Healthcare Industry News:  uterine fibroids 

Devices Interventional

 News Release - January 15, 2008

Study Published in the Journal of Vascular and Interventional Radiology Concludes That Embosphere(R) Microspheres Should Be the Preferred Agent for Uterine Fibroid Embolization When Compared to Boston Scientific's Contour SE(TM) PVA Microspheres

ROCKLAND, Mass.--(HSMN NewsFeed)--BioSphere Medical, Inc. (NASDAQ: BSMD ) (“BioSphere”) today announced that a study published in the January 2008 issue of the Journal of Vascular and Interventional Radiology concluded that Uterine Artery (Fibroid) Embolization (UAE or UFE) performed using BioSphere’s Embosphere® Microspheres showed significantly better results in blocking the flow of blood from arteries that feed benign uterine fibroids compared to procedures performed using Boston Scientific’s Contour SE™ polyvinyl alcohol (PVA) embolic administered in accordance with Boston Scientific’s newly refined treatment protocol. Given their current understanding of the importance of blood vessel occlusion as an endpoint after UFE, the authors concluded that “…tris-acryl gelatin microspheres (Embosphere Microspheres) should be the preferred agent for UAE at this time.”

The clinical study entitled “Leiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres” Siskin, et al (2008; 19:58 65), involved 53 patients, 26 of whom were treated with Embosphere Microspheres and 27 of whom were treated with the competing PVA microspheres.

Two significant findings of the study were:
  • In the Contour SE PVA microsphere group, treatment failure was seen in 29.6% of patients versus 3.8% of patients treated with Embosphere Microspheres
  • 100% artery occlusion was achieved in 92.3% of the patients treated with Embosphere Microspheres as compared to only 66.7% of those treated with the PVA microspheres
Richard Faleschini, BioSphere Medical’s President and Chief Executive Officer, commented, “Embosphere Microspheres was the first embolic cleared by the FDA for UFE, and is the most clinically studied spherical embolic. We believe that as a result of the favorable outcome of this and other studies, physicians will continue to show a strong, sustained preference for Embosphere. We believe that this preference, along with other purchasing considerations, has led to our dominant market share position in UFE. We do not take our leadership position for granted and know we must continue to earn the trust and loyalty of our physician customers every day. We take great pride in the conclusion of this study. As always, we encourage those who are interested to read this paper in its entirety. In it, Dr. Siskin and his colleagues discuss in clear detail the long history of various studies that have been done to assess the performance of various embolics used in UFE. Embosphere continues to outperform any spherical PVA embolic in its current formulation either from Boston Scientific or Terumo/Biocompatibles. We will continue to strive to increase our global market share position in UFE, and based upon studies such as the one we are reporting on today, believe we will be able to do so.”

Two of the authors of this study received funding for the study from Boston Scientific Corporation and BioSphere Medical.

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.

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 Company’s beliefs in the superiority of its Embosphere Microspheres over PVA microspheres, that physicians have, and may in the future, show a strong sustained preference for Embosphere, and the Company’s ability to increase its global market share. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intend," 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’s products to demonstrate adequate safety, efficacy and cost-effectiveness in clinical trials, post-clearance studies and commercial use;
  • the failure of the Company to successfully achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of its lead product, Embosphere® Microspheres, for the treatment of UFE, its HepaSphere™ Microsphere and QuadraSphere® Microsphere products, and its delivery system product line;
  • 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;
  • the failure of the Company to develop and commercialize new applications for its technologies;
  • the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates;
  • the absence of, or delays and cancellations of, product orders;
  • 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 raise additional funds in the near term to finance the development, marketing, and sales of its products;
  • general economic and market conditions; and
  • statements set forth in the section titled "Risk Factors" in BioSphere’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007, 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.
The forward-looking statements in this press release are made as of the date of this press release and the Company disclaims any obligation to update these forward-looking statements as a result of changed events, circumstances or otherwise.

Source: BioSphere Medical

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