Biomarker Envy IV: The Exmobaby

To what lengths would you go to keep your child healthy?  Organic, non-GMO baby food?  Hypoallergenic baby lotions and shampoos?  Bisphenol-free baby bottles?  How about a battery-powered biosensor garment that transmits ECG, skin temperature, and other biometric data about your baby wirelessly to your computer or via SMS message to your smartphone in real time?

Never fear, the Exmobaby is here.  Introduced late last year (and shown in the picture above—by the way, I don’t think that’s Jeff Daniels as a paid spokesman), the Exmobaby is a sleep garment designed for babies aged 0-12 months, which contains “embedded, non-contact sensors, a battery-powered Zigbee transmitter pod, a USB Zigbee receiver dongle that plugs into a Windows PC,” and all the necessary software.  Their slogan is “We Know How Your Baby Feels.”

It sounds like science fiction, but in reality it’s just a souped-up, high-tech version of a baby monitor.  But is it an improvement upon the audio- or video baby monitors currently available?  Exmovere certainly thinks so.  And, luckily for them, there’s no shortage of worried parents who are willing to pay for peace of mind (the device starts at $1000 and goes up to $2500, plus monthly data charges). [Note: please see addendum below.]

But while this might be an example of “a fool and his money being soon parted,” Exmovere makes some claims about the product that are highly questionable.  I first learned about the Exmobaby in a post on the KevinMD website, in which Exmovere’s CEO, David Bychkov, commented that “using Exmobaby to observe and record physiological data symptomatic of emotional changes can be useful… if you are a parent of a child with autism.”

In other words, this isn’t just a fancy monitoring device, this is a high-tech way of understanding your child’s thoughts and emotions—an “emotional umbilical cord between mother and child”—and, quite possibly, a way to diagnose a psychiatric, neurodevelopmental disorder in your newborn, all in the comfort of your own home.

I surfed over to the Exmobaby web site, whose home page shows a smiling, happy infant wearing these newfangled jammies.  Cute!  And the device (?) looks harmless enough.  But the FAQ page is where it gets interesting (or scary, depending on your position).  One question asks, “how is it possible to detect emotional states using Exmobaby?”  The response sounds like pure 21st century biobehavioral mumbo jumbo:

Detection of emotion involves software that compares heart rate, delta temperature and movement data (arousal) to heart rate variability and skin temperature (valence). These data, if tracked over time, enable a system to “guess” from a series of words that could be used to describe an emotional state: anger, fatigue, depression, joy, etc….In the case of babies, Exmovere is asking its users to try something new: name states. Exmobaby software will monitor trends in vital states. Parents will be asked to name states, such as “giggly” or “grumpy,” and the system can and will alert them when the underlying readings that match those states are detected. The idea is … to create a deeper level of communication between babies and their parents at the beginning of such a critical relationship.

In plain English: they’re asking parents to correlate data from the Exmobaby software (rather than their direct observations of the baby, which is how parents used to interact with their kids) with what they consider to be the baby’s emotional state.  Thus:  “My baby’s happy because the software says he is” rather than using old-fashioned signs—you know, like smiles and giggles.

The Exmovere website also includes an article, clearly written for parents, on “Exmobaby and Autism.”  Now, autism and “autism-spectrum disorders” (ASDs) are hot topics receiving a great deal of attention these days.  ASDs currently have an estimated prevalence of 1 in 110 (and rising rapidly), with an average age of diagnosis of approximately 4 years.  Nonetheless, parents of children with ASDs begin to identify concerns by the age of 12 to 18 months, and finding a “biomarker” to enable earlier diagnosis would allay the fears and insecurities of new parents.

