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STAT Tracks Drops in Blood Flow to the Head

Designed for POTS, Dysautonomia, Orthostatic Intolerance, Long Covid, ME/CFS and more.

The STAT program is an in-ear wearable paired with a companion app to help you self-manage chronic symptoms like dizziness, fatigue, brain fog, palpitations, and lightheadedness.

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Who We Are

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It's NotJust In Your Head

Turns out, it is in your head - literally. Poor blood flow to the head is the dominant cause of many chronic symptoms such as dizziness, brain fog, headaches, fatigue, and more.

Doctors at Johns Hopkins, Brigham and Women’s, and Harvard Medical School have demonstrated using ultrasound that illnesses like Dysautonomia, POTS, ME/CFS, Long COVID, and Orthostatic Intolerance suffer from reduced blood flow to the brain upon standing.

MeetSTAT

STAT is an in-ear wearable and paired mobile app that tracks flow to your head to help you better self-manage chronic orthostatic symptoms

24/7 Wearability

STAT co-exists with over 90% of devices that go in/around your ear, can be worn during sleep, and is solar charged. Some may never have to take it out - STAT is truly “Set and Forget."

How does it work?

STAT taps into a shallow ear artery. Measures flow changes in the External Carotid Artery, which is a proxy for “Cerebral Blood Flow.” We don’t measure true “Cerebral Blood Flow” but we measure a proprietary STAT Flow Index, which we’ve demonstrated to correlate with CBF changes caused by standing. NOTE: Since STAT’s Flow Index doesn’t measure Cerebral Blood Flow directly but has only been verified, it’s possible that other daily activities

The Fitting Process

If our scanning app deems your ear incompatible with our current custom-fitting capabilities, we will issue you a full refund.

Track Drops in Blood Flow to Head with STAT

An in-ear wearable and paired mobile app that tracks flow to your head to help you better self-manage chronic symptoms

In people with POTS, Dysautonomia, Long COVID, and ME/CFS, blood flow to the head drops during standing. This causes many symptoms such as dizziness, brain fog, fatigue, fainting, and much more.

These drops have not been possible to track, outside of a few select laboratories. Until now.

STAT is a discreet in-ear wearable and paired mobile app that tracks drops in blood flow to your head to help you better self-manage chronic symptoms. Our proprietary Flow Index has been shown to correlate with Cerebral Blood Flow changes induced by standing.

STAT learns what signals from your body are normal for you, and highlights when there are deviations from your normal. This empowers you to take preemptive actions such as staying on top of your fluids, electrolytes, compression, or just taking it easy.

STAT cannot yet be used to diagnose if your blood flow is objectively normal or abnormal. STAT is instead focused on helping you understand your unique body so you can better self-manage your symptoms.

How It Works

STAT monitors a shallow ear artery, which is a biometric gold mine. STAT uses this ideal window into the brain and heart to empower people to preempt chronic symptoms before they happen. STAT is to Dysautonomia and Orthostatic Intolerance what Continuous Glucose Monitors are to Diabetes.

STAT uses infrared light to measure blood volume changes, similar to how other wearables work. But unlike other wrist-worn wearables that only reach shallow capillaries containing limited cardiac information, STAT aims directly at a shallow arterial branch in your head. This results in unprecedented cardiac signal quality for a non-invasive wearable. This high-quality signal is the secret sauce that enables STAT’s Flow Index and Pressure Index, which are proxies for relative changes in Cerebral Blood Flow and Blood Pressure. See How It Works for more details on the Flow Index and Pressure Index.

*Note how STAT signal during normal flow shows a “full” pulse whereas low flow shows a “spurty” pulse.

Keeps Track of Your Every Stand

Traditional wearables cannot accurately track standing because the motion and orientation of your wrist or finger does not tell you much about your body position. However, STAT is located on the head, which is tightly coupled to the spine and experiences the largest vertical changes upon standing. By using an accelerometer, precision altimeter, and machine learning, STAT tracks exactly when you stand, how long you remain standing, and when you sit/lay back down. This is key to creating a useful orthostatic self-management tool.

Left: STAT CEO’s Intraday Heart Rate (peach curve) and Pressure Trend (blue curve) on April 7, 2023. Right: STAT CEO body’s response to a single stand from 2:17pm-2:22pm on April 7, 2023

Easy to Understand Scores

STAT is constantly at work in the background capturing all of these advanced signals, vigilantly tracking your body’s response to every stand. That’s a lot of data to make sense of, so STAT distills it all down into two easy-to-understand scores: a “Flow Score” and an “Up Score.”

