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BioSphere Medical Reports on Opinion Released by The American College of Obstetricians and Gynecologists Regarding UAE.


Business Editors/Health/Medical Writers

ROCKLAND, Mass.--(BUSINESS WIRE)--Feb. 2, 2004

American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S.  Recommends

Collaboration With Interventional Radiologists in

Uterine Artery Embolization Uterine artery embolization (UAE) or Uterine Fibroid Embolization (UFE) is a procedure where an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the fibroids. See also
  • Uterine fibroids
  • Embolization
 for the Treatment of Fibroids Fibroids
Benign tumors of muscle and connective tissue that develop within or are attached to the uterine wall.

Mentioned in: Menstrual Disorders
 

BioSphere biosphere, irregularly shaped envelope of the earth's air, water, and land encompassing the heights and depths at which living things exist. The biosphere is a closed and self-regulating system (see ecology), sustained by grand-scale cycles of energy and of  Medical, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: BSMD) today reported that on January 30, 2004, The American College of Obstetricians and Gynecologists (ACOG ACOG American College of Obstetricians and Gynecologists.
ACOG American College of Obstetricians & Gynecologists
) released an opinion on uterine artery embolization (UAE (Uninterruptible Application Error) The name given to a crash in Windows 3.0. In subsequent versions of Windows, a crash was called a "General Protection Fault," "Application Error" or "Illegal Operation." See crash in Windows and abend. ) for the treatment of uterine fibroids Uterine Fibroids Definition

Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer.
.

According to the press release, ACOG has reported that "UAE for the treatment of symptomatic fibroids, when performed by experienced physicians, appears to provide good short-term relief among appropriate candidates." The opinion cites case reports, which indicate symptom relief and a low complication rate for women who underwent UAE. According to ACOG, UAE is considered investigational for patients who want to become pregnant. Accordingly, ACOG strongly recommended that "women who wish to undergo UAE have a thorough evaluation with an ob-gyn to help facilitate optimal collaboration with interventional radiologists and ensure that the procedure is appropriate."

A full text of the opinion can be found at the following address: http://www.acog.org.

"It is extremely encouraging to see that ACOG has examined the literature and recognizes the important role that UAE should play in the treatment of symptomatic uterine fibroids. The available data indicate that the procedure is effective in the short and mid-term. Preliminary results from longer-term studies also suggest that the results are durable for most patients," comments James B. Spies M.D., Professor of Radiology and Chief of Service of the Department of Radiology at Georgetown University Hospital Coordinates:

Georgetown University Hospital was founded in 1898 as part of Georgetown University, a Catholic, Jesuit University in the Georgetown neighborhood of
. "Also, I agree that collaboration between physician specialties is the best way to deliver optimal care for women with symptomatic fibroids."

In the United States, approximately 300,000 surgical hysterectomies are performed annually for the treatment of uterine fibroids. Recently, there have been numerous publications urging women to examine newer non-surgical alternatives, like UAE, which is a safe procedure with a shorter recovery course. An interventional radiologist performs UAE. For more information on uterine artery embolization or to locate a physician specialist in your area, please go to www.Ask4ufe.com.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., based in Rockland, Massachusetts, is a medical device company focused on embolotherapy, the treatment of tumors and vascular malformations by occluding their blood supply. The Company is pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolics. BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia and the European Community, which allow the Company to sell its products for use in general embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun)
1. the process or condition of becoming an embolus.

2. therapeutic introduction of a substance into a vessel in order to occlude it.
 procedures, including uterine fibroid embolization Uterine Fibroid Embolization Definition

Uterine fibroids are growths in the muscular tissue of the womb (uterus). Uterine fibroid embolization is non-surgical removal of the growths through the use of a tubular device called a catheter.
.

Cautionary Statement Regarding Forward-Looking Statements - This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. The Company uses words such as "plans," "seeks," "projects," expects", "believes," "may," "anticipates," "estimates," "should" 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 and its distributors to successfully market and sell the Company's products; 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; the failure of the Company to successfully develop, commercialize and achieve widespread market acceptance of the Embosphere(R) Microspheres and EmboGold(TM) Microsphere Not to be confused with Glass microphere.
This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life.
 technologies for uterine fibroid embolization, targeted liver embolization and other applications; risks relating to the Company's ability to obtain and maintain patent and other proprietary protection for its products; the absence of or delays and cancellations of, product orders; delays, difficulties or unanticipated costs in the introduction of new products; competitive pressures; the inability of the Company to raise additional funds to finance the development, marketing, and sales of its products; and general economic conditions. These risk factors are further described in the section titled "Certain Factors That May Affect Future Operations" in the Company's Current report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended September 30, 2003, as filed by the Company with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's expectations and beliefs as of the date of this release. The Company anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation or intention to do so.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Feb 2, 2004
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