Echo Therapeutics (@echotx) had initially anticipated receiving FDA 510k approval for its Prelude SkinPrep System over a year ago, confidently projecting tens of millions in revenue by the end of 2012, all to the delight of nearly every Wall Street analyst covering the company.
Yet here we are at the end of the first quarter of 2012 and not only does the company have yet to receive FDA approval, they can no longer be sure the product will ever receive regulatory approval and have already started hyping their next product in the pipeline, the Symphony tCGM System, in an attempt to change the story from one of failure to one of a promising future.
Last month the company announced it suffered a $16.7 million loss in 2011, which follows a $4.3 million loss in 2010. Echo had hoped to get its Prelude Skin Prep System on the market by Q3 2011, but the FDA has formally referred the product to the DHHS Combination Products Department, which has indefinitely delayed the products launch in the US.
The company has now focused on getting regulatory approval for Prelude in the EU.
See Echo’s SEC filing.