Canadian investigational studies to validate KLOX Biophotonic System for the treatment of venous leg and pressure ulcers
MONTREAL, Jan. 8, 2013 /CNW Telbec/ - KLOX Technologies Inc. ("KLOX" or the "Company") is pleased to announce that, following the receipt of Investigational Testing Authorizations from Health Canada for a Class II medical device, the Company is launching this month two simultaneous investigational studies of the KLOX Biophotonic System for the treatment of chronic venous leg and pressure ulcers, respectively. The launch of these new studies was announced this morning during Biotech Showcase™ 2013 in San Francisco, CA, where Dr. Lise Hébert, President and Chief Executive Officer of KLOX, was presenting.
"We are very pleased to move forward, on schedule, with these two important studies in Canada as we look to extend KLOX's reach into the $5.5 billion global advanced wound healing market. This effort is part of a global strategy to improve the standard of care and bring our proprietary and innovative biophotonic application to market both here and abroad in the non-healing chronic wounds segment within the next 24 months," said Dr. Hébert.
Both the venous leg ulcer and pressure ulcer studies that are being rolled out in Canada are multi-center, open-label, non-controlled, prospective case series of a 26-week maximum duration. Their objectives are to validate the safety and tolerability of the treatment as well as to gather preliminary efficacy data. The goal is to recruit and treat adult patients through a maximum of 3 investigational sites located in Canada for each study, the first of which will be launched in Montreal, Quebec.
In 2013, KLOX intends to pursue its clinical strategy for the treatment of chronic wounds under the auspices of the medical device pathway. The Company has filed in December 2012 its request for a Pre-Market Authorization (PMA) process in the United States to initiate a trial to assess the KLOX Biophotonic System in pressure sores and expects a response from the Food and Drug Administration in the coming weeks. As well KLOX will continue to seek approval from Canadian, European and U.S. regulatory authorities to conduct another series of studies that will include the KLOX Biophotonic System for the treatment for diabetic foot ulcers and Stage III pressure ulcers.
In Europe, KLOX has completed a registration trial with its Biophotonic System for the treatment of moderate-to-severe acne and top-line data will be available soon.
About KLOX Technologies: Leveraging light-based biophotonic technologies
KLOX is a privately-owned company focused on the development and commercialization of a unique, non-invasive patented biophotonic technology using a primary device consisting of a multiple 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 dental, dermatological and medical markets. Treatments for periodontitis are also currently under development for medical applications.
For further information on KLOX, please visit the Company's website: www.kloxtechnologies.com
For information regarding study eligibility and enrollment, please call: 1-450-680-4453.
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.
For further information:
Business, Consumer and Marketing Media:
NATIONAL Public Relations
+1 (514) 843-2345