Medical devices maker Cutera Inc ([stock]CUTR[/stock]) has obtained the 510 (k) clearance from the U.S. Food and Drug Administration (“FDA”) for its GenesisPlus laser for treating onychomycosis (nail fungus). The California-based company’s shares spiked following the news of the approval.
Onychomycosis, a fungal infection of the toenails or fingernails, afflicts roughly 35 million Americans. The condition represents clinical symptoms such as discoloration/ thickening of the nail and separation of the nail plate from the nail bed. It is more likely to develop in people with conditions such as diabetes, psoriasis, and peripheral arterial disease (“PAD”). The worldwide market for onychomycosis therapies is estimated to be more than $ 2 billion.
Roughly 20% of the people affected with onychomycosis seek treatment annually in the U.S. Despite its wide prevalence, there are limited approved treatments for this condition. Currently, widely used prescription therapies are topical and oral drugs.
However, these treatments have limited clinical success rates due to prolonged and inconvenient treatment regimens and side-effects including potential liver toxicity. Moreover, topical drugs generally have poor efficacy. An innovative non-invasive approach for treating onychomycosis is the application of laser energy to the nail plate with an “Nd:YAG” laser such as the GenesisPlus.
The GenesisPlus laser represents a major advancement in the treatment of onychomycosis. It leverages Cutera’s proprietary microsecond technology and delivery system to improve patient experience. The device has a larger laser spot (compared with fiber lasers) which enables fast treatment and uniform coverage. With the approval of GenesisPlus, patients now have a fast and effective therapy option for onychomycosis without the risks of adverse side-effects.
Cutera develops and markets laser aesthetics systems for physicians and qualified practitioners globally and offers its products under three platforms, namely, Solera, Xeo and CoolGlide. The company markets its products through its direct sales force and distributors. Cutera competes with Cynosure Inc. ([stock]ELOS[/stock]) among others.
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