02.01.2008 16:21:00
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Three-Year Data from 1,278 Women Published in Obstetrics & Gynecology Demonstrates Long-Term Efficacy and Durability of Uterine Fibroid Embolization (UFE)
BioSphere Medical, Inc. (NASDAQ: BSMD) ("BioSphere”),
a medical device company that has pioneered the use of bioengineered
microspheres to treat uterine fibroids, hypervascularized tumors, and
vascular malformations by a minimally invasive, image-guided medical
procedure called embolotherapy, today announced that three-year outcomes
data from the FIBROID Registry just published in the January 2008 issue
of Obstetrics & Gynecology concluded that over the long term,
and in a broad range of practice settings, uterine artery embolization
(or "uterine fibroid embolization”
or "UFE”) produces a
high level of durable symptom control and results in a significant
improvement in a woman’s health-related
quality of life. Earlier today, the Society of Interventional Radiology
(SIR) said, "Three-year data from the largest,
multi-center, prospective voluntary registry on any procedure for benign
uterine fibroids showed that 90 percent of the women participating
avoided a hysterectomy, and of these, 85 percent had a substantial
improvement in symptoms and quality of life.”
Additional information about UFE, and other links of related interest,
can be found on the SIR’s Web site, www.sirweb.org,
on BioSphere’s Web site, www.biospheremed.com,
and on www.ask4ufe.com.
Richard Faleschini, BioSphere Medical’s
President and Chief Executive Officer, commented, "The
three-year outcomes reported in this key study are consistent with other
peer-reviewed UFE investigations published in the last two years within
and outside the United States, and provide additional and important
validation of the long-term efficacy and durability of UFE. Also, in 73%
of the cases in this Registry, the primary embolic agent used was
BioSphere Medical’s calibrated embolic, thus
providing specific affirmation of the effectiveness of our tris-acryl
microspheres. Another key finding reported in this study was that the
reintervention rate for UFE was low, and compared very favorably to the
reintervention rate of myomectomy, the surgical Gold standard. In
addition, the mean time to return to work for the patients who completed
the follow-up to the study was 8.8 days. Based on the compelling results
of this Registry — patient satisfaction,
clinical efficacy, and return to normal daily activities —
we believe that UFE should be considered among first-line therapeutic
options for the treatment of uterine fibroids for the majority of women
suffering from this common and incapacitating disease.”
The Fibroid Registry for Outcomes Data for Uterine Embolization study
was funded through the Society for Interventional Radiology Foundation
with funding in part from BioSphere Medical.
About Uterine Fibroids
Symptomatic uterine fibroids are a public health concern, occurring in
at least half of American reproductive-age women. Uterine fibroids may
cause pain, abnormal bleeding, pressure, and other symptoms related to
uterine enlargement. Symptomatic uterine fibroids lead to 30-40% of all
hysterectomies in the United States and to 150,000-200,000
hysterectomies annually. More than 25% of all women will have a
hysterectomy by the time they are 60 years old, making it the second
most frequently performed surgical procedure (after cesarean delivery)
for women of reproductive age in the United States.
Cautionary Note Regarding Web Site
References
BioSphere cautions you that BioSphere’s Web
site, and this press release, contain links to Web sites that are not
operated, reviewed or controlled by BioSphere. BioSphere assumes no
responsibility for the information or statements found on these other
Web sites and such information and statements are not incorporated by
reference into BioSphere’s Web site or this
press release. Moreover, BioSphere also includes in this press release
links to its own Web site. BioSphere cautions you that the information
on its Web site is not incorporated by reference into this press release
and should not be considered to be a part of this press release.
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 that UFE is an effective, durable and safe therapy for the
treatment of symptomatic uterine fibroids, and that UFE should be
considered a primary treatment modality. 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®
Microspheres, for the treatment of UFE, its HepaSphere™
Microsphere and QuadraSphere® 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.
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