Healthcare Industry News:  uterine fibroids 

Devices Interventional

 News Release - October 7, 2009

Study Shows Uterine Artery Embolization Compares Favorably to Laparoscopic Bilateral Occlusion for Treating Uterine Fibroids

Results Published in October Issue of the Journal of Vascular Interventional Radiology

ROCKLAND, Mass., Oct., 7--(HSMN NewsFeed)--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<0.001). Eleven patients (three UAE, eight occlusion) experienced symptom recurrence later than six months. Uterine volume reduction at six months was 24% in this group, compared with 48% in the 37 patients with no recurrence (p=0.004). Incomplete infarction of leiomyomas was seen in eight of the 11 cases of recurrence (73%) versus nine of 37 cases without recurrence (24%) (p=0.009).

“This independent, peer-reviewed study demonstrates again the importance of uterus-sparing UAE/UFE as an efficacious treatment alternative for properly selected women suffering from fibroids,” said Richard Faleschini, president and CEO of BioSphere Medical. “Until recently, there has only been very short-term data available regarding the laparoscopic occlusion of the uterine artery in the treatment of fibroids, but this longer-term study demonstrates a lack of durability when compared with UAE. We believe that the results of this study further support the Level A recommendation of UFE by the American College of Obstetricians and Gynecologists (ACOG) announced last August, and are added to the now large body of data that shows UFE to be an excellent therapeutic alternative for properly selected women with symptomatic fibroids. We look forward to disseminating the results of this study to the targeted physicians who refer patients for UFE and perform the procedure.”

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 use of its products for 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 benefits of UFE for the treatment of uterine fibroids, including its favorable performance over laparoscopic occlusion of uterine arteries in the treatment of uterine leiomyomas in cases where hysterectomy or myomectomy are not options, and the Company’s belief that UFE is an excellent alternative for properly selected women with symptomatic fibroids. 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. 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, including, 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 sales and marketing strategies;
  • 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 and product candidates, including, without limitation, the risk that the Company will not gain necessary regulatory approvals to market and sell its products in Japan through its agreement with Nippon Kayaku;
  • the Company’s ability to obtain and maintain patent and other proprietary protection for its products and product candidates;
  • the absence of, or delays or cancellations of, product orders;
  • delays, difficulties or unanticipated costs in the introduction of new products;
  • competitive pressures;
  • the risk of adverse outcomes in the Company’s previously disclosed product liability claims, which could adversely impact market acceptance of products and materially adversely affect the Company’s operating results;
  • the inability of the Company to successfully execute on its plans and strategies for future growth, including its plans to grow its business in both the UFE and interventional oncology fields and its plans for international 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 domestic and abroad; and
  • risk factors described in the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and the Form 10-Q for the quarter ended June 30, 2009, each 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.

Source: BioSphere Medical

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