ST. LOUIS, March 25, 2013 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (Nasdaq:STXS) announced today that it has received regulatory approval of its Niobe® remote magnetic technology for cardiac ablations in Japan, a critical milestone in securing full market entry into the country. This approval allows the Company to begin marketing efforts, including establishing a local business infrastructure with in-country distributors, while working on obtaining reimbursement approval for full market entry, or the ability to initiate sales. Reimbursement approval is expected by the end of 2013.
Approval by the Pharmaceuticals and Medical Devices Agency, Japan's equivalent to the U.S. Food and Drug Administration, follows a successful three-year clinical trial of the Niobe system at the Tokyo Women's Medical University. The clinical trial was led by Dr. Morio Shoda and supported by the Company's industry collaborators in Japan.
William Mills, Chairman of the Stereotaxis Board of Directors, says the Japanese market, the second largest for medical devices behind the U.S., represents a significant growth opportunity for the Company. "An aging population, prominent cardiovascular institutions that embrace new technologies and favorable, universal health coverage create a very attractive environment for us to leverage our one-of-a-kind robotic navigation system," says Mr. Mills. "Our entry into Japan provides opportunity for meaningful growth in the Asia Pacific region and marks a major step towards our vision of becoming the first choice in the treatment of complex electrophysiology ablations for the global marketplace."There are currently 570 hospitals in Japan performing approximately 38,000 electrophysiology (EP) procedures annually, 45% of which are atrial fibrillation (AF) cases. With the highest life expectancy among developed nations – 82.9 years – Japan has a rapidly growing senior population, currently at 23% and expected to reach 40% in the next 50 years. As AF and other arrhythmias are typically present in older individuals, the rate of EP ablations is anticipated to rise with the aging population. By 2018, industry analysts expect the country to experience 12% annual growth in EP procedures and a 22% annual increase in AF cases.