Healthcare Industry News:  Uterine Fibroids 

Devices Interventional FDA

 News Release - August 14, 2006

FDA Clears BioSphere Medical's Next Generation EmboCath(R) Plus Infusion Microcatheter

ROCKLAND, Mass.--(HSMN NewsFeed)--Aug. 14, 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 has cleared for marketing in the United States BioSphere Medical's EmboCath® Plus Infusion Microcatheter. EmboCath Plus is expected to begin shipping in the United States in September 2006.

Richard Faleschini, BioSphere Medical's president and chief executive officer, said, "The approval of EmboCath Plus further expands BioSphere Medical's portfolio of proprietary embolization system solutions. It is designed to provide exceptional performance in the delivery of embolic, diagnostic, and therapeutic agents into the peripheral vascular system for interventional procedures such as uterine fibroid embolization and the embolization of hypervascularized tumors. EmboCath Plus was designed for use with BioSphere Medical's existing and planned new products, including: our Sequitor(TM) Steerable Guidewire, which received FDA approval in June 2006 and which will begin shipping this month, our currently marketed Embosphere® Microspheres, EmboGold® Microspheres, and our QuadraSphere(TM) Microspheres product candidate, for which we have submitted a 510(k) premarket notification to the FDA."

EmboCath Plus is designed to possess performance characteristics that include:
  • Controlled delivery, featuring the largest internal lumen diameter in its class - 0.028"- which provides a 10% greater flow rate than competitive products
  • A flexible, kink-resistant, durable design that offers optimal balance for agile tracking
  • A clear, chemo-compatible hub designed for smooth, fluent injection of microspheres
  • Enhanced fluoroscopic ability via an extra-bright tip
Gary Saxton, BioSphere Medical's executive vice president and chief operating officer, commented, "EmboCath Plus is the second FDA approval received by BioSphere Medical this year. I believe that this approval demonstrates our ability to effectively advance new product candidates rapidly through development and engineering, and regulatory approval. EmboCath Plus and our recently approved Sequitor Steerable Guidewire build upon the advantages of our first generation embolic delivery system by providing a new fully integrated system for optimal embolic performance."

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 launches of the EmboCath Plus Infusion Microcatheter and the Sequitor Steerable Guidewire in the U.S., the expected benefits of the EmboCath Plus Infusion Microcatheter and the Company's ability to move new product candidates rapidly through research and development to FDA submission. 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 new products and product enhancements;
  • the failure of the Company to successfully launch and achieve widespread market acceptance of new product introductions such as its EmboCath Plus Infusion Microcatheter and the Sequitor Steerable Guidewire;
  • the failure of the Company to successfully commercialize and achieve widespread market acceptance of its currently marketed products, including, without limitation, widespread market acceptance of its lead product, Embosphere Microspheres for the treatment of UFE and of its other microsphere products and delivery system devices;
  • 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 June 30, 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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