Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology
Dressing Offers a Highly Effective and Affordable New Option to Help Combat the Escalating MRSA Crisis
Speaking about the FDA clearance, Derma Sciences’ CEO
The gauze-based line of dressings incorporates Quick-Med Technologies, Inc.’s patented NIMBUS(R) (Novel Intrinsically Micro Bonded Utility Substrate) cationic biocide technology, licensed by Derma Sciences in 2007. This represents the first FDA clearance for a product with NIMBUS – an innovative technology so unique that it was put through the FDA’s De Novo process, a special clearance program for medical devices that are found to be “not substantially equivalent” to any predicate device. Subsequent to its review of the data, the FDA has approved product labeling indicating various organisms such as MRSA, VRE, Pseudomonas aeruginosa and Escherichia coli are killed at levels exceeding 99.999%.(1) NIMBUS was a featured technology in TIME Magazine’s 2006 Annual issue on innovation. The article, “Microbe-Busting Bandages”, can be seen at the following url: http://www.time.com/time/magazine/article/0,9171,1172215,00.html.
Along with a superior rate of target-specific kill, what makes BIOGUARD different from other infection control dressings is the permanent, non-leaching bond between the dressing substrate and the active agent. The NIMBUS cationic biocide is permanently bonded to the gauze, keeping it from depleting in the presence of wound fluid and bacteria, while killing microbes that are drawn into the absorbent dressing. Active components that leach, such as silver and iodine-based dressings, currently make up the majority of the
However, in today’s environment of increasing bacterial resistance, creating new non-leaching alternative dressings is critical. According to Dr.
Regarding surgical site infections and MRSA, the Centers for Disease Control and Prevention cite the following statistics:
- There are over 500,000 surgical site infections in the US annually, accounting for one-quarter of all hospital acquired infections (2)
- Two of the three most common procedures associated with MRSA infections are surgical treatment of skin/subcutaneous infection and the debridement of wound infection (3)
- In 2005, researchers estimated there to be 94,360 invasive MRSA infections in the US. This amount is nearly triple the CDC 2001 estimate of 31,440 (4)
- There is a 20% mortality rate associated with MRSA infections (5)
- Deaths attributable to MRSA began to exceed deaths attributable to HIV/Aids in the US in 2005 (6)
(1) Internal report, in vitro data. (2) Centers for Disease Control and Prevention, National Center for Health Statistics Vital and Health Statistics, Detailed diagnoses and procedures national hospital discharge survey 1994. Vol 127. Hyattsville (MD): Department of Health and Human Services; 1997. (3) Healthcare-Associated Methicillin Resistant Staphylococcus aureus (HA-MRSA). Centers for Disease Control and Prevention. www.cdc.gov/ncidod. (4) Fact Sheet: Invasive MRSA. Centers for Disease Control and Prevention. www.cdc.gov/ncidod. (5) MRSA: Methicillin-resistant Staphylococcus aureus in Healthcare Settings. Centers for Disease Control and Prevention. www.cdc.gov/features/MRSA. (6) Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States. A CDC Report. Journal of the American Medical Association. Oct 2007.
Contact: Derma Sciences, Inc. Edward J. Quilty Chairman and CEO firstname.lastname@example.org (609) 514-4744 Allen & Caron Inc Rudy Barrio (US Investors) email@example.com (212) 691-8087 Brian Kennedy (Media) firstname.lastname@example.org (212) 691-8087
SOURCE Derma Sciences, Inc.