Navigation Links
FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing With pDADMAC
Date:10/28/2009

PRINCETON, N.J., Oct. 28 /PRNewswire-FirstCall/ -- Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a specialty medical device / pharmaceutical company specializing in advanced wound care, announced today that the Food and Drug Administration has issued its Guidance Document to support the classification of the Company's BIOGUARD(TM) barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's De Novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device.

Commenting on the move by the FDA, Derma Sciences CEO Edward J. Quilty stated, "This guidance document is significant in that it will allow us to quickly expand the product offerings within the BIOGUARD line. Notably, the document covers only the use of the active compound in BIOGUARD - polyDADMAC. As a result, through our license with Quick-Med Technologies, Inc. (QMDT.OB), the patent and patents pending around the use of this antimicrobial will ensure that this milestone not only helps us broaden our line, but also gives us a strong competitive advantage against other companies seeking to develop similar cost-effective products." Quilty concluded, "The guidance document states that BIOGUARD could be used as part of an overall infection prevention program. This is significant for us, as we believe that - due to its unique properties - BIOGUARD represents the best product on the market for cost-effective broad spectrum infection protection, without the risk of creating antimicrobial resistant strains."

The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, one of the molecular entities covered in nine Quick-Med U.S. patents/patents pending and in 24 foreign counterparts.

