Healthcare Industry News:  steerable guidewire 

Devices Interventional FDA

 News Release - November 9, 2006

BioSphere Medical Receives FDA Approval For QuadraSphere(TM) Microspheres

ROCKLAND, Mass.--(HSMN NewsFeed)--BioSphere Medical, Inc. (NASDAQ: BSMD ; "BioSphere"), a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations, today announced that the U.S. Food and Drug Administration has cleared the 510(k) notification for BioSphere's proprietary QuadraSphere(TM) Microspheres, permitting the sale of this product in the United States. U.S. shipments through BioSphere's direct sales force are expected to begin immediately.

BioSphere's QuadraSphere Microspheres ("QuadraSphere"), which are indicated to treat hypervascularized tumors and peripheral arteriovenous malformations, are delivered by interventional radiologists who perform embolization procedures. Embolization is an image-guided, minimally invasive therapy that selectively occludes the blood supply of benign or malignant hypervascularized tumors, including liver tumors. QuadraSphere is technically identical to BioSphere's HepaSphere(TM) Microspheres ("HepaSphere"), an embolic currently marketed in Europe.

Richard Faleschini, president and chief executive officer of BioSphere Medical, commented, "We are very excited to expand our product portfolio and, in doing so, broaden the options physicians have to treat their patients. BioSphere's growing success in Europe with HepaSphere Microspheres, and in countries around the world with products such as Embosphere® Microspheres and EmboGold® Microspheres, reflects our commitment to support the development of treatment protocols through the introduction of new embolic products."

Gary Saxton, BioSphere Medical's executive vice president and chief operating officer, added, "We believe that U.S. physicians will appreciate and come to rely on the unique absorbing, expanding, and conforming properties of QuadraSphere. QuadraSphere can be delivered through BioSphere's EmboCath®Plus Infusion Microcatheter and Sequitor(TM) steerable guidewire, and is designed to offer physicians a complete embolic solution to customize and target patient treatment."

QuadraSphere's technical attributes are designed to provide a unique and versatile embolization platform. Its spherical shape allows for a predictable, flow-directed occlusion. The product rapidly expands up to four times its dry-state diameter and thus absorbs aqueous media up to 64 times its dry-state volume. In addition to the absorption process, the negatively charged polymer is also capable of selective bonding with positively charged substances through ionic interaction. Also, QuadraSphere affords atraumatic conformability to the vessel architecture, leading to a more complete vessel occlusion.

In the European Union, BioSphere's HepaSphere embolic product has market clearance for the treatment of primary and metastatic liver cancer. BioSphere is currently selling HepaSphere through its direct sales force in France and its network of distributors in the remaining countries of the European Union. HepaSphere has also been used in clinical evaluation in Japan since 1992.

About QuadraSphere Microspheres

QaudraSphere is technically identical in all respects to HepaSphere. BioSphere's 510(k) clearance for QuadraSphere does not include specific indications for the treatment of primary and metastatic liver cancer. FDA regulations require that BioSphere conduct formal clinical trials prior to seeking to claim the use of QuadraSphere for the treatment of a specific disease or condition, such as primary and metastatic liver cancer, while European Union regulations do not require trials for this class of medical device. Accordingly, in order for BioSphere to seek FDA clearance to promote the use of QuadraSphere for the embolization of primary and metastatic liver cancer, it must conduct clinical trials in the United States.

About BioSphere Medical, Inc.

BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, has pioneered and is commercializing minimally invasive diagnostic and therapeutic products based on its 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 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, expected benefits and market acceptance of QuadraSphere Microspheres, as well as the Company's beliefs with respect to the global growth of its business. 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 successfully develop, commercialize and achieve widespread market acceptance of its products, including, without limitation, widespread market acceptance of QuadraSphere Microspheres;
  • the absence of, or delays and cancellations of, product orders;
  • delays, difficulties or unanticipated costs in the introduction of new products, including, without limitation, the Company's Quadrasphere Microspheres and its other microsphere and ancillary device products that have recently been approved for marketing and sale;
  • 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;
  • competitive pressures;
  • the Company's ability to obtain and maintain patent and other proprietary protection for its products and product candidates;
  • 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 quarter 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

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.