BSMD Biosphere Medical (MM)

BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere” or the “Company”) – the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – reports the publication of a study in the October 2009 issue of the Journal of Vascular Interventional Radiology in which the authors conclude that uterine artery embolization (UAE) compares favorably to laparoscopic occlusion of uterine arteries in the treatment of uterine leiomyomas (fibroids) in cases where hysterectomy or myomectomy are not options.

The article, entitled Uterine Artery Embolization versus Laparoscopic Occlusion of Uterine Arteries for Leiomyomas: Long-term Results of a Randomized Comparative Trial, was authored by Kirsten Hald, MD, Hans Jorgen Noreng, MD, Olav Istre, MD, PhD and Nils-Einar Klow, MD, PhD of the Departments of Obstetrics and Gynecology and Radiology, Ulleval, Oslo University Hospital, Norway. In the trial, 66 women with uterine leiomyomas were randomized to receive either UAE or laparoscopic occlusion of the uterine artery, and 58 patients received treatment. Contrast-enhanced magnetic resonance (MR) imaging was performed before treatment and after six months. Median follow-up time was 48 months.

According to the study authors, “Recurrence rate was significantly lower after UAE than after laparoscopic treatment. Larger volume reduction and more complete devascularization of leiomyomas were found after UAE treatment and among patients with no recurrence.”

Clinical failure and symptom recurrence occurred in 14 patients after laparoscopy (48%) and in five patients (17%) after UAE (p=0.02). Hysterectomy was performed in two patients after UAE (7%) and in eight patients (28%) after laparoscopy (p=0.041). Six-month MR imaging results were available for 26 patients treated with UAE and 22 treated with laparoscopy, and showed that mean uterine volume was reduced by 51% after UAE treatment, compared with 33% after laparoscopy (p=0.001). Complete leiomyoma infarction was seen in all 26 patients in the UAE group and in only five patients in the laparoscopy group (p

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