KLOX Technologies Announces European CE Mark Approval for its Innovative, Non-Invasive Acne Vulgaris Product
Quebec (ots/PRNewswire)
LumiCleanse[TM]is a clinically-proven treatment now available for all severities of acne vulgaris developed by KLOX in Canada, destined for the global acne market
KLOX Technologies Inc. ("KLOX" or the "Company") is pleased to announce 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 KLOX's LumiCleanse[TM] System, a first-in-class innovative, non-invasive acne vulgaris treatment with a clinically-proven superior safety and efficacy profile. The LumiCleanse[TM] System was previously approved for the treatment of all severities of acne vulgaris in Canada in September of this year.
"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.
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 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 who had met the primary efficacy endpoint in the registration trial, thus demonstrating a persistence of effect of at least 6 months.
About Acne Vulgaris 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 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 light-based treatments for acne vulgaris are characterized by inconsistent efficacy/persistence, systemic treatment schedules, problems with patient tolerability and in most cases, side-effects.
About LumiCleanse[TM]System The LumiCleanse[TM] 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.
About KLOX Technologies: Leveraging multi-indication Biophotonic platform 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 cosmetic, dermatological, and tissue repair markets.
For further information on KLOX, please visit the Company's website: http://www.kloxtechnologies.com.
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.
For further information: Roch Landriault NATIONAL Public Relations +1(514)843-2345 Geneviève Hinse NATIONAL Public Relations +1(514)843-2304