BioSphere Medical Announces That a Live-Case and Scientific Presentation Featuring BioSphere's QuadraSphere Microspheres Are Scheduled at the 2007 International Symposium on Endovascular Therapy.ROCKLAND, Mass. -- BioSphere biosphere, irregularly shaped envelope of the earth's air, water, and land encompassing the heights and depths at which living things exist. The biosphere is a closed and self-regulating system (see ecology), sustained by grand-scale cycles of energy and of Medical (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BSMD) announced today that a live-case demonstration using its QuadraSphere[TM] Microspheres ("QuadraSphere") in a tumor embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun) 1. the process or condition of becoming an embolus. 2. therapeutic introduction of a substance into a vessel in order to occlude it. procedure will be conducted at the International Symposium on Endovascular Therapy The International Symposium on Endovascular Therapy (ISET) is an educational meeting for physicians, scientists, engineers and allied health professionals working in the multidisciplinary field of peripheral and cardiac interventional medicine. ("2007 ISET") on February 1, 2007 in Hollywood, Florida. The procedure will be performed at the Baptist Cardiac and Vascular Institute and broadcast to the 2007 ISET audience live via closed-circuit television. Located in Miami, Florida, the Baptist Cardiac and Vascular Institute is an affiliate of Baptist Health South Florida, the largest not-for-profit healthcare organization in the region. This event has been organized by James Benenati, M.D., Medical Director of the Peripheral Vascular Laboratory at Baptist Cardiac and Vascular Institute, and a featured speaker at the 2007 ISET. QuadraSphere will also be the subject of a 2007 ISET scientific presentation given by Dr. Benenati entitled, "New Spherical Embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism. em·bol·ic adj. 1. Relating to, or caused by an embolus or embolism. 2. Relating to emboly. Agent for the Treatment of Liver Tumors." Dr. Benenati commented, "Early results suggest QuadraSphere is a promising new technology. This technology is now gaining international recognition with over 1,700 cases having been performed to date in the United States, Europe and Japan. We expect to see more scientific studies and further presentations on QuadraSphere technology throughout the year and look forward to reviewing such studies and presentations." Gary Saxton, BioSphere Medical's executive vice president and chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , commented, "Dr. James Benenati has done pioneering work in the area of vascular therapy, including participating in national trials involving embolization for the treatment of uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. . We appreciate his leadership and that of the Baptist Cardiac and Vascular Institute. This live, closed-circuit broadcast at one of the industry's premier scientific meetings provides QuadraSphere with a unique opportunity, less than three months after its approval by the U.S. Food and Drug Administration, to be seen by interventional radiologists and healthcare professionals from around the world and physicians who will be attending the ISET conference." About QuadraSphere Microspheres QuadraSphere Microspheres ("QuadraSphere"), which are indicated to treat hypervascularized tumors and peripheral arteriovenous malformations Arteriovenous Malformations Definition Arteriovenous malformations are blood vessel defects that occur before birth when the fetus is growing in the uterus (prenatal development). The blood vessels appear as a tangled mass of arteries and veins. , are delivered by interventional radiologists who perform embolization procedures. Embolization is an image-guided, minimally invasive therapy that selectively occludes the blood supply of benign or malignant hypervascularized tumors. QuadraSphere's technical attributes are designed to provide a unique and versatile embolization platform. Its spherical shape is designed to allow for a predictable, flow-directed occlusion. The product has been demonstrated to rapid expand to four times its dry-state diameter and thus absorb aqueous media up to 64 times its dry-state volume. In addition to the absorption process, the negatively charged polymer is also capable of selective bonding with positively charged substances through ionic interaction. Also, QuadraSphere is designed to afford atraumatic atraumatic /atrau·mat·ic/ (a?traw-mat´ik) not producing injury or damage. atraumatic not producing injury or damage. atraumatic adjective Without injury conformability con·form·a·ble adj. 1. Corresponding; similar: plans that are conformable to your wishes. 2. Quick to comply; submissive. 3. to the vessel architecture, leading to a more complete vessel occlusion. QuadraSphere is technically identical to BioSphere's HepaSphere[TM] Microspheres, an embolic currently marketed in Europe. Although QuadraSphere is indicated to treat hypervascularized tumors and peripheral arteriovenous malformations, BioSphere's 510(k) clearance for QuadraSphere does not include specific indications for the treatment of primary and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. . FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regulations require that BioSphere conduct formal clinical trials prior to seeking to claim the use of QuadraSphere for the treatment of a specific disease or condition, such as primary and metastatic liver cancer, while European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community regulations do not require trials for this class of medical device. Accordingly, in order for BioSphere to seek FDA clearance to promote the use of QuadraSphere for the embolization of primary and metastatic liver cancer, it must conduct clinical trials in the United States. About BioSphere Medical, Inc. BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, seeks to pioneer and commercialize minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere Not to be confused with Glass microphere. This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life. technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties, which the Company believes have the potential for use in a variety of medical applications. BioSphere's principal focus is the use of its EmboSphere Microsphere product for the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization Uterine Fibroid Embolization Definition Uterine fibroids are growths in the muscular tissue of the womb (uterus). Uterine fibroid embolization is non-surgical removal of the growths through the use of a tubular device called a catheter. , or UFE UFE Uterine Fibroid Embolization UFE United for a Fair Economy UFE Ufficio Federale dell'Energia UFE Uniform Final Examination UFE Urban Challenge Final Event (DARPA) UFE Unidentified Flags and Ensigns UFE Unrestricted Free Agent . The Company's products continue to gain acceptance in this rapidly emerging procedure as well as in a number of other new and established medical treatments. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including, without limitation, statements regarding the expected benefits and market acceptance of QuadraSphere Microspheres and the Company's other products. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intend," and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. There are a number of important factors that may affect the Company's actual performance and results and the accuracy of its forward-looking statements, many of which are beyond the Company's control and are difficult to predict. These important factors include, without limitation, risks relating to: * the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of QuadraSphere Microspheres; * the absence of, or delays and cancellations of, product orders; * delays, difficulties or unanticipated costs in the introduction of new products, including, without limitation, the Company's QuadraSphere Microspheres and its other microsphere and ancillary device products that have recently been approved for marketing and sale; * the failure of the Company to achieve or maintain necessary regulatory approvals, either in the United States or internationally, with respect to the manufacture and sale of its products and product candidates; * competitive pressures; * the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates; * the inability of the Company to raise additional funds in the near term to finance the development, marketing, and sales of its products; * general economic and market conditions; and * the risk factors described in the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2006, as filed by the Company with the Securities and Exchange Commission, and described in other filings made by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's estimates as of the date of this release. The Company anticipates that subsequent events and developments may cause its forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances after the date of this press release. |
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