- Company Advances Expanded General Hemostasis Surgery Indication
and Leadership Position in Surgical Hemostasis Market -
OMRIX Biopharmaceuticals, Inc. ("OMRIX" or "The Company") (NASDAQ:
OMRI), a commercial-stage biopharmaceutical company that develops and
markets biosurgical and passive immunotherapy products, announced
today that it has been granted marketing clearance from the U.S. Food
and Drug Administration (FDA) for its second generation fibrin
sealant, Evicel(TM), to control bleeding (hemostasis) during liver
surgery. Evicel differs from OMRIX's first generation fibrin sealant,
Crosseal(R), in that Evicel does not contain a stabilizer, and
therefore will not have the neurosurgical contraindication required of
Crosseal.
The Company also announced that it submitted a Prior Approval
Supplement (PAS) to the FDA containing the results of a prospective,
randomized multi-center Phase III controlled study comparing the
hemostatic efficacy of Evicel to standard-of-care in peripheral
vascular surgery in 150 patients. The first subject was randomized on
June 9, 2005 and the last subject completed the study on March 29,
2006. OMRIX submitted this PAS in order to expand the indication of
Evicel to include vascular surgery.
"Together with our distributor, ETHICON, Inc., we are re-defining
the hemostasis market," stated Robert Taub, President and Chief
Executive Officer of OMRIX Biopharmaceuticals, Inc. "Uncontrolled
surgical bleeding is a severe clinical issue. We are poised to provide
today's market with the safest and most technically superior products
that address the need for effective and quick hemostasis."
Mr. Taub continued, "An indication for general hemostasis requires
the completion of at least three pivotal clinical studies, of which we
have now completed two -- liver and peripheral vascular surgery. A 150
patient study in kidney surgery is currently underway. The achievement
of today's strategically important milestones provides a foundation on
which to expand the commercialization potential of our hemostasis
franchise, and brings us one step closer to a general hemostasis label
of Evicel, our liquid fibrin sealant. We look forward to announcing
additional validating events for Evicel and our other biosurgical
products: Thrombin and Biological Hemostatic Dressing, or BHD."
Evicel's Competitive Advantages
Evicel is unique in its ease of use, immediate availability to the
surgeon and in its bovine-free formulation. It provides for important
hemostasis support when conventional surgical techniques (i.e.,
suture, ligature, and cautery) prove to be inefficient, ineffective or
impractical. When compared to the already successful Crosseal, Evicel
does not require the addition of the stabilizing agent Tranaxemic
Acid.
About OMRIX Biopharmaceuticals, Inc.
OMRIX, a commercial-stage biopharmaceutical company, develops and
markets innovative biosurgical and passive immunotherapy products,
utilizing its proprietary protein purification technology and
manufacturing know-how. As part of its business strategy, OMRIX
commercializes certain of its biosurgical products through
collaborations with companies whose marketing and sales expertise are
a complement to OMRIX's own areas of specialty. OMRIX's novel and
easy-to-use biological-device convergence products address unmet
medical needs. For more information, please visit: www.omrix.com.
Safe Harbor Statement
This press release contains forward-looking statements.
Forward-looking statements provide the company's current expectations
or forecasts of future events. Forward-looking statements include
statements about the company's expectations, beliefs, plans,
objectives, intentions, assumptions and other statements that are not
historical facts. Words or phrases such as ''anticipate,''
''believe,'' ''continue,'' ''ongoing,'' ''estimate,'' ''expect,''
''intend,'' ''may,'' ''plan,'' ''potential,'' ''predict,'' ''project''
or similar words or phrases, or the negatives of those words or
phrases, may identify forward-looking statements, but the absence of
these words does not necessarily mean that a statement is not
forward-looking.
Forward-looking statements are subject to known and unknown risks
and uncertainties and are based on potentially inaccurate assumptions
that could cause actual results to differ materially from those
expected or implied by the forward-looking statements. The company's
actual results could differ materially from those anticipated in
forward-looking statements for many reasons, including the factors
described in the sections entitled ''Risk factors'' and "Management's
discussion and analysis of financial condition and results of
operations" in the company's Prospectus as filed with the Securities
and Exchange Commission on April 21, 2006. Accordingly, you should not
unduly rely on these forward-looking statements, which speak only as
of the date of this press release.
Unless required by law, the company undertakes no obligation to
publicly revise any forward-looking statement to reflect circumstances
or events after the date of this press release or to reflect the
occurrence of unanticipated events. You should, however, review the
factors and risks we describe in the reports the company will file
from time to time with the Securities and Exchange Commission after
the date of this press release.
