PinPointe™ FootLaser™ Submits Its Breakthrough Laser Treatment For Toenail Fungus To Health Canada For Approval

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology;  Regulatory Affairs / Drug Approvals
Article Date: 22 Jul 2009 - 2:00 PDT

email to a friend   printer friendly   opinions  

PinPointe FootLaser announced it has submitted its innovative new laser treatment for toenail fungus (Onychomycosis) to Health Canada for approval. As the Federal department responsible for helping Canadians maintain and improve their health, Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. PinPointe FootLaser has been awarded the CE Mark certifying it has met European Union consumer health and safety standards, has been cleared for use in the treatment of toenail fungus in the EU, and can be offered by healthcare providers throughout Europe. Additionally, the treatment is FDA cleared for applications in dermatology, plastic surgery, and podiatry in the United States.

John Strisower, CEO of PathoLase, noted that he is confident the 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."

Safe Quick Treatment - No Drugs, Pain or Anesthesia

Introduced in 2008, PinPointe FootLaser uses a patented laser technology to target the pathogens that cause toenail fungus. With PinPointe FootLaser, patients are treated safely and quickly with no drugs, no anesthesia and no pain. PinPointe's laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in healthy and clear. Unlike medication-driven treatments for toenail fungus, PinPointe FootLaser presents minimal risk of side effects. Competing medication procedures can result in a wide variety of side effects, including liver toxicity.

New Clinical Trial Currently Underway

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 U.S.

About PinPointe FootLaser

PinPointe™ FootLaser™ is a groundbreaking laser treatment for toenail fungus that was launched in September 2008 by Chico, CA-based PathoLase, Inc. PinPointe FootLaser targets the pathogens that cause toenail fungus (Onychomycosis), an infection that afflicts an estimated 40 million people in the U.S. alone. PinPointe FootLaser recently received the first and only medical device clearance for toenail fungus treatment in Europe (CE Mark). For more information please visit http://www.pinpointefootlaser.com.

Source
PathoLase, Inc.

• Additional
• References
• Citations