Healthcare Industry News: ICE Catheter
News Release - March 25, 2013
Stereotaxis Receives Regulatory Approval of Niobe(R) Technology in Japan; Begins Commercialization EffortsST. LOUIS, March 25, 2013 -- (Healthcare Sales & Marketing Network) -- Stereotaxis, Inc. (STXS) announced today that it has received regulatory approval of its Niobe(R) 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.
Mr. Mills adds that the Niobe's demonstrated strength in significantly reducing radiation exposure to physicians and patients will be particularly appealing to a Japanese society highly sensitive to radiation risk. The Company looks forward to showcasing its Niobe technology for prospective Japanese clients at the annual Heart Rhythm Society (HRS) scientific session in May and the Japanese HRS meeting in July.
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. With over 100 patents for use in a hospital's interventional surgical suite, Stereotaxis helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced collaboration of life-saving information. Stereotaxis' core technologies are the Niobe(R) ES Remote Magnetic Navigation system, the Odyssey(R) portfolio of lab optimization, networking and patient information management systems and the Vdrive(TM) Robotic Mechanical Navigation system and consumables.
The core components of Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. The V-Loop(TM) circular catheter manipulator is currently in clinical trials in order to obtain clearance by the U.S. Food and Drug Administration; the Company also is pursuing U.S. clearance for the V-Sono(TM) ICE Catheter manipulator. For more information, please visit www.stereotaxis.com and www.odysseyexperience.com.
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, our continued access to capital and financial resources on a timely basis and on terms that are acceptable, our continued listing on the Nasdaq Global Market, continued acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase our systems and the timing of such purchases, the outcome of various shareholder litigation recently filed against us, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
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