FDA approval received on Covalon silver ion releasing coating
February 20, 2006
Mississauga, Ontario – February 20, 2006: Covalon Technologies Ltd. (“Covalon”) (TSX VENTURE: COV) announces that the FDA has approved Covalon’s proprietary silver ion releasing coating on Foley Catheters for use in the United States.
Dr. DiCosmo, President and CEO stated that the approval of Covalon’s proprietary silver ion-releasing coating is a break-through for the coating division as it is our first FDA approval on a coating application. The coating is applicable to many indwelling medical devices such as catheters. In-dwelling medical devices are crucial to patients in hospitals. The devices, often in the form of tubes, provide access to the body for the delivery of fluids, drugs, and even nutrition and air (Endotracheal tubes). The devices also provide a means of removing waste substances from the body through urinary catheters, kidney dialysis, and wound drains. The insertion of such devices, for example urinary (Foley) catheters and other tubes into the body provide a conduit for skin bacteria and yeast to gain entry and cause infection. Infections arising from the use of in-dwelling biomedical devices, especially catheters, are associated with increased morbidity and mortality, prolonged hospitalization, patient discomfort and increased medical costs. Urinary tract infections (UTIs) caused by Foley catheters are among the most prevalent type of hospital acquired infections as noted below:
- UTIs account for 40% of Hospital Acquired Infections
- Foley catheter use causes 80 to 90% of UTIs
- 15 to 50% of hospitalized patients with a urinary catheter experience UTI from urinary catheterization
- Infection risk increases by 5% each day of catheterization
- Bacteremia (bacteria in the blood) occurs in up to 4% of cases
- 1 to 3.8 extra hospital days are due to UTI and $680 to $3,800 per patient/episode of UTI added to the healthcare system
- UTIs increase the costs associated with treatment by more than US$1.8 billion per year in the USA
Ionic silver is well accepted as an antiseptic and is a proven broad-spectrum antimicrobial agent that eradicates gram positive and gram negative bacteria including antibiotic-resistant bacteria like methicillin-resistant Staphylococus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE). Ionic silver also kills moulds (fungi) including yeast such as Candida albicans. Covalon has developed a proprietary coating that is applicable to a wide variety of medical devices that include dialysis lines, PICC lines, and various catheters.
Covalon Technologies Ltd. is a company with advanced medical products that has developed and patented advanced therapeutic biomaterials for wound care and surgical applications and coatings. Polymer chemistry and surface coating technology have been combined to create a range of time-release drug delivery platforms that are applied to many medical devices to treat many critical conditions. A variety of applications for these technologies have been identified and specific products have been developed. The products offer features and benefits providing solutions to many of the problems caused by current devices and their material properties which are used by most medical device manufacturers and suppliers. The problems include infection, poor biocompatibility, and microbial attachment.
For further information please contact:
William Jackson, CFO & COO
Covalon Technologies Ltd.
T: (905) 568-8400
F: (905) 568-5200
www.covalon.com
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