Canada OKs Cutera's GenesisPlus - Analyst Blog
23 7월 2011 - 2:16AM
Zacks
Medical devices maker Cutera Inc (CUTR) 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), 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
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