Industry and Product News

1000 Clinicians Globally Trained in New WOUNDCHEK™ Protease Test

  More than 1000 clinicians from over 400 sites across Europe, the Middle East, and South Africa have been trained in the 4 months since the launch of Systagenix’s (Gatwick, UK) WOUNDCHEK™ Protease Status, the world’s first point of care test for Elevated Protease Activity (EPA) in chronic wounds.   The introduction of WOUNDCHEK Protease Status is a much-awaited adjunct to current clinical diagnosis and assessment, as EPA cannot be detected by visual cues. Recent clinical trial data have shown that a chronic wound with EPA has a 90% probability of not healing without appropriate intervention to lower protease activity. Twenty-eight percent of the nonhealing wounds in the clinical trials had EPA. With WOUNDCHEK Protease Status clinicians will be able to identify these patients as soon as possible, and prescribe the appropriate therapy, instead of going undetected and potentially not healing for months or years.   WOUNDCHEK Protease Status is not currently cleared by the FDA for sale within the US market.   Visit www.systagenix.co.uk for more information.

CMS Issues a Proposed National Coverage Determination Memo for PRP Gel

  The Centers for Medicare & Medicaid Services (CMS) issued a proposed National Coverage Determination (NCD) memo for autologous blood-derived products for chronic nonhealing wounds. In its decision memo, CMS proposed coverage through its Coverage with Evidence Development program for all three major wound categories: diabetic, venous, and pressure wounds.   The release of the proposed NCD memo follows 6 months of CMS analysis and consideration, subsequent to formal approval of a reconsideration request made by Cytomedix, Inc (Gaithersburg, MD) and several clinical practitioners and industry opinion leaders.   Cytomedix’s comprehensive request for Medicare coverage reconsideration proposed that there is sufficient and compelling clinical evidence to validate the use of autologous PRP gel to treat chronic, nonhealing pressure ulcers, venous ulcers, and diabetic foot ulcers. The request sets out the reasons why PRP gel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life, as compared with standard wound care in the Medicare-eligible population.   isit www.cytomedix.com for more information.

BioLargo Forms Medical Products Subsidiary to Focus on Advanced Wound Care

  BioLargo, Inc (La Mirada, CA) announced the development of novel antimicrobial products for the advanced wound care industry and the formation of a wholly owned subsidiary BioLargo Medical Group, Inc, formed to advance proof of claims and pursue regulatory approvals. To run the new subsidiary, BioLargo is assembling a team of experts to capitalize on the industry’s demand for novel products. Unlike other iodine products, BioLargo’s iodine is nontoxic, nonstaining, and can be delivered on demand in precision dosing at much higher levels.   BioLargo’s new products have achieved high levels of antimicrobial efficacy without cytotoxicity in lab tests and are being developed and refined in preparation for market introduction upon receiving appropriate regulatory approvals. BioLargo’s CupriDyne® technology is green, and can be delivered in a liquid, gel, or ointments.   Visit www.biolargo.com for more information.

Celleration, Inc Enrolls First Patient in IN-BALANCE Venous Leg Ulcer Trial

  Celleration, Inc (Eden Praire, MN), announced the first patient enrollment in IN-BALANCE VLU (Inflammation, Bacteria, & Angiogenesis effects in Launching Venous Leg Ulcer [VLU] healing: A Clinical Evaluation). IN-BALANCE VLU is designed to expand on the body of evidence on MIST Therapy® that currently includes 12 peer-reviewed studies and a 444 patient meta-analysis supporting the clinical and economic benefits of the FDA cleared wound healing therapy.   IN-BALANCE VLU is a prospective, randomized, controlled, multi-center study of MIST Therapy in chronic VLU. The study will compare the effect of MIST Therapy on wound healing rates to traditional standard of care. The study will be performed at up to 20 study centers with an estimated 124 subjects enrolled in the study overall. This study also includes sub-analyses of fluid and tissue samples to characterize cellular and molecular changes surrounding inflammation, angiogenesis, and bio-burden impact of the treatments.   Visit www.celleration.com for more information.

