ALISO VIEJO, Calif., June 28, 2007 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced the first procedures using its new Multi-Lumen Radiation Balloon at two clinical sites. SenoRx received 510(k) clearance from the U.S. Food and Drug Administration to market its Multi-Lumen Radiation Balloon for brachytherapy on May 23, 2007. The procedures took place at two of the five initial sites where the balloon is being introduced.
SenoRx is performing pre-launch activities for its balloon through 2007, in preparation for full commercial launch in 2008. The balloon is being introduced to select clinical sites where initial evaluation is being conducted prior to beginning further clinical and market testing studies. Certain patients are currently excluded from balloon brachytherapy because of the location of the lesion within the breast. Because the multi-lumen approach may address this issue, the company believes that it may better quantify the increased number of patients that could become eligible for short-term, partial-breast radiation therapy as a result of the new balloon product, and thereby expand the product's commercial opportunity.
About SenoRx
SenoRx (Nasdaq:SENO), which completed its initial public offering of common stock in March 2007, develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis of breast cancer. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 17 products that have already received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the timing of full commercial launch of the Multi-Lumen Radiation Balloon, SenoRx's ability to successfully expand the balloon market, and offer a solution for patients that are not otherwise candidates for balloon therapy, are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its quarterly report on Form 10-Q as filed with the Securities and Exchange Commission on May 15, 2007. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.