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KLOX Technologies announces European CE mark approval for its innovative, non-invasive acne vulgaris product

November 19, 2013

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

LAVAL, QC, Nov. 19, 2013 /PRNewswire/ – 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: 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.

SOURCE KLOX Technologies Inc.


Source: PR Newswire