KLOX Technologies launches two studies for chronic wound healing using biophotonic technology
KLOX Technologies is launching two simultaneous investigational studies of the company's Biophotonic System for treating chronic venous leg and pressure ulcers, respectively.
KLOX Technologies (Montreal, QC, Canada) is launching two simultaneous investigational studies of the company's Biophotonic System for chronic wound healing, respectively. Slated to begin this month (January 2013), the two studies for treating chronic venous leg and pressure ulcers, respectively, using the system follow receipt of Investigational Testing Authorizations from Health Canada for a Class II medical device.
Both the venous leg ulcer and pressure ulcer studies that are being rolled out in Canada are multi-center, open-label, non-controlled, prospective case series of a 26-week maximum duration. Their objectives are to validate the safety and tolerability of the treatment, as well as to gather preliminary efficacy data. The goal is to recruit and treat adult patients through a maximum of three investigational sites located in Canada for each study, the first of which will be launched in Montreal.
In December 2012, the company filed a request for a Pre-Market Authorization (PMA) process in the U.S. to initiate a trial to assess the system in pressure sores, and expects a response from the FDA in the coming weeks. The company will continue to seek approval from Canadian, European and U.S. regulatory authorities to conduct another series of studies that will include the system for treating diabetic foot ulcers and Stage III pressure ulcers.
In Europe, the company has completed a registration trial with its system for treating moderate to severe acne. Top-line data will be available soon.
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