FDA Agrees to UltraShape 510(k) Pathway

June 8, 2010

YOKNEAM, Israel, June 8, 2010 /PRNewswire-FirstCall/ –

– Expected to Shorten FDA Clearance Process

UltraShape Ltd. announced today that the US Food and Drug Administration
advised the company that it may submit a request for clearance of its Contour
I system under the 510(k) regulation rather than as a Pre-Market Approval
(PMA) as was previously advised.

Proceeding under the 510(k) pathway is expected to simplify and shorten
the submission process to the FDA for clearance to sell the Company’s Contour
I system in the United States.

UltraShape CEO, Assaf Eyal, said “The United States is the largest and
most important market in the world, and represents a huge opportunity for our
products. Submission for FDA market clearance under the 510(k) regulation is
a major milestone for UltraShape. The recent launch of our new third
generation product, together with our efforts to gain regulatory approval in
the United States and China, provide us with a major growth opportunity.”

Currently, the Contour I system is marketed in more than 50 countries in
Europe, South America, Asia and North America, including Canada and Mexico.
Since introduction of the company’s products in 2005, more than 175,000
patient treatments have been performed worldwide.

About UltraShape

UltraShape redefines aesthetic medicine by developing, manufacturing and
marketing innovative non-invasive technologies for fat reduction and body
contouring. The company provides clinically proven safe and effective
solutions that enhance the lives of patients. UltraShape’s proprietary
technology uses focused ultrasound that targets and selectively disrupts fat
cells without affecting surrounding structures. Founded in 2000, UltraShape
has sold Contour I devices worldwide, demonstrating safety and efficacy of
its novel technology.

The Contour I system has not been approved for sale in the United States.

Contour I is a trademark and UltraShape(R) is a registered trademark of
UltraShape Ltd.

UltraShape Ltd. is a unit of UltraShape Medical Ltd. (Tel Aviv: ULSP)


Forward-Looking Statements This press release contains forward-looking
statements which involve risks and uncertainties which may cause the actual
results and performance of the Company to be materially different from what
may be expressed or implied by such forward-looking statements. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. The Company undertakes
no obligation to release publicly any revisions to any forward-looking
statements or to report future events except as required by law.

    Inbar Elfasy-Poran
    UltraShape Ltd.
    +972-4-909 4045


SOURCE UltraShape Ltd

Source: newswire

comments powered by Disqus