LOS ANGELES, Nov. 5 Cardo Medical(OTC Bulletin Board: CKST), a company engaged in the development of orthopedicmedical devices, announces the FDA 510k clearance of its Align 360 Total KneeSystem. The Align 360 Total Knee System is planned for commercial releaseduring the second quarter of 2009. Cardo Medical's innovative Total KneeSystem is the flagship product within its Align 360 platform, which hasalready received FDA clearance for its Uni-Compartmental and Patello-Femoralsystems. All three systems feature a unique modular approach and commoninstrumentation system with a revolutionary concept designed to deliversimplified, reproducible surgical outcomes. Cardo Medical's Uni-CompartmentalSystem, which was the first product release within the Align 360 platform, hasbeen used successfully in over 500 surgeries to date.
John Kuczynski, Cardo Medical's Vice-President of Research andDevelopment, commented: "The Align 360 Total Knee System is truly an advancedknee platform. Its femoral component features a funnel-shaped patella trackthat accommodates the quadriceps angle anatomy for both male and femalepatients, without the need for gender specific components which provides atremendous inventory savings for all operating rooms. In addition, theanterior geometry of the femoral component has been designed to reduceantero-medial overhang of the femoral component, which has been clinicallyproven to be a cause of post-operative knee pain."
Dr. Andrew Brooks, Chairman and Chief Executive Officer of Cardo Medical,stated: "We are pleased to have achieved this regulatory milestone and areexcited to have rounded out our Align 360 platform. Our Total Knee Systembuilds upon our Uni-compartmental and Patella-Femoral systems and is designedas a high performance treatment for tri-compartmental arthritis with choice ofeither a cruciate sparing or posterior stabilizing device. We now have aunique and comprehensive knee system which allows the surgeon to use matchedinstrumentation for surgical treatment of uni-compartmental, bi-compartmentaland tri-compartmental arthritis. Our Align 360 platform boasts a common,modular instrument set and component design heritage and philosophy. Ournovel, minimally invasive instrumentation is designed to enable surgeons toachieve superior surgical outcomes. Cardo Medical looks forward to introducingthese and other orthopedic design innovations to the US market over theupcoming quarters."
About Cardo Medical, Inc.
Cardo Medical (OTC Bulletin Board: CKST) develops reconstructiveorthopedic and spinal surgery products through advanced engineering andfocuses on product development, marketing and distribution within the USmarket. Cardo Medical's superior engineering talent closely collaborates withleading surgeons around the country to create products that reduce oreliminate joint pain and allow patients to achieve more active lives. Thecompany's cutting edge products are specifically developed with patients,surgeons and OR staff in mind and are designed to reduce operative time,enhance surgical technique, shorten hospital stays, reduce recovery time andimprove outcomes. Cardo Medical's product portfolio includes devices for knee,hip, spinal fusion and motion preservation arthroplasty and replacement, manyof which have already received FDA clearance. Cardo Medical has a robust andinnovative product pipeline pending both USPTO and FDA submission andclearance.
Cardo Medical works in small, focused development teams in concert withphysicians to rapidly develop products from concept to launch. We arecommitted to exceeding the standards by which any device company is judged.Please visit our website at http://www.cardomedical.com for more informationon the Align 360 Total Knee System in addition to our portfolio of otherReconstructive and Spinal Implant systems.
This press release contains "forward-looking statements," as that term isdefined under the Private Securities Litigation Reform Act of 1995 (PSLRA),regarding product development efforts and other non-historical facts aboutexpectations, beliefs or intentions regarding the business, technologies andproducts, financial condition, strategies or prospects. Many factors couldcause actual activities or results to differ materially from the activitiesand results anticipated in forward-looking statements. These factors includethose described in our filings with the Securities and Exchange Commission, aswell as risks inherent in funding, developing and obtaining regulatoryapprovals of new, commercially-viable and competitive products and treatments,including the risks that any products under development may fail, may notachieve the expected results or effectiveness and may not generate data thatwould support the approval or marketing of products for the ailments beingstudied or for other ailments. In addition, forward-looking statements alsomay be adversely affected by general market factors, competitive productdevelopment, product availability, federal and state regulations andlegislation, the regulatory process for new products and indications,manufacturing issues that may arise, patent positions and litigation, amongother factors. We do not undertake any obligation to update forward-lookingstatements. We intend that all forward-looking statements be subject to thesafe-harbor provisions of the PSLRA.
CONTACT: Cardo Medical, Inc.Andrew A. Brooks, M.D., CEO (310) 274-2036
SOURCE Cardo Medical, Inc.