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Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology

February 27, 2009

Dressing Offers a Highly Effective and Affordable New Option to Help Combat the Escalating MRSA Crisis

PRINCETON, N.J., Feb. 27 /PRNewswire-FirstCall/ – Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a provider of advanced wound care products, announced today that its first BIOGUARD Barrier Dressings have received clearance from the U.S. Food and Drug Administration for marketing and distribution. BIOGUARD will offer surgeons, wound care clinicians, infection control experts and primary care doctors a new weapon against the transmission of such virulent bacteria as Methicillin-resistant Staphylococcus aureus (MRSA). Coming on the heels of Derma Sciences’ successful launch of its MEDIHONEY(TM) dressing line in 2008, BIOGUARD is the company’s latest new product entrant into the $14 billion global wound care market. Sales of the dressings are expected to commence in June, 2009.

Speaking about the FDA clearance, Derma Sciences’ CEO Ed Quilty stated, “This clearance represents a significant milestone for Derma Sciences and provides another large step in implementing our strategic plan. We believe that BIOGUARD, a cost-effective gauze-based dressing that has been shown to kill 99.999% of MRSA, will be a great asset to healthcare providers as they look for more effective and efficient ways to combat the transmission of virulent pathogens throughout their facilities. Surgical site infections are a serious concern, and with changes in reimbursement, prevention has become a major objective for hospitals.” Quilty continued, “This gives our sales reps yet another novel wound care product to sell, and will help Derma Sciences reach our goal of profitability in a quicker timeframe. BIOGUARD will open many new doors for us, especially on the gauze side of the business, a large component of the $14 billion global wound care market.”

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 $200 million infection control dressings category in the US.

However, in today’s environment of increasing bacterial resistance, creating new non-leaching alternative dressings is critical. According to Dr. Gregory Schultz, Ph.D., Professor, Institute for Wound Research at the University of Florida and Past President of the Wound Healing Society, since BIOGUARD is non-leaching, “it poses no risk of bacteria developing resistance, or of releasing toxic material into the wound and impeding the wound healing process. NIMBUS is a novel technology: bonded and effective even in high concentrations of body fluids.”

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
    equilty@dermasciences.com
    (609) 514-4744

    Allen & Caron Inc
    Rudy Barrio (US Investors)
    r.barrio@allencaron.com
    (212) 691-8087

    Brian Kennedy (Media)
    brian@allencaron.com
    (212) 691-8087

SOURCE Derma Sciences, Inc.


Source: newswire



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