Tag Archives: Aki Backman

Don’t use HumanCharger for Seasonal Affective Disorder: Valkee fools the FDA

As reported earlier on earlightswindle.com, the U.S. Food and Drug Administration has refused the import of Valkee’s HumanCharger earlight headset into the States, when it was misbranded as a therapy device. But now Valkee Ltd actually did a rererere-launch of their hokuspokus in Canada and the US. How is this possible?

Valkee’s resellers explain on amazon.com, how Valkee circumvents FDA requirements.
Hold on to your seats!

“Doesn’t this need FDA approval?”

valkee-fuck-fda

“Only if advertised for use in Seasonal Affective Disorder. The product is advertised for Winter Blues”

It can not make any effectiveness claims, it gets no FDA approval – but it works “for winter blues”? That’s a synonym.

The USA is a known minefield for health fraud businesses like Valkee’s, because of class action suits. Power Balance, the magnetic wrist band sellers, had to return most of their shady businesses’ profits, because they made false health claims.

Valkee really doesn’t know better than to fool around with U.S. legislation. On the other hand, there is nothing to regain from Valkee, as the Company has no assets. They didn’t make even profits.

Congratulations to Merieux Developpement, TEKES and SITRA for making these shameful maneuvres possible. This is what sustainable businesses look like (in Finland)!

Valkee Ltd to go belly-up: The 2016 balance

Traditionally, earlightswindle.com makes Valkee’s balance sheets publicly available. Here is it for the fiscal year 3/2015 – 2/2016:

Valkee balance 2016

Revenue is down to 426.000 Euro from 645.000, again -35%. That’s directly continuing the long-time downward trend (2014: -44%, 2015: -40%).

Loss is also down, to “only” 1,646 million. Now the equity ratio (omavaraisuusaste) fell sharply, own capital is now negative (-1,049 million). In other words, there’s nothing left than debt. Banks and investors will not recover what they gave.

Last year, there was still some money left from the 7,3M investment. That’s completely burned now, and an additional million evaporated. As last year, Valkee got an audit warning. Now plus a clear prognosis, that the company will run out of capital during the next 12 months – cease to exist – if no new cash is found from some easy-to-fool investor. Or the americans buy millions of HumanChargers.

Update:
The snail media has reacted to this post: Kauppalehti 1 | Kauppalehti 2 | Talouselämä

Valkee’s CEO Aki Backman made absurd comments. Interestingly, he admitted that the earlight does “practically” not sell anymore in Finland. An open secret, now confirmed.

The 3rd Relaunch of the Valkee Scam: “SummerLight”!

With worldwide sales nearing zero, the finnish earlight maker Valkee Ltd undertakes the next (and probably last) “relaunch” of its 10 year-old scam. The product is now called SummerLight. The accompanying website summerlight.com is a shady copy of the previous humancharger.com fraud.

valkee-summerlight-therapy-deviceNo further comment needed.

Update: Valkee’s scam sites won’t open w/ earlightswindle.com referrers. They also block me on Twitter. OMG. OMG!!1!

New (not so) independent study: Valkee’s HumanCharger is a placebo (Update)

The finnish earlight maker Valkee Ltd is putting all-in on the american market after plunging sales in Europe. Its product, the premium-priced placebo HumanCharger, is sold with wonder claims online by Walmart and others:

Walmart as a co-scammer!

  • Keep in sync, all the time: regular exposure to light helps maintain the rhythm of our natural body clock, so with HumanCharger you always feel “in sync”
  • Better sleep, better health: HumanCharger reduces the need for excess sleep and reduces food cravings associated with jetlag, tiredness and low energy levels

At the same time, the second independent study about the device’s effects (or the lack thereof) is published. The result … is the same as in all other placebo-controlled tests.

Independent trial: Valkee is a sleep and mood placebo

It is concluded that transcranial bright light, at times where conventional light therapy has phase-advancing properties, did not influence any sleep parameters differently than placebo.

This is by no means surprising, as the first independent trial, published in November 2013, came to similar conclusions with a somewhat different methodology. Valkee’s HumanCharger has no effects on circadian rhythms. The new independent study is from the University of Bergen, Norway. With 50 participants, it was adequately powered to detect any effects consistent with Valkee claims.

The company has admitted, that their earlight doesn’t have any physiological effect comparable to standard light therapy. Their own data also show, that it does not influence Melatonin or Cortisol like real light therapy. Now we know, it doesn’t improve or at least change sleep in any way.

The HumanCharger does not influence the biological clock.
No “better sleep. better health – sync with the sun”. It’s all made up.

Ironically, Valkee Ltd is just touring the US with exactly these false claims. The company has been presenting on the Consumer Electronics Show CES2016 from Jan 6-9 in Las Vegas. It would be interesting to see the reactions of any resellers, when they realize that the HumanCharger again is scientifically demonstrated to be humbug.

 

Update 1: I got the study pdf. Cool, that was fast! Big thanks to J. – and to all the other nice readers whose support I am experiencing regularly.

Update 2: According to the small print in the full text, Valkee Ltd paid 12.000 Euros for this trial. That’s more than for the ice hockey trial a few years ago. But they did not get full control over the results and the publishing. Literally a bad investment. (16.1.2016)

U.S. FDA refused import of Valkee HumanCharger devices

Valkee Ltd now began the third launch of their product – the second relaunch of the LED headset – with its new target North America. But: How could the mighty U.S. Food and Drug Administration (FDA) allow such a scam device onto the market?

It turns out, they didn’t. The FDA had refused the Valkee “HumanCharger” import into the U.S.A. earlier this year. For a number of reasons, mainly misbranding.

fda-refusal

There are several ways to get “approved” by the FDA, depending on the classification. Valkee’s HumanCharger got no 510(k) clearance, and certainly not a Premarket Approval (PMA), for which one must present sufficient clinical trial data.

It is not listed as approved with the FDA (the listings here) in any possible way. [- If any reader has additional information, please let us know. -]

That, however, does not mean it is sold illegally. Many light therapy devices, for example such for cosmetic uses, are exempt from FDA regulation. Then they can’t make relevant medical claims. That’s exactly what Valkee Ltd demonstrates: The device is sold as a lifestyle – weight loss aid – sleep promoter – energy booster. Just typical scam claims. It may work on tech people who are prone to fall for such innovations.

as jet-lag cure ...

Valkee does not need any research staff for this strategy, the marketing trial being published. So the company fired its Research Manager Heidi Jurvelin, the Research and Science Liaison Manager Melanie Rueger PhD, sales people, and replaced the CEO Pekka Somerto with Aki Backman. (Jurvelin and others now appear at Valkee’s sister project JouZen Oy  aka OURA, fulfilling predictions by the social media influencer Vesa Linja-aho: Valkee scales down to a sales bureau, and JouZen takes over.)

The new course is set. Personally, I would miss this absurd tale when it came to an abrupt end, now as they finally seem to stop scamming of sick people and look for the too-healthy jet-set clients. However, it does not look good for Valkee Ltd. There are many wonder treatments for jet lag already.

 

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p.s. at least left Valkee

  • Heidi Jurvelin (to JouZen/Oura)
  • Melanie Rueger
  • Tuukka Josefsson
  • Tero Vallius (to JouZen/Oura)
  • Jonna Muurinen