BioSphere Medical Launches New EmboGold Microspheres.Business Editors & Health/Medical Writers ROCKLAND, Mass.--(BUSINESS WIRE)--Sept. 6, 2001 Improved Version of Company's Lead Product, Embosphere(R) Microspheres, Receives Positive Customer Response 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: BSMD), a medical device company that is pioneering the use of bioengineered microspheres in embolotherapy, announced today the U.S. launch of its newest product, EmboGold(TM)Microspheres. EmboGold Microspheres were developed based on feedback from physicians who are currently using BioSphere's lead product, Embosphere(R) Microspheres, which was cleared for marketing 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. in April 2000 for non-invasive treatment of hypervascularized tumors and 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. . The new 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 is colored and offered in a pre-filled syringe. These enhancements are designed to provide physicians with increased visibility, easy set-up and superior handling to better facilitate controlled, targeted 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. . Said John M. Carnuccio, BioSphere Medical president and chief executive officer, "We recently conducted a limited launch of our new EmboGold Microspheres. Based on the positive feedback we received from our customers, we are excited about the prospects for this new product offering. Last week we trained our nationwide field sales organization for the full launch this week on schedule. EmboGold Microspheres represent a value-added offering that complements our Embosphere Microspheres lead product. We are excited about EmboGold Microspheres, and plan to introduce additional products and product extensions that will support our goal of maintaining leadership in the field of embolotherapy." Initial marketing of EmboGold Microspheres will be targeted to both BioSphere's existing and new customers. The Company expects the improved offering to command a premium pricing Premium pricing is the practice of keeping the price of a product or service artificially high in order to encourage favorable perceptions among buyers, based solely on the price. . About BioSphere Medical, Inc. BioSphere Medical, Inc., based in Rockland, Massachusetts Rockland is a town in Plymouth County, Massachusetts, United States. The population was 17,670 at the 2000 census. with 10,199 total registered voters as of December 31, 2005. , 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 product, Embosphere Microspheres, was cleared by the FDA in April 2000 for marketing for hypervascularized tumors and vascular malformations. The Company is currently conducting clinical trials of Embosphere 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 ) 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. 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 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's words such as "expects," "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," and similar expressions identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon the Company's beliefs and assumptions. These forward-looking statements include the Company's expectations regarding the Company's ability to sell EmboGold Microspheres at premium pricing, the Company's ability to introduce additional products and product extensions that will support the Company's goal of maintaining leadership in the field of embolotherapy, and the market penetration of the products. 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 and commercialize the Embosphere(R) Microspheres and HepaSphere SAP(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; the delay 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. |
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