The Flow Score, which monitors your Flow Index, Pressure Index, and Heart Rate in different positions (standing, sitting, and laying), adapts to your unique "normal" over time. By learning your daily symptoms and fluctuations, STAT fine-tunes the Flow Score to match both your good and bad days. For instance, if you have POTS, STAT may identify that higher standing heart rates indicate bad days and lower standing heart rates signify good ones. By inputting your daily symptom scores, STAT personalizes your Flow Score to best reflect your experience.

Once trained, the Flow Score can become a predictive tool, detecting deviations from your personal baseline, enabling you to preempt worsening symptoms. While we've collected promising early at-home data demonstrating this analytical approach, ongoing validation with a diverse group of 500 "Beta Customers" will confirm the generalizability of this approach across various forms of orthostatic intolerance.

The Up Score keeps track of how much time you spend upright, whether sitting, standing, or walking/running. Time spent upright is a useful marker of orthostatic intolerance symptom burden, and thus we believe a helpful way to track your self-management.

Currently, we assign Up Score points based on your upright time (0.5 for 1 minute upright, 1 for 1 minute standing, and 3 for 1 minute of walking/running), but acknowledge that this scoring system may evolve as we continue to gather feedback from users and physicians.

For many with these conditions, it’s hard to figure out how hard you should push yourself to be upright. In general, to improve orthostatic tolerance, you must give your body practice fighting gravity. However, for some people too much up time is over-exertion that triggers Post-Exertional Malaise, while others may benefit from gradual reconditioning. By combining the Up Score with the Flow Score, STAT aims to help you learn how much is too much for you so you can properly pace yourself in your personal journey.

Daily Journal Powered Insights

The Daily Journal allows you to log symptoms as well as various interventions, medications, etc. that you’re doing. This lets you do an A/B self-test to see how your symptom scores and objective biometrics look on the days you do something vs the days that you don’t. This lets you better understand with objective data if what you’re doing is actually helping.

In addition to the insights generated from your manually recorded daily journal items, STAT will generate insights from automatically recorded data as well. For example, on the days you score a significantly higher Up Score than normal, does your body respond negatively or positively in subsequent days? Or how sensitive are you to environmental factors such as temperature, barometric pressure, and humidity?

Blends Seamlessly Into Your Day

STAT can be worn simultaneously with all your regular daily wear, whether Airpods, hearing aids, headphones, glasses, masks, and more. STAT co-exists with over 90% of devices that go in/around your ear.

STAT can also be worn throughout all your regular daily activities, whether sleeping, exercising, or showering.

How Charging Works

STAT is charged by bright light, such as sunlight, using a micro solar panel. It can charge in your ear while you are outside, but you can also leave it on a windowsill to charge faster - you don't have to bring a wall charger with you everywhere you go! We also offer a magnifying carry case to charge on-the-go faster as well as a Base Station to charge on your nightstand. The charge will last for up to 3-4 days assuming zero solar charging occurs.

Custom Fitting Process

Ear shapes are extremely diverse, and the upper nook that STAT sits in has many different geometries that make finding a 24/7 comfortable and stable fit a unique challenge. Ears are not one-size-fits-all. In fact, STAT needs about 20 different sizes of silicone adapters in order to fit most ears.

To match the right silicone adapter to your ear, we have you conduct a 3D scan of your ear using your iPhone. You can conduct the scan yourself, or have someone else do it for you. See scanning process below:

After completing and uploading your scan, STAT team members test different silicone adapters in virtual 3d space to see which will fit your ear best. After selecting the right size, we assemble your custom earpiece along with a couple extra silicone adapters for you to make minor tweaks on your own!

There are some ears that no STAT silicone adapter is compatible with, but we believe this should be much less than 10% of ears. If we find that your ear is incompatible during the virtual fitting process, we will refund you the full amount without charging the custom fitting fee. This fitting process is dynamic - it may change over time and look different for different people.

Validation

Johns Hopkins tested STAT during routine Tilt Table Testing. During this study, STAT detected drops in Flow minutes before fainting occurred, capturing continuous data throughout, even when the Blood Pressure cuff failed to capture readings. These findings were published in JACC: Electrophysiology.

