[HN Gopher] Launch HN: SafeBeat Rx (YC S21)- At-home ECG softwar...
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Launch HN: SafeBeat Rx (YC S21)- At-home ECG software to replace
hospitalization
Hey HN! We're Rachita Navara, MD and Kunj Patel, MD, MSc: co-
founders of SafeBeat Rx (https://www.safebeatrx.com). I (Rachita)
am a bioengineer and cardiologist specializing in heart rhythm
disorders, and Kunj is a pain physician with a Masters in applied
mathematics. We make life-saving ECG software to replace a 3-day
hospitalization and let patients start heart meds safely at home.
34M people have atrial fibrillation (AFib), the most common heart
rhythm disorder in the world. It causes 1 in 4 strokes in people
over 40 and increases the risk of death by 4x. Antiarrhythmic meds
improve symptoms and save lives. Unfortunately, these pills can
only be started during a 3+ day hospitalization because early drug
trials showed <0.6% risk of causing sudden cardiac death. This can
be prevented by ECG monitoring, but there hasn't been an
alternative to hospitalization since the drugs were approved 30
years ago. For low-risk patients, the risks of hospitalization
outweigh the risk of medication side effects, and patients in
underserved areas often don't even have access to hospitals. From a
hospital/insurer perspective, each of these hospitalizations costs
$17k and takes a hospital bed that would otherwise go to someone
who actually needs hospital-level care. Because of unnecessary
expenditures like this, AFib costs >$26B in the US alone, 75% of
which is for hospitalizations. As a cardiologist specializing in
heart rhythm disorders, I regularly cared for patients who were
stuck in the hospital just to start these oral pills. All I was
doing for these folks (as a physician with >10 years of medical
training!) was making a tiny measurement on a paper ECG with
physical calipers to check for drug side effects. Given my
engineering background, I knew we could develop software that
automates this process. I also knew, as an AFib researcher
presenting at international heart rhythm conferences, that this was
a large market desperate for improvement. When COVID-19 brought
telehealth to the forefront, it became clear that we should build a
startup to solve this. Our take-home kit combines FDA-approved
wearable hardware devices with our ECG software that automates
measurements, recommends drug dosing, and catches changes before
they become heart attacks. Here's a demo of our portal, which is a
functional prototype that allows doctors to interact with our
algorithm (and helps us get feedback on performance):
https://drive.google.com/file/d/10iBo_EznZOQ_RHLiFzcGTnA-GER....
Doctors approve our algorithm's measurements and dosing at every
step for safety. Our interface aims for simplicity, based on what
we wanted ourselves while treating patients. We've done a 103
patient pilot study, which showed that our software successfully
interpreted 100% of ECGs and could even replicate doctors' clinical
decisions. Our FDA path is short due to using existing FDA-cleared
hardware, and we are seeking EUA (Emergency Use Authorization)
during the pandemic. Some drugs tried on COVID-19 early in the
pandemic caused people to die due to heart rhythm side effects. Our
technology can prevent such deaths--not only from heart meds, but
from 300+ meds that can cause sudden cardiac death, and thus
require close ECG monitoring. Insurers are incentivized to
reimburse our kit, and hospitals want to preserve valuable beds for
sicker patients. Because heart rhythm side effects are the #1
reason drugs are declined FDA approval, we also aim to partner with
pharmaceutical companies testing new drugs. Our automated system to
monitor heart rhythm safety while starting drugs can tap the giant
market of drug safety trials. We're excited to share what we've
been building and look forward to your thoughts!
Author : rnavara
Score : 60 points
Date : 2021-08-24 17:33 UTC (5 hours ago)
| traceroute66 wrote:
| Lots of potential questions here, but let's start with three:
|
| - What makes you "better" than your competitors, perhaps
| especially those of your competitors with substantially deeper
| pockets than you ? (e.g. Apple Watch which also has "ECG"
| functionality).
|
| - Building on the above, how's the prior art looking on the
| patents ?
|
| - Finally, general cynicism on "home ECG".... clinical evaluation
| is 12 lead ECG. Can you really get away with substantially less
| input ? (Garbage In - Garbage Out).
| Rssnkgp02 wrote:
| Great questions. The Apple Watch is a single lead, so doesn't
| have the resolution to do the computations. Also, the
| algorithms aren't trivial for automation this, but the data
| moat is extremely important for capturing and appropriately
| testing this population. There is prior art, which our own
| filing took into accout. Lastly, the hardware devices we use
| are all FDA approved to measure the appropriate interval, one
| of which is FDA approved 12-lead ECG patch approved for patient
| self-administration.
| neurotech1 wrote:
| That and the Apple Watch is on the wrist, which could
| introduce artifact to the ECG.
|
| There are single lead chest ECG patches used for specific
| diagnostic reasons. Zio patch is one common device used. [0]
|
| [0] https://www.irhythmtech.com/patients/how-it-works
| Rssnkgp02 wrote:
| Excellent points. Artifact is indeed a tricky problem for
| EKGs, and the ziopatch is a great device. Generally,
| multiple leads are needed (ideally 6 or 12 leads) to
| accurately measure repolarization of the heart.
| Nilef wrote:
| I'm in my 20s and have been through the 3 day hospitalisation
| process NINE times so far - I cannot stress how huge a deal what
| you've built is for me
|
| The amount of hassle and anxiety this will save me is impressive
| on its own, but so to is the ability to have a normal lifestyle
| (such as going out for a drink) without having to worry about
| whether or not I'm always in range of a hospital that I want to
| spend 3 days in if I'm unlucky
|
| Thank you and good luck!
