Healthcare Industry News:  vascular embolization 

Devices Interventional

 News Release - March 28, 2008

BioSphere Medical Commences Sales of Embosphere(R) Microspheres in the People's Republic of China

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 announced that the Company has shipped its first order of Embosphere® Microspheres to the People’s Republic of China. In January 2008, China’s Medical Device Department of the State Food and Drug Administration approved the Company’s Embosphere Microspheres for clinical use for vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids.

Richard Faleschini, president and chief executive officer of BioSphere, commented, "We are pleased to have commenced shipments into China, as scheduled, and view this as a key milestone for BioSphere. We believe that among the estimated 150 to 200 million Chinese with health coverage are a large number of patients who have been and are being treated for benign and malignant hypervascularized tumors, such as uterine fibroids and hepatocellular carcinoma, respectively. Based on the estimated size of the potential market, we believe that over time China has the potential to be an attractive market for our embolic and delivery system products and a meaningful contributor to our international revenues. As important, we are excited to make available to physicians in China the necessary tools to provide state-of-the-art, minimally invasive treatments that have been demonstrated to improve patient outcomes and enhance quality of life.”

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 of the potential patient market for the Company’s Embosphere Microsphere product in China and the Company’s expectation that China will be an attractive market for its embolic and delivery system products and a meaningful contributor to its international revenues. 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 both domestically and abroad, including, without limitation, widespread market acceptance of its lead products, Embosphere Microspheres, HepaSphere™ Microspheres, QuadraSphere® Microspheres and its delivery system products, in each case for the specific indications for which such product has been cleared for marketing;
  • 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-K for the year ended December 31, 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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