Duke also tested STAT during Tilt Table Testing, but with simultaneous Trascranial Doppler Ultrasound and Continuous Blood Pressure. Dr Fudim, the Duke cardiologist conducting the study, shared preliminary data at the 2023 Dysautonomia International conference. A publication is still in progress, but you can see the pre-published data in the DI Conference Research Update as well as the August 2023 SolveME Research Update delivered by STAT's CEO.

Much more validation is continuing to be conducted, with publications in the works. See Science for more details.

JACC Publication reporting STAT usage in Johns Hopkins Tilt Table Testing

View Publication

STAT and Duke Research Update at Dysautonomia International

View Update

STAT Research Update at Solve ME

View Update

Pricing

Only STAT can track blood flow drops to the head — no other wearable compares! The signals STAT analyzes are complex and require many levels of sophisticated post-processing in order to interpret. This new breakthrough will require big investment to advance its full potential to help people. The STAT program needs significant support — not just the processing of data in every moment, but hardware and software updates, low-cost device replacements for lost or damaged hardware, ongoing clinical studies, etc.

 We are working toward status as a medical device with FDA approval, covered by insurance. But, as this can take years, we are launching the STAT Program direct to you with the lowest pricing we can safely offer at this time.

The STAT program, similar to Continuous Glucose Monitoring, is composed of the in-ear device itself, and membership. The device is $349 ($100 of which is a non-refundable custom-fitting fee) and the membership is planned to be between $13.99 to $19.99 a month, depending on membership length.

For individuals backing our Crowdfunding campaign, you will receive special membership offers, as well as an ability to buy longer term memberships at never-again crowdfunding prices. In exchange for your early support, you will be offered the best deal possible.

All that said, we know these syndromes have caused significant financial hardship, and that hundreds of dollars out of pocket is not realistic for 30-40% of those we want to help. This is why we are setting consumer pricing as low as we safely can, facilitating “Gift-a-STAT” for people with low-income, and are actively pursuing insurance-reimbursement pathways so that STAT can be accessible to everyone who needs it. For more details on how to apply for Financial Assistance, sign up for program notifications here.

Known Limitations

  • STAT cannot fit all ears. During the virtual fitting process, if we find that your ear is not a fit, you will be automatically refunded in full without being charged the custom fitting fee.
  • STAT’s Flow Index does NOT measure Cerebral Blood Flow / Blood Flow to Brain, but measures flow to the ear and face. The “Internal Carotid Artery” is the main source of blood flow to the brain, whereas the “External Carotid Artery” is the source of blood flow to the ear which is what STAT uses. It is already known that External Carotid Artery flow can deviate significantly from Internal Carotid Artery flow in some situations (e.g. during hyperventilation). However, during orthostatics, we have demonstrated that both the Internal and External Carotid Arteries have a similar drop in flow which is what STAT is primarily focused on. All that to say, STAT’s Flow Index cannot be used interchangeably with Cerebral Blood Flow or Blood Flow to the Brain.
  • Not all symptoms are caused by drops in blood flow to the head. STAT is intended for use in individuals who have been diagnosed with conditions known to suffer from drops in blood flow to the head, such as Dysautonomia, POTS, OH, Long COVID, and ME/CFS. This is why we are asking screening questions during the ordering process, to help qualify that everyone who orders STAT will be a good candidate to bnefit from tracking blood flow to head. It is possible that someone might have similar symptoms without a drop in blood flow to the head - in this case, STAT may not be able to detect anomalies that correlate with your subjective symptom scores.
  • Intermittent monitoring may miss events. Part of how STAT achieves such a long battery life despite the tiny battery is by prioritizing measuring when it matters with smart intermittent monitoring. STAT takes a reading once every 10 minutes, as well up to 5 continuous minutes after it detects you have stood up. This means that events that occur after 5 minutes of standing or between the 10 minute intermittent checks would not be captured. We plan to add a feature to allow users to trigger extended monitoring, such as double-tapping to initiate a 10 minute monitoring session, but this feature may not be immediately accessible.
  • Will not be a real-time fainting prevention tool. Due to the device's intermittent monitoring, STAT cannot be a reliable real-time fainting prediction tool in the near term. This is in spite of promising initial findings from Johns Hopkins. Real-time faint prediction will likely be part of a future regulated medical device product. However, STAT's Flow Score may be helpful for helping you understand when you may be at greater risk that might be worth taking extra steps of precaution.

Setting Expectations

  • Crowdfunding is Not a Normal Product Purchase. Crowdfunding is supporting a vision for a product that you believe should exist, and being on the ground floor of helping shape that vision into reality so it can one day become an accessible product that helps many people. You should not back a crowdfunding campaign with a normal consumer mentality - this is not buying a mature off-the-shelf product. Crowdfunding requires an eagerness to join the journey of a new product getting to market, excitement when you see your feedback materially change/evolve the product, and patience to wait 6-12 months before delivery. Crowdfunding is not for everybody, but it’s a stepping stone to get STAT to a place that STAT can be for everybody. That said, unlike other crowdfunding campaigns, STAT’s development is separately funded by professional investors so we can guarantee delivery of STAT or your money back.
  • Features Could Change: Part of the beauty of crowdfunding is the ability for backers to provide feedback and materially change the product/features along the way, with an unusually deep relationship between creators and backers. However, this means that what is initially represented in this campaign may change as we continue to learn from our backers which features we should add, which features are working, which features are not working, etc. While backer feedback should improve the product/features overall, it’s possible that features you personally want are changed, de-prioritized, or even removed as we navigate the highly heterogeneous nature of these conditions. If changes happen that make STAT no longer interesting to you, you always have the option to get a refund before shipment, and during the 30 day return window after shipment - we will keep your money untouched in a separate bank account until that point.
  • The Beta Period Could Take Longer than Projected: The estimated shipment timelines assume a 3-6 month Beta Period to refine the product (April-October). However, if the product needs more time to mature in Beta before shipping to later customer groups, shipment timelines may be adjusted. We don’t want to begin our post-Beta backers’ membership timers until we are confident that the product experience has sufficiently matured. If the shipment timeline becomes longer than you are comfortable with, you are again welcome to get a refund.

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FAQ

Who exactly is this product for?

STAT is designed for people within the Dysautonomia (POTS, ME/CFS, Orthostatic Intolerance, etc.) community. However, we know there are many other populations who could benefit from STAT. If you're interested in STAT but not because of standing induced symptoms, please go through "Reserve Launch Invite" and let us know why in the short survey. This will help us prioritize where to help next!

Is STAT a medical device? Do I need a prescription to use it?

STAT is a low-risk general wellness product, as defined by the FDA’s “General Wellness” guidelines, that may help you live well with orthostatic intolerance. You do not need a prescription to use STAT.

How is this different from a heart rate monitor?

Part of being a 24/7 wearable product is to co-exist simultaneously with the many other devices that go in your ear. So we specifically designed STAT to be in a part of the ear such that it can be worn simultaneously with 90%+ of earbuds, 90%+ of hearing aids, glasses, masks, etc. STAT is designed to be a truly “set and forget” wearable.

I already know I have these symptoms. How can STAT help me?

STAT is charged by bright light, such as sunlight, using a micro solar panel. It can charge in your ear while you are outside, but you can also leave it on a windowsill to charge faster - you don't have to bring a wall charger with you everywhere you go! We also offer a magnifying carry case to charge on-the-go faster as well as a Base Station to charge on your nightstand. The charge will last for up to 3-4 days assuming zero solar charging occurs.

What mobile devices will the STAT app be compatible with?

STAT is compatible with iPhone devices (minimum iOS v11.0). It is not yet compatible with Android devices.

Why is STAT designed for the ear and not the wrist like most wearable devices?

The wrist has inherent limitations as a monitoring site, from the limited cardiac signal available, to the significant noise artifacts masking what is available. In comparison, the ear has a stronger cardiac signal, so the wearable cardiac information available is unparalleled. Additionally, the ear is relatively mechanically decoupled from daily activities (e.g. think how many times a day you move your arm to type, text, etc. compared to how many times you move your ear), so there is a greater continuity of high-quality data available during your daily life.

When will this be available outside of the US?

STAT is launching a 30-day crowdfunding campaign on October 19, 2023, during which you can place pre-orders. STAT will eventually charge a $349 Initiation Fee and a $13.99-$19.99 per month Membership Fee, depending on the length of membership. However, we will offer crowdfunding specials during the 30-day campaign.

The Initiation Fee includes a custom-fitted STAT earpiece and a Base Station. Membership Fee includes a lifetime warranty, free upgrades to the latest STAT hardware if at least 6 months of membership remain, subsidized earpiece replacements if lost, as well as access to the STAT app which includes personalized insights, built-in coaching, short/long term trend analysis, A/B self-test capabilities, and continuous software feature updates.

