clinical Investigation Plan that it intends to conduct outside the United States (OUS). The company has retained an international Contract Research Organization, has identified OUS clinical sites and investigators, and is actively working through the regulatory process.
The company has been exploring the technical feasibility of a semi-active system (an embodiment that would not allow for remote operation) that it anticipates could minimize cited technical differences with its predicate and potentially obviate the need for clinical data with its 510(k) submission. The company is exploring submitting a semi-active modality 510(k) first without clinical data and then submitting for the active modality after obtaining OUS clinical data. This approach is still under investigation but could theoretically be favorable to the company’s commercialization timeline.
Market
The company intends to market its products to orthopaedic surgeons, hospitals (or other medical facilities), and patients globally. The company’s ideal customers are hospitals and outpatient facilities in high population metropolitan regions that employ high-volume technology-focused surgeons. The company is considering including clinical data obtained outside the United States with its 510(k) submission. In the United States, provided the company obtains FDA approval for its surgical robotic system.
History
The company was founded in 2015. It was incorporated in 2016. The company was formerly known as Monogram Orthopaedics, Inc. and changed its name to Monogram Technologies Inc. in May 2024.
