BioSphere Medical Updates Clinical Trial Results at International Society of Endovascular Therapy.Business Editors and Medical/Health Writers ROCKLAND, Mass.--(BW HealthWire)--Jan. 28, 2002 Company's new EmboGold(TM)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. product featured in successful live case during conference 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(TM), Inc. (Nasdaq: BSMD) today announced updated results of its U.S. clinical trial to evaluate the company's Embosphere (R) Microspheres 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 ). James Spies, Associate Professor of Radiology at Georgetown University Georgetown University, in the Georgetown section of Washington, D.C.; Jesuit; coeducational; founded 1789 by John Carroll, chartered 1815, inc. 1844. Its law and medical schools are noteworthy, and its archives are especially rich in letters and manuscripts by and , and the study's principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences presented one-year follow-up on the patients included in phase I of the study and updated the status of the pivotal study phase at the International Society of Endovascular Therapy (ISET) held in Miami last week. The results demonstrate that improvements measured in each of the three symptom categories at the six-month follow-up were preserved at one year. "Changes in bleeding, pain and overall quality of life were all highly significant at six months," said Spies, "and the fact that these improvements are maintained at one year is also a strong indication of durability." "We continue to be enthused by this data," said Jonathan McGrath, Vice President of Research and Development of Biosphere Medical. "The uniformity, magnitude and durability of improvement in all measures of symptoms, general quality of life and satisfaction are very gratifying grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. . We are also very fortunate to be working with investigators of such high caliber; it adds substantially to the credibility and influence of the study." James Benenati, Medical Director, Peripheral Vascular Lab at the Miami Cardiac and Vascular Institute, also performed a live case at the conference, using the company's new EmboGold(TM) Microsphere product. The case highlighted the product's ease of use and enhanced visibility. "We are very pleased to play a role in developing this promising alternative to surgical treatment for 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. ," said Dr. Benenati. Last week, Biosphere Medical announced enrollment completion of the final arm of its clinical study and reiterated its intention to submit this data to 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 expansion of its approved indication approved indication, n 1. reliable signs that a certain remedy should be used. Not synonymous with “authorized.” 2. FDA-approved condition for a drug or other treatment that allows labeling. during the second quarter of this year. Uterine fibroid embolization is a catheter-based procedure that treats uterine fibroids by starving the blood supply that feeds them. During the procedure, guided by external imaging, an interventional radiologist injects tiny, spherical shaped gel-like particles into the arteries leading 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 . The particles are then guided by blood flow into the vessels surrounding the fibroids and lodges there, stopping flow of nutrients to the tumors. Uterine fibroids affect more than 25 million women in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and about six million of these women seek treatment annually. More than 200,000 of these patients undergo invasive hysterectomies for fibroids and many others have fibroids removed surgically. Industry sources have stated that worldwide demand for UFE will grow substantially during the next five years. BioSphere Medical was the first company to begin clinical testing under an FDA approved IDE for UFE. About BioSphere Medical, Inc. BioSphere Medical(TM), Inc., based in Rockland, Massachusetts, is a medical device company focused on embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The Company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics. BioSphere Medical's lead products, Embosphere(R) Microspheres and EmboGold(TM) Microspheres, have been cleared by the FDA for marketing for hypervascularized tumors and vascular malformations. The Company is currently conducting clinical trials of Embosphere Microspheres for uterine fibroid embolization (UFE) in the United States under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) granted by the FDA. BioSphere Medical has received CE Mark approval in the European Community and approvals in Canada and Australia which allow the Company to sell Embosphere Microspheres 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. 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," 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; to successfully develop, commercialize and achieve widespread market acceptance of the Embosphere (R) Microspheres and EmboGold(TM) Microsphere technologies for uterine fibroid embolization, targeted liver embolization and other applications; to provide patent and other proprietary protection for the Company's 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 to finance the development, marketing, and sales of its products; general economic conditions; as well as those risk factors detailed in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2000 filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent BioSphere Medical's estimates as of the date of this release. BioSphere Medical anticipates that subsequent events and developments will cause its estimates to change. However, while BioSphere Medical may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing BioSphere's estimates or views as of any date subsequent to the date of this release. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion