New Products and Industry News

Five products introduced in Singapore and Malaysia

  Oculus Innovative Sciences, Inc’s (Petaluma, CA) partner, Dyamed Biotech Pte. Ltd, is initiating rollout of five new Microcyn® Technology-based products in Singapore and Malaysia, both in the hospital and consumer markets. The five products, which include Dermacyn™ BabyGuard, Dermacyn DermaGuard, Dermacyn SkinGuard Solution, Dermacyn SkinGuard Hydrogel, and Dermacyn Wound Care Hydrogel, will be rolled out sequentially with all products commercialized by year’s end.

  For more information, visit www.oculusis.com.

FDA clears transfer dressing

  The US Food and Drug Administration has cleared Mepilex® Transfer Ag (Mölnlycke Health Care US, Norcross, GA), a transfer dressing that minimizes trauma and reduces risk of infection. The dressing is a wound contact layer that minimizes infection while providing less-painful healing. It is the world’s first antimicrobial transfer dressing with Safetac® technology.

  Using this technology for gentle adhesion and minimal wound disturbance and pain, the dressing creates an optimal environment for the body to heal the wound. The technology provides an undisturbed healing environment. It adheres gently to dry tissue but not to moist wound surfaces. It also molds to the skin’s irregularities, covering more skin surface and spreading peel forces on removal to prevent skin stripping. The dressing also provides a combined rapid and sustained antimicrobial effect and has a soft, flexible foam technology that absorbs and transfers exudate away from the wound. By moving exudate, the dressing minimizes the risk of maceration and enables management of difficult-to-dress wounds. It also allows for fewer dressing changes, because clinicians can leave the wound contact layer in place and replace only the secondary layer.

  For more information, visit www.molnlycke.com/us.

Licensing, distribution agreement signed for nonantibiotic wound therapy

  SteadMed Medical (Fort Worth, TX) signed an agreement with PuriCore (Malvern, PA) to market and distribute Vashe® Wound Therapy, a nonantibiotic alternative treatment for acute and chronic wounds that is demonstrated to be extremely gentle and hypoallergenic. Under the terms of the multiyear agreement, SteadMed will provide marketing and distribution services for Vashe in the United States, Canada, and Mexico and will target hospitals, wound care centers, nursing homes, and home health agencies.

  Available by prescription only, the therapy is intended for use in cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, including Stage I to Stage IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical wounds, first- and second-degree burns, abrasions, and minor irritations of the skin. It has been rigorously safety tested and is noncytotoxic, nonirritating, and nonsensitizing. It has no oral toxicity or clinical contraindications for use.

  For more information, visit www.steadmed.com.

Hydroconductive wound dressing receives innovative technology award

  SteadMed Medical (Fort Worth, TX) received a Novation Innovative Technology Contract for Drawtex hydroconductive wound dressings. Novation is the primary healthcare supply chain expertise and contracting company for the members of VHA Inc, UHC, Children’s Hospital Association, and Provista LLC. Through its Innovative Technology Program, the company ensures its members have access to groundbreaking healthcare technology, while rewarding products that significantly benefit patient care, patient safety, or healthcare worker safety.

  The 3-year contract allows the members served to take advantage of special pricing and pre-negotiated terms, including a 27% savings in the aggregate compared to list price.

  To become an awarded supplier, a product must undergo a rigorous review. The process, which can take between 4 and 6 months to complete, includes a clinical member council or task force evaluation to determine whether the technology represents an incremental advantage for patients and providers.

  For more information, visit www.steadmed.com.

Research shows silver-coated antimicrobial dressings kill superbugs

  Study results suggest ACTICOAT Silver-Coated Antimicrobial Dressings (Smith & Nephew, London, UK) are bactericidal against some antibiotic-resistant organisms carrying the NDM-1 enzyme, often referred to as “superbugs”. An in vitro laboratory study showed the dressing can kill the antibiotic-resistant enzyme, New Delhi metallo-beta-lactamase 1 (NDM-1 bacteria strain), which is carried by four of the same carbapenem-resistant enterobacteriaceae (CRE) bacteria cited by the Centers for Disease Control and Prevention. In this study, the dressing killed Escherichia coli and Klebsiella spp. which are responsible for most carbapenem resistance in the United States.

  The nanocrystalline silver used is different from the silvers used in other dressings because of its potency, fast-kill action of 30 minutes, and broad-spectrum activity. The dressing provides bactericidal activity for up to 7 days, so it helps protect patients with wounds or incisions from environmental contamination, even after they leave the hospital. It is contraindicated in patients with known hypersensitivity to any of the components of the product.

  For more information, visit www.smith-nephew.com.

Strategic partnership formed involves superabsorbent wound dressings

  Systagenix (Gatwick, UK) and Sorbion (Senden, Germany) signed a distribution agreement for a superabsorbent wound dressing to be marketed under Systagenix branding. Superabsorbent dressings are one of the fastest growing categories in the advanced wound care market, providing a solution for fluid management in moderate to highly exuding wounds.

  Sorbion is a German, owner-operated company based in the Münsterland region. The company specializes in the development, production, and sale of high-quality medical products for modern wound treatment.

  For more information, visit www.systagenix.com.

Skin allograft heals recalcitrant diabetic foot ulcers

  AlloSkin RT™ (Allosource, Centennial, CO), a sterile, room-temperature storage skin allograft, proved efficacious in closing recalcitrant diabetic foot ulcers in a case series conducted by Dr. Pam Sabet and Dr. Donald Green of Scripps Mercy Hospital in an outpatient wound care clinic setting.

  In a 20-week case series, 10 patients with diabetic foot ulcers were treated with the product, resulting in complete wound closure. In one of the evaluated cases involving a neuropathic 57-year-old man, previous wound closure attempts had been made using negative wound pressure therapy. However, after 12 weeks of treatment, wound closure was not achieved, and skin graft treatments began using the allograft approach. After 10 weeks of outpatient care, the wound closed and completely healed.

  Details on the series, as well as additional clinical studies involving the product were available at the Symposium of Advanced Wound Care, May 1–5.

  For more information, visit www.allosource.org.

$1M series A2 funding for tissue-regeneration technology completed

  Kerecis Limited (Reykjavik/Isafjordur, Iceland) has secured $1 million in series A2 funding. The financing, a mixture of equity and grants, is provided by a group of existing and new stakeholders.

  The company is the developer of the MariGen Omega3 tissue-regeneration technology, which is intact, decellularized fish skin that has had all of its cells and antigenic materials removed. When applied to areas of tissue damage, the product recruits the body’s own cells and ultimately is incorporated into the wound and converted into functional, living tissue. Patents are pending for the technology in several countries around the world.

  Kerecis recently signed an agreement with Medline Industries (Mundelein, IL), which will sell products that utilize the regenerative technology for the management of chronic wounds, including diabetic, vascular, and other hard-to-heal wounds. Initially, Medline will sell these products in the United Kingdom and several Middle Eastern countries.

  For more information, visit www.kerecis.com.

Damaged medical bed mattress covers pose contamination risk

  From January 2011 to January 2013, the US Food and Drug Administration (FDA) received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting, and laundering procedures. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.

  The FDA is concerned that fluid ingress from worn or damaged medical bed mattress covers may be widespread and largely under-recognized by healthcare providers, healthcare facility staff, and caregivers. The FDA will continue to monitor this issue and keep the public informed if new information becomes available.

  For more information, visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm348677.htm?source=govdelivery.

This article was not subject to the Ostomy Wound Management peer-review process.