February New Products and Industry News

Foam dressing helps wounds that need bridging
  Kinetic Concepts Inc ([KCI] San Antonio, TX) launched its new V.A.C.® GranuFoam™ Bridge XG Dressing. The new dressing enables more complete coverage of large wounds requiring bridging, including difficult to access pressure ulcers. Intended for use with the company’s Vacuum Assisted Closure (V.A.C.)® Therapy Units, the dressing offers the traditional healing benefits of the V.A.C.® GranuFoam™ Dressing, while allowing for bridging of the SensaT.R.A.C.™ Pad away from the wound site and simplified dressing application. Retrospective studies have shown the therapy has potential advantages for the treatment of pressure ulcers. The therapy systems with SensaT.R.A.C. technology are the only negative pressure wound therapy devices that monitor and adjust negative pressure delivery at the wound site.   For more information, visit www.kci1.com.

eLearning portal provides educational programs and solutions
  Derma Sciences (Princeton, NJ) launched a new eLearning Portal to keep clinicians abreast of the latest information and product solutions in the company's advanced wound care line. The portal contains both new and aggregated content, including archived webinars to support educational needs on topics such as wound debridement, the use of Medihoney™ on stalled wounds and those with atypical etiologies, and the benefits of super absorbent polymer technology in moist wound dressings. New webinars will be added approximately every 6 weeks. The portal also aggregates abstracts, articles, and peer-reviewed clinical posters on honey, as well as broadcast media coverage of the company's products and product literature available for download. Clinicians also can request product samples directly from the eLearning portal.  

 For more information, visit www.dermasciences.com.

Bariatric mattress overlay prevents pressure ulcers
  EHOB Inc (Indianapolis, IN) released its newest static air overlay designed for bariatric patients. The Waffle® Bariatric Mattress Overlay is filled with air, which is the ideal media to support and float the most vulnerable soft tissues of the body, and the overlay design allows the body to sink down into the product, protecting and comforting while contouring to the body. The low-profile chamber of air redistributes the patient’s weight evenly on the surface. The overlay is clinically effective in keeping the patient stable and comfortable while preventing pressure ulcers. The new overlay is designed for a bariatric-size bed, measuring 76" x 47" x 3" and also may be used on a standard full-sized bed for the home. Additionally, skin temperature and moisture control are achieved through the overlay’s diamond-patterned holes, which naturally circulate air while allowing skin to breathe. Combined with a nonabrasive, medical grade vinyl, the new overlay substantially reduces pressure and tissue tear. The product accompanies the patient from acute care to long-term care to their homes.

  For more information, visit www.ehob.com.

Distribution/licensing agreements reached for wound and skin therapy products
  SteadMed™ Medical LLC (Fort Worth, TX) and Swiss-American Products Inc. (Carrollton, TX) entered into an exclusive distribution agreement for Elta® branded medical products sold throughout North America. Developed and manufactured by Swiss-American, the Elta wound and skin therapy product line includes incontinence products, silver antimicrobial products, protease-enhanced products, moisturizers, and dressings.

  Additionally, SteadMed™ Medical LLC and South African-based Beier Drawtex® Healthcare (Pty) Ltd. entered into an exclusive licensing and distribution agreement for the US and Canada. SteadMed Medical is the first and sole US distributor of Drawtex, a patented, hydroconductive, nonadherent wound dressing with LevaFiber™ technology. This technology is a combination of two types of absorbent, cross-action structures facilitate movement of large volumes of fluid and other debris from the wound through the dressing. This hydroconductive action allows the dressing to lift, hold, and transfer the wound exudate both horizontally and vertically into the dressing, where it can absorb 500% of its own weight. The hydroconductive action disperses dressing contents in such a way that multiple layers of the dressing can be used for more heavily exuding wounds. The licensing and distribution agreement between the companies will allow SteadMed to bring a first-of-its-kind product into the US.

  For more information, visit www.steadmed.com and www.drawtex.com.