Has this technology been tested by doctors?

STAT was tested at Johns Hopkins during tilt table testing, and was able to detect fainting episodes before they happened, which a BP cuff was unable to do. This was published in JACC: Electrophysiology. A follow-up tilt table test comparing STAT against Transcranial doppler (TCD) Ultrasound and beat-to-beat Blood Pressure (BP) monitoring at Duke University is complete and undergoing data analysis.

Track Drops in Blood Flow to Head with STAT

An in-ear wearable and paired mobile app that tracks blood flow to your head to help you better self-manage chronic symptoms

In people with POTS, Dysautonomia, Long COVID, and ME/CFS, blood flow to the head drops during standing. This causes many symptoms such as dizziness, brain fog, fatigue, fainting, and much more.

These drops have not been possible to track, outside of a few select laboratories. Until now.

The STAT program combines a discreet in-ear wearable and paired mobile app that tracks drops in blood flow to your head to help you better self-manage chronic symptoms. Our proprietary Flow Index has been shown to correlate with Cerebral Blood Flow changes induced by standing.

STAT learns what signals from your body are normal for you, and highlights when there are deviations from your normal. This empowers you to take preemptive actions such as staying on top of your prescribed medications, fluids, electrolytes, compression, or just taking it easy.

STAT cannot yet be used to diagnose if your blood flow is objectively normal or abnormal. Instead, STAT focuses on helping you understand your unique body so you can better self-manage your symptoms.

How It Works

STAT monitors a shallow ear artery, which is a biometric gold mine. STAT uses this ideal window into the brain and heart to empower people to preempt chronic symptoms before they happen. STAT is to Dysautonomia and Orthostatic Intolerance what Continuous Glucose Monitors are to Diabetes.

STAT uses infrared light to measure blood volume changes, similar to how other wearables work. But unlike other wrist-worn wearables that only reach shallow capillaries containing limited cardiac information, STAT aims directly at a shallow arterial branch in your head. This results in unprecedented cardiac signal quality for a non-invasive wearable. This high-quality signal is the secret sauce that enables STAT’s Flow Index and Pressure Index, which are proxies for relative changes in Cerebral Blood Flow and Blood Pressure. See How It Works for more details on the Flow Index and Pressure Index.

*Note how STAT signal during normal flow shows a “full” pulse whereas low flow shows a “spurty” pulse.

Keeps Track of Your Every Stand

Traditional wearables cannot accurately track standing because the motion and orientation of your wrist or finger do not tell you much about your body position. However, STAT is on the head, which is tightly coupled to the spine and experiences the largest vertical changes upon standing. By using an accelerometer, pressure sensor, and machine learning, STAT tracks exactly when you stand, how long you remain standing, and when you sit/lay back down. This is key to creating a useful orthostatic self-management tool.

Left: STAT CEO’s Intraday Heart Rate (peach curve) and Pressure Trend (blue curve) on April 7, 2023. Right: STAT CEO body’s response to a single stand from 2:17pm-2:22pm on April 7, 2023

Easy to Understand Scores

STAT is constantly at work in the background capturing all of these advanced signals, vigilantly tracking your body’s response to every stand. That’s a lot of data to make sense of, so STAT distills it all down into two easy-to-understand scores: a “Flow Score” and an “Up Score.”

The Flow Score, which monitors your Flow Index, Pressure Index, and Heart Rate in different positions (standing, sitting, and laying), adapts to your unique "normal" over time. By learning your daily symptoms and fluctuations, STAT fine-tunes the Flow Score to match both your good and bad days. For instance, if you have POTS, STAT may identify that higher standing heart rates indicate bad days and lower standing heart rates signify good ones. By inputting your daily symptom scores, STAT personalizes your Flow Score to best reflect your experience.

Once trained, the Flow Score can become a predictive tool, detecting deviations from your personal baseline, enabling you to preempt worsening symptoms. While we've collected promising early data demonstrating this approach, ongoing validation with a diverse group of 500 "Beta Customers" will confirm this approach works across various forms of orthostatic intolerance.

The Up Score keeps track of how much time you spend upright, whether sitting, standing, or walking/running. Time spent upright is a useful marker of orthostatic symptom burden, and thus we believe a helpful way to track your self-management.

