News January 2022

PolarityTE Gets FDA Nod for SkinTE for DFUs

PolarityTE, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug application for the evaluation of SkinTE for the treatment of chronic cutaneous ulcers. The company says the approval enables PolarityTE to commence the first of two expected pivotal studies needed to support a biologics license application seeking a chronic cutaneous ulcer indication for SkinTE. 

PolarityTE says the first planned pivotal study is a multi-center, randomized controlled trial evaluating SkinTE in the treatment of Wager 2 diabetic foot ulcers (DFUs) entitled "Closure Obtained with Vascularized Epithelial Regeneration (COVER) for DFUs with SkinTE."  The study will enroll up to 100 patients at up to 20 sites in the U.S. in COVER DFUs, which will compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone. The company notes the primary endpoint is the incidence of DFUs closed at 24 weeks, while secondary endpoints include percent area reduction at 4, 8, 12, 16, and 24 weeks, improved quality of life, and new onset of infection of the DFU.

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Study: MolecuLight i:X^® Improved Sensitivity of Detecting Bacterial Burden in Surgical Site Wounds by 11-Fold

MolecuLight Inc. announced the publication of “Uncovering the high prevalence of bacterial burden in surgical site wounds with point-of-care fluorescence imaging” in International Wound Journal. The publication reports on the results of an analysis of 58 imaged and biopsied surgical site wounds from the 350-patient multi-center FLAAG (Fluorescence Imaging Assessment And Guidance) clinical trial.
 
As the company notes, key findings of the study include:
•    76% of surgical sites that reach the stage of referral to a wound specialist had clinically significant bacterial loads (10⁴ to 10⁹ CFU/g), however only 6.8% exhibited symptoms of infection, resulting in delayed infection management.
•    Point-of-care fluorescence imaging (using the MolecuLight i:X device) for detecting high bacterial loads improved sensitivity by 5.7-fold compared to clinical signs and symptoms alone.
•    Clinician experience with fluorescence imaging and interpretation (>200 imaging sessions) increased sensitivity of fluorescence imaging by 11.3-fold compared to clinical signs and symptoms alone, and increased accuracy by 2.6-fold.

MolecuLight says these findings are part of an initiative by the International Surgical Wound Complications Advisory Panel (ISWCAP) to study surgical site infections on a global scale and highlight the need for more objective diagnostic techniques to support the early and accurate detection of clinically concerning bacterial burden in surgical wounds. The authors note that this is the first study reporting the use of an advanced diagnostic device for the visualization and diagnosis of bacterial burden in surgical wounds. 

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