19.01.2006 13:47:00
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HepaSphere(TM) Microsphere Initial European Clinical Experience to Be Presented at the International Symposium on Endovascular Therapy
Recently, physicians in Europe have utilized the Company'sproprietary HepaSphere Microspheres in treatment protocols forpatients with primary liver cancer. These initial clinical casesfollow the September 2005 introduction of HepaSphere Microspheres toEuropean interventional radiologists at the meeting of theCardiovascular and Interventional Radiological Society of Europe(CIRSE). The Company has CE Mark approval in Europe for HepaSphereMicrospheres for the embolization of liver tumors.
Richard Faleschini, president and chief executive officer ofBioSphere Medical, commented, "Although early, we are pleased with theinitial responses we have received from the European medical communityregarding the use of HepaSphere Microspheres in the treatment of livercancer. The rising incidence of primary liver cancer in Europe mirrorsits growth around the world, where an estimated 600,000 patients areafflicted. We expect HepaSphere Microspheres will provide physiciansflexibility and additional options in treating the large number ofpatients with liver cancer, which we believe will drive marketacceptance."
HepaSphere Microspheres are designed to embolize hypervascularizedtumors via a minimally invasive, catheter-based procedure. The purposeof the procedure is to occlude the blood vessels feeding the tumor,causing tumor infarction.
Gary Saxton, executive vice president and chief operating officerof BioSphere, added, "We are encouraged by the initial experience thatEuropean interventional radiologists are having with HepaSphereMicrospheres for use in the treatment of liver cancer. Its ease of useand handling characteristics appear to be favorable and fit wellwithin existing embolization protocols."
BioSphere filed a 510(k) notification in the third quarter of 2005with the U.S. Food and Drug Administration, or FDA, seeking regulatoryapproval for use of the product in the United States for embolizationof hypervascularized tumors and peripheral arteriovenousmalformations. The Company expects marketing clearance in the UnitedStates in the first half of 2006.
About BioSphere Medical, Inc.
BioSphere Medical, Inc., a medical device company based inRockland, Massachusetts, pioneers and commercializes minimallyinvasive diagnostic and therapeutic applications based on proprietarybioengineered microsphere technology. The Company's core technologies,patented bioengineered polymers and manufacturing methods, are used toproduce microscopic spherical materials with unique beneficialproperties for a variety of medical applications. BioSphere'sprincipal focus is the treatment of symptomatic uterine fibroids usinga procedure called uterine fibroid embolization, or UFE. The Company'sproducts continue to gain acceptance in this rapidly emergingprocedure as well as in a number of other new and established medicaltreatments.
BioSphere Medical has received clearance in many countries,including the United States, Canada, Australia, the European Communityand Latin America, which allow the Company to sell its products foruse in general embolization procedures, including uterine fibroidembolization. The terms uterine fibroid embolization (UFE) and uterineartery embolization (UAE) are generally used interchangeably in theliterature. The most common side effect of UFE is "post-embolizationsyndrome," a collection of symptoms including abdominal pain,discomfort, low-grade fever and nausea. UFE is currentlycontraindicated for women who are, or who intend to become, pregnant,because the effects of UFE on the ability of a woman to conceive, andto carry a fetus to term, have not been determined.
Cautionary Statement Regarding Forward-Looking Statements - Thispress release may contain forward-looking statements within themeaning of the Private Securities Litigation Reform Act of 1995,including, without limitation, statements regarding the Company'sexpectations with regard to market acceptance and market penetrationfor its HepaSphere Microsphere product, expectations as to thepercentage of cases in which the product could be used and theexpected receipt and timing of marketing approval from the FDAregarding the Company's HepaSphere product. The Company uses wordssuch as "plans," "seeks," "projects," "believes," "may,""anticipates," "estimates," "should" and similar expressions toidentify these forward-looking statements. These statements aresubject to risks and uncertainties and are based upon the Company'sbeliefs and assumptions. There are a number of important factors thatmay affect the Company's actual performance and results and theaccuracy of its forward-looking statements, many of which are beyondthe Company's control and are difficult to predict. These importantfactors include, without limitation, risks relating to: the failure ofthe Company and its distributors to successfully market and sell theCompany's products; the failure of the Company to achieve or maintainnecessary regulatory approvals, either in the United States orinternationally, with respect to the manufacture and sale of itsproducts and product candidates; the failure of the Company tosuccessfully develop, commercialize and achieve widespread marketacceptance of its products, including, without limitation, widespreadmarket acceptance of its lead product, Embosphere(R) Microspheres forthe treatment of UFE and its HepaSphere Microspheres product for thetreatment of liver cancer; risks relating to the Company's ability toobtain and maintain patent and other proprietary protection for itsproducts and product candidates; the absence of or delays andcancellations of, product orders; delays, difficulties orunanticipated costs in the introduction of new products; competitivepressures; the inability of the Company to raise additional funds inthe near term to finance the development, marketing, and sales of itsproducts; and general economic and market conditions, as well as therisk factors described in the section titled "Factors That May AffectFuture Results" in the Company's Quarterly Report on Form 10-Q for thequarter ended September 30, 2005, as filed by the Company with theSecurities and Exchange Commission, and described in other filingsmade by the Company from time to time with the Securities and ExchangeCommission. In addition, the forward-looking statements included inthis press release represent the Company's estimates as of the date ofthis release. The Company anticipates that subsequent events anddevelopments may cause its forward-looking statements to change. TheCompany specifically disclaims any obligation or intention to updateor revise these forward-looking statements as a result of changedevents or circumstances after the date of this press release.
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