Monogram Engages Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S. - Seite 2

While the clinical study is focused primarily on providing safety data, the Investigators may also collect additional data that could be helpful for post-launch marketing. Such data could include detailed accuracy studies (for example, physical measurements of bone cuts and post-operative laxity gaps) and time studies that researchers could correlate to surgical time and learning curve.

Sexson continued, "The Company continues to see a significant and growing market opportunity for an active cutting robotic system that does not utilize haptic controls. We believe that press fit knee adoption and robot utilization go hand in hand. The IP landscape has created interesting dynamics in orthopedics. We continue to believe there is a significant and growing opportunity for a next-generation active cutting robot that can efficiently resect bone. An OUS clinical pipeline will be helpful for Monogram to try and capitalize on any potential market product gaps."

About Monogram Orthopaedics

Monogram Orthopaedics (NASDAQ: MGRM) is working to develop a product solution architecture with the long-term goal of enabling patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. The Company has a robotic system that can autonomously execute optimized paths for high-precision insertion of implants in synthetic bone specimens. Monogram intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. The Company has not yet made 510(k) premarket notification submissions or obtained 510(k) clearances for its robotic products. FDA approval is required to market these products, and the Company has not obtained FDA approval for any of its robotic products, and it cannot estimate the timing or assure the ability, to obtain such clearances.

Monogram Orthopaedics is working to advance the way orthopedic surgery is done. Our system is being developed to combine personalized knee implants with precision robotic surgical systems to give patients a better-fitting knee replacement with minimally invasive surgery. One hundred thousand knee replacements failing each year in a $19.4B market represents an enormous opportunity for us.