OMNIlife science™, Inc. Receives 510(k) Clearance from FDA for Revolutionary Robotic Tissue Balancing Device
AYNHAM, Mass., Sept. 6, 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 the FDA has issued 510(k) clearance for its proprietary robotic tissue balancing device which is used with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement technology platform.
This new technology, 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 perspective as well as a soft tissue perspective.
“Our proprietary Active Spacer technology represents a unique and significant step in the development of our OMNIBotics robotic platform. We have been convinced that a perfect knee alignment is not enough to enable good outcomes for our surgeons and their patients,” said Guy Mayer, Executive Chairman of OMNI’s Board of Directors. “We believe that our surgeons can now perform the perfect total knee replacement with our innovative robotic soft tissue balancing technology coupled with the optimum knee alignment provided by our OMNIBotics technology.”
The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART™ software. With more than 16,000 OMNIBotics procedures performed to date worldwide, it 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.1,2
“This is a major milestone for both OMNI and for the orthopedic market,” stated Christian Joly, Vice President of Robotics at OMNI. “We are now the only company in the world to provide a robotic technology to quantitatively drive the total knee replacement surgical procedure with both alignment and ligament balancing.”
1Koenig JA, Suero EM, Plaskos C: Surgical Accuracy and Efficiency of Computer-Navigated TKA with a Robotic Cutting Guide – Report on First 100 Cases. J Bone Joint Surg Br 2012 vol 94-B no. SUPP XLIV 103.
2Revenga C, et al, Computer-Assisted Navigation Versus Conventional Total Knee Arthroplasty In A Spanish Multicenter Study. 16th EFORT Congress. London. 2014.
ABOUT OMNI
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.
CONTACT
Cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444
cholloway@omnils.com
SOURCE OMNIlife science, Inc.
