US-based NuvoLase has obtained approval from the Australian Therapeutic Goods Administration (TGA) for its PinPointe FootLaser device to treat nail disorders (or diseased nails) caused by nail fungus, onychomycosis.
This approval will allow the company to market the device in Australia. NuvoLase has already obtained the US Food and Drug Administration approval for the PinPointe FootLaser device.
Research indicates the PinPointe FootLaser achieves the target temperature necessary to reach the fungi beneath the nail plate, the company said.
The proprietary pulse structure enables the laser to produce ample energy without damaging underlying or surrounding tissue.
NuvoLase president and CEO Steve Duddy noted that the TGA clearance is critical to the company’s expansion plans and comes on the heels of several other key clearances including Korea and Japan.
"As in other countries around the world, clinicians are seeking a non-pharmacologic approach to this annoying problem.
"With nearly 150,000 procedures performed worldwide and growing, the PinPointe FootLaser remains one of the only devices with documented clinically proven efficacy," Duddy added.