LAVAL, QC, July 6, 2012 /CNW Telbec/ - KLOX Technologies Inc. ("KLOX" or the "Company") held its 2012 Annual General Meeting of Shareholders. President and Chief Executive Officer Dr. Lise Hébert provided shareholders the renewed vision on the Company's innovative biophotonic technology and the strategic focus in advancing its therapeutic programs to treat important unmet needs in tissue repair, dermatology and dentistry while leveraging the value of the existing commercial products.
"Over the past 12 months, the Company has refocused its activities and resources into a two-pronged strategy: first to focus on its two development programs to significantly advance the clinical trials in the fields of acne vulgaris and non-healing chronic pressure sores. Additionally, while successfully growing its revenues KLOX has undertaken steps to maximize the value of its aesthetic products in the whitening and rejuvenation arenas and is now in advanced discussions," said Dr. Lise Hébert. "Our human and financial resources are now aligned with our primary goals to set new standards in healthcare and creating long term value."
KLOX Technologies: Leveraging light-based technologies
KLOX Technologies is focused on the development and commercialization of a unique, non-invasive technology using a multiple LED lighting system that interacts with an oxygen-rich gel containing light-trapping molecules.
Today, KLOX's cosmetics and medical devices are destined for the rapidly growing aesthetics, dental, dermatological and tissue repair markets.
Tissue Repair Program:
KLOX is developing WH-1, an innovative light-based treatment for the multi-billion dollar tissue repair market. During the year, the Company advanced its program as follows:
- Initiated two 15-patient investigator-based case studies in Europe to document the safety and preliminary efficacy profiles in patients suffering from Grade II and III pressure sores. The first study is well advanced and the second one was approved in June 2012 to start this summer. The safety and preliminary efficacy data are both promising.
- Filed the documentation and has requested to meet with the U.S. Food and Drug Administration along with Health Canada to discuss its Investigational Device Exemption towards initiating a feasibility study to investigate the treatment of Grade II pressure sores. The meetings are expected to take place this summer.
- Preparing to file for a registration trial in Europe in the fourth quarter of this year to study the safety and efficacy of WH-1 in Grade III chronic pressure sores.
In the dermatology segment, KLOX has developed:
- A promising Acne treatment system, AC-1, which is currently in a final registration trial towards a Class IIa medical device in Europe. The Company initiated this prospective clinical trial to evaluate the efficacy and safety of the KLOX biophotonic system on moderate-to-severe acne in early 2012. Treatment protocol dictated that only one hemiface of each patient would be treated against a control segment being the untreated hemiface. Patient recruitment is expected to be completed this month. Data is expected in the fourth quarter of 2012 with the subsequent filing towards approval in Q1:2013.
- A subsequent extension clinical trial that has been approved this month to treat the other hemiface of the participating patients as well as investigating safety and persistence of outcomes over an additional three (3) month period.
- KLOX's skin rejuvenation product SKR-1 has cleared the regulatory paths in Canada, the U.S. and Europe and is ready to be fully commercialized and marketed across those geographies. KLOX is in advanced discussions to globally partner this program.
Three important factors in our field of aesthetic dentistry led the Company to pursue strategic partnering activities on the global front for its whitening products:
- KLOX has significantly increased revenue growth of its professional Fast&Mild+™ 1 and over-the-counter (OTC) LifeSmile™ 2 whitening products - both positioned to rapidly take a strong foothold in the professional and OTC teeth whitening markets.
- A new European regulation issued in 2011 that all cosmetic whitening systems that contain greater than 6% hydrogen peroxide will be banned from the European Union as early as in Fall 2012 3.
- KLOX's efficient and unique response to the challenge: irrespective of the low peroxide content proposed to be allowed in Europe, the Company created a NEW formulation based on the unique properties of its biophotonic technology, without hydrogen peroxide. This NEW product is characterized by increased gentleness and the same efficacy profile as its Fast&Mild™ professional kit.
The Company is presently considering strategic alternatives to realize the value of its aesthetic dentistry products.
KLOX provided shareholders with a review and an update on its financial position along with the financial results of the Company.
KLOX has successfully raised private placement financings totaling $7.25 million.
Strong Management and Sponsorship
Headquartered in Laval, Canada, KLOX Technologies is a private company chaired by Dr. Francesco Bellini and managed by a group of seasoned executives and advisors with extensive experience bringing medical products to market. The board of directors is composed of a multidisciplinary team of entrepreneurs and scientists with extensive international experience.
Board of Directors
KLOX also announced that Dr. Harry Baikowitz is being proposed for nomination to the Board of Directors subject to the approvals required. Dr. Baikowitz is expected to be joining Dr. Francesco Bellini, Chairman, Mr. Carlo Bellini, Mr. Jean Lamarre, Ms. Cesilde Spalvieri and Dr. Giovanni Scapagnini on the Company's Board of Directors.
1 For more information, go to http://www.fastandmild.com/en/home.html.
2 For more information, go to http://www.lifesmilepen.com/en/home.html
3 http://www.obelis.net/news/new-eu-directive-regarding-tooth-whitening-products/ Annex III, Part I of the Cosmetics Directive, 76/768/EEC
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