Healthcare Industry News: brachytherapy
News Release - November 1, 2007
SenoRx Announces a Third Symposium Regarding Registry Study for Its Contura Multi-Lumen Balloon CatheterALISO VIEJO, Calif., Nov. 1, 2007 (Healthcare Sales & Marketing Network) -- SenoRx, Inc. (NasdaqGM:SENO ) today announced that it held its third symposium on October 29, 2007 for Contura(tm), its Multi-Lumen Balloon (MLB) Catheter, at the American Society for Therapeutic Radiology and Oncology (ASTRO) Conference in Los Angeles, California.
The event was attended by radiation oncologists and physicists from approximately 30 institutions across the United States. The presenters at the symposium were Douglas W. Arthur, M.D., Professor and Vice Chairman, Department of Radiation Oncology, Virginia Commonwealth University/Massey Cancer Center of Richmond, Virginia; Dorin A. Todor, Ph.D., Assistant Professor, Medical College of Virginia, Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia; and Philip Z. Israel, M.D., Director, The Breast Center, Marietta, Georgia. Dr. Arthur outlined the study protocol, including the clinical endpoints for the Contura Registry Study, while Dr. Todor described the appropriate dosimetric models as they apply to Contura and provided an overview of the physics training tools available to users of Contura. Dr. Israel spoke on the early patient experiences with Contura.
The study will evaluate the clinical outcomes of approximately 500 patients for five years. Endpoints of the study will evaluate dosimetric parameters, local disease control and cosmetic endpoints. The company further hopes to demonstrate that the Contura design enables clinicians to increase the number of patients technically eligible for accelerated partial breast irradiation (APBI).
SenoRx President and Chief Executive Officer Lloyd Malchow said, ``We are pleased with our progress related to introducing Contura to selected institutions. We believe it is important for the radiation oncologists, physicists and surgeons to work together as a team for partial breast radiation treatment planning and patient management, and in this regard, this symposium was successful. Meetings such as this one give us an excellent opportunity to enhance the quality of clinical education that we provide to our customers. We are developing novel devices that would extend and improve the currently accepted treatment paradigms.''
SenoRx received 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007 for Contura(tm), its Multi-Lumen Balloon (MLB) Catheter delivering brachytherapy to the surgical margins following lumpectomy for breast cancer. Contura 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 can play an important role in the shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. Some patients who are presently 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. The first uses of Contura took place in late June 2007, at two clinical sites. SenoRx has subsequently expanded the use of Contura to additional clinical sites.
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 18 products having 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.
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 future clinical development plans for Contura 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 prospectus dated March 29, 2007 and its most recent quarterly report on Form 10-Q, in each case 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.
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