KLOX Technologies Inc., a leading life sciences specialty pharma company, has received CE mark approval in Europe for its topical photo-converter gel, LumiHeal, as a Class IIb Medical Device for the treatment of acute and chronic wounds. This gel is part of KLOX's innovative, non-invasive, and patented BioPhotonic platform which is designed to promote healing of wounds while addressing bacterial contamination. KLOX plans to independently commercialize LumiHeal in Europe in 2015.
"KLOX's global strategic partnerships in dermatology have enabled us to solidify our position as a leading specialty pharma company. With this regulatory approval in hand, we intend to focus our financial and human resources on independently commercializing and realizing the value of our promising wound care franchise as part of a multi-billion dollar global market. We plan to initially launch LumiHeal in Europe and subsequently leverage the CE mark in other geographies where the CE mark is recognized," stated Dr. Lise Hébert, President and CEO of KLOX. "Our BioPhotonic platform is truly innovative in the way it harnesses light and oxygen to accelerate healing, while carrying bactericidal properties. Accordingly, we believe that our treatment will represent a much-awaited solution for patients suffering from acute and chronic wounds while also helping to reduce the cost of treatments which currently represents a large financial burden to the global healthcare system," she concluded.
"Chronic wounds are frequently challenging to treat for physicians and are both debilitating and painful for patients. LumiHeal is positioned to become a leading and effective treatment to optimize the patients' own physiological responses to injured tissues thus promoting healing," added Dr. Andreas Nikolis, Plastic Surgeon, Division of Plastic Surgery, Université de Montréal.
A chronic wound is a wound that fails to progress through the various phases of wound healing. Chronic wounds generally result from the presence of several intrinsic and extrinsic factors and, as such, are often complicated, debilitating and painful. They can be lengthy and expensive to treat, and can lead to serious complications such as severe infections and amputations. Any wound has the potential to become chronic, however such wounds most commonly arise from one of three aetiologies: diabetes (diabetic foot ulcers), venous insufficiency (venous leg ulcers) and pressure (pressure ulcers) and as such create significant and costly challenges for healthcare systems. The cost of lower extremity ulcers is estimated to be greater than the annual cost of treating colorectal and breast cancer (Barshes, et al, 2013) and the relative five-year mortality rate after limb amputation is 68%. To put this into perspective, it is estimated that in the United States alone, chronic wounds are estimated to affect 6.5 million patients, with over $25 billion spent annually on treatment.
It is documented that there are 20 million chronic wounds globally and, while several treatment options currently exist, efficacy cannot be guaranteed. While some wounds can be brought to a favorable state using existing therapies, many currently continue to remain and require complex, lengthy and expensive treatment in order to ensure wound closure if they indeed close.
The KLOX BioPhotonic Systems are innovative and non-invasive treatment solutions that harness the power of light and oxygen to treat serious skin and tissue disorders. The proprietary KLOX BioPhotonic System for wounds is comprised of a multi-LED light and a topical photo-converter gel that is applied on the open wound. The illumination of the gel with the multi-LED light permits the synergistic effects of oxidants and photons (fluorescence), which are produced by the photo-converting gel in specific ratios. The treatment duration lasts only a few minutes and is repeated twice a week until the wound is healed. This technology is non-abrasive, non-thermal, and has been reported to be comfortable for the patient.
KLOX is focused on the development and commercialization its non-invasive BioPhotonic platform, with a focus on the dermatological, wound care and oral health markets.