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BSMD Reports 3-Year UF Embolization Data

http://biz.yahoo.com/bw/080102/20080102005543.html?.v=1

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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)

Wednesday January 2, 11:21 am ET

UFE Shown to Offer a Safe, Effective, Minimally Invasive, Uterine-Sparing Option for Symptomatic Women with Uterine Fibroids

ROCKLAND, Mass.--(BUSINESS WIRE)--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.

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.
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