Here’s a link to the original 510(k) letter from the FDA to Sontra (nka Echo) from August, 2004: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040525.pdf
The device, at the time called SonoPrep is intended to be used with 4% lidocaine.
Based on the author’s review of SONT/ECTE’s filings, this device, which has been cleared for sale since 2004 generated the following revenues for ECTE:
This technology has generated, life to date, $223,000.00. The idea that the same technology, for the same application, under a new name, “Prelude” as opposed to “SonoPrep” will be any more successful is absurd. That is not an idea I would be buying.