FDA Approval Received on Covalon Silver Ion Releasing Coating.MISSISSAUGA, Ontario -- Covalon Technologies Ltd. ("Covalon") (TSX VENTURE:COV) announces that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has approved Covalon's proprietary silver ion releasing coating on Foley Catheters for use in the United States. Dr. DiCosmo, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 indwelling /in·dwell·ing/ (in´dwel-ing) pertaining to a catheter or other tube left within an organ or body passage for drainage, to maintain patency, or for the administration of drugs or nutrients. 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 Morbidity and Mortality can refer to:
- UTIs account for 40% of Hospital Acquired Infections - Foley catheter use causes 80-90% of UTIs - 15-50% of hospitalized patients with a urinary catheter experience UTI UTI urinary tract infection. UTI abbr. urinary tract infection UTI urinary tract infection. UTI Urinary tract infection, see there from urinary catheterization - Infection risk increases by 5% each day of catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. - Bacteremia (bacteria in the blood) occurs in up to 4% of cases - 1-3.8 extra hospital days are due to UTI and $680-$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 MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ) and Vancomycin-resistant Enterococcus (VRE VRE vancomycin-resistant enterococcus. VRE Vancomycin-resistent enterococcus, see there ). 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 PICC Peripherally-inserted central catheter Critical care An IV catheter inserted in the superior vena cava for long-term infusion of bolus or continuous delivery of therapeutics or TPN–drugs, fluids, nutrients, chemotherapy. Cf Catheter. 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. The TSX Venture Exchange TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved of the contents of this release. The TSX Venture Exchange has not reviewed and does not accept resp onsibility for the adequacy or accuracy of this release. Covalon Technologies Ltd. (TSX VENTURE:COV) |
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