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:

2009: $0
2008: $0
2007: $12k
2006: $40k
2005: $171k
Total: $223k

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.

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