Healthcare Industry News: surgical margin
News Release - May 23, 2007
SenoRx Announces 510(k) Clearance for Its Multi-Lumen Radiation Balloon
ALISO VIEJO, Calif., May 23, 2007 (Healthcare Sales & Marketing Network) -- SenoRx (NasdaqGM:SENO ) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Multi-Lumen Radiation Balloon Applicator for brachytherapy. The Multi-Lumen Radiation Balloon is intended to provide brachytherapy to the surgical margins following lumpectomy for breast cancer. The company believes that its Multi-Lumen Radiation Balloon can play an important role in the paradigm shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. The radiation balloon uses vacuum to remove excess fluid and to adhere closely to often irregularly shaped lumpectomy cavities in order to deliver precise radiation dosing through multiple seed lumens.``We are excited at the prospect that our radiation balloon product may actually expand the balloon market,'' said Lloyd Malchow, SenoRx President and Chief Executive Officer. ``Certain patients who are presently candidates for balloon therapy are currently excluded because of the location of the lesion relative to their breast size. Our multi-lumen approach offers a solution to this problem.''
The company expects to ship product for post-FDA clearance human clinical trials supporting marketing claims and host clinical education events in the second half of 2007. Full launch of the Radiation Balloon product is expected in early 2008.
About SenoRx
SenoRx (NasdaqGM: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 16 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 http://www.senorx.com.
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 SenoRx's ability to successfully expand the balloon market, offering a solution for patients that are not otherwise candidates for balloon therapy, as well as statements about the timing of full commercial launch of the Multi-Lumen Radiation Balloon, 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.
Source: SenoRx
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