Currently, we assign Up Score points based on your seated upright time (0.5 for 1 minute upright, 1 for 1 minute standing, and 3 for 1 minute of walking/running), but acknowledge that this scoring system may evolve as we continue to gather feedback from users and physicians.

For many with these conditions, it’s hard to figure out how hard you should push yourself to be upright. For some people, too much up time is over-exertion that triggers Post-Exertional Malaise, while others may benefit from gradual reconditioning. By combining the Up Score with the Flow Score, STAT aims to help you learn how much is too much for you so you can properly pace yourself in your personal journey.

Daily Journal Powered Insights

The Daily Journal allows you to log symptoms as well as various interventions, medications, etc. that you’re doing. This lets you see how your symptom scores and objective biometrics look on the days you do something vs the days that you don’t. This lets you better understand if what you’re doing is actually helping.

In addition to the insights generated from your manually recorded daily journal items, STAT will generate insights from automatically recorded data as well. For example, on the days you score a significantly higher Up Score than normal, does your body respond negatively or positively in subsequent days? Or how sensitive are you to environmental factors such as temperature, barometric pressure, and humidity?

Blends Seamlessly Into Your Day

STAT can be worn simultaneously with all your regular daily wear, whether Airpods, hearing aids, headphones, glasses, masks, and more. STAT co-exists with over 90% of devices that go in/around your ear.

STAT can also be worn throughout all your regular daily activities, whether sleeping, exercising, or showering.

How Charging Works

STAT is charged by bright light, such as sunlight, using a micro solar panel. It can charge in your ear while you are outside, but you can also leave it on a windowsill to charge faster - you don't have to bring a wall charger with you everywhere you go! We also offer an add-on carry case to charge on-the-go faster as well as a Base Station to charge on your nightstand. The charge will last for up to 3-4 days assuming zero solar charging occurs.

Custom Fitting Process

Ear shapes are extremely diverse, and the upper nook that STAT sits in has many different geometries that make finding a 24/7 comfortable and stable fit a unique challenge. Ears are not one-size-fits-all. In fact, STAT needs about 20 different sizes of silicone adapters in order to fit most ears.

To match the right silicone adapter to your ear, we have you conduct a 3D scan of your ear using your iPhone. You can conduct the scan yourself, or have someone else do it for you. See scanning process below:

After completing and uploading your 3D scan, STAT team members virtually test different silicone adapters to see which will fit your ear best. After selecting the right size, we assemble your custom earpiece along with a couple extra silicone adapters for you to make minor tweaks on your own!

There are some ears that no STAT silicone adapter is compatible with, but we believe this should be much less than 10% of ears. If we find that your ear is incompatible during the virtual fitting process, we will refund you the full amount without charging the custom-fitting fee. This fitting process is dynamic - it may change over time and look different for different people.

Validation

Johns Hopkins tested STAT during routine Tilt Table Testing. During this study, STAT detected drops in Flow minutes before fainting occurred, capturing continuous data throughout, even when the Blood Pressure cuff failed to capture readings. These findings were published in JACC: Electrophysiology.

Duke also tested STAT during Tilt Table Testing, but with simultaneous Trascranial Doppler Ultrasound and Continuous Blood Pressure. Dr Fudim, the Duke cardiologist conducting the study, shared preliminary data at the 2023 Dysautonomia International conference. A publication is still in progress, but you can see the pre-published data in the DI Conference Research Update as well as the August 2023 SolveME Research Update delivered by STAT's CEO.

Much more validation is continuing to be conducted, with publications in the works. See Science for more details.

JACC Publication reporting STAT usage in Johns Hopkins Tilt Table Testing

View Publication

STAT and Duke Research Update at Dysautonomia International

View Update

STAT Research Update at Solve ME

View Update

Pricing

Only STAT can track blood flow drops to the head — no other wearable compares! The signals STAT analyzes are complex and require many levels of sophisticated post-processing in order to interpret. This new breakthrough will require big investment to advance its full potential to help people. The STAT program needs significant support — not just the processing of data in every moment, but hardware and software updates, low-cost device replacements for lost or damaged hardware, ongoing clinical studies, etc.

 We are working toward status as a medical device with FDA approval, covered by insurance. But, as this can take years, we are launching the STAT Program direct to you with the lowest pricing we can safely offer at this time.

The STAT program, similar to Continuous Glucose Monitoring, is composed of the in-ear device itself, and membership. The device is $349 ($100 of which is a non-refundable custom-fitting fee) and the membership is planned to be between $13.99 to $19.99 a month, depending on membership length.

