BioSphere Medical Receives CE Mark Approval for EmboGold Microspheres.Business Editors/Health & Medical Writers ROCKLAND, Mass.--(BW HealthWire)--March 26, 2002 Global Commercialization Strategy Expanding Company Also Receives Canadian Marketing Approval 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, Inc. (Nasdaq: BSMD), a medical device company that is pioneering the use of bioengineered microspheres to treat tumors and vascular malformations by occluding their blood supply, announced today that it has received the CE Mark approval for its new 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. product, EmboGold(TM) Microspheres, for 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. including 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. . The approval allows the Company to sell the product for approved uses in the 19 countries of the European Economic Area European Economic Area: see European Free Trade Association; European Union. . Effective immediately, EmboGold(TM) Microspheres will be sold in Europe exclusively by the Company's distribution partner, Terumo Europe N.V., an affiliate of Terumo(R) Corporation, Japan. About EmboGold(TM) Microspheres The EmboGold(TM) Microspheres product was developed based on extensive discussions with physicians who were already using the Company's flagship product A primary product of a company, which is typically why the company was founded and/or what made it well known. For example, MS-DOS, Windows and the Microsoft Office suite have been flagship products of Microsoft. CorelDRAW is a flagship product of Corel Corporation. , EmboSphere(R) Microspheres, but who wanted enhanced functionality. EmboGold(TM) Microspheres are tinted to improve visibility and packaged in a pre-filled syringe to provide easy handling along with superior procedural efficiency. Like the EmboSphere(R) Microspheres, EmboGold(TM) Microspheres minimize aggregation in the catheter, unwanted proximal embolization and unpredictable distal embolization due to particle fragmentation that can occur with alternative embolization products. EmboGold(TM) Microspheres were launched in the U.S. in September 2001 with strong and rapid market acceptance. "The CE Mark for EmboGold(TM) Microspheres is an important development in the advancement of commercializing our embolotherapy products worldwide," stated John Carnuccio, President and Chief Executive Officer of BioSphere Medical. "We can now offer physicians and their patients in Europe an improved embolic product and delivery system previously only available 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. ." European Distribution to be Conducted by Major Medical Technology Partner In January, BioSphere Medical's wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , BioSphere Medical, S.A., France, entered into a distribution agreement for its embolotherapy products with Terumo Europe N.V, an affiliate of Terumo(R) Corporation, Japan, a global medical technology company that develops, manufactures and markets a broad range of products and services, including market leading microcatheters and guidewires designed for most interventional procedures, including embolotherapy. Under terms of the multi-year, pan European agreement, Terumo Europe N.V. has become the exclusive distributor and marketing partner of BioSphere Medical's EmboSphere(R) Microspheres and EmboGold(TM) Microspheres products to interventional radiologists and neuro-interventional radiologists through Terumo's direct sales organization in Germany, the United Kingdom, Scandinavia, Switzerland, Belgium, Portugal, Ireland, Greece, the Czech Republic Czech Republic, Czech Česká Republika (2005 est. pop. 10,241,000), republic, 29,677 sq mi (78,864 sq km), central Europe. It is bordered by Slovakia on the east, Austria on the south, Germany on the west, and Poland on the north. , Poland, Tunisia, Morocco, Algeria and Russia. For its part, BioSphere Medical is providing guidance and market development support through its European headquarters based outside of Paris, France. Carnuccio continued, "Our distribution agreement with Terumo is designed to aggressively address the European market in order to capture a significant share of embolization procedures and develop markets outside the U.S. Now, Terumo's powerful sales and distribution network in Europe will be strengthened as we add EmboGold(TM) Microspheres, packaged in a convenient pre-filled syringe, to the product offering for these customers." BioSphere Medical Receives Canadian Marketing Approval The Company also announced today that it has received approval of its Canadian Device Licensing Application for EmboGold(TM) Microspheres. In Canada, the Company has seen significant interest in the product by the 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 and interventional neuroradiology interventional neuroradiology A subspecialty of neuroradiology in which minimally invasive therapy can be effected by advancing various devices within a blood vessel to a point of a previously identified lesion–eg, an intracranial aneurysm. Cf Clipping, Trapping. communities. BioSphere Medical will continue to service and support the Canadian market through its direct U.S. sales force. Carnuccio concluded, "The progress we have made in our strategy to commercialize EmboGold(TM) Microspheres is significant, as we continue to deliver on the promise of embolotherapy and improve patient care. We believe we are building a solid worldwide distribution network for our products as we reach our goal of achieving strong market acceptance within the rapidly growing uterine fibroid Uterine fibroid A noncancerous tumor of the uterus that can range from the size of a pea to the size of a grapefruit. Small fibroids require no treatment, but those causing serious symptoms may need to be removed. , liver tumor Hepatic tumors are tumors or growths on or in the liver (medical terms pertaining to the liver often start in hepato- or hepatic from the Greek word for liver, hepar). These growths can be benign or malignant (cancerous). and neuro embolotherapy markets worldwide." About BioSphere Medical BioSphere Medical, 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 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 marketing for hypervascularized tumors and vascular malformations. The Company is currently conducting clinical trials of Embosphere(R) Microspheres for uterine fibroid embolization (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 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(R) Microspheres and EmboGold(TM) Microspheres for use in general embolization procedures, including uterine fibroid embolization. For more information on BioSphere Medical, visit the Company's website at http://www.biospheremed.com. 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 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. 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 Medical's estimates or views as of any date subsequent to the date of this release. |
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