News Products and Industry News

New CPT and HCPCS J codes assigned to wound, burn matrix

    Healthpoint (Fort Worth, Tex) announces two new CPT codes and a new HCPCS Level II code relevant to the application of OASIS® products. The codes went into effect January 1, 2006.

    The new code descriptions are:
  • 15430: Acellular xenograft implant; first 100 cm² or less, or 1% of body area of infants and children
  • 15431: Acellular xenograft implant; each additional 100 cm², or each additional 1% of body area of infants and children or part thereof (list separately in addition to code for primary procedure)
  • HCPCS Level II J7341: Dermal (substitute) tissue of non-human origin, with or without other bioengineered or processed elements with metabolically active elements, per square centimeter.

    The product is a bioresorbable, three-dimensional, cell-free matrix derived from porcine small intestinal submucosa. The product is indicated for the management of partial and full-thickness wounds such as venous stasis ulcers and diabetic foot ulcers. The OASIS Wound Matrix is designed to replace the missing or dysfunctional extracellular matrix; thereby, aiding in the management of these wounds by providing an environment that supports the body’s natural mechanisms.

    For more information, visit https://www.healthpoint.com.

Multicenter, pivotal study on diabetic foot ulcers initiated

    KeraCure, Inc. (Chicago, Ill) announces the first patients have been treated in a multicenter pivotal study recently approved by the US Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers. The study tested the safety and efficacy of the KeraPac™ device in approximately 270 subjects in 16 clinical sites across the US. The company expects to complete enrollment in approximately 1 year.

    The device is comprised of non-woven fabric combined with porous microcarrier beads and human keratinocytes. The device is placed externally on a clean wound and removed several days later. The product is distinguished by its simplicity, low production cost, and storage capability. KeraCure has signed a strategic agreement with Genzyme Corporation (Cambridge, Mass) to manufacture the device for the study.

    For more information, visit https://www.keracure.com.

Presentation to focus on protease enzyme product

    Swiss-American Products, Inc. (Dallas, Tex), has developed a product line that will be the focus of a presentation during the upcoming Wound Healing Society meeting to be held May 14–17, 2006 in Scottsdale, Ariz.

    The presentation, Elta Hydrovase Wound Dressing Components Degrade Proteins Detrimental to Wound Healing, will provide information from a recent study conducted at the University of Florida on a proprietary blend of protease enzymes developed by Swiss-American. The study results show that the blend helps speed the healing process for a wide variety of wounds, including pressure ulcers, ulcers caused by incontinence, and wounds resulting from injury, as well as certain diseases that affect the skin.

    For more information, visit https://www.elta.net.

Super-oxidized, non-irritating wound treatment receives OTC clearance

    Oculus Innovative Sciences (Petaluma, Calif), announces that the US Food and Drug Administration (FDA) has granted clearance to market a consumer-specific version of Dermacyn™ Wound Care as an over-the-counter (OTC) product in the US. The FDA approved the company’s OTC product with more limited label claims than the company’s prescription formula.

    The product received two FDA 510(k) clearances in May 2005 and is currently available in the US by prescription only. The product moistens absorbent wound dressings and can be used to debride and clean acute and chronic dermal lesions, such as 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.

    This consumer, OTC version of the product is intended for general purpose use, including moistening absorbent wound dressings and cleaning minor and superficial skin abrasions.

    For more information, call (800) 759-9305 or visit https://store.oculusis.com.

Wound healing corporation receives JCAHO certification

    National Healing Corporation (NHC, Boca Raton, Fla) has earned the Gold Seal of Approval™ for healthcare quality. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) awarded the firm a Disease Specific Care Certification for wound care.

    An industry leader with a proven track record of results partnering with hospitals nationwide, NHC accounts for more than 20% of managed wound healing centers specializing in the treatment of chronic and non-responsive conditions in the US. The certification applies to all NHC centers that have been open for more than 4 months and have begun participating in the Disease-Specific Care Quality Indicators.

    To earn JCAHO certification, a disease management program undergoes an extensive on-site evaluation review by a team of Joint Commission reviewers once every 2 years. The program is evaluated against Joint Commission standards through an assessment of a program's processes, the program’s ability to evaluate and improve care within its own organization, and interviews with patients and staff.

    The Joint Commission launched the Disease-Specific Care Certification program in 2002.

    For more information, visit https://www.nationalhealing.com.

Wound care groups forge meeting agreement

    HMP Communications (HMP, Malvern, Pa), sponsor of the annual Symposium on Advanced Wound Care (SAWC), in cooperation with the Association for the Advancement of Wound Care (AAWC), announces a 2-year agreement with the Wound Healing Society (WHS) for a combined clinical and scientific meeting beginning in April 2007.

    The annual SAWC is the largest wound care meeting in the US. This year, more than 2,200 wound care physicians, podiatrists, nurses, therapists, and scientists from academia and industry attended the Symposium, which was held at the Henry B. Gonzalez Convention Center, San Antonio, Tex from April 30 – May 3, 2006.

    The agreement provides wound care clinicians and researchers the opportunity to meet concurrently, assimilating cutting-edge science with practical wound care education to better serve the constantly expanding clinical and research audience. Participating organizations will develop a program that integrates the spectrum of wound healing interests into a comprehensive offering for a broad participant base. Plus, the combined meetings will ensure that exhibitors have access to the largest number of key clinical wound care decision-makers in the US.

    The SAWC is the official annual meeting site for the AAWC, the largest, multidisciplinary organization in North America dedicated to the professional and personal advancement of wound care specialists and those interested in wound care. The combined SAWC/WHS meetings also will foster and strengthen relationships between the WHS and the AAWC and further mutual goals.

    The 20th Annual SAWC meeting, to be held at the Tampa Convention Center from April 28 – May 1, 2007, will mark the first year of the joint SAWC and WHS program. The Wound Healing Society’s participation will consist of both joint and WHS-only sessions and the WHS will continue to conduct the important, abstract-driven symposia as well as their “Young Investigator Session.” The SAWC and WHS also will continue to be co-sponsored by the University of Miami.

   For more information, please visit https://www.SAWC.net.