For individuals backing our Crowdfunding campaign, you will receive special membership offers, as well as an ability to buy longer term memberships at never-again crowdfunding prices. In exchange for your early support, you will be offered the best deal possible.

All that said, we know these syndromes have caused significant financial hardship, and that hundreds of dollars out of pocket is not realistic for 30-40% of those we want to help. This is why we are setting consumer pricing as low as we safely can in the near-term, facilitating “Gift-a-STAT” for people with low-income, and are actively pursuing insurance coverage so that STAT can be accessible to everyone who needs it. For more details on how to apply for Financial Assistance, sign up for program notifications here.

Setting Expectations

  • This is Not Your Normal Product Purchase. This is not buying a mature off-the-shelf product. Pre-ordering at this stage requires an eagerness to join the journey of a new product getting to market, excitement when you see your feedback materially change/evolve the product, and patience to wait 6-12 months before delivery.
  • Features Could Change: Part of the beauty of crowdfunding is the ability for backers to provide feedback and materially change the product/features along the way, with an unusually deep relationship between creators and backers. However, this means that what is initially represented in this campaign may change as we continue to learn from our backers which features we should add, which features are working, which features are not working, etc. While backer feedback should improve the product/features overall, it’s possible that features you personally want are changed, de-prioritized, or even removed as we navigate the highly heterogeneous nature of these conditions. If changes happen that make STAT no longer interesting to you, you always have the option to get a refund before shipment, and during the 30 day return window after shipment - we will keep your money untouched in a separate bank account until that point.
  • The Beta Period Could Take Longer than Projected: The estimated shipment timelines assume a 3-6 month Beta Period to refine the product (April-October). However, if the product needs more time to mature in Beta before shipping to later customer groups, shipment timelines may be adjusted. We don’t want to begin our post-Beta backers’ membership timers until we are confident that the product experience has sufficiently matured. If the shipment timeline becomes longer than you are comfortable with, you are again welcome to get a refund.

Known Limitations

  • STAT cannot fit all ears. During the virtual fitting process, if we find that your ear is not a fit, you will be automatically refunded in full without being charged the custom fitting fee.
  • STAT’s Flow Index does NOT measure Cerebral Blood Flow / Blood Flow to Brain, but measures flow to the ear and face. The “Internal Carotid Artery” is the main source of blood flow to the brain, whereas the “External Carotid Artery” is the source of blood flow to the ear which is what STAT uses. It is already known that External Carotid Artery flow can deviate significantly from Internal Carotid Artery flow in some situations (e.g. during hyperventilation). However, during orthostatics, we have demonstrated that both the Internal and External Carotid Arteries have a similar drop in flow which is what STAT is primarily focused on. All that to say, STAT’s Flow Index cannot be used interchangeably with Cerebral Blood Flow or Blood Flow to the Brain.
  • Not all symptoms are caused by drops in blood flow to the head. STAT is intended for use in individuals who have been diagnosed with conditions known to suffer from drops in blood flow to the head, such as Dysautonomia, POTS, OH, Long COVID, and ME/CFS. This is why we are asking screening questions during the ordering process, to help qualify that everyone who orders STAT will be a good candidate to bnefit from tracking blood flow to head. It is possible that someone might have similar symptoms without a drop in blood flow to the head - in this case, STAT may not be able to detect anomalies that correlate with your subjective symptom scores.
  • Intermittent monitoring may miss events. Part of how STAT achieves such a long battery life despite the tiny battery is by prioritizing measuring when it matters with smart intermittent monitoring. STAT takes a reading once every 10 minutes, as well up to 5 continuous minutes after it detects you have stood up. This means that events that occur after 5 minutes of standing or between the 10 minute intermittent checks would not be captured. We plan to add a feature to allow users to trigger extended monitoring, such as double-tapping to initiate a 10 minute monitoring session, but this feature may not be immediately accessible.
  • Will not be a real-time fainting prevention tool. Due to the device's intermittent monitoring, STAT cannot be a reliable real-time fainting prediction tool in the near term. This is in spite of promising initial findings from Johns Hopkins. Real-time faint prediction will likely be part of a future regulated medical device product. However, STAT's Flow Score may be helpful for helping you understand when you may be at greater risk that might be worth taking extra steps of precaution.

