Industry and Product News
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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).