Healthcare Industry News:  Uterine Fibroids 

Devices Interventional FDA

 News Release - June 9, 2006

FDA Clears BioSphere Medical's Next Generation Sequitor(TM) Steerable Guidewire

ROCKLAND, Mass.--(HSMN NewsFeed)--June 9, 2006--BioSphere Medical, Inc. (NASDAQ: BSMD ), a medical device company that pioneered the use of bioengineered microspheres to treat Uterine Fibroids, hypervascularized tumors and vascular malformations by a procedure called embolization, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the BioSphere Medical Sequitor(TM) Steerable Guidewire ("Sequitor") Premarket Notification (510K) that allows Sequitor to be marketed in the United States. Sequitor is expected to begin shipping in the United States in July 2006.

BioSphere's internally developed Sequitor guidewire is the newest addition to the company's line of embolic delivery products. Designed specifically to address the needs of interventionalists, Sequitor facilitates the placement of catheters within the peripheral vasculature for various interventional procedures, including both uterine fibroid embolization and embolization of hypervascularized tumors, such as liver tumors.

Following the completion of certain documentation requirements to conform to European regulations, BioSphere also expects to complete the CE marking of Sequitor and to launch it in Europe in July 2006. CE marking denotes conformity with European Medical Device Directive (EC Council Directives 93/42/EEC) and allows for marketing in European Union countries.

Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "The introduction of Sequitor is a next step toward our goal to optimize BioSphere delivery systems products for peripheral embolization procedures. With Sequitor's trackability, torque response, distal steerability, visibility under fluoroscopy, and innovative hydrophilic coating, we believe we have developed a best-in-class guidewire that will clearly establish BioSphere's technical leadership in delivery system technology. In addition, while Sequitor can be used with our existing products, including our EmboCath® infusion catheter, it has also been designed to be used with our new EmboCath® Plus infusion catheter, which is under development, and whose 510K we expect to submit to the FDA during the third quarter of 2006."

Mr. Faleschini noted that Sequitor possesses:
  • A durable atraumatic polymer tip that reduces the risk of vascular spasm but retains its shape for selective vessel access;
  • A highly visible distal segment, comprised of a radiopaque coil and polymer jacket, which provides visibility under live imaging;
  • A specially tempered wire core designed to transmit one-to-one torque response without kinking; and
  • PASSTHRU(TM) lubricious, hydrophilic coating that facilitates wire trackability.
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 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 planned launch of the Sequitor guidewire in the U.S. and Europe, the timing of filing a 510(k) application with the FDA seeking marketing clearance for the EmboCath Plus Catheter under development and the expected benefits of the Sequitor guidewire product. The Company uses 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 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® Microspheres for the treatment of UFE;
  • 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;
  • general economic and market conditions; and
  • the risk factors described in the section titled " Risk Factors" in the Company's Quarterly Report on Form 10-Q for the period ended March 31, 2006, 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: BioSphere Medical

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