Healthcare Industry News: PLC Systems
News Release - May 17, 2006
PLC Systems' CO2 TMR Heart Laser Technology Receives Marketing Approval in JapanKtec Corporation, PLC's Exclusive Japanese Distributor, Receives Approval From Japanese Ministry of Health to Market Laser Based Angina Relief Therapy
FRANKLIN, Mass., May 17 (HSMN NewsFeed) -- PLC Systems Inc. (Amex: PLC ), a leader in cardiac laser technologies, today reported that Ktec Corporation, PLC's exclusive distributor in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market PLC Systems' first generation CO2 TMR Heart Laser System (HL1) in Japan. CO2 TMR offers a treatment option for angina patients who suffer from severe coronary artery disease. Coronary artery disease is expected to increase as the worldwide population continues to age. Working with leading researchers and premier heart centers around the world, PLC developed the CO2 Heart Laser, which is the world's first TMR angina relief device approved by both the Japanese MHLW and the U.S. Food and Drug Administration.
"We are very pleased to announce Japanese marketing approval for our CO2 TMR Heart Laser," stated Mark R. Tauscher, president and CEO of PLC Systems. "The Japanese approval process included a lengthy review of a Japanese CO2 TMR clinical trial; our CO2 TMR U.S. Phase III clinical trial; as well as scientific literature. We believe the Japan Ministry of Health approval reinforces the strength of the scientific data and clinical evidence that supports the use of CO2 TMR by cardiac surgeons for very sick heart patients."
To date, Tokyo-based Ktec Corporation (formerly known as Imatron Japan, Inc.), has made investments in purchasing our Heart Lasers, funding a clinical trial in Japan, and supporting the regulatory approval process in Japan. Going forward, Ktec will manage the ongoing regulatory, clinical, marketing, and sales activity for CO2 TMR in Japan. For the remainder of 2006, Ktec will begin the process of establishing the TMR market through hosting educational seminars, attending scientific trade shows and conducting training events. Currently, Ktec has 12 HL1s in Japan, which were purchased by Ktec in the mid- 1990's. Ktec, which has more than 20 sales people in Japan, can sell HL1 immediately.
Tauscher continued, "We are pleased that our angina relief technology is now available to the Japanese market. TMR fits very well within the portfolio of tools and technologies that surgeons have to treat the expanding population of heart patients who have limited choices available for revascularization therapies."
About PLC Systems Inc.
PLC Systems is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Mass., PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. Additional company information can be found at http://www.plcmed.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including Ktec may decide not to pursue or continue the sales and marketing activities for the Heart Laser; Ktec may be unsuccessful in selling these products, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, we may be unable to convince health care professionals and third party payers of the medical and economic benefits of the CO2 Heart Lasers, and there can be no assurance that all payers will reimburse health care providers who perform TMR procedures or that reimbursement, if provided, will be adequate, and additional risk factors described in our Report on Form 10-K for the year ended December 31, 2005, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser are trademarks of PLC Systems Inc.
Source: PLC Systems
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