Monday, November 15, 2021 7:06:45 AM
slides 20-27 are impressive: "Where the iTBra is launching globally in 2018," "500,000 anticipated orders," and "4,000,000 units /month manufacturing capacity by end of 2018...."
Unfortunately, that was all BS:
* Where it actually launched: nowhere.
* actual orders: Did they get orders? not in China, the first country in which they promised to launch, because it was never cleared by the CFDA.
* actual units/month manufacturing capacity: who knows. They made a few SOMEWHERE.
Benardis and Royea pitched a good pump back in 2017-2018. They got $3.8M seed money for Cyrcadia-Asia in 2018 (from FlyTek), but they burned that up in a couple of years, and it doesn't look like they accomplished much with it. They paid some designers to mock up screens for the phone app (slide 40) and made this PP presentation and travelled around the world with this pitch, and Royea CLAIMS they are conducting clinicals in Asia, but I don't see concrete proof of any clinicals in Asia and I don't see an actual phone app anywhere -- the clinical trials in the USA use a hard-wired recording device instead of a phone.
And the Cyrcadia website reveals that the clinical trial in El Camino has other problems:
http://cyrcadiahealth.com/core-technology/
* Only 66 of 173 patients enrolled... after six years.
* of those 66 patients enrolled, only 47 patients had "valid data recordings." huh?
* They call it a "pilot study." Even if they finished, the FDA wouldn't accept a pilot study as proof of efficacy.
Will Cyrcadia ever finish the clinical trial in El Camino? Not unless they PAY participants. The assumption that women would participate for free was ignorant. Slide 18 shows the BACK of the device (which they have never shown anywhere else). It looks even less comfortable from the back. Imagine putting that plastic thing into a bra and wearing it. If it ever got to market, it would probably be more comfortable than a mammogram, but in an unpaid clinical trial?
Will the device ever get to market? Not unless Cyrcadia sells the tech to someone else who would run a REAL clinical trial... in which case Cyrcadia and Cyrcadia-Asia disappear.
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