10/31/17 First Clinical Evaluations of Revolutionary OMNIBotics® Active Spacer Robotic Tissue Balancing Device for Robotic-Assisted TKR
Raynham, MA - October 31, 2017 /PRNewswire/ -- OMNIlife science, Inc. ("OMNI™"), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that they have begun clinical evaluations of their exclusive OMNIBotics Active Spacer robotic tissue balancing device at three U.S. sites. This technology received 510(k) clearance from the FDA on September 1, 2017.
The OMNIBotics Active Spacer, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective.
"I believe that the active spacer technology is the tool we have been looking for to create even better predictability and reproducibility for knee replacement surgery," said Jeffrey M. Lawrence, M.D. Viroqua, WI. "I'm very excited to offer this system to my patients."
Of his early experience, John M. Keggi, MD, Middlebury, CT said, "The active spacer technology is a great step forward that brings the most advanced measurement and analysis tools directly to each patient and surgeon right in the operating room. It's an unprecedented, real-time evaluation of the knee that optimizes each step of the procedure."
Studies indicate that a significant percentage of knee replacement patients do not achieve full satisfaction even with well-placed implants. One potential contributing factor is sub-optimal soft tissue balancing.
"The active spacer is an amazing new technology for knee replacement. It actually shows your surgeon, in real time, how tight or loose your knee is on each side as it bends. This information is then fed into a robot, which plans how your knee is replaced on an individual basis for optimum results," said Amber Randall, MD an orthopedic surgeon in Arizona.
OMNI, a pioneer in robotic-assisted total knee replacement, now offers the only robotic technology that quantitatively drives the total knee replacement surgical procedure with both alignment and ligament balancing. Dr. Randall continues, "I believe that this revolutionary, never before seen technology will get us not one--but several--steps closer to the Holy Grail of knee replacement: the freely moving, perfectly stable and pain free knee."
OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon's ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.
Forward Looking Statements
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms "plans," "believes" or similar expressions are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management's current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI's markets, decrease in the demand for OMNI's products, delays in OMNI's product research and development cycles, decreases in the use of OMNI's principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI's current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI's current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI's sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI's products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.
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