Company also filed to receive CE mark in Europe
Lumigel Cleanse System is safe, efficacious and poised to become a game-changer for acne sufferers and dermatologists alike
LAVAL, QC, Oct. 2, 2013 /PRNewswire/ - KLOX Technologies Inc. ("KLOX" or the "Company") announces 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."
Benefits for Acne Vulgaris sufferers
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).
About Lumigel Cleanse system
The Lumigel Cleanse System is comprised of a multi-LED light, which activates a topical photo-converter gel applied on the affected area to achieve safe and efficacious results in the treatment of acne vulgaris. This is done by targeting the underlying problems that lead to acne vulgaris as well as stimulating collagen in traumatized skin. The system is designed to promote healing in both the epidermis and deeper in the dermis in a non-invasive manner. Completed within a 15-minute treatment cycle including preparation, the treatment requires applications twice a week for a six-week period. The technology is non-abrasive, non-thermal, and is comfortable for the patient.
The clinical evidence of the medical device was based on a European registration and extension trials 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 favourable 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, thus demonstrating a persistence of effect of at least 6 months.
About KLOX Technologies: Leveraging multi-indication Biophotonic
Based in Laval, Quebec, KLOX is a privately-owned company focused on the development of a unique, non-invasive patent-protected biophotonic platform using a primary device consisting of a multi-LED lighting system that interacts with an oxygen-rich gel containing light-trapping molecules. KLOX's cosmetics and medical devices are destined for the rapidly growing aesthetics, dermatological, and tissue repair markets.
For further information on KLOX, please visit the Company's website:
Forward Looking Statements
Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward looking statements include those regarding cosmetics and medical devices and medical applications and clinical trials and the status and related results thereto, as well those regarding continuing and further development efforts. Such statements, based as they are on the current analysis and expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond KLOX Technologies Inc.'s control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the medical, cosmetics and/or consumer goods industries, changes in the regulatory environment in the jurisdictions in which KLOX Technologies Inc. does business, financial and commercial markets volatility, fluctuations in costs, and changes to the competitive environment, as well as other risks. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. In the case of forward-looking statements regarding investigational product candidates and continuing and further development efforts, specific risks which could cause actual results to differ materially from KLOX Technologies Inc.'s current analysis and expectations include: failure to demonstrate the safety, tolerability and efficacy of our products, final and quality controlled verification of data and the related analyses, and the expense and uncertainty of obtaining regulatory approval.
SOURCE KLOX Technologies Inc.