Covalon Announces Major Milestone: FDA Clearance for MediClear™ PreOp

  • Covalon’s first medical product that can be sold over-the-counter at
    pharmacies without the need of a prescription
  • Covalon’s first product cleared to access the multi-billion dollar
    pre-surgical skin antisepsis market
  • Provides continuous antimicrobial activity to reduce the risk of
    bacterial contamination of a patient’s skin prior to surgery

MISSISSAUGA, Ontario–(BUSINESS WIRE)–Covalon Technologies Ltd. (the “Company” or “Covalon”) (TSXV: COV;
OTCQX: CVALF), an advanced medical technologies company, announced today
it has received United States Food and Drug Administration (“FDA”)
clearance to legally market and sell MediClear™ PreOp in the US to
hospitals, clinics and directly to patients, without the need for a
prescription.

MediClear PreOp is a breathable, transparent, self-adhesive, silicone
barrier film-drape that smoothly conforms to the contours of a patient’s
skin at the planned incision or insertion site to protect the patient
from exposure to bacteria, yeast and viruses. MediClear PreOp’s
application is so simple, it can be applied by patients themselves or by
clinicians at a consultation before their surgery. MediClear PreOp is
then removed immediately prior to surgery by a clinician in the
operating room under sterile conditions.

“MediClear PreOp is Covalon’s first product to be cleared that enables
us to enter the multi-billion dollar pre-surgical skin antisepsis
market,” said Brian Pedlar, Covalon’s Chief Executive Officer. “With an
over-the-counter (“OTC”) designation by the FDA, Covalon can now provide
patients easy access to a world-class infection prevention product to
protect themselves from exposure to bacteria, viruses and fungi before a
surgery.”

The silicone adhesive in MediClear Pre-Op contains two antimicrobials –
chlorhexidine and silver. The chlorhexidine and silver contained in the
adhesive provides continuous antimicrobial activity while a polyurethane
barrier film acts as a protective barrier to isolate a procedural site
from microbial and other contamination. MediClear PreOp’s silicone
adhesive provides a rapid bactericidal and fungicidal effect against a
broad-spectrum of microorganisms, averaging a 99.9% reduction at 10
minutes and a 99.99% reduction at 30 minutes, and prevents their
re-growth for up to 7 days during wear.

“In an effort to reduce surgical site infections, hospitals in the
United States spend billions of dollars every year on products to
antiseptically clean and prep patients’ skin before surgery and a
further $3.3 billion a year treating surgical site infections that
current products and practices couldn’t prevent,” said Pedlar. “We see
great promise with MediClear PreOp to help in reducing the instances of
surgical site infections by protecting patients all the way into the
operating room. There is no other OTC product on the market that
provides the dual-antimicrobial and physical protection of MediClear
PreOp.”

MediClear™ PreOp provides an effective physical barrier against external
contamination including fluids, bacteria, and yeast. In vitro
testing demonstrates that the chlorhexidine and silver incorporated
within the silicone adhesive provide a rapid bactericidal and fungicidal
effect against microorganisms including Staphylococcus aureus
(MRSA), Staphylococcus epidermidis, Enterococcus faecalis
(VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa,
Enterobacter cloacae, Candida albicans, and Candida
tropicalis, and prevents their re-growth for up to 7 days while
wearing MediClear PreOp.

About Covalon
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.

Contacts

Covalon Technologies Ltd.
Brian Pedlar, 905-568-8400 x 233
Toll
free: 1-877-711-6055
CEO
bpedlar@covalon.com
Web
site: www.covalon.com
Twitter:
@covalon