Cutera's GenesisPlus Laser Cleared - Analyst Blog
12 Abril 2011 - 10:59AM
Zacks
Medical devices maker Cutera Inc (CUTR) 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. (CYNO), Palomar Medical
Technologies (PMTI) and Syneron Medical
Ltd. (ELOS) among others.
CUTERA INC (CUTR): Free Stock Analysis Report
CYNOSURE INC-A (CYNO): Free Stock Analysis Report
SYNERON MED LTD (ELOS): Free Stock Analysis Report
PALOMAR MED TEC (PMTI): Free Stock Analysis Report
Zacks Investment Research
Syneron Medical Ltd. - Ordinary Shares (NASDAQ:ELOS)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Syneron Medical Ltd. - Ordinary Shares (NASDAQ:ELOS)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024