New ACTICOAT(TM) Silver Coated Anti-microbial Barrier Dressing Receives 510(k) Clearance from the US FDA
29 Julio 2009 - 8:00AM
PR Newswire (US)
PRINCETON, NJ, July 29 /PRNewswire-FirstCall/ -- NUCRYST
Pharmaceuticals, a developer and manufacturer of medical products
that fight infection and the Advanced Wound Management division of
Smith Nephew plc announced today that the US Food Drug
Administration (FDA) granted marketing clearance for Acticoat(TM)
Flex. Acticoat(TM) Flex is an antimicrobial barrier dressing
designed to conform to body contours and allow for flexible
movement for injuries that require sustained antimicrobial
activity. Acticoat(TM) Flex represents a new addition to the
Acticoat(TM) family and is coated with NUCRYST's patented
SILCRYST(TM) nanocrystalline silver technology. "We are pleased
that the US FDA has granted marketing clearance for Acticoat(TM)
Flex," said David B. Holtz, Interim President and Chief Executive
Officer, and Chief Financial Officer of NUCRYST. "The launch of
Acticoat(TM) Flex by Smith Nephew is the latest result of the
successful partnership between Smith Nephew and NUCRYST to provide
advanced antimicrobial protection to acute trauma and burn
patients, as well as to patients with complex chronic wounds." The
Acticoat(TM) brand is a leader in the antimicrobial advanced wound
care market. Acticoat(TM) Flex simplifies the dressing of wounds
with its unique conformable design that easily contours to
surfaces, including difficult-to-protect articulating regions such
as knee or elbow joints. "We are delighted with the US FDA
clearance for Acticoat(TM) Flex. We have had excellent feedback
from Canada where Acticoat(TM) Flex was launched at the end of
2008. The approval from the FDA allows us to further roll out the
technology and support the fight against healthcare acquired
infection" commented Roger Teasdale, President of Smith Nephew's
Advanced Wound Management business. "This product launch is a key
to our focus on Infection Management, one of the three focused
elements of the Wound Management Global Business Unit strategy
along with Exudate Management and Negative Pressure Wound Therapy."
About Acticoat(TM) Dressings with SILCRYST(TM) Nanocrystals
Antimicrobial barrier dressings are used to help prevent infection,
a major cause of delays in the wound healing process. Acticoat(TM)
dressings with NUCRYST's proprietary SILCRYST(TM) nanocrystalline
silver coatings provide effective antimicrobial activity thereby
providing an improved environment for the wound to heal.
Acticoat(TM) dressings are now sold by Smith Nephew in over 30
countries and are used extensively for serious wounds and traumatic
injury. About Smith Nephew Smith Nephew is a global medical
technology business, specialising in Orthopaedics, including
Reconstruction, Trauma and Clinical Therapies, Endoscopy and
Advanced Wound Management products. Smith Nephew is a global leader
in arthroscopy and advanced wound management and is one of the
leading global orthopaedics companies. Smith Nephew is dedicated to
helping improve people's lives. The Company prides itself on the
strength of its relationships with its surgeons and professional
healthcare customers, with whom its name is synonymous with high
standards of performance, innovation and trust. The Company
operates in 32 countries around the world. Annual sales in 2008
were $3.8 billion. About NUCRYST Pharmaceuticals NUCRYST
Pharmaceuticals (NASDAQ: NCST; TSX: NCS) develops, manufactures and
commercializes medical products that fight infection and
inflammation using SILCRYST(TM), its patented atomically disordered
nanocrystalline silver technology. NUCRYST licensed world-wide
rights for SILCRYST(TM) wound care coating products to Smith Nephew
plc, which markets these products in over 30 countries under their
Acticoat(TM) trademark. NUCRYST is also developing pharmaceutical
products to address medical conditions that are characterized by
pain, infection and inflammation. The Company has developed its
proprietary nanocrystalline silver in a powder form, referred to as
NPI 32101, for use in medical devices and as an active
pharmaceutical ingredient. Acticoat(TM) is a trademark of Smith
& Nephew plc SILCRYST(TM) is a trademark of NUCRYST
Pharmaceuticals Corp. This news release contains forward-looking
statements within the meaning of securities legislation in the
United States and Canada (collectively "forward-looking
statements"). The words "believes", "expects", "plans",
"anticipates", "estimates", "intends", "projects", "may", "might",
"would", "will", "could", "should" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements in this news release include, but are
not limited to, statements about: the future plans of our
management in relation to resolving our exchange listing
deficiency. With respect to the forward-looking statements
contained in this news release, readers are cautioned that numerous
risks, uncertainties and other factors could cause our actual
results to differ materially from those indicated in these
statements including, but not limited to: the performance of stock
markets generally; our ability to satisfy regulatory and stock
exchange standards and requirements to maintain our exchange
listing; our future operation results are uncertain and likely to
fluctuate; our ability to maintain our collaboration with Smith
Nephew; our reliance on sales of Acticoat(TM) products with our
SILCRYST(TM) coatings by Smith Nephew; future financial performance
and operating performance of Smith Nephew; we may not be able to
retain existing and obtain new regulatory approvals for any future
products; continued development and market acceptance of new
products; the impact of delays and challenges with new product
introductions; the impact of new product introductions on the sales
of existing products; the impact of competitive products and
pricing; we may not be able to establish successful
commercialization programs, through new corporate collaborations or
otherwise; changes in currency exchange rates; our ability to
protect our intellectual property rights and to not infringe on the
intellectual property rights of others. Although we have attempted
to identify the important risks, uncertainties and other factors
that could cause actual results or events to differ materially from
those expressed or implied in forward-looking statements, there may
be other factors that cause actual results or events to differ from
those expressed or implied in forward looking statements. For a
more thorough discussion of the risks associated with our business,
see the "Risk Factors" section in our Annual Report on Form 10-K
for the year ended December 31, 2008 and in our Quarterly Report on
Form 10-Q for the quarter ended March 31, 2009, filed with the U.S.
Securities and Exchange Commission on EDGAR at http://www.sec.gov/
and with securities authorities in Canada on SEDAR at
http://www.sedar.com/. All forward-looking statements are expressly
qualified in their entirety by this cautionary statement and
NUCRYST disclaims any intention or obligation to revise or update
any forward-looking statements whether as a result of new
information, future developments or otherwise after the date
hereof. DATASOURCE: NUCRYST Pharmaceuticals Corp. CONTACT: David
Wills, Gillian McArdle, Investor Relations, (416) 504-8464,
Copyright