Cardo Medical Announces FDA Clearance Of The Align 360 Total Knee System

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 31 Oct 2008 - 0:00 PDT

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Cardo Medical (OTC Bulletin Board: CKST), a company engaged in the development of orthopedic medical devices, announces the FDA 510k clearance of its Align 360 Total Knee System. The Align 360 Total Knee System is planned for commercial release during the second quarter of 2009. Cardo Medical's innovative Total Knee System is the flagship product within its Align 360 platform which has already received FDA clearance for its Uni-Compartmental and Patello-Femoral systems. All three systems feature a unique modular approach and common instrumentation system with a revolutionary concept designed to deliver simplified, reproducible surgical outcomes. Cardo Medical's Uni-Compartmental System, which was the first product release within the Align 360 platform, has been used successfully in over 500 surgeries to date.

John Kuczynski, Cardo Medical's Vice-President of Research and Development, commented, "The Align 360 Total Knee System is truly an advanced knee platform. Its femoral component features a funnel-shaped patella track that accommodates the quadriceps angle anatomy for both male and female patients, without the need for gender specific components which provides a tremendous inventory savings for all operating rooms. In addition, the anterior geometry of the femoral component has been designed to reduce antero-medial overhang of the femoral component, which has been clinically proven 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 are excited to have rounded out our Align 360 platform. Our Total Knee System builds upon our Uni-compartmental and Patella-Femoral systems and is designed as a high performance treatment for tri-compartmental arthritis with choice of either a cruciate sparing or posterior stabilizing device. We now have a unique and comprehensive knee system which allows the surgeon to use matched instrumentation for surgical treatment of uni-compartmental, bi-compartmental and tri-compartmental arthritis. Our Align 360 platform boasts a common, modular instrument set and component design heritage and philosophy. Our novel, minimally invasive instrumentation is designed to enable surgeons to achieve superior surgical outcomes. Cardo Medical looks forward to introducing these and other orthopedic design innovations to the US market over the upcoming quarters."

About Cardo Medical, Inc.

Cardo Medical develops reconstructive orthopedic and spinal surgery products through advanced engineering and focuses on product development, marketing and distribution within the US market. Cardo Medical's superior engineering talent closely collaborates with leading surgeons around the country to create products that reduce or eliminate joint pain and allow patients to achieve more active lives. The company'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 and improve outcomes. Cardo Medical's product portfolio includes devices for knee, hip, spinal fusion and motion preservation arthroplasty and replacement, many of which have already received FDA clearance. Cardo Medical has a robust and innovative product pipeline pending both USPTO and FDA submission and clearance.

Cardo Medical works in small, focused development teams in concert with physicians to rapidly develop products from concept to launch. We are committed to exceeding the standards by which any device company is judged. Please visit our website at http://www.cardomedical.com for more information on the Align 360 Total Knee System in addition to our portfolio of other Reconstructive and Spinal Implant systems.

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development efforts and other non-historical facts about expectations, beliefs or intentions regarding the business, technologies and products, financial condition, strategies or prospects. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that any products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the ailments being studied or for other ailments. In addition, forward-looking statements also may be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. We do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Cardo Medical
http://www.cardomedical.com