What if you could somehow inject drugs without a needle? A company called Echo Therapeutics has been working on this very problem, and took a small step forward yesterday when it received comments from the FDA. It anticipates approval in time to launch its product, called "Prelude," later this year.
For the time being, Echo is focusing on the problem of speeding up the effects of Lidocaine, a common topical numbing agent. Echo claims to have demonstrated that its device drastically shortens the time it takes for topical 4% lidocaine cream to produce its numbing effects, from about an hour on untreated skin to just a few minutes on Prelude-treated skin.
The Prelude device sits on the skin, measuring the thickness of the dead skin layer (which might be as high as 25 microns, or as low as 10). Then the device engages, its tip spins, and shaves off the dead skin, explains Echo's CEO Patrick Mooney. The very moment it reaches live skin, it stops. "You sit a couple of microns away from blood vessels" at that point, he tells Fast Company. "Now you can deliver drugs."
One reason why ultimate FDA approval of this device seems likely is that it already approved an earlier version, Soniprep, back in 1994, following its invention by MIT's Robert Langer. But Echo doesn't market Soniprep anymore; Mooney likens it to one of those briefcase-sized cell phones from circa 1991, compared with the Prelude. Another reason Mooney is more excited about this version of the device is that he's settled on a more profitable business model--one where he gives the device away basically at cost, then reaps profits by supplying disposable tips. "The razor blade business model is a much better business model," he says. "The potential theoretical market opportunity is multiple billions of dollars. There were 1.3 million botox injections last year"--a procedure that could be made less painful with the use of the Prelude and lidocaine. Echo has a corporate partner in the Michigan-based Ferndale Pharma Group, which makes the lidocaine cream. Ferndale will sell the device for Echo, bundled with its own 4% lidocaine cream.
Of course, once you open up a portal to the capillaries, you potentially open a two-way street. Not only could the device enable drug delivery, it could also enable the extraction of information. To that end, Echo has also developed something it's calling "Symphony." (Notice a pattern? That beautiful dead-skin-shaving process is just like a "prelude" to a symphony, don't you think?) Once the dead skin is removed, Symphony can track glucose levels in diabetes patients via a remote monitoring system, and can warn of the onset of hypo- or hyperglycemia.
That whole getting-things-in-and-out-of-the-body thing has traditionally been one of the more unpleasant parts of medicine; with a painless new portal, Echo does seem to be onto a good idea here. When Fast Company recently spoke to Mooney, he was "cautiously optimistic" about FDA approval; the recent milestone reached only reinforces that optimism, and he thinks that Echo should finally be bringing in revenue soon.
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