Study Published in the Journal of Vascular and Interventional Radiology Concludes...

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Tue Jan 15, 2008 8:48am EST

Study Published in the Journal of Vascular and Interventional Radiology Concludes That Embosphere(R) Microspheres Should Be the Preferred Agent for Uterine Fibroid Embolization When Compared to Boston Scientific's Contour SE(TM) PVA Microspheres

ROCKLAND, Mass.--(Business Wire)--BioSphere Medical, Inc. (NASDAQ: BSMD) ("BioSphere") today
announced that a study published in the January 2008 issue of the
Journal of Vascular and Interventional Radiology concluded that
Uterine Artery (Fibroid) Embolization (UAE or UFE) performed using
BioSphere's Embosphere(R) Microspheres showed significantly better
results in blocking the flow of blood from arteries that feed benign
uterine fibroids compared to procedures performed using Boston
Scientific's Contour SE(TM) polyvinyl alcohol (PVA) embolic
administered in accordance with Boston Scientific's newly refined
treatment protocol. Given their current understanding of the
importance of blood vessel occlusion as an endpoint after UFE, the
authors concluded that "...tris-acryl gelatin microspheres (Embosphere
Microspheres) should be the preferred agent for UAE at this time."

   The clinical study entitled "Leiomyoma Infarction after Uterine
Artery Embolization: A Prospective Randomized Study Comparing
Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres"
Siskin, et al (2008; 19:58-65), involved 53 patients, 26 of whom were
treated with Embosphere Microspheres and 27 of whom were treated with
the competing PVA microspheres.

   Two significant findings of the study were:

   --  In the Contour SE PVA microsphere group, treatment failure was
        seen in 29.6% of patients versus 3.8% of patients treated with
        Embosphere Microspheres

   --  100% artery occlusion was achieved in 92.3% of the patients
        treated with Embosphere Microspheres as compared to only 66.7%
        of those treated with the PVA microspheres

   Richard Faleschini, BioSphere Medical's President and Chief
Executive Officer, commented, "Embosphere Microspheres was the first
embolic cleared by the FDA for UFE, and is the most clinically studied
spherical embolic. We believe that as a result of the favorable
outcome of this and other studies, physicians will continue to show a
strong, sustained preference for Embosphere. We believe that this
preference, along with other purchasing considerations, has led to our
dominant market share position in UFE. We do not take our leadership
position for granted and know we must continue to earn the trust and
loyalty of our physician customers every day. We take great pride in
the conclusion of this study. As always, we encourage those who are
interested to read this paper in its entirety. In it, Dr. Siskin and
his colleagues discuss in clear detail the long history of various
studies that have been done to assess the performance of various
embolics used in UFE. Embosphere continues to outperform any spherical
PVA embolic in its current formulation either from Boston Scientific
or Terumo/Biocompatibles. We will continue to strive to increase our
global market share position in UFE, and based upon studies such as
the one we are reporting on today, believe we will be able to do so."

   Two of the authors of this study received funding for the study
from Boston Scientific Corporation and BioSphere Medical.

   About BioSphere Medical, Inc.

   BioSphere Medical, Inc., a medical device company based in
Rockland, Massachusetts, seeks to pioneer and commercialize minimally
invasive diagnostic and therapeutic applications based on proprietary
bioengineered microsphere technology. The Company's core technologies,
patented bioengineered polymers and manufacturing methods, are used to
produce microscopic spherical materials with unique beneficial
properties for a variety of medical applications. BioSphere's
principal focus is the treatment of symptomatic uterine fibroids using
a procedure called uterine fibroid embolization, or UFE. The Company's
products continue to gain acceptance in this rapidly emerging
procedure as well as in a number of other new and established medical
treatments.

   Cautionary Note Regarding Forward-Looking Statements

   This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements regarding the Company's
beliefs in the superiority of its Embosphere Microspheres over PVA
microspheres, that physicians have, and may in the future, show a
strong sustained preference for Embosphere, and the Company's ability
to increase its global market share. The Company may use words such as
"plans," "seeks," "projects," "believes," "may," "anticipates,"
"estimates," "should," "intend," 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's products to demonstrate adequate
        safety, efficacy and cost-effectiveness in clinical trials,
        post-clearance studies and commercial use;

   --  the failure of the Company to successfully achieve widespread
        market acceptance of its products, including, without
        limitation, widespread market acceptance of its lead product,
        Embosphere(R) Microspheres, for the treatment of UFE, its
        HepaSphere(TM) Microsphere and QuadraSphere(R) Microsphere
        products, and its delivery system product line;

   --  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 and product candidates;

   --  the failure of the Company to develop and commercialize new
        applications for its technologies;

   --  the Company's ability to obtain and maintain patent and other
        proprietary protection for its products and product
        candidates;

   --  the absence of, or delays and cancellations of, product
        orders;

   --  delays, difficulties or unanticipated costs in the
        introduction of new products;

   --  competitive pressures and the risk of product liability
        claims, either of which may impact market acceptance of
        products and adversely affect the Company's operating results;

   --  the inability of the Company to raise additional funds in the
        near term to finance the development, marketing, and sales of
        its products;

   --  general economic and market conditions; and

   --  statements set forth in the section titled "Risk Factors" in
        BioSphere's Quarterly Report on Form 10-Q for the quarter
        ended September 30, 2007, as filed by the Company with the
        Securities and Exchange Commission, and described in other
        filings made by the Company from time to time with the
        Securities and Exchange Commission.

   The forward-looking statements in this press release are made as
of the date of this press release and the Company disclaims any
obligation to update these forward-looking statements as a result of
changed events, circumstances or otherwise.

BioSphere Medical, Inc.
Martin Joyce, 781-681-7925
Executive Vice President and Chief Financial Officer
or
Investor Relations:
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President

Copyright Business Wire 2008
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