New agreement generates the development of an antimicrobial dressing
  ULURU Inc (Addison, TX) has signed a Binding Letter of Intent (“Agreement”) with Exciton Technologies Inc (Edmonton, Alberta, Canada) to develop and market a product that combines ULURU’s Altrazeal® with Exciton’s proprietary exSALT™ Antimicrobial Technology. Exciton has developed a silver technology that has equivalent or greater antimicrobial efficacy at a lower silver concentration compared to other currently marketed silver products. Preliminary testing has been conducted on the combination of the products in an in vitro log reduction assay, which meets draft guidance from the FDA for testing of medical devices containing an antimicrobial agent. This testing has been performed against Staphylococcus aureus and was compared to five market-leading silver containing products.

  Under the terms of the agreement ULURU will be granted a worldwide license, excluding China, to market the Altrazeal® exSALT™ product. Exciton will be responsible for conducting the necessary product testing, filing a 510(k) application with the FDA and interacting with the FDA to secure product approval. ULURU will be responsible for product approval in international markets including gaining CE mark approval. ULURU will pay Exciton to prepare the 510(k) application, milestone payments on the attainment of sales targets, and a royalty based on product sales. The parties have agreed to negotiate a final agreement that will supersede the Binding Letter of Intent.

  For more information, visit www.uluruinc.com.

Wound care system now available in the US
  Spiracur® (Sunnyvale, CA), the developer of an ultraportable and single-use, negative pressure wound therapy (NPWT) device, has been added to Marathon’s Medical (Commerce City, CO) existing Federal Supply Schedule (FSS) contract, administered by the Department of Veterans Affairs (VA) on behalf of the US General Services Administration (GSA). The arrangement allows Spiracur to expand the availability of its SNaP® (Smart Negative Pressure) Wound Care System in partnership with Marathon Medical throughout the entire federal healthcare system, the largest healthcare provider in the US.

  The newly secured contract offers opportunities to sell the wound care system and ensures that veterans and active soldiers have access to the device. Spiracur’s partnership with Marathon Medical offers a breadth of coverage within the VA system. The negative pressure system is changing the approach of how NPWT is delivered to patients. It eliminates electric or battery power in the healing process; therefore, the delivery device is completely silent, as well as lightweight and small (less than 3 oz). The wound care system is disposable and can easily fit under a patient's clothing, which has resulted in significantly improved patient acceptance and compliance of the therapy.

  For more information, visit www.spiracur.com.

Regenerative tissue matrix technology licensed
  KCI (San Antonio, TX) forged an agreement, effective imediately, to license Wright Medical Group, Inc.’s (Arlington, TN) GRAFTJACKET® brand for use in marketing the LifeCell™ acellular human dermal-based regenerative tissue matrix. The matrix is indicated for repair or replacement of damaged or inadequate integumental tissue, such as diabetic ulcers, or for other homologous uses of human integument. Proprietary processing allows the body to accept the matrix, reducing the potential for a rejection response. The matrix provides immediate coverage to the wound and is repopulated with the patient’s own cells and revascularized by the body, acting as a scaffold to convert the matrix to functional host tissue in ulcer repair. The matrix can be used as part of the overall treatment regimen in a variety of care settings.

  KCI now can offer both negative pressure wound therapy (NPWT) and regenerative tissue matrix for the treatment of hard-to-heal wounds across the care continuum. The matrix may be used in conjunction with NPWT. Clinical studies have shown the matrix provided a higher probability of healing when used as part of the standard treatment regimen; most diabetic foot ulcers can be treated successfully with one application of the matrix. The matrix is covered by many insurers, including Medicare.

  KCI’s Active Healing Solutions™ business unit will sell the regenerative tissue matrix under the GRAFTJACKET® brand name. During the next 6 months, Wright will transition out of its wound care sales of the matrix as KCI increases its sales and marketing of the product.

