Delay in FDA approval has delayed the company’s plan for a Nasdaq IPO.
UltraShape Ltd. has obtained Canadian approval for its flagship ultrasound Contour 1 system for non-invasive fat emulsification. Canada is the 46th country to approve the product. The company also signed an exclusive distribution agreement for the system in Canada with Coherent-AMT Inc.
The approval by Canada’s Ministry of Health is a step forward in UltraShape’s goal of obtaining US Food and Drug Administration (FDA) marketing approval. FDA approval is the most difficult to obtain because it examines both the safety and effectiveness of medical devices in comparison with existing products. For innovative devices, the FDA also demands complex clinical trials.
Delay in FDA approval has also delayed UltraShape’s plan for a Nasdaq IPO.
Published by Globes [online], Israel business news - www.globes.co.il - on May 6, 2007
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