OMNIlife science, Inc. ("OMNI™"), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today the first clinical use of a novel robotic tissue balancing device for use with OMNI's market-leading OMNIBotics® robotic-assisted total knee replacement technology platform. The successful initial procedure took place in Sydney, Australia and was performed by Dr. Brett Fritsch, MD, FRACS, who is also a member of OMNI's surgeon clinical evaluation and research team. The device has received the CE Mark and a 510(k) has been submitted to FDA for clearance in the United States.
The OMNBotics system enables optimized knee implant placement using robotics driven by OMNI's proprietary ART™ software. With more than 13,000 OMNIBotics procedures performed to date worldwide, it provides patient-specific procedures and eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.1 This new robotic tissue balancing device takes patient-specificity one step further and customizes the procedure not only from a skeletal perspective but also from a soft tissue perspective.
"The OMNIBotics tissue balancer provides dynamic real time feedback on the interplay between the soft-tissue envelope and bone cuts in Total Knee Replacement," said Dr. Brett Fritsch. "Providing a quantitative tool to actively manage soft tissue in combination with the accuracy of a robotic bone cutting guide has the potential to be a significant step forward towards a more natural feeling knee replacement for the patient."
"The main objective of the OMNI robotics development program is to leverage the capabilities of robotics to assist orthopaedic surgeons in improving patient outcomes at a lower overall cost for the episode of patient care," said Rick Randall, OMNI CEO. "Our surgeon customers believe a properly aligned and balanced knee throughout the entire range of motion will lead to optimized patient outcomes. The unique capability of robotic-assisted soft tissue balancing, added to the OMNIBotics alignment of the APEX Knee™ is an exciting breakthrough that further advances our value-based outcomes goals."