  For more information, visit www.kci1.com

. Second-generation bioengineered wound care alternative in production
  Aubrey Inc (Carlsbad, CA) announced that after a successful soft release and product evaluation phase of its second-generation product, AWBAT® Plus, the product is now in full production and currently available for purchase. The product not only utilizes the same patented technology for the precision-porous silicone-nylon membrane as the platform product, AWBAT®, but also contains significantly more collagen and chondroitin-4-sulfate, chondroitin-6-sulfate, vitamin C, vitamin E, and Immuno-10 (activated mixture of polysaccharides from aloe). The FDA determined this to be a combination product consisting of device components as well as drugs. In subsequent laboratory testing, immuno-10 was found to stimulate human dermal fibroblast proliferation, as well as fibroblast collagen and alpha-SMA production. Human keratinocyte production also was enhanced by immuno-10. The product currently is indicated for partial-thickness burns, meshed autografts, and donor sites. The company intends to seek clearance for use of the product on chronic wounds this year.  For more information, visit www.aubreyinc.com.

Wound care dressings secure reimbursement codes
  PolyRemedy (Boston, MA), a provider of personalized wound care systems, has announced the Centers for Medicare and Medicaid Services (CMS) confirmed reimbursement codes for its customized antimicrobial dressings. Customized dressings comprise the therapeutic portion of the company’s integrated Personalized Woundcare System (PWS™), which also includes expert, protocol-driven wound assessment and dressing selection tools, as well as real-time feedback and alert notification throughout the wound healing process. The CMS confirmed coding for the PolyFIT™ Antimicrobial Dressings that promote an optimized wound healing environment without causing resistance to specific bacteria. Embedded with a 0.3% concentration of polyhexamethylene biguanide (PHMB), the dressings are designed to manage wound exudate and microbial proliferation within the dressing while maintaining a moist wound environment. PHMB is bonded to proprietary microfibers to ensure an optimal healing environment while reducing bioburden in the dressing.

  For more information, visit www.polyremedy.com.

Pressure ulcer partnership reports positive results from ongoing ulcer reduction efforts
  The Pennsylvania Pressure Ulcer Partnership, a collaboration involving 58 hospitals across the state, reported a reduction in the rate of pressure ulcers and an increase in ulcers that did not worsen. The Hospital & Healthsystem Association of Pennsylvania, the Healthcare Improvement Foundation, and the Hospital Council of Western Pennsylvania created the partnership in 2008 to encourage cooperation among medical centers to develop and share methods and strategies for reducing pressure ulcers. The partnership has resulted in a 23% decrease in the development of pressure ulcers at participating hospitals between December 2008 and February 2010 and an 81% decrease in the rate of pressure ulcers that progressed or worsened. The 21 Philadelphia-area hospitals that participated in the project experienced a nearly 30% reduction in the number of pressure ulcers developed by patients during hospital stays, along with a 75% reduction in the number of pressure ulcers present on patients’ admission to the hospital or that worsened during their hospital stays. Hospitals across the state focused their pressure ulcer reduction efforts on the processes of care: risk assessments, turning and repositioning, pressure reduction devices and techniques, nutrition, skin cleansing and moisturizing, and diligent wound care. With access to the latest, evidence-based clinical information and a web-based tool for tracking and comparing pressure ulcer rates, hospitals in the state and region and have significantly reduced the impact of this painful, costly complication.

  For more information, visit www.bizjournals.com/philadelphia/news/2011/01/06/pennsylvania-pressure-ulcer.html.

“Green” solutions for wound care
  PuriCore (Malvern, Pa), a life sciences company focused on developing and commercializing proprietary, green solutions that safely, effectively, and naturally kill infectious pathogens, launched its new bottled Vashe® Wound Therapy. The solution contains hypochlorous acid, the same naturally occurring chemical used by the human body to defend against invading pathogens and used in wound care clinics and hospitals throughout the country to treat chronic and acute wounds.

  The new solution is intended for moistening, irrigating, cleaning, and debriding acute and chronic wounds including Stage I through Stage IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical wounds, first- and second-degree burns, abrasions, and minor irritations of the skin. Hypochlorous acid has been shown in laboratory testing to rapidly kill 99.999% of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), Acinetobacter baumannii,Escherichia coli, and other dangerous pathogens with no known microbial resistance.

  Tissue-friendly, the solution can be applied directly to wounds even around eyes, mouth, and nose. It has also been rigorously safety tested and is noncytotoxic, nonirritating, non-sensitizing, non-mutagenic, and indicates no oral toxicity. It also shows no antibiotic resistance and has no clinical contraindications for prescription use.

  For more information, visit www.puricore.com.