SINGAPORE, Jan. 18 /PRNewswire/ -- International Group, Ltd.
(Bloomberg: BIG SP, Company or Biosensors), today announced that the
Company has received Conformite Europeenne (CE) Mark approval for its
BioMatrix(R) drug-eluting stent system, enabling commercialization of this
product in the European Union and the countries in Asia and Latin America
that recognize the CE Mark. The BioMatrix drug-eluting stent system,
developed internally by the Company, consists of a unique drug-eluting
stent that incorporates a biodegradable polymer and the Company's
proprietary drug, Biolimus A9(R), which inhibits restenosis, or
re-narrowing of the arteries, following stent implantation.
Terumo Corporation (Terumo), a licensee of Biosensors' BioMatrix
technology, also announced CE Mark approval for its NOBORI(TM) drug-eluting
stent system. In October 2003, Biosensors and Terumo entered into a
licensing agreement that granted Terumo the rights to sell the NOBORI
drug-eluting stent system exclusively in Japan and non-exclusively in
countries outside Japan excluding the United States. Under this agreement,
Terumo will share a portion of the revenues from the sales of NOBORI with
Biosensors. In May 2007, Terumo commenced the clinical trial of the NOBORI
drug-eluting stent system required for Japanese regulatory approvals.
"We are very pleased to have received CE Mark approval for our
BioMatrix stent and will immediately implement our strategy to make this
product available in the approved markets. Our growth potential in these
markets is very strong, as BioMatrix and NOBORI will be the only
drug-eluting stents currently available which incorporate a biodegradable
polymer coating together with an immunosuppressive drug. Positive clinical
data position the BioMatrix stent system to be a potential break-through
product for patients and physicians," stated Mr. Yoh-Chie Lu, Chairman and
Chief Executive Officer.
Professor Eberhard Grube, Chief of Angiology and Cardiology at Siegburg
Heart Center in Germany and a principal investigator for the BioMatrix
clinical trial program commented, "BioMatrix will provide a valuable
alternative to the drug-eluting stents currently available to
interventional cardiologists. The results from the BioMatrix clinical
trials have been consistently very positive and promising. The three-year
follow-up data released at the Transcatheter Cardiovascular Therapeutics
Conference last year continued to demonstrate BioMatrix's superior results
in terms of safety and clinical effectiveness. The BioMatrix drug-eluting
stent has shown excellent procedural performance and outcome
Mr. Lu added: "We are also pleased with the timing of this approval, as
the increasing complexity of worldwide regulatory requirements will make it
even more difficult to introduce new technologies into the marketplace. We
plan to commence a staged launch of BioMatrix commencing 1 April 2008. The
initial stage will be to introduce BioMatrix through our existing
distribution channels. We will expand these channels to increase
geographical coverage during the first half of our fiscal year beginning in
April 2008 and plan a significant ramp up in sales over the second half of
our fiscal year.
"Many years of effort devoted to developing the BioMatrix drug-eluting
stent system have been validated by this approval. We would like to take
this opportunity to recognize the contributions of our people and the
collaborative efforts of our licensees, especially Terumo Corporation, in
achieving this milestone. This is truly an historic day for Biosensors,"
concluded Mr. Lu.
BioMatrix offers the unique combination of an innovative
anti-restenosic drug, Biolimus A9(R), a biodegradable polymer, and advanced
Biolimus A9 was designed specifically to maximize stent efficacy. In
addition to effective immunosuppressive and anti-inflammatory properties,
the drug has a higher lipophilic and hydrophobic profile than other drugs
in its class, enabling the drug to be rapidly absorbed into tissue, with
reduced systemic exposure.
The PLA polymer fully degrades into water and carbon dioxide as the
drug is released, ultimately leaving in place a biocompatible stent
surface. The polymer is coated onto the outer (abluminal) side of the stent
only, enabling the drug to be released to targeted tissue. The
internally-developed stent used in the BioMatrix system is designed for
increased flexibility in delivery.
About Biosensors International Group, Ltd
Biosensors develops, manufactures and markets innovative medical
devices used in interventional cardiology and critical care procedures.
Biosensors is well-positioned to emerge as a leader in drug-eluting stents,
an evolving therapy that is rapidly gaining market share from traditional
therapies such as bare-metal stenting and open-heart surgery. Biosensors
has internally developed technology to address each component of a
drug-eluting stent system, including a stent, a stent delivery catheter, a
biodegradable polymer and a proprietary anti-restenosis drug. It is
pursuing three separate drug-eluting stent programs, BioMatrix(R),
Axxion(TM), and BioMatrix(R) Freedom(TM), a polymer-free drug-eluting
stent, and has licensed aspects of its drug-eluting stent technology to
Forward Looking Statements
Certain statements herein include forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Forward-looking statements generally can be identified by the use of
forward-looking terminology, such as "may," "will," "expect," "intend,"
"estimate," "anticipate," "believe," "project" or "continue" or the
negative thereof or other similar words. All forward-looking statements
involve risks and uncertainties, including, but not limited to, customer
acceptance and market share gains, competition from companies that have
greater financial resources; introduction of new products into the
marketplace by competitors; successful product development; dependence on
significant customers; the ability to recruit and retain quality employees
as Biosensors grows; and economic and political conditions globally. Actual
results may differ materially from those discussed in, or implied by, the
forward-looking statements. The forward-looking statements speak only as of
the date of this release and Biosensors assumes no duty to update them to
reflect new, changing or unanticipated events or circumstances.
SOURCE Biosensors International Group, Ltd.