ConaTec Introduces AQUACEL® EXTRA™ Wound Dressing With Hydrofiber Technology in Europe

  ConvaTec (Skillman, NJ) announced the availability of AQUACEL® EXTRA™ wound dressing with strengthening fiber in certain countries in Europe.   AQUACEL EXTRA wound dressing is composed of 2 layers of Hydrofiber® Technology stitched together and designed to make it 9 times stronger than current AQUACEL® wound dressings and give it an increased absorbency of 39% over the current AQUACEL wound dressing. AQUACEL EXTRA wound dressing will be specifically suitable when managing moderate to highly exuding wounds.   The company introduced AQUACEL EXTRA dressing during the 22nd Conference of the European Wound Management Association in Vienna, Austria, May 23–25 2012. The new dressing is already available in several countries throughout Europe including Germany, Spain, United Kingdom, Ireland, and the Benelux and Nordic regions. ConvaTec has plans to continue to expand the launch of AQUACEL EXTRA dressing throughout the European region throughout the year.   AQUACEL EXTRA wound dressings are available in 4 sizes: 5 cm x 5 cm, 10 cm x 10 cm, 10 cm x 12 cm, and 15 cm x 15 cm.   Visit www.convatec.com for more information.

Spiracur Announces Final Results From Multicenter, Randomized, Controlled, Clinical Trial

  The final results of a 17-center prospective randomized-controlled clinical trial evaluating the safety and efficacy of Spiracur Inc’s (Sunnyvale, CA) SNaP® Wound Care System for the treatment of chronic lower extremity wounds, and noninferiority compared to the electrically powered KCI V.A.C.® Therapy System (KCI, San Antonio, TX) have been published in the May/June 2012 issue of Wound Repair and Regeneration. It is the first-ever comparative effectiveness study of its kind in the field.   One hundred thirty-two patients with lower extremity wounds were enrolled in the study and randomly assigned to treatment with either the SNaP or V.A.C. systems. Of the 118 patients who received treatment, 115 patients had follow-up data available for analysis, and 83 patients completed the study with either healing (complete closure of the ulcer) or 16 weeks of therapy.   To establish noninferiority to traditional NPWT, this study was powered assuming 80% wound closure with an 18.5% standard deviation for both groups at 16 weeks using a margin of noninferiority of 12.5%. For final analysis, a Wilcoxon Rank Sum Test was conducted on 115 patients from 17 centers. Results indicate that the SNaP-treated subjects demonstrate noninferiority to the V.A.C.-treated subjects at 4, 8, 12, and 16 weeks (P = 0.0030, 0.0130, 0.0051, and 0.0044, respectively). Noninferiority was demonstrated between the two therapies in percent wound size reduction to the *P Medicinal Honey Improves Wound Healing, Decreases Pain   A new prospective observational study published online in the International Wound Journal found that medicinal honey can promote healing and reduce the affected area of many wounds, when used as a secondary dressing.   The study was financed in part by Derma Sciences (Princeton, NJ), a manufacturer of Medihoney, a unique line of dressings containing active Leptospermum honey from New Zealand.   More information on the study can be found at www.medscape.com/viewarticle/762958.

New Chronic Wound Treatment Device Receives Award from Veterans Healthcare Program

  Electrochemical Oxygen Concepts (EO2™ Concepts, [San Antonio, TX]) has been added to Marathon Medical’s (Commerce City, CO) existing Federal Supply Schedule (FSS) contract, administered by The Department of Veterans Affairs (VA). The TransCu O2®, a noninvasive, electrochemical low-dose tissue oxygenation system for the treatment of difficult-to-heal wounds, is now available to all organizations that purchase from the FSS, including the entire federal health care system, the largest health care provider in the United States with more than 1300 Veterans health facilities, Department of Defense medical treatment facilities, Military Hospitals, and Indian Health Service Hospitals.   EO2 Concepts is a privately held, advanced wound care technology company whose flagship product, the TransCu O2, is an FDA cleared Class III medical device.   Visit www.eo2concepts.com for more information.

BioElectronics RecoveryRx Approved for Surgical Recovery and Chronic Wounds in Canada

  BioElectronics Corporation (Frederick, MD) announced that the Therapeutic Products Directorate, Medical Devices Bureau of Health Canada has issued a Class II License for the RecoveryRx™ Post-Surgical and Wound Care Recovery product. RecoveryRx uses pulsed electromagnetic field therapy to reduce pain and inflammation and promote healing of injured tissue.   RecoveryRx is an appropriate therapy for treating pain and inflammation after oral, joint replacement, hernia repair, cosmetic, and general surgeries.   Visit www.bielcorp.com for more information.