KLOX Technologies Inc. announced the approval in Canada of the Klox Biophotonic System (also known as the Lumigel Cleanse System) for the treatment of acne vulgaris after receiving this week a Medical Device License from the Therapeutic Products Directorate – Medical Devices Bureau of Health Canada. The Lumigel Cleanse System is a first-in-class innovative acne vulgaris treatment which has shown in clinical trials a superior profile in terms of combined safety and efficacy. “KLOX is proud to receive its first approval here in Canada. This important milestone fits perfectly into our regulatory strategy that we are pursuing around the world and to that end the company has also filed in Europe for a CE mark,” said Dr. Lise Hébert, President and CEO of KLOX. With this new, cutting edge topical product, of a different category than photodynamic therapy, KLOX is now actively pursuing its goals which are two-fold: to create important returns for its shareholders and to advance its large pipeline of products for unmet needs in dermatology. Acne vulgaris is a chronic disease that can have devastating physical, social and psychological effects on those who suffer from it, particularly in moderate to severe cases. Acne vulgaris affects over 5 million people in Canada, and approximately 150 million people worldwide. It accounts for over 30% of dermatology visits and over 40% of those suffering from this disease are looking for treatments with a better safety and efficacy profile than what is currently available. Many of the topical, oral and photodynamic treatments for acne vulgaris are characterized by inconsistent efficacy/persistence, systemic treatment schedules, lower patient tolerability and in most cases, side-effects. “Based on the new technology, the KLOX Lumigel Cleanse System is a first-in-line Class II medical device with an unmatched clinical profile in terms of efficacy and safety. Patients will appreciate its visible and long-lasting effects, as demonstrated clinically, with the benefit of being non-invasive in nature. On the other hand, practitioners will be able to offer an easy-to-administer and accessible treatment option,” said Dr. Steven Bernstein, Chief of Dermatology Surgery at the University of Montreal Hospital Center (CHUM).
