BioSphere Medical, Inc. Signs Pan European Distribution Agreement With Terumo Europe; Initial Rollout of BioSphere Medical's Embolotherapy Products to Begin Immediately.Business Editors and Medical/Health Writers ROCKLAND, Mass.--(BW HealthWire)--Jan. 29, 2002 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 that its 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., has entered into a distribution agreement for its embolotherapy products with Terumo Europe N.V. Terumo(R) Europe N.V. is 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 agreement, Terumo Europe N.V. will become the exclusive distributor and marketing partner of BioSphere's EmboSphere(R) 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. and EmboGold(TM) Microsphere 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. Terumo's distribution plans call for a phased rollout of BioSphere's products to these countries throughout 2002. Other terms of the agreement were not disclosed. Commenting on today's news, John Carnuccio, BioSphere Medical's President and Chief Executive Officer, stated, "We are delighted to announce this important distribution agreement and marketing partnership with a company of Terumo's stature and reputation. With the backing of Terumo's powerful and proven sales and distribution network in Europe, our goal is that BioSphere's products receive wide recognition, and ultimately, 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 which we are currently targeting." Under the agreement, BioSphere will provide guidance and market development support through its European Headquarters based outside of Paris. Alain Brunier, President, BioSphere Europe stated, "We now can more efficiently begin to accelerate development of the growing embolotherapy markets in Europe through a dedicated and unified partner." Alain Poncet, President, Terumo Europe N.V., commented, "We are equally pleased to have forged this arrangement with BioSphere. It will greatly enhance Terumo's position within the embolotherapy field in Europe, providing customers with a well-matched line-up of unique and innovative embolics from BioSphere and leading edge delivery system products from Terumo." 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 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 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(R) 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. For more information on BioSphere, go to 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 Terumo 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; 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 Medical's estimates or views as of any date subsequent to the date of this release. |
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