Healthcare Industry News:  embolotherapy 

Devices Regulatory

 News Release - January 28, 2008

BioSphere Medical Receives Market Clearance to Sell Embosphere(R) Microspheres in the People's Republic of China

BioSphere's State-of-the-Art Embolic Now Available to the World's Largest Population of Patients with Primary Liver Cancer Tumors

ROCKLAND, Mass.--(HSMN NewsFeed)--BioSphere Medical, Inc. (Nasdaq: BSMD), 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, today reported that the Medical Device Department of the State Food and Drug Administration of the People’s Republic of China has approved BioSphere’s Embosphere Microspheres for clinical use for vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids. BioSphere expects to commence shipments of Embosphere Microspheres to China in the first quarter of 2008.

Richard Faleschini, President and Chief Executive Officer of BioSphere, commented, "China, of course, has a very large population, and our in-country partners estimate that currently approximately 200 million Chinese have health coverage. We believe that among these covered lives are a large number of patients who have and are being treated for benign and malignant hypervascularized tumors, such as uterine fibroids and hepatocellular carcinoma, respectively. Therefore, we believe that China has the potential to be an attractive market for us, and a catalyst for potential future revenue growth.”

In China, the annual incidence of hepatocellular carcinoma (HCC or primary liver cancer) is approximately 350,000, roughly half of the total worldwide incidence. The high occurrence of HCC in Asia in general and China in particular is attributed to a high historical prevalence of the hepatitis B and C viruses. These viruses damage the liver and can contribute in time to the development of primary liver cancer. As the cancer progresses, physicians may embolize the resulting tumors, and may often perform multiple procedures on each patient.

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, the Company’s estimate that it will commence the shipment of Embosphere Microspheres to China in the first quarter of 2008, the potential market for the Company’s Embosphere Microsphere product in China and the potential for such sales to accelerate future revenue growth for the Company, and statements regarding the potential benefits of Embosphere Micropheres in addressing liver cancer. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intends," 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

Issuer of this News Release is solely responsible for its content.
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