BioSphere Medical’s HepaSphere Highlighted at Two Scientific Meetings in Europe

ROCKLAND, Mass.-(Business Wire)-September 8, 2009 - BioSphere Medical, Inc. (NASDAQ:BSMD) (“BioSphere” or the “Company”) – 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 – reports further development of its oncology program as its HepaSphere™ and Embosphere® product are highlighted in posters and podium presentations at the International Liver Cancer Association (ILCA) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings. HepaSphere Microspheres are CE marked in the European Union for delivery of doxorubicin for embolization of hepatocellular carcinoma (HCC) and hepatic metastases.

The International Liver Cancer Association is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines. Its stated objective for this annual conference was to link research to practice, with the ultimate goal to advance liver cancer science and care worldwide. The ILCA Third Annual Meeting was held September 4-6 in Milan, Italy, and included the following:

A podium presentation entitled Phase II trial of bevacizumab combined with transarterial chemoembolisation (TACE) for hepatocellular carcinoma: initial experience at two institutions, presented by Diane K. Reyes, from the Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore. The objective of this Phase II pilot study was to evaluate tumor response and safety of concurrent bevacizumab, an antiangiogenic drug that works by preventing new blood vessel growth, and transarterial chemoembolization (TACE) using BioSphere’s Embosphere microspheres, in patients with advanced hepatocellular carcinoma. The authors concluded that the combination therapy was reasonably well tolerated in advanced HCC patients, with no progression of disease by imaging criteria during the study period and relatively long progression-free survival of 16 months.
A presented poster entitled A randomized phase II study of transarterial chemoembolisation with doxorubicin-eluting HepaSpheres in patients with hepatocellular carcinoma, delivered by Hannah van Malenstein, Department of Hepatology, University Hospital Gasthuisberg, Leuven, Belgium. The poster detailed the safety data from the first prospective randomized phase II study with doxorubicin-eluting HepaSphere compared to conventional transarterial chemoembolization, in which the doxorubicin was delivered into the vasculature of the tumor and then embolic material was used to occlude the vessels. The authors demonstrated that patients treated with HepaSpheres had lower circulating levels of the chemotherapeutic drug doxorubicin, which minimized toxicity and serious side effects compared to patients who received conventional TACE.

The CIRSE annual Scientific and Postgraduate Educational meeting has established itself as the premier gathering for all professionals devoted to the field of cardiovascular and interventional radiology in Europe. CIRSE 2009 will be held in Lisbon, Portugal, from September 19 to September 23 and will include the following presentations related to HepaSphere:

A podium presentation entitled Optimal method of doxorubicin loading and elution in superabsorbent polymer microspheres: in vitro analysis, presented by D.M. Liu, Department of Radiology/Interventional Radiology Section, University of British Columbia, Vancouver, BC, Canada. This presentation will discuss the results of a study to establish the ability of HepaSphere to actively uptake doxorubicin and transfer the drug into a buffer to simulate its elution activity in vivo, as well as to optimize the method of loading the chemotherapeutic agent in terms of handling and elution. This data will be presented on Sunday, September 20 at 4:15 p.m. local time.
A poster presentation entitled TACE with HepaSphere in treatment of unresectable HCC: preliminary results of a monocentric study and comparison with historical personal series of standard TACE, presented by M. Grosso, Department of Radiology, Hospital S. Croce e Carle, Cuneo, Italy. The poster will provide an update on a study whose initial results were published in the journal Cardiovascular and Interventional Radiology in 2008, and will discuss the outcomes of patients treated with HepaSphere compared to an earlier series of patients treated with conventional TACE. It will be available for viewing throughout the conference.

About Hepatocellular Carcinoma

Hepatocellular carcinoma is the 5^th most frequently diagnosed malignancy, and the 3^rd largest cause of cancer death worldwide. Over 600,000 new incidences are diagnosed yearly. More than 20,000 cases are diagnosed annually in the US, and that number is expected to continue to increase over the next 10 years.

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 the Company’s HepaSphere product. 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.

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