Canada OKs Cutera's GenesisPlus

Medical devices maker Cutera Inc ( CUTR - Snapshot Report ) has obtained the approval of Health Canada for its GenesisPlus laser for treating onychomycosis (nail fungus). The California-based company has secured approval of the U.S. Food and Drug Administration (“FDA”) for the device in April 2011. GenesisPlus is also marketed in Europe.

Onychomycosis is a fungal infection of the toenail or fingernail representing 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 diabetes, psoriasis, and peripheral arterial disease (“PAD”). The global market for onychomycosis therapies is estimated to be more than $2 billion.

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 Genesis Plus.

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, patients in Canada now have a fast and effective therapy option for onychomycosis without the risk 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. ( CYNO - Snapshot Report ) , Palomar Medical Technologies ( PMTI - Snapshot Report ) and Syneron Medical Ltd. ( ELOS - Snapshot Report ) among others.