But is Exmovere preying on precisely these fears and insecurities?  Well, let’s first ask: is it even reasonable to think about diagnosing ASDs before the age of 12 months (when the Exmobaby garment would be worn?).  A recent study showed that ASDs could be diagnosed as early as 14 months of age, based on social and communication development (but no biometric measures).  The American Association of Pediatrics recommends ASD screening (an interview with the parents and structured observation of the child) at ages 18 and 24 months, no earlier.  And a recent article in Pediatrics remarked that there are few measures sensitive and specific enough to detect ASD before 2 years of age (and, again, no “biological” measures to speak of).

The Exmobaby handout (which I’ve uploaded here), on the other hand, is a perfect example of a drug/device manufacturer capitalizing on the fears of parents by conflating statistics, commentary, and recommendations in a way that makes their device sound like a vital necessity for healthy infant development.  It’s deceptive marketing, pure and simple.

For example, it states “One of the ‘red flags’ in early diagnosis of ASDs is a lack of response from baby to the use of their name. Parents can potentially use Exmobaby to record times when baby’s name was said so that the reports will correlate any movement or vital sign response.”  Also, “specific tests can be designed in consultation with pediatricians to use Exmobaby to assist with diagnoses of ASDs and related developmental disorders.”  Never mind that there’s nothing in the literature correlating movement or vital-sign responses with diagnosing ASDs in this age group.

Conveniently, Exmovere also included its marketing strategy on its website (available here). It’s clear they’re planning to market Exmobaby as a garment (“a $5 billion per year worldwide market”) and not as a medical device.  That’s probably a good idea.  Or is it?  Bypassing medical professionals and tapping into a wide market of “worried well” might be good for business, but what about the “downstream” impact on our health care system?

So many questions.  But I’ll have to address them some other time, because I need to go make a sandwich.  I just got a text message telling me I’m hungry.

Addendum:  After posting this article, I received an email from Exmovere’s Investor Relations Advisor who pointed out that the $1000-$2500 prices I quoted above are for Evaluation Kits, specifically for distributors, researchers, and hospitals.  Exmobaby is not available for retail purchase at this time.  They anticipate a lower cost when the device/garment is sold directly to end users.

Advertisements

12 Responses to Biomarker Envy IV: The Exmobaby

  1. Jackie says:

    I just can’t get past the whole “baby/wet diaper/battery/radiation” combination long enough to think about ASD.

    And thanks for the Jeff Daniels info because I was actually pondering that very point.

  2. Marce says:

    Yah, good points. Someone at Healthdatapalooza last weektried to make claim that you could diagnose autism by taking a kid’s picture with cell phone so there’s a lot of misinformation going on.

  3. Rob Lindeman says:

    Why on earth would you actually look at your baby when you’ve got a device that can do it for you. I can’t see why a mother would have to give up Angry Birds for her child.

    Minor quibble – The first sign of autism is often the absence of the “social smile” that is supposed to appear around 8 weeks. When it doesn’t appear on time, some parents worry. I know I did (pediatrician with too much information in his head and not enough common sense).

    But to detect the social smile you’d actually have to look at the baby, so I guess that’s out.

    • stevebMD says:

      Rob,

      Thanks for your input. In the interest of full disclosure, I’m not a child psychiatrist and decidedly not an expert in autism (and, FWIW, don’t even have kids of my own), so it’s good to get your take.

      I don’t know how predictive the lack of “social smile” is, but if it appears at 8 weeks, it just reinforces the fact that the Exmobaby capitalizes on the insecurities and fears of new parents. If a well-meaning parent thinks something’s amiss in their 8-week-old infant, it seems to me the best response is to seek a professional evaluation (and maybe some reassurance) instead of dropping $2500 for a “biosensor garment” whose use has absolutely no scientific basis, no diagnostic value, and– as you point out– may damage the parent-child relationship even further.

      (Not to mention the worries about a wet diaper causing a short-circuit. Ouch.)

  4. Check Virginia SCC recent Actions Case Number SEC-2011-00018 : Exmovere Holdings Inc consent order dated 6/14/11.L whereby a temporary stop trade was placed against Exmovere by the Virginia State Corporation Commission

    It seems Bychkov is not only preying on fears of new parents but also on investors luring them into investing in violation of SEC regulations. Interesting.

