Navigation Links
Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology
Date:2/27/2009

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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Coria Laboratories Announces Acanya(TM) Gel Data Presentations at 67th American Academy of Dermatology Annual Meeting
2. Christian Diaz Joins Rodan + Fields(R) Dermatologists as Vice President of Sales
3. Galderma Launches New Cetaphil(R) SPF 50 Product
4. High and Super-High Potency Topical Corticosteroids Will Remain Decision Resources Clinical Gold Standard Through 2017 for the Treatment of Atopic Dermatitis
5. Skinvisible Signs Dermatology Agreement With RHEI Pharmaceuticals
6. Galderma Wins FDA Approval for Vectical(TM) Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis
7. Direct Selling Luminary, Robert M. Henry, Partners With Rodan + Fields(R) Dermatologists as Strategic Business Advisor
8. New Source of Information on Scleroderma Medications
9. Dr. Sherrell Aston Addresses the Popularity of Dermal Fillers and Possible Long Term Side Effects
10. Galderma Announces Availability of Epiduo(TM) Gel, the First and Only Combination Treatment with a Retinoid and Benzoyl Peroxide to Treat Acne
11. PriCara(R) Recalls 50 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... ... May 04, 2016 , ... The preeminent surgical aftercare ... Dickinson needed following breast cancer surgery. In March 2016, the 61-year-old model and reality ... breast cancer that occurs in the milk ducts, according to an interview with ...
(Date:5/4/2016)... (PRWEB) , ... May 04, 2016 , ... ... in medical coding, billing and compliance. In upcoming months, AudioEducator has lined up ... specialties. Every conference is designed to give complete compliance know-how and practical, easy-to-apply ...
(Date:5/4/2016)... Columbia – , ... ... , a manufacturer of innovative infant and child products, today revealed ... But their ability to help babies deal with teething pain is ... approved, contain no toxic gels, and are BPA-, PVC-, and phthalate-free. ...
(Date:5/4/2016)... ... 2016 , ... DESCO Medical Service, also known as Diagnostic ... service and sales company located in Pennsylvania. The terms of the deal were ... management services to the medical and academic research industries. The acquisition will help ...
(Date:5/4/2016)... , ... May 04, 2016 , ... ... Scientific Group is scheduled on July 25-27, 2016 at Las Vegas. It aims ... care professionals from educational institutes and research organizations across the globe; making the ...
Breaking Medicine News(10 mins):
(Date:5/2/2016)... Leading Economies with Fastest Real GDP Annual Percentage Change, 2015  ... 7.3, , Source: IMF and TechSci Research   ... Brazil , Russia , India , ... the fastest GDP growth during the first decade of the 21 st ... Brazil and Russia , along with policy ...
(Date:5/2/2016)... -- While nearly three-quarters of Americans (71%) are aware of ... only about half report taking any steps to prevent ... new survey announced today by Hologic (Nasdaq: ... Month, Hologic is raising awareness of this major threat ... Osteoporosis is a disease that causes low ...
(Date:5/2/2016)... SAN FRANCISCO , May 2, 2016 /PRNewswire/ ...  is expected to reach USD 11.1 billion by ... Grand View Research, Inc. Major drivers of the ... in therapeutic areas and government recommendations for periodic ...      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) ...
Breaking Medicine Technology: