KLOX Technologies Announces European CE Mark Approval for Non-Invasive Acne Vulgaris Product


KLOX Technologies Inc. announced that it has received CE mark approval in Europe for its topical photo-converter gel as a Class IIa Medical Device for the treatment of acne vulgaris, including all severities. The gel is part of the company's LumiCleanse System, a first-in-class, non-invasive acne vulgaris treatment with a clinically-proven safety and efficacy profile. The LumiCleanse System was previously approved for the treatment of all severities of acne vulgaris in Canada in September of this year.

The clinical evidence for the medical device application was based on a European registration trial conducted in Europe. In the study, the system demonstrated effectiveness in moderate to severe acne vulgaris patients and was clinically and statistically significant on the primary (p < 0.0001) and all of the secondary endpoints, with an extremely favorable safety profile. The three-month extension study demonstrated a similar effectiveness and safety profile. The persistence of effect was maintained in 92% of the cohort who had met the primary efficacy endpoint in the registration trial, thus demonstrating a persistence of effect of at least 6 months.

"We are pleased to reach another significant milestone in our regulatory and commercial roadmap and in our efforts to expand the reach of KLOX's innovative treatment in the $3 billion global acne market. Europe represents a significant pool of potential patients with unmet needs when it comes to the effective treatment of mild to severe acne," stated Dr. Lise Hébert, President and CEO of KLOX.

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