PinPointe FootLaser has filed an application for the Health Canada approval of its innovative new laser treatment for toenail fungus (Onychomycosis). The company received CE Mark for use in the treatment of toenail fungus and can be offered by healthcare providers throughout Europe. The treatment is also FDA cleared for applications in plastic surgery, dermatology and podiatry in the US.
John Strisower, CEO of PathoLase, is confident that device will be made available to licensed Canadian medical practitioners after the Health Canada review process is completed. Stated Strisower: “Onychomycosis afflicts approximately 900 million people around the world, including millions in Canada. We’re very much looking forward to making PinPointe FootLaser available to Canadian practitioners as well, offering them an excellent opportunity for providing a unique and valuable service to their patients.”
PinPointe FootLaser makes use of a patented laser technology to target the pathogens which cause toenail fungus. Patients are treated safely and quickly with PinPointe FootLaser without using drugs and anesthesia. The laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in clear and healthy . PinPointe FootLaser presents minimal risk of side effects. Competing medication procedures can result in a wide variety of side effects which includes liver toxicity.
Following an early study conducted among a small group of patients (Harris, McDowell and Strisower, Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009), which indicated a potential efficacy rate as high as 87%, the treatment is currently undergoing a major multi-site clinical trial entitled “Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)”. The study, which has been granted approval by Health Canada, is being conducted at the dermatology clinic and research facility of Aditya K. Gupta, M.D., Ph.D., M.A. (Cantab), DABD, FAAD, FRCPC in London, Ontario, as well as at three additional sites in the US.