Boston, MA 10/28/2013 (wallstreetpr) – Stereotaxis Inc (NASDAQ:STXS) has received the highest reimbursement classification in Japan for its Noibe ® Magnet Navigation System. The system now carries C2 medical device classification following the approval by the Ministry of Health, Labor and Welfare in Japan. As such, the technology is regarded as new, distinctive and with clinical benefits. C2 medical device recognition is the highest of the possible five categories for the medical devices reimbursement in Japan.
This reimbursement approval captured two electrophysiology ablation catheters which are compatible with the Noibe ® Magnet Navigation System. The MHLW has authorized a temporary technical fee for the procedures using Noibe system of roughly $3,500 per procedure effective October 1’13. This temporary technical fee is enough to cover the costs of Noibe’s disposable unit for the catheter advancement. A more permanent technical fee for the Noibe system will be established during MHLW’s biennial review of reimbursement pricing of C2 medical devices around April 2014. MHLW is the Japanese organ that controls insurance reimbursement rates.
Stereotaxis has had milestones in Japan, considering that the company received the regulatory approval of the Shonin order from Noibe in March and the company is now identifying customers and scouting for an in-country distributor. Japan is the largest medical devices market behind the U.S. As such, steps towards establishing more permanent insurance reimbursement rates makes a lot of business sense for Stereotaxis and its investors.
Stereotaxis has over 100 patents in interventional surgical suite. The healthcare technology company is the industry innovation leader in robotic cardiology instruments aimed at enhancing treatment of coronary disease, arrhythmias and information management solutions. Stereotaxis systems have obtained regulatory approvals in Europe, Canada, the U.S., Japan and elsewhere. The company’s innovative V-Loop ™ circular catheter manipulator is under clinical trials in pursuit of the U.S. clearance.
In the Friday’s trading, Stereotaxis traded southward, losing 1.24% to settle at $4.76. The company traded nearly three times the daily average volume. It now has $69.67 million in market cap.
