Article Published in the Journal of Vascular and Interventional Radiology Supports Long-Term Efficacy and Durability of Embosphere Microspheres.ROCKLAND, Mass. -- BioSphere Medical, Inc. (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 study published in the March 2007 issue of Journal of Vascular and Interventional Radiology interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade concluded that over the long term, 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. ("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 ") using BioSphere Medical's Embosphere[R] Microspheres is safe and effective, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction. The multi center prospective study is entitled "Long-term Outcome from Uterine Fibroid Embolization with Tris-acryl Gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. Microspheres: Results of a Multicenter Study." Spies, et al. The study focused on patients undergoing UFE with tris-acryl gelatin microspheres (TAGM TAGM Technical and Administrative Guidance Memorandum (document for environmental cleanup objectives in NYS) ) - the material that comprises Embosphere Microspheres. Three-year clinical outcomes were assessed. Measures of the outcomes included the Ruta Menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea. men·or·rha·gia n. See hypermenorrhea. Questionnaire, patient self-assessment of symptoms and impact on activities, patient satisfaction, and health-related quality of life as measured by the SF-12 (collectively, "the measurable indices"). Long-term re-intervention rates were also assessed. Among the key findings of the study were: * 72% of patients had known outcomes at three years after treatment. * 88.4% of the patients with known outcomes completed a three-year follow-up without the need for a major intervention. * 8.3% of the patients underwent fibroid fibroid /fi·broid/ (fi´broid) 1. having a fibrous structure; resembling a fibroma. 2. fibroma. 3. leiomyoma. 4. in the plural, a colloquial term for leiomyoma of the uterus. surgery within three years. * All measurable indices demonstrated sustained or continual improvement from baseline to 36 months, representing a high level of durable symptom control, health-related quality of life, and patient satisfaction. * On the basis of this and other studies, the majority of UFE procedures performed in the United States and Europe are currently performed using tris-acryl gelatin microspheres (Embosphere Microspheres). * Limitations of the study were frankly identified by the authors, but these did not undermine the results. Rather, they concluded, "This study provides new data with respect to broad improvements to long-term health status in women undergoing UFE." Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "The three-year outcomes reported in this study represent the longest UFE follow-up period for any of the currently marketed spherical embolics. These findings are compelling and validating. Embosphere Microspheres, the first 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. cleared by the 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. for UFE and the most clinically studied spherical embolic, is cited as the dominant product used to treat symptomatic 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. . Patients without intervention experienced significant improvement in symptoms such as bleeding, pelvic pain, and urinary problems, while reporting substantial improvement in their quality of life. This latest data further supports our belief that in the majority of cases of symptomatic fibroids Fibroids Benign tumors of muscle and connective tissue that develop within or are attached to the uterine wall. Mentioned in: Menstrual Disorders , UFE should be considered as a primary therapy that produces impactful and durable symptom relief." This study was the basis for BioSphere's 510(k) clearance from the Food and Drug Administration, or FDA, to market our Embosphere Microspheres for UFE in November 2002. Initial results were published in the American Journal of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. in 2004. About BioSphere Medical, Inc. BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, has pioneered and is commercializing minimally invasive diagnostic and therapeutic products based on its 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 application of its Embosphere Microsphere product for the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products have continued to gain acceptance in this emerging procedure as well as in a number of other new and established medical treatments. BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, the European Community, and Latin America, which allows the Company to sell its products for use in general 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. procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) and uterine artery embolization Uterine artery embolization (UAE) or Uterine Fibroid Embolization (UFE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the fibroids. See also
Cautionary Statement Regarding Forward-Looking Statements - This press release may contain 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 Company's belief's regarding the suitability of its Embosphere Microsphere products as primary therapy for UFE. 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 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; * the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of its lead product, Embosphere Microspheres, for the treatment of UFE and its HepaSphere Microspheres and recently-launched QuadraSphere[TM] Microspheres; * the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates; * the absence of, or delays and cancellations of, product orders; * delays, difficulties or unanticipated costs in the introduction of new products; * competitive pressures; * 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 as 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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