May New Products and Industry News
Sanuwave Health Reports 2010 Financial Results
Sanuwave Health Inc (Alpharetta, GA) has reported the financial results for the year ended on December 31, 2010 in addition to reviewing the year’s accomplishments and progress. The company completed its dermaPACE® pivotal Phase III clinical trial to treat diabetic foot ulcers (DFU) and reported safety and efficacy results during the fourth quarter. The company also submitted the first of three modules of their Premarket Approval (PMA) application to the US Food and Drug Administration (FDA), which included preclinical data and the results of prior clinical testing. By completing this rigorous Phase III clinical trial and immediately initiating their modular PMA submission process, the company has surpassed a key milestone for transforming the brand from a development stage entity in to a commercial company. As demonstrated by the notable results from the DFU clinical trial, the product has the potential to help a large number of patients who suffer through the physical and emotional distress of debilitating foot ulcers. Pending FDA approval, the company looks forward to bringing the product to medical professionals and patients alike, while aiming to make a significant impact on wound healing and quality of life.
Visit www.sanuwave.com for more information.
Derma Sciences Presents Posters and Presentations At 24th Annual SAWC
Derma Sciences Inc (Princeton, NJ), offered both poster and expert presentations featuring Medihoney® and Xtrasorb® at the Symposium on Advanced Wound Care and Wound Healing Society Meeting (SAWC/WHS), which took place April 14–17, 2011 in Dallas, TX. Use of Active Leptospermum Honey to Heal Pressure Ulcers: A Case Series of Pressure Ulcer Patients by Cynthia Bridgman BSN, RN, CWOCN and Carol Hall BSN, RN, CWOCN, CFCN of The University of Texas Southwestern Medical Center at Dallas and Protease Modification by Super Absorbent Polymer Dressings by Marcy Turkos, PT, DPT, CWS; Kimberly Stallo, BS, RN, CWOCN, of Derma Sciences were the two posters presented that featured both products from the company’s wound care portfolio. The following presentations highlighting the products took place at the company’s booth: The Versatility of Medihoney for Use on a Variety of Stalled Wounds and Wounds of Atypical Etiologies and Medihoney and Xtrasorb, The Value of an Osmotic Gradient on Chronic Wounds: A Combination Therapy.
Visit www.dermasciences.com for more information.
Leading Health Insurer Announces Coverage of Spiracur’s SNaP Wound Care System
Spiracur Inc (Sunnyvale, CA), which recently developed an ultraportable and disposable negative pressure wound therapy (NPWT) device, and Highmark Inc (Pittsburgh, PA) a health insurer announced new coverage for Spiracur’s SNaP® Wound Care System and related supplies. The SNaP Wound Care System (Smart Negative Pressure) is changing the approach of how wound healing is delivered to patients. Its inventive design eliminates the electric or battery powered pump used to deliver NPWT. The system is completely silent and lightweight, weighing only 2.2 ounces. As innovation is a top priority at Highmark, the company is providing their customers with creative solutions to meet patient needs. The wound care system is a prime example of such an innovative approach that will greatly benefit Highmark members suffering from diabetes, circulatory problems, and additional conditions. Highmark is an independent licensee of the Blue Cross and Blue Shield Association offering a variety of indemnity and managed care health insurance products, along with consumer-driven health plans and Medicare supplemental products in western Pennsylvania, central Pennsylvania, and the Lehigh Valley. Spiracur is thrilled that Highmark has elected to provide coverage for the wound care system as more payers continue to offer coverage for the device, the multitude of patients suffering from chronic wounds will have better access to an effective system.
Visit www.spiracur.com for more information.
NovaBay Pharmaceuticals Spotlights Positive Results From NeutroPhase Study
NovaBay Pharmaceuticals Inc (Emeryville, CA), is in the process of developing its anti-infective Aganocide® compounds for the local non-systemic treatment and prevention of antibiotic-resistant infections, presented a poster on the efficacy of NeutroPhase® solution (NVC-101) with the hydrophobic mesh Sorbact® in healing chronic nonhealing wounds at the recent 24th Annual Symposium on Advanced Wound Care and Wound Healing Society Meeting (SAWC/WHS) in Dallas, TX.
The poster, NeutroPhase® with Sorbact® Dramatically Enhances the Speed of Wound Healing, was written by researchers from the company and San Francisco Center for Advanced Wound Care at the Seton Medical Center (Daly City, CA). The poster reported on multiple case studies in the clinic in which a combination of 0.01% NeutroPhase with Sorbact as a wound mesh dressing capable of reducing maceration of adjacent skin and binding and inactivating pathogenic microorganisms, in conjunction with negative pressure wound therapy administered to 26 patients with chronic nonhealing wounds. The researchers demonstrated that the solution was capable of destroying biofilm in the wounds without damaging the surrounding tissues and was an effective topical antimicrobial that improved wound healing. Moreover, the hydrophobic mesh was found to help reduce tissue maceration. The company has two FDA 510(k) clearances for the solution and has begun moving forward toward larger scale manufacturing and eventual marketing by its Hospital Business Unit.
Visit www.novabaypharma.com for more information.
In-vitro Study Data Show Wound Dressing With Silver Kills MRSA and Other Antibiotic Resistant Infections
ConvaTec (Skillman, NJ) released new in-vitro study results showing that a wound dressing containing ionic silver is able to kill several strains of highly resistant bacteria. The study showed that bacteria found beneath the dressing died within 48 hours. The study results were presented at the 24th Annual SAWC/WHS in Dallas, Texas.
A simulated wound fluid (serum and peptone water) model was designed to measure antimicrobial activity over a 7-day wear time. A sample of the silver-containing sodium carboxymethyl cellulose wound dressing was aseptically transferred to the simulated wound fluid containing 1 x 106 cfu/mL of a wound pathogen (A baumannii, C difficile, CA-MRSA, or ESBL-producing bacteria). Following incubation, total viable counts (TVCs) were performed on each test model using a pour plate method. TVCs were performed on each model at 4, 24, 48, 72, and 96 hours, and at 7 days. All models were re-inoculated with a fresh challenge of the same bacteria at 72 hours. In the study, bacteria samples were covered with silver-containing sodium carboxymethyl cellulose wound dressing. The dressing was shown to be effective against emerging pathogens over a 7-day period, including against re-inoculation.
Visit www.convatec.com for more information.
MiMedx Group Launches EpiFix™ and announces Wound Care Division’s new Vice President
MiMedx Group Inc (Marietta, GA) has nationally launched their latest product, EpiFix™, a biologic implant specifically processed to offer a wide variety of wound healing and wound care options. The company also recently hired Frank Burrows as its Vice President of Wound Care. EpiFix is the wound care branded tissue resulting from the company’s proprietary Purion® process. The amniotic tissue produced using the process has generated a growing demand for easy to use, minimally manipulated allografts and has experienced increased growth in the areas of ophthalmology, dental, spine and sports medicine. The company’s tissues have been used in over 30,000 implants to date. Frank Burrows joins the company in the newly created capacity of Vice President of Wound Care. Frank brings to more than 20 years of experience and expertise in developing and implementing sales and marketing programs that have created growth for numerous medical devices and pharmaceuticals in the areas of wound closure, wound healing, tissue engineering, and bio-active therapeutics. Frank’s expertise and in-depth command of the wound care, wound healing, and tissue markets was gained through key roles at J & J Wound Management, Smith & Nephew, Advanced Tissue Sciences, and Histogen Aesthetics.
Visit www.mimedx.com for more information.