    • stevebMD says:

      Interesting. Coincidentally enough, in my research to determine who is that man holding the baby (i.e., maybe it really is Jeff Daniels?), it appears to be Cheyenne Crow, COO of Exmovere. Which led me to these fascinating tidbits:

      Link Number One
      Link Number Two

    • Dale Allman says:

      This Virginia SCC Action (Case Number SEC-2011-0018) was NOT related to anything other than the company registering to market securities within the state. And, as I understand, the company and CEO entered into this agreement volutarily.

      Not sure where the second sentence comes from , but it seems a huge leap, based on the company’s products and concern for others.

  5. Dale Allman says:

    My comments on your post are as follows:

    For your paragraph:

    “It sounds like science fiction, but in reality it’s just a souped-up, high-tech version of a baby monitor. But is it an improvement upon the audio- or video baby monitors currently available? Exmovere certainly thinks so. And, luckily for them, there’s no shortage of worried parents who have a lot of money to burn (the device starts at $1000 and goes up to $2500, plus monthly data charges).”

    Comments: the Exmobaby garment with its biosensors and wireless communications do not require human intervention in dramatic contrast to “a baby monitor”. Traditional baby monitors are only as good as the parents or caregivers who are awake and using them. With the Exmobaby garment, the monitoring is continuous and the system will send alerts even if parents, grandparents or care providers are asleep. This is a clear advantage of the new technology and corrects one of the fallible parts of the baby monitors on the market today. Exmobaby is an innovative, truly new product, not a “souped-up” version of anything.

    And, for your paragraph:

    “In plain English: they’re asking parents to correlate data from the Exmobaby software (rather than their direct observations of the baby, which is how parents used to interact with their kids) with what they consider to be the baby’s emotional state. Thus: “My baby’s happy because the software says he is” rather than using old-fashioned signs—you know, like smiles and giggles.”

    1) You missed the point. Parents who buy and use one of the Exmobaby pajamas will be observing their infants (of course) while at the same time recording the mentioned “name states” only when they first have the baby wearing the product. But, they only have to do this once. And, these named states or records are input into the system only once. After that point, or when the system has record of a baby’s behaviors and how that matches with the named state (giggly, grumpy, crying, hungry, wet diaper, etc.), the system will produce reports and alerts on a continuous basis. Parents (or other care providers) will only interact with or put new information into the system at first, much like you have to input your contact information into a new iPhone or laptop computer. The record keeping at the beginning will not be a tedious process, nor will it take much time. It’s simply a necessary part of using the innovative new product.

    2) the system does all the correlating and reporting. Your statement that Exmovere is “asking parents to correlate data from the … software” could not be further from the truth. The products, software, and wireless communications are designed to process and report data, perform correlations and send alerts as needed. Thus, the system works without human intervention.

    3) the Exmobaby product is not designed to produce reports or alerts for parents when baby is acting “normally” (based on the parent’s first-time inputs and baby’s biophysical information), but rather to send alerts when baby is in trouble or needs attention. Traditional monitors and parent observation are not sensitive enough nor designed to pick up biophysical clues or cues that an infant is in trouble. Too often, it’s too late when someone notices. Exmobaby is a product that can provide alerts when needed in order to bring assistance when baby needs it.

    The American Association of Pediatrics recommends ASD screening (an interview with the parents and structured observation of the child) at ages 18 and 24 months, no earlier. And a recent article in Pediatrics remarked that there are few measures sensitive and specific enough to detect ASD before 2 years of age (and, again, no “biological” measures to speak of).

    and you also said “Never mind that there’s nothing in the literature correlating movement or vital-sign responses with diagnosing ASDs in this age group.”

