ROCKLAND, Mass.--(Business Wire)--
BioSphere Medical, Inc. (NASDAQ:BSMD) ("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
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
Copyright Business Wire 2009