BIOGUARD dressings, which were introduced in June, are the
'/>"/>

SOURCE Derma Sciences, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues
2. PowerBar Issues Open Call for 2008-2009 PowerBar Team Elite(TM) Athlete Sponsorship Program
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
4. American Red Cross Issues Blood Supply Alert
5. OSHA Issues Draft Ergonomics Guidelines on Preventing Musculoskeletal Injuries in Shipyards
6. New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
7. National Quality Forum Issues First Consensus Standards for the Treatment of Substance Use Conditions
8. Audio: New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
9. Dallas-Area Transplant Meeting Puts Spotlight on Key Issues
10. Elder Care Author Doctor Marion Launches Second National Tour to Raise Awareness About Aging & Elder Care Issues in America
11. California State PTA Issues Statement Regarding Presidents Veto of SCHIP Legislation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... easier to predict both breast cancer relapses and ... unique gene. The newly found marker could help ... a treatment regimen that is more effective. The ... A*STAR,s Institute of Molecular and Cell Biology (IMCB), ... Singapore) at the National University of Singapore (NUS). ...
(Date:8/20/2014)... It’s no secret that millions of Americans are ... on Drug Abuse, nearly 24 million Americans are using ... is the fact that the total number of users ... in a struggle with substance abuse often feel there ... newly-redesigned AbuseTreatmentCenters.net has released updated lists of substance ...
(Date:8/20/2014)... Mateo, CA (PRWEB) August 20, 2014 ... newest product—the Really Little Green Pouch —to meet ... to feed babies and toddlers homemade foods. , ... Little Green Pouch co-founder Maggie Crawford. She continues, ... kids, to limit exposure to things like pesticides and ...
(Date:8/20/2014)... Botanica Day Spa has ... new and popular stem cell line from Pevonia®, ... wrinkles and naturally repairs the skin. The spa ... service by offering clients a complimentary dermaplaning session ... , Pevonia® continues to be a global leader ...
(Date:8/20/2014)... car at home and getting to work by walking, cycling ... study indicates. Researchers looked at thousands of people in ... and 72 percent of women drove to work, 10 percent ... and 14 percent of men and 17 percent of women ... more and had higher levels of body fat than those ...
Breaking Medicine News(10 mins):Health News:Novel gene predicts both breast cancer relapse and response to chemotherapy 2Health News:Re-Launched AbuseTreatmentCenters.net Offering New List of Substance Abuse Resources 2Health News:Little Green Pouch Launches New Product to Help Health-conscious Parents Reduce Babies’ Eco-footprint 2Health News:New Stem Cell Facial Unveiled at Botanica Day Spa 2Health News:New Stem Cell Facial Unveiled at Botanica Day Spa 3Health News:Want to Stay Slim? Leave the Car at Home 2
... 7 (HealthDay News) -- In November, the U.S. Food and ... the treatment of breast cancer. But, a new study ... with a specific type of aggressive breast tumor when used ... (bevacizumab) had been approved in the United States in 2008 ...
... the fierce national debate over a new federal law ... widely assumed that private health insurance can do a ... U.S. government. But a first-of-its-kind analysis of newly ... comes to infants covered by insurance. Among the ...
... HealthDay Reporter , WEDNESDAY, Dec. 7 (HealthDay News) ... with low-risk prostate cancer, a new draft report released ... concluded that research on the safety of "active surveillance" ... men opt for surgery or other treatments that can ...
... have altered natural bioelectrical communication among cells to directly ... at a particular location within a vertebrate organism. Using ... biologists at Tufts University,s School of Arts and Sciences ... of the head area. The researchers achieved most ...
... California,s low-income seniors with disabilities are struggling to remain in ... and may be slashed even further, according to a new ... with support from The SCAN Foundation. Should ... to In-Home Supportive Services (IHSS) on Dec. 15, as proposed ...
... Amanda Gardner HealthDay Reporter , WEDNESDAY, Dec. 7 ... through strategically placed "seeds" had double the risk of a ... their entire breast, new research finds. This type ... side effects, including infection, according to the study. "We ...
Cached Medicine News:Health News:Avastin Boosted Survival for Type of Aggressive Breast Cancer: Study 2Health News:Public health insurance offers insured infants better, less costly care than private plans 2Health News:Public health insurance offers insured infants better, less costly care than private plans 3Health News:Public health insurance offers insured infants better, less costly care than private plans 4Health News:Public health insurance offers insured infants better, less costly care than private plans 5Health News:Active Surveillance May Benefit Men With Low-Risk Prostate Cancer 2Health News:Researchers discover that changes in bioelectric signals cause tadpoles to grow eyes in back, tail 2Health News:Researchers discover that changes in bioelectric signals cause tadpoles to grow eyes in back, tail 3Health News:Older Californians with disabilities struggle to remain at home as public programs lose funding 2Health News:Older Californians with disabilities struggle to remain at home as public programs lose funding 3Health News:Older Californians with disabilities struggle to remain at home as public programs lose funding 4Health News:Targeted Radiation May Not Be Better for Breast Cancer 2Health News:Targeted Radiation May Not Be Better for Breast Cancer 3
(Date:8/20/2014)... Aug. 20, 2014 Trovagene, Inc. (NASDAQ:   ... that results from two clinical studies will be presented ... Company,s urine-based diagnostic test for the detection of high ... is scheduled to take place in Seattle ... th . Additionally, a new U.S. patent was issued ...
(Date:8/20/2014)... , August 20, 2014 ... of Glenmark Pharmaceuticals Limited India (GPL), announces the ... a novel clinical development candidate, GBR 1302, a ... developed by the Glenmark Biologics Research Centre located ... GBR 1302 is based on Glenmark,s innovative BEAT ...
(Date:8/19/2014)... KIRKLAND, Wash. , Aug. 19, 2014 ... solutions, will be exhibiting at the 2014 NPPA Summer ... The company will be showcasing its 340B software products ... leader in 340B splitting solutions, supplying over 400 customers ... a range of 340B solutions including its latest solution, ...
Breaking Medicine Technology:Trovagene Provides Update on Its Urine-Based HPV Test 2Trovagene Provides Update on Its Urine-Based HPV Test 3Glenmark Enters Oncology With the Discovery and Initiation of IND Enabling Studies of an Innovative Bispecific Antibody 2Glenmark Enters Oncology With the Discovery and Initiation of IND Enabling Studies of an Innovative Bispecific Antibody 3Talyst Exhibits at the NPPA Summer Conference 2