BioSphere Medical, Inc. Submits Investigational Device Exemption to FDA for QuadraSphere(R) Microspheres for Use with Doxorubicin for the Treatment of Primary Liver Cancer
Published: Oct 27, 2009
ROCKLAND, Mass.--(BUSINESS WIRE)--BioSphere Medical, Inc. (NASDAQ:BSMD - News) (“BioSphere” or the “Company”) – the leader in 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 the submission to the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application for a clinical trial for the use of BioSphere’s QuadraSphere® Microsphere product (QuadraSphere) to deliver the chemotherapeutic agent doxorubicin for the treatment of primary liver cancer. Provided that the FDA accepts the planned clinical protocol, the Company plans to begin enrolling patients into the study within 60 days of FDA approval.
The proposed investigation will be a prospective, randomized, double-blinded clinical trial conducted at approximately 15 sites in the U.S., European Union and Brazil. The clinical trial will focus on treating patients with advanced hepatocellular carcinoma (HCC), also known as primary liver cancer, and will compare QuadraSphere with doxorubicin against conventional transarterial chemoembolization (cTACE) with doxorubicin. BioSphere anticipates that patient enrollment will take approximately 12 months, and that it will file a premarket approval application (PMA) with the FDA approximately 12 months after the final patient is enrolled. The Company expects to fund trial costs from current working capital and cash flow from operations.
Richard Faleschini, chief executive officer of BioSphere Medical, said, “Only a small percentage, about 25%, of the more than 600,000 patients diagnosed each year with hepatocellular cancer worldwide can be treated with surgery or transplant. For the majority of patients with hepatocellular cancer, conventional transarterial chemoembolization (cTACE) is the standard of care. At the present time, there is not an embolic in the United States with FDA market clearance for the treatment of hepatocellular cancer.”
Mr. Faleschini added, “Independent studies in Europe of our embolic loaded with doxorubicin have generated positive results, and the pivotal study is designed to further evaluate clinical performance. The QuadraSphere with doxorubicin clinical trial is an important milestone for BioSphere, and if the trial is successful and the PMA is approved by the FDA, it is expected to be the first FDA approval for hepatocellular carcinoma using chemoembolization, providing further demonstration of our leadership position in embolotherapy.”
About QuadraSphere Microspheres
QuadraSphere’s technical attributes are designed to provide a unique and versatile embolization platform. Its spherical shape is designed to allow for a predictable, flow-directed occlusion. The product has been demonstrated to expand to four times its dry-state diameter. Also, QuadraSphere is designed to afford atraumatic conformability to the vessel architecture, leading to a more complete vessel occlusion. QuadraSphere is technically identical to BioSphere's HepaSphere™ Microspheres, an embolic currently CE marked in the European Union for delivery of doxorubicin for embolization of HCC and hepatic metastases.
About Conventional Transarterial Chemoembolization (cTACE)
Conventional transarterial chemoembolization (cTACE) is a two-stage process involving the injection of a concentrated dose of chemotherapeutic drugs, e.g., doxorubicin, directly into the blood vessels that feed a tumor, followed by the infusion of an embolic agent through a catheter and into the blood vessels that feed a tumor, thus selectively blocking the tumor’s blood supply. Because the blood vessels are blocked with the embolic material, the chemotherapeutic drug is thought to dwell in direct contact with the tumor longer and target the tumor more effectively than would a systemic chemotherapeutic treatment.
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 properties that may be beneficial in 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, statements regarding the Company’s planned clinical trials and FDA submissions for its QuadraSphere Microsphere product and the expected benefits of QuadraSphere for the treatment of primary liver cancer. 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 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 its Embosphere® Microspheres for the treatment of UFE, its HepaSphere™ Microsphere and QuadraSphere® Microsphere products, and its delivery systems product line; * the Company’s ability to obtain FDA authorization to investigate the safety and efficacy of QuadraSphere loaded with a chemotherapeutic agent for the treatment of HCC; the failure to demonstrate safety or effectiveness in clinical trials; or the failure to obtain PMA approval; * the failure of the Company to increase the rate of UFE procedures, and concomitant use of its products for UFE, with its 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 testing, manufacture and sale of its products and product candidates, including, without limitation, the risk that the Company will not gain necessary regulatory approvals to market and sell its products in Japan through its agreement with Nippon Kayaku and that it will not successfully advance its QuadraSphere clinical trials; * the Company’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 the Company’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 the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and for the Quarter ended June 30, 2009, each 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.
Company Contact: BioSphere Medical, Inc. Martin Joyce, EVP & CFO, 781-681-7925 www.biospheremed.com or Investor Relations Contacts: Lippert/Heilshorn & Associates, Inc. Kim Golodetz, 212-838-3777 email@example.com or Bruce Voss, 310-691-7100 firstname.lastname@example.org