Long Term Vision

While we're initially focused on creating a consumer digital health app that enables better self-management of symptoms to improve quality of life, our long-term vision is to increase accessibility by being a regulated medical device that is covered by health insurance. This is why we’re continuing to conduct validation research with top research institutions to one day be used both as a reimbursed remote patient diagnostic (akin to Holter Monitors but for Orthostatic Intolerance instead of arrhythmias) and as a reimbursed medical monitor (akin to Continuous Glucose Monitor). We're committed to helping the millions of those suffering from these conditions, and it is clear to us that insurance coverage is the only way we’re going to reach the majority of the people we want to help!

But we’re still at stage 1 of this multi-stage journey, and we're inviting you to join us in our journey. Pre-order today and join us in transforming how orthostatic syndromes are managed. Plus, get never-again specials for being an early adopter!

FAQ

Who exactly is this product for?

STAT is designed for people struggling to manage symptoms caused by POTS, Dysautonomia, ME/CFS, Orthostatic Hypotension, Orthostatic Intolerance, and other orthostatic syndromes. STAT is intended to help people better self-manage their syndromes by providing the ability to measure what matters - blood flow to head changes!

Is STAT a medical device? Do I need a prescription to use it?

STAT is a low-risk general wellness product, as defined by the FDA’s “General Wellness” guidelines, that may help you live well with orthostatic intolerance. You do not need a prescription to use STAT.

How is this different from a heart rate monitor?

STAT tracks drops in blood flow to the head, often when heart rate is unchanged! A large body of research has shown that for many patients, blood flow to the head drops and causes symptoms despite normal heart rate and blood pressure. We often hear the question “why do I feel bad if my heart rate and blood pressure are normal?” It’s because you’re not measuring the right thing - you need to measure blood flow to the head!

I already know I have these symptoms. How can STAT help me?

STAT learns about your body with a level of precision that is difficult to achieve on your own when a cloud of symptoms confound your judgment. STAT uses this learning to help you better self-manage your daily symptoms.

STAT listens to what you log about your symptoms and interventions, then teaches you how these different variables affect blood flow to your head. This teaching may come in the form of trend charts to observe your body's response to a new medication, or a gentle nudge to take timely proactive steps to preserve maximum blood flow to the head.

There are many lifestyle factors under your control such as fluids, electrolytes, compression, and more but it's often difficult to know when and how much. STAT helps you decipher how much the interventions you're doing are actually helping, and when it might be a really good time to do them.

What mobile devices will the STAT app run on?

STAT is compatible with iPhone devices (minimum iOS v11.0). It is not yet compatible with Android devices.

The reasons we are prioritizing iOS over Android are 1) our customer surveys indicated ~70% of prospective customers were using iOS and ~80% of our mobile web visitors visited from an iOS device 2) Android is incredibly expensive to develop for, compared to iOS. To develop the Android app for Bose sleepbuds, we needed well over a million dollars to build it to an acceptable level of reliability. Apple runs a tighter ship with respect to how their bluetooth integrates with their hardware. This allows for much more reasonable development time/cost.

That said, we are planning to support Android in the future, but this will likely not be until 2025 at the earliest.

Why is STAT designed for the ear and not the wrist like most wearable devices?

The wrist has inherent limitations as a monitoring site, from the limited cardiac signal available, to the significant noise artifacts masking what is available. In comparison, the ear has a stronger cardiac signal, so the wearable cardiac information available is unparalleled. Additionally, the ear is relatively mechanically decoupled from daily activities (e.g. think how many times a day you move your arm to type, text, etc. compared to how many times you move your ear), so there is a greater continuity of high-quality data available during your daily life.

Is STAT available outside of the US?

STAT is only available in the US during our initial launch. While we hope to expand to other countries as soon as possible, this would be in the future with no fixed timelines yet. As a startup, we have to walk before we run. Join our email list to stay updated for when we launch in other countries!

Is it FDA covered by insurance? What about HSA/FSA?

Not yet but we’re working on it! This is a process that takes years and a lot of investment. We are working on this in the background, however we believe it is more important to get the STAT program out there to help this community as soon as possible, so we are launching as a direct to consumer wellness device first.

On HSA/FSA, we are working on this process but cannot yet accept HSA/FSA funds. We did just get approval from the IRS body that governs HSA/FSA that STAT is HSA/FSA eligible, but we still have to set up a compliant payment system before accepting payments.

For updates on both these topics, please make sure you join our email list. A signup box is in the footer of our website.

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