Healthcare Industry News:  Uterine Fibroids 

Devices Distribution

 News Release - April 16, 2009

BioSphere Medical Enters into Exclusive Distribution Agreement with Nippon Kayaku for Japanese Market

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 signed an exclusive agreement with Nippon Kayaku Co., Ltd. for the planned distribution of HepaSphere™ Microspheres and Embosphere® Microspheres in Japan. According to the agreed-upon terms, Nippon Kayaku will be responsible for regulatory strategy and seeking to obtain requisite product registrations, including performing any clinical studies that may be required as a condition to product registration, and will bear the related cost for these activities. Assuming either or both of the products receive market clearance and the government reimbursement rate is set, BioSphere will provide the approved product to Nippon Kayaku for distribution and sale based on a predetermined formula indexed to the final Japanese government reimbursement rate. The agreement calls for BioSphere to receive a $1.0 million milestone payment in 2009. Also, Nippon Kayaku has agreed to pay up to $3.0 million in additional milestone payments in subsequent periods based on achievement of product registration goals and revenue targets.

“Japan is one of the major world markets for the treatment of liver cancer with approximately 75,000 transcatheter arterial embolizations performed in 2008,” commented Richard Faleschini, chief executive officer of BioSphere. “As a leading, well-respected chemical and pharmaceutical company in Japan with a substantial oncology franchise, we believe that Nippon Kayaku is well positioned to gain regulatory approval for our embolic products and drive market adoption with interventional oncologists in this significant market.”

About BioSphere Medical, Inc.

BioSphere Medical, Inc. 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.

About Nippon Kayaku

Founded in 1916, Nippon Kayaku is a leading Japanese pharmaceutical, functional chemical, automotive occupant safety systems and agrochemical company with over $1.45 billion in revenues. In their Pharmaceutical Division, they manufacture and sell anticancer drugs, cardiovascular drugs, immunosuppressants, and other pharmaceuticals and diagnostics for prescription. In the anticancer drug field in particular, they offer a lineup of 22 anticancer drug products, and are at the top level worldwide both in terms of technology and business performance. They are working with cutting-edge technologies, and have recently entered the clinical phases in development of DDS (Drug Delivery System) pharmaceuticals utilizing nanotechnology.

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, statements regarding BioSphere’s expectations regarding the benefits of its distribution agreement with Nippon Kayaku and the ability of Nippon Kayaku to successfully obtain regulatory approval for, and sell, BioSphere’s products in Japan. The Company may use words such as "plans," "seeks," "projects," "believes," "may," "anticipates," "estimates," "should," "intends," “looking forward,” and similar expressions to identify these forward-looking statements. These statements are subject to risks and uncertainties and are based upon BioSphere’s beliefs and assumptions. There are a number of important factors that may affect BioSphere’s actual performance and results and the accuracy of its forward-looking statements, many of which are beyond BioSphere’s control and are difficult to predict. These important factors include, without limitation, risks relating to:
  • the failure of BioSphere to successfully maintain its distribution agreement with Nippon Kayaku or to obtain and maintain the required regulatory approval to sell its products through Nippon Kayaku in Japan;
  • 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 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 increase the rate of UFE procedures, and concomitant use of its products for UFE, with its expanded sales force and its recently initiated sales and marketing strategies;
  • 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;
  • BioSphere’s ability to obtain and maintain patent and other proprietary protection for its products and product candidates;
  • the absence of, or delays or 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 BioSphere’s operating results;
  • the inability of the Company to successfully execute on its plans and strategies for future growth, including its plans to grow its business in both the UFE and interventional oncology fields and its plans for international growth;
  • 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, both domestic and abroad; and
  • risk factors described in the section titled "Risk Factors" in BioSphere’s Quarterly Report on Form 10-K for the quarter ended December 31, 2008, 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 BioSphere’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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