Sonic Tech Inc. is developing a unique energy-based therapy called CLENS"""""""" (Coincident Light Energy and Non-focused ultraSound). Using two well-established clinical energy sources in a novel way, the technology is intended to treat dermal diseases caused by biofilms, a bacterially generated slime layer. Biofilms shield bacteria from attack by both antibiotics and the immune system, and often induce a chronic inflammatory response. Biofilms contribute directly to the difficulty of treating many recalcitrant bacterial diseases including moderate to severe acne and atopic dermatitis (eczema), which severely affect, in total, over 25 million children, teens, and adults in the US. Current drugs and treatments for these diseases may have safety issues, are not always effective, are costly, may lead to drug resistance, and do not target the underlying biofilm. Due to the inability to disrupt the biofilm component of these disease, there have been few novel treatments which improve safety or effectiveness. However both are life-altering diseases for which new treatment options are needed. Simultaneous application of therapeutic, biocidal blue/violet light with ultrasound will synergize the demonstrated beneficial properties of each, and create a technologically new method to target and eliminate biofilms. CLENS treatment has the potential to significantly, and safely, improve the symptoms, suffering, quality of life, and economic burden of a large patient population. Preliminary data indicate the feasibility of the approach. The proposed Phase I research program includes developing a flexible test exposure system capable of a range of blue/violet light and low intensity ultrasound output conditions, and a method for producing biofilms in an appropriate in vitro system for treatment testing. The exposure system will then be thoroughly tested for effectiveness against a range of in vitro biofilms, and the optimal exposure conditions of light and ultrasound will be determined. Next, in vitro bactericidal effectiveness wil be demonstrated to a level (1000:1 reduction) that is necessary to predict clinical utility. Finall, the data will be used to create the design for a clinical prototype CLENS system. At the end of this funding cycle, Sonic Tech will be ready to build a hand held clinical CLENS unit suitable for testing in atopic dermatitis and acne patients for human Proof of Concept evaluation(during Phase II).
This project addresses two common skin diseases: severe acne and atopic dermatitis (eczema), which affect over 25 million children, teens, and adults in the US. Chronic bacterial infections (biofilms) underlie both diseases, which limits the effectiveness of current drug treatments. This project targets these infections by combining light and ultrasound energies into a new, non-drug therapy, providing improved care at reduced cost, while eliminating harmful drug side effects.