LAVAL, Quebec, May 03, 2017 (GLOBE NEWSWIRE) -- Today, the final results on KLOX Technologies’ (Klox) EUREKA study, which evaluated LumiHeal in the treatment of hard-to-heal, non-responsive, chronic wounds, were reported at the European Wound Management Association, in Amsterdam.
LumiHeal is a CE marked, first-in-class, proprietary, non-thermal and non-invasive treatment solution that utilizes hyper pulsed fluorescence light (HPFL) to treat acute and chronic wounds.
“LumiHeal has shown that it is a viable and effective treatment solution for patients with debilitating hard-to-heal, chronic wounds,” stated Dr. Marco Romanelli, MD, PhD, Associate Professor of Dermatology at the School of Medicine, University of Pisa, and Chief of the Wound Healing Research Unit, and President Elect of the World Union of Wound Healing Societies. “LumiHeal represents a new option in the way practitioners can manage and treat hard-to-heal chronic wounds.”
“We are very pleased that the data released today confirmed the interim analysis reported in September 2016 on 33 patients,” said Dr. Michel Cimon, MD, Senior Vice President, Chief Medical and Scientific Officer at Klox. “It’s an important day for LumiHeal and for FB Advanced Wound Care, our wound care franchise.”
Clinical final results from EUREKA study on LumiHeal TM and chronic wounds management
Professor Marco Romanelli reported the final study results on the evaluation of real-life use of LumiHeal in Chronic Wounds Management (Venus Leg Ulcers, Diabetic Foot Ulcers, and Pressure Ulcers). The results reported were on 99 patients who completed treatment in the EUREKA study.
Investigators’ final analysis supports the strong efficacy profile of LumiHeal in promoting wound closure along with wound bed preparation in hard-to-heal chronic wounds. These results indicate LumiHeal’s ability, in a majority of cases, to transition hard-to-heal, non-responsive, chronic wounds into an acute wound setting.
Investigators found the treatment to be safe, easy to administer and very well tolerated by the subjects’ population. Compliance to the study visits was excellent.
The excellent tolerability and compliance profiles is reinforced by the positive action on pain reduction observed during this study, especially in the VLU population.
Final results show:
Out of the 99 patients reported, 71% of them had a prognosis factor of poor healing at study entry;
The average treatment duration for all types of wounds was 80.5 days;
47 of these hard-to heal, chronic wounds, closed completely during the study period VLUs (26), DFUs (16), PU (5);
96% of wounds that closed completely, remained closed throughout the follow up period;
69.2% of VLUs and 68.8% of DFUs were ready for skin graft according to clinician’s opinion;
The table below summarizes the top line data:
| Median Wound Age (Months) | Total Wounds Treated | Total Wounds Closed | Median baseline area (cm 2 ) | Median area at last Study visit (cm 2 ) | p-value | |
| VLU | 9.3 | 52 | 32 | 6.85 | 0.40 | <0.001 |
| DFU | 4.0 | 32 | 16 | 1.60 | 0.35 | 0.001 |
| PU | 12.5 | 15 | 5 | 1.90 | 1.20 | 0.268 |
The final results of the EUREKA study show, that taken together with efficacy, treatment ease of use, safety, and a positive impact on pain reduction, LumiHeal has the ability to become a leading option for the treatment and management of hard-to-heal, chronic wounds.
About LumiHeal TM LumiHeal is a CE marked, first-in-class, proprietary, non-thermal and non-invasive treatment solution that generates hyper pulsed fluorescence light to treat acute and chronic wounds. It is used in conjunction with a multi-LED light. LumiHeal is a topical gel comprising of light absorbing molecules, which is applied to a wounded area. The HPFL generated have the capacity to penetrate various depths of the skin (epidermis, dermis, hypodermis). Treatment duration lasts only a number of minutes, while maintaining a safe and well tolerated product profile.
About KLOX Technologies Klox is a specialty pharmaceutical company focused on developing and commercializing products based on its proprietary Fluorescence Biomodulation technology platform, previously known as BioPhotonics, to address skin and soft tissue disorders. Klox is advancing its programs as part of its multiple franchises focusing on indications across Dermatology, Wound Care, and Oral Health. For more information and to consult the abstracts, please visit www.kloxtechnologies.com .
Forward Looking Statements Certain statements contained in this newswire, 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 and commercialization 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 more information: Jade Lavallée Labossière Hill+Knowlton Strategies 514-375-2730 Jade.lavallee-labossière@hkstrategies.ca
