August 14, 2008
BioSphere Medical Announces ACOG Practice Bulletin Recommendation of Uterine Artery Embolization As Alternative to Hysterectomy
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.