Level A Evidence Shows UAE Safe and Effective Option for the
Treatment of Fibroids in Appropriately Selected Women
ROCKLAND, Mass.--(BUSINESS WIRE)--Aug. 14, 2008--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 in its August Practice Bulletin,
the American College of Obstetricians and Gynecologists (ACOG)
recommended uterine artery embolization (UAE) (also known as UFE) as
an alternative to hysterectomy in the management of leiomyomas
(fibroids). The bulletin cites the availability of Level A research,
which is based on "good and consistent scientific evidence" that shows
that UAE "is a safe and effective option for appropriately selected
women who wish to retain their uteri." The recommendation is also
based on both long- and short-term treatment outcomes.
"We are pleased UFE has obtained this important recognition, and
believe it is a significant step in the ongoing development of the
market for this minimally invasive, uterus-sparing alternative to
hysterectomy," commented Richard J. Faleschini, president and CEO of
BioSphere Medical. Mr. Faleschini continued, "Gynecologists are one of
the key providers in women's health. We believe the new guidelines in
this Practice Bulletin should result in more gynecologists discussing
UFE as a mainstream treatment option with their patients and forging
collaborative relationships with interventional radiologists to
optimize the quality of care offered to women with fibroids."
About BioSphere Medical, Inc.
BioSphere Medical, Inc. 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 expected
favorable benefits of the ACOG Practice Bulletin on gynecologists'
treatment and referral behaviors. The Company may use words such as
"plans," "seeks," "projects," "believes," "may," "anticipates,"
"estimates," "should," "intends," "looking forward," and similar
expressions to identify these forward-looking statements. 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
successfully develop, commercialize and achieve widespread market
acceptance of its products; the failure of the Company to increase the
rate of UFE procedures, and concomitant use of its products for UFE,
with its expanded sales force and its recently initiated sales and
marketing strategies; the failure of the Company to achieve or
maintain necessary regulatory approvals; the Company's ability to
obtain and maintain patent and other proprietary protection; the
absence of, or delays or cancellations of, product orders, and 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 successfully execute on its plans and strategies for future
growth; 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, both domestically
and abroad; and risk factors described in the section titled "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, 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. In addition, the forward-looking statements included in
this press release represent the Company's estimates as of the date of
this release. The Company anticipates that subsequent events and
developments may cause its forward-looking statements to change. The
Company specifically disclaims any obligation or intention to update
or revise these forward-looking statements as a result of changed
events or circumstances after the date of this press release.
CONTACT: Company Contact:
BioSphere Medical, Inc.
Martin Joyce, EVP & CFO, 781-681-7925
www.biospheremed.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: BioSphere Medical, Inc.