    1) precisely because there have not been sensitive or specific measures up to this point, Exmobaby offers an opportunity to more fully explore those indicators (biophysical in particular) which are early warning signs of ASD.

    2) somebody has to be first. Exmobaby is leading the charge.

    You also stated:

    It’s deceptive marketing, pure and simple.

    1) You’ve reached this conclusion without a complete understanding of the facts and the rationale for the Exmobaby product. The reason the Exmobaby product “…sounds like a vital necessity for healthy infant development” is precisely the point. The product has enormous potential for assisting parents who worry about their babies. You have cast dispersions (seemingly at random throughout your article) on a product which can help parents with SIDs, autism, ASDs, and other general concerns (especially for first-time parents). It’s instructive to see in your comments that “I’m not a child psychiatrist and decidedly not an expert in autism (and, FWIW, don’t even have kids of my own)” … without kids of your own, or without being a child psychiatrist or an expert in autism, this reinforces the idea that you’ve reached this conclusion in error.

    2) Exmovere Holdings Inc. believes that pediatricians and qualified medical professionals are always the best judges of baby’s condition. Parents as well as these professionals, though, need more information. Exmobaby is designed to help gather and report much-needed information to help parents, doctors and ultimately infants gain a higher quality of life through additional knowledge and insights. Do you think that a series of reports from Exmobaby would make a pediatrician’s job easier? We do.

    Thank you for the notice and writeup of Exmobaby. I hope that with these few comments, your readers will better understand the product and its enormous potential to make a difference in people’s lives.

    Sincerely,
    Dale Allman
    Special Advisor for Investor Relations
    Exmovere Holdings, Inc.

    • Jackie says:

      Have you guys run this Exmobaby device past US Federal regulators? For example:

      If you are going to market it as “pajamas” or a “garment”, does it comply with the childrens’ sleepwear regulations, with it having a battery?

      If you are going to market it as something “which can help parents with SIDS, autism, ASDs”, does it comply with Federal regulations for medical devices?

      My personal view as a parent is that it would not be a good idea to hook a baby up to a device that has a battery and emits radiation. This month there was a big pronouncement that cell phones may be linked to brain cancer, because of radiation. Babies — whose brains are still growing — would be even more vulnerable.

      That’s why I ask, do you have the go-ahead from the Feds for this product and, if so, where can I read about that on your web-site?

  6. Sherman Harris says:

    PLEASE refer to this URL regarding Exmovere, David Bychkov, Cheyenne Crow, owners of the company:

    http://www.ripoffreport.com/Search/david-bychkov.aspx

    PLEASE refer to this URL

  7. S. Nelson says:

    Exmobaby is a scam, just like the Chariot, the Exmogate and that one medical clinic that Byschov had that failed. It’s said he tried to market female biofeedback by developing a device women were supposed to insert into their vaginas, he called it ‘pu*sy meditation’.

    Exmovere was forced to stop selling company stock (sold then for $7 to $10 and now worth less than $2.00 by the way) because a.) the stock was unregistered and b.) he and Cheyenne Crow sold stock to unqualified investors. Moreover, the SCC noticed a pattern of complaints from women (yes, women) who had invested their life savings and their 401-k plans into a ‘sure-fire return’. This after Cheyenne Crow, the former COO who fled the company after the feds started looking into things……

    Dale Allman will be legally held accountable for acting in concert with Byckov, who may be headed to federal prison for bilking targeted investors (Crow would have a ‘relationship’ with the women until they handed over their cash, then he vanished).

    This guy Bychkov, in my opinion is a crook. Of course that’s also the opinion of the Virginis SCC it seems. This Exmobaby is just another scam in a long line of scams that started with 1-900 JAckpot – which is now Exmovere.

  8. Tabatha says:

    Great post. I was checking constantly this blog and I’m impressed!
    Very useful info specifically the last part 🙂 I care for
    such information a lot. I was looking for this particular
    information for a long time. Thank you and best of luck.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: