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BioSphere Medical, Inc. Announced Launch Plans for HepaSphere(TM) Microspheres at the 2005 Cardiovascular and Interventional Radiological Society Meeting in Europe

Posted on: Tuesday, 20 September 2005, 09:00 CDT

BioSphere Medical (NASDAQ: BSMD) recently announced the planned fourth quarter 2005 European launch of its proprietary HepaSphere(TM) Microspheres, an embolic previously issued the CE mark and intended for the embolization of liver tumors. CE mark declaration denotes conformity with European standards for safety and allows for marketing in European Union countries. The product was introduced to European interventional radiologists at the meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), which took place in Nice, France from September 10 - 14. European shipments are expected to begin in the fourth quarter of 2005. HepaSphere Microspheres will be sold by the Company's direct sales force in France and through its network of distributors in the remaining countries of the European Union.

Richard Faleschini, president and chief executive officer of BioSphere Medical, commented, "We were encouraged by the enthusiastic response to our HepaSphere product at the CIRSE meeting. The development of the HepaSphere Microsphere demonstrates BioSphere's commitment to new product development for the treatment of liver cancer. In the first six months of 2005, approximately 19% of our worldwide sales of Embosphere(R) and EmboGold(R) Microspheres were used in this therapeutic area. We believe that the introduction of HepaSphere Microspheres in Europe will expand the treatment options available to physicians and their patients. It is also an important next step in our efforts to address the clinical needs of an estimated 600,000 patients worldwide with primary liver cancer."

Liver cancer is one of the most prevalent forms of cancer worldwide. Although surgical removal of the tumor is the best treatment option for liver cancer, and is a potentially curative approach, the vast majority of patients are not eligible for surgery. Currently, embolotherapy is used as a palliative treatment to extend and improve the quality of life in patients whose liver cancer is at a state that is too advanced for surgical cure. The Company's HepaSphere product is designed for use in these embolotherapy procedures to treat hypervascularized tumors, such as those found in the liver.

Gary Saxton, senior vice president and general manager of BioSphere added, "We believe that the unique expanding and conforming properties of our HepaSphere product will help to improve the current treatments for liver cancer by enabling physicians to deliver targeted, customized treatment to their patients."

Key characteristics of HepaSphere Microspheres include:

-- Absorption of fluids, such as saline, contrast agents and human serum, that create expansion up to 4x its dry-state diameter - 64 times its initial volume - while maintaining its spherical form.

-- A high degree of conformity to vessel anatomy and minimal tracking into smaller vessels beyond the targeted occlusion site.

-- Complete occlusion of a vessel with, on average, just a single particle.

In connection with this launch, BioSphere will be sponsoring a multi-site HepaSphere product registry at key cancer centers throughout Europe beginning in the fourth quarter of 2005. The purpose of this registry is to collect and analyze procedure and patient data that is submitted by physicians using HepaSphere Microspheres in their clinical practice.

Mr. Faleschini concluded, "Embolization has been used to treat liver cancer for over ten years. We are hopeful that the launch of our HepaSphere product in European Union countries, together with the ongoing collection of clinical data through our newly formed European registry, and subsequent publications will support the use of this product by physicians in liver tumor embolization procedures."

The Company's HepaSphere product is currently not cleared by the U.S. Food and Drug Administration, or FDA, and, accordingly, is not available for sale in the United States. However, BioSphere anticipates filing a 510(k) notification with the FDA during the fourth quarter of 2005 seeking marketing clearance for HepaSphere Microspheres.

Since 2000, BioSphere has had exclusive worldwide rights to the HepaSphere Microsphere technology under a license from Dr. Shinichi Hori of Osaka, Japan. The Company also has three issued or pending patents on the product. Dr. Hori has used the HepaSphere product in approximately 1,500 clinical cases in Japan, where HepaSphere Microspheres have been under clinical evaluation since 1992.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, pioneers and commercializes 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.

BioSphere Medical has received clearance in many countries, including the United States, Canada, Australia, the European Community, and Latin America, which allows the Company to sell its products for use in general embolization procedures, including uterine fibroid embolization. The terms uterine fibroid embolization (UFE) and uterine artery embolization (UAE) are generally used interchangeably in the literature. The most common side effect of UFE is "post-embolization syndrome," a collection of symptoms including abdominal pain, discomfort, low-grade fever, and nausea. UFE is currently contraindicated for women who are, or who intend to become, pregnant, because the effects of UFE on the ability of a woman to conceive, and to carry a fetus to term, have not been determined.

Cautionary Statement Regarding Forward-Looking Statements - This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the Company's expectations with regard to the planned shipment of its HepaSphere product in Europe in the fourth quarter of 2005, its expectations regarding market acceptance and market penetration for its HepaSphere product and the expected timing of its 510(k) notification with the FDA to seek US marketing clearance for its HepaSphere product. The Company uses words such as "plans,""seeks,""projects,""believes,""may,""anticipates,""estimates,""should" 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 and its distributors to successfully market and sell the Company's products; 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 successfully develop, commercialize and achieve widespread market acceptance of its products, including without limitation, widespread market acceptance of its lead product, Embosphere(R) Microspheres for the treatment of UFE and its HepaSphere Microspheres product for the treatment of liver cancer; risks relating to 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; the inability of the Company to raise additional funds in the near term to finance the development, marketing, and sales of its products; and general economic and market conditions, as well as the risk factors described in the section titled "Factors That May Affect Future Results" in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2005, 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: Business Wire

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