NuvoLase’s PinPointe™ FootLaser™ Receives Korean Regulatory Approval
Chico, Calif., Nov. 4, 2013 – NuvoLase Inc. announced today that it received approval from the Korea Food & Drug Administration (KFDA) for its Pinpointe FootLaser .
The PinPointe FootLaser was the first light-based device to receive FDA clearance specific to clearing nails infected by onychomycosis, commonly known as nail fungus. With over 125,000 procedures performed worldwide, the PinPointe FootLaser remains one of the only devices on the market today with documented clinically proven efficacy.
Approximately 5% – 18% of the global population suffers from Onychomycosis. The most common organism that causes the condition, Trichophyton rubrum, gets into the nail bed of the fingers and toes. Oral prescription medications which have to be given in doses that reach a therapeutic blood and tissue level, are expensive, have a definite side effect profile which, although not of frequent occurrence, is potentially dangerous, and many times either doesn’t cure the problem or if it does, the problem recurs (comes back)
“I am pleased and excited about receiving approval from the KFDA for our PinPointe FootLaser,” says Steven P. Duddy, President and Chief Executive Officer of NuvoLase Inc. “Success in the international markets is key to our long term growth strategy. The PinPointe FootLaser has quickly become the light-based procedure of choice for many clinicians worldwide seeking alternative methods for onychomycosis (nail fungus). The FootLaser is an effective alternative to oral medications, which can be risky for the patient.”
The KFDA approval in Korea is the most recent of regulatory clearances for the PinPointe FootLaser, adding to its existing regulatory approvals which include FDA clearances, CE Mark, TGA, shonin Japan and Health Canada.
“We’re working to expand to as many markets as possible, both domestically and abroad,” Duddy explains. “We’ll continue to invest in science, technology, intellectual properties and clinical studies that will help us expand our applications, create new beneficial products, and garner regulatory clearances worldwide.”