ALISO VIEJO, Calif., July 1, 2008 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a second Contura(tm) MLB short-term breast radiation balloon design.
"The novel proprietary design of our newest Contura Multi-Lumen Radiation Balloon (MLB) Catheter allows the clinician greater flexibility in appropriately fitting the lumpectomy cavity with a balloon catheter," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "The new-size Contura balloon may be appropriate for approximately 10 to15 percent of patients where a larger balloon is warranted and will allow us to compete for these cases. The product is currently being evaluated at several clinical sites and is expected to become generally available during the third quarter of 2008. The original Contura is 4 to 5 centimeters in diameter, while the new balloon can be used for larger lumpectomy cavities ranging from 5 to 6 centimeters in diameter."
About Contura(tm)
SenoRx received 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007 for Contura(tm), its Multi-Lumen Radiation Balloon (MLB) catheter for delivering radiation to the tissue surrounding the lumpectomy cavity following surgery for breast cancer. For appropriate patients, Contura MLB is one of a new class of devices which can reduce treatment time to five days from six to eight weeks. SenoRx believes that the Contura MLB may play an important role in the shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. Some patients who are potential candidates for balloon therapy are currently excluded because of the location of the lesion and their breast size. Contura's advanced multi-lumen design may address this issue for certain patients. In addition, the Contura MLB uses vacuum to remove excess seroma and air to enhance conformance of often irregularly shaped lumpectomy cavity walls to the balloon surface in order to deliver precise radiation dosing through multiple radiation source lumens. SenoRx has been granted three patents related either to the design or manufacturing of Contura MLB. The first procedures using the original Contura MLB took place in late June 2007.
About SenoRx
SenoRx (Nasdaq:SENO) develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its EnCor(r) vacuum-assisted breast biopsy system and Contura(tm) MLB catheter for delivering radiation to the tissue surrounding the lumpectomy cavity following surgery for breast cancer. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. In addition, SenoRx has recently launched several of its products through distributors in more than 15 countries outside the U.S. and Canada. The company's line of breast care products includes biopsy disposables, biopsy capital equipment, diagnostic adjunct products and therapeutic disposables. SenoRx is developing additional minimally invasive products for the 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 second Contura MLB, including its expected uses and expected commercial launch, 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. Information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its most recent quarterly report on Form 10-Q, as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks 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.