BioSphere Medical Reports: Key Study Shows Fibroid Embolization Controls Symptoms Similar to Hysterectomy with Fewer Complications.ROCKLAND, Mass. -- Publication in prestigious journal assures wide exposure to gynecologists BioSphere Medical (Nasdaq: BSMD), a medical device company that pioneered the use of bioengineered microspheres to treat 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. , hypervascularized tumors and vascular malformations by occluding their blood supply, today reports the publication of a multi-center study comparing outcomes for 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's Embosphere(R) Microspheres with outcomes for hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries in patients with symptomatic uterine fibroids. The study appears in the latest issue of 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. . The authors of the study, "Outcome of uterine 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. and hysterectomy for leiomyomas: Results of a multicenter study" concluded that both procedures substantially improved symptoms for most patients 12 months after treatment. Regardless of therapy, most patients were moderately or very satisfied with their symptom relief. The study also reported that women who received UFE experienced a shorter hospital stay, a faster return to normal activity and fewer complications than women who received a hysterectomy. "Reporting of this long term follow-up data is an important milestone for UFE" says Dr. James B. Spies, lead author of the study and Chief of Service at the Department of Radiology at Georgetown University Hospital Georgetown University Hospital was founded in 1898 as part of Georgetown University, a Catholic, Jesuit University in the Georgetown neighborhood of in Washington, D.C. "It is clear that the results of UFE are comparable to those of traditional surgical removal of the uterus and that UFE represents an attractive non-surgical alternative for most women with symptomatic uterine fibroids." UFE is a non-surgical technique using a small catheter to deliver miniature gels into the blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. , disrupting supply to the fibroids Fibroids Benign tumors of muscle and connective tissue that develop within or are attached to the uterine wall. Mentioned in: Menstrual Disorders . As a result, the fibroids are devitalized de·vi·tal·ized adj. Devoid of vitality or life, as a tooth with destroyed pulp. without permanent injury to normal uterine tissue. The technique has been in clinical use for over ten years and nearly 50,000 patients have been treated with the procedure. "I hope that this publication will encourage reluctant gynecologists to consider UFE as a logical, effective and safe alternative to the current surgical approaches for uterine fibroids." comments Dr. Marco Pelosi, Director of the Pelosi Women's Health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. Center in Bayonne, NJ and Director of the Department of Gynecology at Bayonne Medical Center The Bayonne Medical Center is a hospital in Bayonne, New Jersey. It is currently foregoing Chapter 11 Bankruptcy. . The data reported in this study shows that women who received the UFE option experienced a shorter hospital stay, a faster return to normal activity and fewer adverse complications than the surgical group. "These differences are important considerations, especially for women with today's non-stop lifestyle," continued Dr. Pelosi. Symptoms of uterine fibroids (leiomyomas) can include excessive menstrual bleeding, pelvic discomfort and abnormal urinary function. It is estimated that 5.5 million women in the United States suffer some symptoms associated with uterine fibroids. Uterine fibroid embolization is a non-surgical treatment performed by an interventional radiologist. "The concept of the gynecologist gynecologist /gy·ne·col·o·gist/ (-kol´ah-jist) a person skilled in gynecology. gy·ne·col·o·gist n. A physician specializing in gynecology. working with the interventional radiologist as a team is highly desirable," adds Dr. Pelosi. "Some patients will be candidates for traditional surgery while others will be better suited for UFE." For more information about UFE or to find a physician in your area, please visit www.ask4ufe.com. About BioSphere Medical, Inc. BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on applying our proprietary 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 to medical applications using embolotherapy techniques. Our core technologies, patented bio-engineered polymers and manufacturing methods, are used to produce miniature spherical beads with uniquely beneficial properties for a variety of medical applications. Our principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. Our products have already begun to gain wide acceptance in this rapidly emerging procedure as well as in a number of other, new and established medical treatments. Cautionary Statement Regarding Forward-Looking Statements: 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. The Company uses words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should'" 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 and its distributors to successfully market and sell the Company's products; 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 the Embosphere(R) Microspheres and EmboGold Microsphere technologies; risks relating to the Company's ability to obtain and maintain patent and other proprietary protection for its products; 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; and general economic conditions. These risk factors are further described in the section titled "Certain Factors That May Affect Future Results of Operations" in the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 30, 2004, as filed by the Company 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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