Kinamed Receives Japan Ministry of Health Approval for SuperCable®
June 5, 2014
Kinamed begins SuperCable distribution in Japan with Yufu Itonaga Co., Ltd.
Camarillo, CA June 5, 2014 – Kinamed Inc. announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory clearance for Kinamed’s SuperCable® Iso-elastic, Polymer Cerclage System. MHLW clearance enables Kinamed to begin SuperCable commercialization in Japan through its longtime Japanese distribution partner, Yufu Itonaga Co., Ltd. of Tokyo. The SuperCable System is used in a wide range of orthopedic reconstructive and trauma applications, and it is the only iso-elastic, polymer cerclage system on the market anywhere in the world.
Bob Bruce, Kinamed’s Vice President of Global Sales and Marketing notes that, “The SuperCable polymer cerclage system has been in clinical use in the United States for ten years and has enjoyed tremendous growth as orthopedic surgeons have become focused on issues of metal debris generation and corrosion from metal/metal interfaces in orthopedic implants.” Traditional metal cerclage cables are made up of many tiny braided metal wire filaments that, by the very nature of their construction, result in a large number of metal on metal wear interfaces. According to Mr. Bruce, “the polymer construction of the SuperCable eliminates the potential for such metal particle generation while also offering improved fatigue strength, and an engineered elasticity that allows the cable to flex with dynamically loaded bone.”
Mr. Hironori Sagawa, Yufu Itonaga Surgitec Division Director, commented, “I am very pleased that our company can now offer such a unique and innovative cerclage system to the Japanese orthopedic community. It is exciting to be able to offer a product that has such significant clinical benefits versus older technologies and that also offers important synergies in our product portfolio.” Yufu also represents two other Kinamed product lines in Japan: the CarboJet® CO2 Lavage System used for cleaning and drying the bone bed in cemented arthroplasty procedures and the NeuroPro® Cranial Fixation System used by neurosurgeons for cranial closure.
“We are very appreciative of our very longstanding relationship with Yufu Itonaga and particularly for the work they have done in obtaining the Japanese regulatory approval for SuperCable”, stated Vineet Sarin PhD, Kinamed’s President. According to Dr. Sarin, “Commercializing SuperCable into the Japanese orthopedic market is a major milestone for Kinamed.”
Kinamed offers unique and clinically proven products in the orthopedic reconstructive and neurosurgical products space. A true innovator, the company utilizes proprietary technologies to develop, manufacture and commercialize products that solve significant unmet clinical challenges. The company’s portfolio includes the SuperCable® Polymer Cerclage System and associated cable-plates and trochanteric grips; the CarboJet® CO2 Bone Lavage System; the KineMatch® Patello-Femoral Replacement, a CT based custom arthroplasty technology; the NaviPro® Surgical Navigation System, and the NeuroPro® Cranial Plating System.
For further information please contact Bob Bruce at firstname.lastname@example.org