New Products and Industry News

Wound care gel receives reimbursement code

  Elta® SilverGel (Swiss-American Products, Inc, Carrollton, TX) received a reimbursement code from the Centers for Medicare and Medicaid Services. The product is now eligible for reimbursement under Part B Medicare and Medicaid guidelines when billed using the appropriate Medicare HCPCS code, A6248, for Hydrogel dressing, wound filler, gel, per fluid ounce.

  The product is a broad-spectrum antimicrobial wound gel that can be applied directly to the wound bed, forming a clear coating that allows healthcare providers to easily view the wound. The gel has a sustained silver ion release for three or more days and can be used on pressure ulcers, diabetic foot ulcers, chronic wounds, lacerations or abrasions, and many other types of wounds.

  For more information, visit www.elta.net.

Silicone adhesive technology preferred in dressing changes survey

  Results from a large multinational survey published in WOUNDS UK show that using dressings with Safetac® soft silicone adhesive technology reduced pain during dressing changes compared to advanced dressings with traditional adhesives. The Pain on Removal Cases survey involved more than 3,000 patients from 20 countries with a variety of wounds. More than 90% of the patients preferred the dressings with soft silicone adhesive technology to their previous dressing regimen.

  The dressings comprise a patented soft silicone adhesive technology. The soft silicone layer adheres gently to the skin and can be removed easily without causing trauma to either the wound or the surrounding skin, facilitating undisturbed wound healing that can minimize pain for the patient.

  For more information, visit www.molnlycke.com.

New assurance boot released for total contact cast system

  MedEfficiency, Inc. (Westminster, CO) has released a new Assurance Boot designed for use with its TCC-EZ™ total contact cast system. The boot features a combination locking top strap and a secured inside cast that facilitates compliance with a patient’s offloading treatment regimen. The total contact cast system uses a patented fishnet mesh cast technology that constructs a one-layered cast protected by an outer shell that provides support and stability for the diabetic foot ulcer patient. Both the boot and cast system allow tissue to heal without being disturbed or traumatized by repetitive injury or sheer forces.

  For more information, visit www.medefficiency.com.

Wound care company awarded contract

  Hollister Wound Care, LLC (Libertyville, IL) has been awarded a Novation contract under the Novation New Technology Program for its products featuring TRIACT Technology.

  The technology is a scientific formulation comprised of 100% non-occlusive mesh, hydrocolloid particles, and a petrolatum-based formulation, all allowing for pain-free dressing removal that can help reduce trauma to the wound bed and the patient.

  The company plans to feature the technology in its Restore brand dressings, including the Restore Contact Layer, Restore Contact Layer Silver, Restore Adhesive Foam, Restore Non-Adhesive Foam, and the Restore Non-Adhesive Foam Silver

  For more information, visit www.hollister.com.

Presentations on medicinal honey planned

Derma Sciences, Inc. (Princeton, NJ) will present seven abstracts detailing the clinical usage of its newly released MEDIHONEY™ Wound and Burn Dressings with Active Leptospermum Honey at the upcoming Symposium on Advanced Wound Care, being held April 24-27 in San Diego, Calif. Two of the seven abstracts will be delivered as oral presentations; the other five are available as poster presentations.

  For more information, visit www.dermasciences.com.

Research results released for antimicrobial treatment

  Oculus Innovative Sciences, Inc. (Petaluma, CA) announced positive results from its US Phase II clinical trial evaluating Microcyn® Technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers. The clinical success rate for the technology by the end of therapy was 77.8% compared to 61.1% for the levofloxcin plus saline-treated patients. This success rate increased to 93.3% by the next visit, compared to the 56.3% for the levoflaxacin plus saline-treated patients.

  The company plans to request an end-of-Phase-II meeting with the Food and Drug Administration to discuss the results and define the scope and parameters for advancing the clinical program to a New Drug Application.

  For more information, visit www.oculisis.com.

Biotechnology company retains manufacturer of enzyme

  Kane Biotech, Inc. (Winnipeg, Manitoba, Canada) announced it has retained BioVectra, Inc. (Charlottetown, Prince Edward Island, Canada) to manufacture clinical grade DispersinB™ for the treatment of chronic wounds. The antibiofilm enzyme inhibits and disperses bacterial biofilms formed on medical devices by the contaminants Staphylococcus epidermis, S. aureus, and Echerichia coli.

  The company is presently evaluating the enzyme alone and in combination with other antimicrobal agents to develop a wound care therapy and a proprietary medical device coating.

  For more information, visit www.kanebiotech.com.

Poster presentation unveils results of topical treatment for diabetic foot infection

  MacroChem Corporation (Wellesley Hills, MA) presented a poster entitled “Topical versus Systematic Antimicrobial Therapy for Treating Infected Diabetic Foot Ulcers: A Randomized, Controlled, Double-Blinded, Multicenter Trial of Pexiganan Cream,” at the Diabetic Foot Global Conference 2008 in Los Angeles, Calif, March 13-15. The poster presented the results of the company’s two Phase III clinical studies for pexiganan. The studies compared the efficacy of the investigational topical antimicrobial peptide preparation, pexiganan acetate cream, against a systemic therapy with the oral fluoroquinolone antibiotic, ofloxacin, for mildly infected diabetic foot ulcers.

  The product is a 22-amino acid linear peptide formulated as a cream and has a mechanism of action based on its ability to disrupt the integrity of bacterial cell membranes.

  For more information, visit www.machrochem.com.

Phase II clinical trial launched for nitric oxide

  Nitric BioTherapeutics, Inc. (Bristol, PA) has begun a Phase II clinical trial using nitric oxide for the treatment of chronic wounds. The gas has a number of properties believed to be beneficial for healing wounds when applied topically – antimicrobial and anti-inflammatory action, regulation of collagen formation, and the ability to increase blood flow. The company anticipates that using nitric oxide for treating chronic wounds could accelerate the time of healing and increase the quality of life for the patient.

  For more information, visit www.nitricbio.com.

Enrollment complete in phase IIa study of topical gel

  Glycotex, Inc. (Rockville, MD) announced completion of the patient enrollment in a Phase IIa study evaluating the effect of GLYC-101 on wound closure in patients undergoing carbon dioxide laser skin resurfacing.   The product is intended to stimulate and modulate a natural cascade of wound healing activities over several cell populations and can be used to treat laser ablation, burn wounds, surgical wounds, venous ulcers, and diabetic wounds. The product candidate is a topical gel that can be applied directly to the wound surface.

  The randomized, double-blind, placebo-controlled clinical study in Beverly Hills, CA, has enrolled 12 patients undergoing laser skin ablation. The study also is investigating efficacy endpoints such as the promotion of wound healing and cosmetic outcomes, in addition to safety endpoints.

  For more information, visit www.glycotexinc.com.