FDA Agrees to UltraShape 510(k) Pathway
By Ultrashape Ltd, PRNETuesday, June 8, 2010
Expected to Shorten FDA Clearance Process
YOKNEAM, Israel, June 9, 2010 - 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)
www.ultrashape.com
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.
Contact: Inbar Elfasy-Poran UltraShape Ltd. +972-4-909-4045 inbar@ultrashape.com www.ultrashape.com
Contact: Inbar Elfasy-Poran, UltraShape Ltd., +972-4-909 4045, inbar at ultrashape.com
Tags: Israel, June 9, Ultrashape Ltd, Yokneam