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Covalon Announces FDA Clearance for Its New SilverCoat™ Silicone Foley Catheter

 

MISSISSAUGA, Ontario – November 30, 2015 – /CNW/ - Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV), an advanced medical technologies company, announces United States Food and Drug Administration (“FDA”) clearance of its new SilverCoatTM Silicone Foley Catheter that is designed to allow clinicians to drain a patient’s bladder, help reduce the likelihood of getting a catheter-related urinary tract infection (“CAUTI”) and remain permanently lubricious. The US Centers for Disease Control and Prevention (“CDC”) identifies catheters as the primary cause of urinary tract infections, making them one of the most commonly reported Hospital Associated Infections (“HAI”). 

 

Covalon’s new SilverCoat Silicone Foley Catheter is a 100% silicone Foley catheter that has a permanent lubricious coating impregnated with silver ions. The silver is retained in the hydrophilic coating through ionic bonding and is covalently bonded to the silicone surface through Covalon’s patented surface modification technology. The SilverCoat coating on the silicone Foley catheter provides a zone of inhibition to bacteria around the catheter surface and resists microbial colonization on the surface of the device thereby reducing the likelihood of catheter-related urinary tract infections. 

 

"Obtaining FDA clearance on our new SilverCoat Foley catheter opens the United States market for Covalon to license and sell our catheters.” said Brian Pedlar, Covalon’s CEO. “We believe our patented technology that is incorporated into our SilverCoat Foley provides superior protection for patients at risk of developing a CAUTI. With up to 25% of the patients hospitalized in the United States catheterized and annually over 500,000 patients with indwelling catheters developing an infection, we believe the opportunity for Covalon’s SilverCoat Foley to make a strong clinical impact is compelling.” 

 

Covalon’s new SilverCoat Foley Catheter will be available to hospitals, ambulatory surgical centers and home-healthcare providers through Covalon and available for license and private label by distribution partners of Covalon. 

 

To learn more about Covalon, please contact: 

Brian Pedlar, CEO, Covalon Technologies Ltd. 

Email: bpedlar@covalon.com 

Phone: 905.568.8400 x 233 

Toll free: 1.877.711.6055 

Web site: www.covalon.com 

Twitter: @covalon 

 

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. ©Covalon Technologies Ltd. Page 2 of 2 

 

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.