BioSphere Medical Completes Acquisition of Minority Interest in BioSphere S.A.; Announces Changes to the Board.Business Editors and Health/Medical Writers ROCKLAND, Mass.--(BW HealthWire)--Nov. 29, 2001 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) today announced that it has acquired the remaining 15 percent ownership interest in Biosphere Medical S.A. (BMSA BMSA Board on Mathematical Sciences and Their Applications (National Academy of Sciences) BMSA Bermuda Masters Swimming Association BMSA Bahrain Mind Sports Association BMSA British Medical Students Association ) for approximately $1.0 million. BMSA currently serves as European headquarters and as the Company's primary manufacturing facility. BMSA recently relocated its manufacturing plant to a new, modern facility near Charles De Gaulle Airport. Due to the increased manufacturing capacity of the new facility and improvements in the manufacturing process, the Company expects that it will have adequate capacity to meet its production needs for the foreseeable future. "Acquiring the remaining minority interest in BMSA provides us with full control over all intellectual property license agreements, manufacturing and distribution, which we expect will facilitate our ability to achieve our long-term goals Long-term goals Financial goals expected to be accomplished in five years or longer. ," stated John M. Carnuccio, president and chief executive officer of BioSphere Medical. BioSphere Medical also announced the resignation of Jean-Marie Vogel as chairman of the board. Mr. Vogel will continue to be associated with the Company as a business advisor. "During his tenure as an officer and on the board of directors, Jean-Marie provided valuable guidance and support to management," stated Mr. Carnuccio. "We would like to thank him for his vision which drove the creation of our embolotherapy business and look forward to his contributions as an ongoing business advisor." Mr. Vogel previously served as president and chief executive officer of BioSepra Inc., a chromotography media company, until May 1999, at which time the Company strategically refocused its business on the development and commercialization of microspheres for medical applications. 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 Microspheres and EmboGold 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 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 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 HepaSphere SAP(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's estimates as of the date of this release. BioSphere anticipates that subsequent events and developments will cause its estimates to change. However, while BioSphere 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. |
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