Covalon Technologies Inc. Announces Major Milestone: Achieves FDA Approval for IV Clear™ - a Breakthrough Antimicrobial Silicone Adhesive Film Dressing for Securing Vascular Access Medical Devices
5/15/2012 7:23:22 AM
MISSISSAUGA, ON, May 15, 2012 /PRNewswire/ - Covalon Technologies Ltd. (the
"Company" or "Covalon") (TSXV: COV), an advanced medical technologies
company, today announced United States Food and Drug Administration
("FDA") approval of IV ClearTM, a breakthrough antimicrobial silicone adhesive film dressing designed
for securing vascular intravenous access devices.
Covalon's IV Clear antimicrobial film dressings have a number of unique
and highly desirable characteristics:
IV Clear is the only vascular access securement dressing approved by the
FDA that combines the comfort of skin-friendly silicone adhesive
technology with the advanced antimicrobial protection of two gold-standard antimicrobial agents - chlorhexidine and silver.
IV Clear has uniquely bonded the two antimicrobials into the actual
adhesive of the soft and non-sensitizing silicone that allows the clear
film dressing to comfortably secure vascular access devices to the skin
while providing antimicrobial protection for up to 7 days.
IV Clear is breathable unlike most other silicone dressings.
Patients are able to bathe while wearing the waterproof silicone IV
All the current leading suppliers of vascular access securement
dressings use acrylic adhesives instead of the much superior and more
Studies have shown that IV Clear is up to ten times less painful on
removal than leading film dressings that use acrylic adhesives.
"IV Clear is truly a new innovation in the fight against Catheter
Related Blood Stream Infections (CRBSI), for which the Center for
Disease Control (CDC) calls one of the most deadly and costly threats
to patient safety," said Brian Pedlar, Covalon's Chief Executive
Officer. "Having an antimicrobial silicone adhesive is a clear
advantage over the older generation of patches, pads or acrylic
adhesive technologies currently available in the market. With over 350
million IV catheter stabilization devices used in the United States
alone and the adoption of antimicrobial securement devices experiencing
double-digit growth, we fully expect IV Clear to be a strong competitor
in the market."
IV Clear is intended to cover and protect insertion sites and to secure
the various intravenous devices to a patient's skin. FDA approval
included the following indications for use: IV catheters, central
venous lines, peripherally inserted central catheters (PICCs), suction
catheters, epidural catheters, hemodialysis catheters, orthopedic pins,
other intravascular catheters and percutaneous devices.
Mr. Pedlar continued, "This is a major achievement for Covalon's
talented team of scientists. Our lab continues to innovate and work on
many other applications that will be announced in due course. It is an
exciting time at Covalon."
IV Clear is available immediately for sale and/or license in the United
States and Canada by contacting Covalon at email@example.com or calling 1.877.711.6055.
Covalon Technologies Ltd. researches, develops and commercializes new
healthcare technologies that help save lives around the world.
Covalon's patented technologies, products and services address the
advanced healthcare needs of medical device companies, healthcare
providers and individual consumers. Covalon's technologies are used to
prevent, detect and manage medical conditions in specialty areas such
as wound care, tissue repair, infection control, disease management,
medical device coatings and biocompatibility. To learn more about
Covalon, visit our website at www.covalon.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.
This news release contains forward-looking statements which reflect the
Company's current expectations regarding future events. The
forward-looking statements are often, but not always, identified by the
use of words such as "seek", "anticipate", "plan, "estimate", "expect",
"intend" and statements that an event or result "may", "will",
"should", "could" or "might" occur or be achieved and other similar
expressions. These forward-looking statements involve risk and
uncertainties, including the difficulty in predicting product
approvals, acceptance of and demands for new products, the impact of
the products and pricing strategies of competitors, delays in
developing and launching new products, the regulatory environment,
fluctuations in operating results and other risks, any of which could
cause results, performance, or achievements to differ materially from
the results discussed or implied in the forward-looking statements.
Many risks are inherent in the industry; others are more specific to
the Company. Investors should consult the Company's ongoing quarterly
filings for additional information on risks and uncertainties relating
to these forward-looking statements. Investors should not place undue
reliance on any forward-looking statements. The Company assumes no
obligation to update or alter any forward-looking statements whether as
a result of new information, further events or otherwise.
SOURCE Covalon Technologies Ltd.