Stereotaxis Niobe System Receives C2 Medical Device Classification in Japan

Stereotaxis STXS announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has classified its Niobe® Magnetic Navigation System as a C2 medical device. The C2 classification recognizes the Niobe system as a new, distinctive technology with clinical benefits and is the highest of five reimbursement categories for medical devices in Japan. The MHLW also approved reimbursement for two electrophysiology (EP) ablation catheters compatible with Niobe magnetic navigation, effective October 1, 2013. Japan's MHLW, which controls the country's reimbursement rates, will establish a more permanent "technical fee" for procedures using the Niobe system during its biennial review of insurance reimbursement pricing for C2 devices before April 1, 2014. Until then and effective October 1, 2013, MHLW authorized a temporary "technical fee" of 343,700 yen (or approximately $3,500) per Niobe procedure, which the Company says sufficiently covers the costs associated with Niobe's disposable unit for catheter advancement (QuikCAS). This milestone represents an important step toward a more permanent reimbursement coverage of the Niobe system in Japan, the second largest medical device market worldwide, behind the U.S. Stereotaxis received Shonin, or regulatory, approval of Niobe in Japan in March and is See full press release