| rnavara wrote:
| So kind of you to share your personal experience and support -
| you are such a powerful reminder of why we are building
| SafeBeat Rx!! No one should ever have to go through what you
| have been through, let alone NINE times. We're eager to change
| that. Very best wishes from all of us
| ttcbj wrote:
| My 72 year old mother was just in the hospital for 5 days with
| AFib (not her first). We had an escalating series of
| interventions and procedures, none of which proved effective. By
| the end, I suspected she had been substantially over treated, at
| high cost to medicare and with high risk of complications.
|
| So, I think this is a great idea.
|
| She is currently waiting for an ablation, which was a close call
| vs leaving her in it, but she wanted to try it.
| rnavara wrote:
| Thank you so much for sharing your personal experience. Best
| wishes for a speedy recovery for your mother - this is
| unfortunately a common theme among our patients and we're
| excited to make a big change here. Let your mother know that
| we're pulling for her!
| linsomniac wrote:
| Somewhat related: William Osman saves $70K by building his own
| home X-ray: https://youtu.be/IiJAq53knwc
| rnavara wrote:
| Ha awesome link, thank you!
| Rssnkgp02 wrote:
| That's a cool hack. Xray machines are quite costly for clinics
| to purchase, and clinics have to perform hundreds of xrays
| before they recoup their cost.
| foolinaround wrote:
| Amazing, seeing how you as a doctor could think of processes that
| you do, and conceptualize it in software!
|
| Congratulations on the launch, and I wish you well, and hope it
| is of great use to thousands!
|
| > existing FDA-cleared hardware Can you please link to this?
| rnavara wrote:
| Thanks so much! Medicine is often a mix of extremely high tech
| and very low tech, so we're in a great position to fix the
| latter :) We can actually pair with multiple different types of
| hardware (our software is hardware-agnostic) but we have a
| couple preferred hardware devices. One of which is
| https://www.kardia.com/kardiamobile6l/
| OJFord wrote:
| So you recommend their hardware, and compete with them on
| software? (Assuming I understood that correctly -) what stops
| them catching up/replicating your (presumably) better
| software?
|
| Or perhaps more to the point - the problem you mention in OP
| seems, as described, like it's already solved by Kardia, what
| was missing that you had to build?
| rnavara wrote:
| Great point, indeed the problem of automated ECG analysis
| has been around for the last several decades and there's
| still no automated solution accurate for AFib patients (one
| of the the hardest categories for making ECG measurements).
| Our software is specifically trained on AFib ECGs and our
| specific focus of this market and guiding drug dosing, as
| well as our clinical expertise in the field gives us our
| edge. It's a similar reason why startups can do things that
| Google and Amazon can't :)
| neurotech1 wrote:
| They are referring to 510(k) Clearance [0]
|
| > The 510(k) Clearance process is one of two ways by which a
| medical device manufacturer can obtain approval from the Food
| and Drug Administration, although legally, a device clearance
| under this section is not a true "approval." 510(k) Clearance
| simply gives the company permission to market its product,
| based on comparison to a "predicate" [previously approved]
| device.[1]
|
| Basically, If a somewhat similar device is already on the
| market, the FDA will clear the new device for the market.
|
| [0] https://www.fda.gov/medical-devices/device-approvals-
| denials...
|
| [1] https://www.levinlaw.com/fda-510k
| JayJoh wrote:
| Slightly off topic: We are looking for investors for an arm
| sleeve that can measure blood pressure (Pressure not pulse, NOT
| based on pulse wave velocity). If interested post here.
|
| We have a rudimentary, un-inspirational website:
| http://www.koalasleeve.com/
|
| Just filed the patents.
| 35mm wrote:
| How does a 3 day hospital stay cost $17k?
|
| I am genuinely curious to see the breakdown of where that money
| goes
| pvarangot wrote:
| That's not expensive if they are doing tests and stuff. I got
| an MRI of my foot and did it at a hospital after getting
| rescheduled three times at an outpatient facility. It lasted an
| hour and was $2700.
|
| On the outpatient facility they would have charged $1100.
| rnavara wrote:
| So true, and a revealing insight into US healthcare! The vast
| majority actually goes toward hospital room and board, with a
| fraction of the cost for the ECG monitoring. This is why
| insurers are keen to reimburse an out-of-hospital alternative
| [deleted]
| carbocation wrote:
| Fascinating. The anti-arrhythmic load was one of the less
| interesting reasons for hospitalization from my days in
| residency, and more important than my own intellectual curiosity
| is the ability to keep people out of the hospital.
|
| Typically at my institution we load first and cardiovert later if
| needed. How is that handled in your system?
|
| Also, what is the clinicaltrials.gov registration for your
| completed Phase I?
| rnavara wrote:
| Yes, you get it - it's a boring hospitalization all around! For
| patients getting a cardioversion after their drug-load, they
| can fortunately come get one as an outpatient (most
| cardioversions are for elective outpatients, and in fact the
| inpatients often get bumped for the scheduled outpatients).
| Hospitals are particularly happy about our workflow because
| they don't get dinged for readmissions - whether for
| cardioversions or for drug dose adjustments, which also require
| readmission under the current standard.
|
| Phase I Software validation doesn't require clinicaltrials.gov
| registration, but our Phase II trial will be per FDA!
| carbocation wrote:
| Thanks! Glad you've already considered the cardioversion
| workflow. If your system is good enough to do the
| load+monitoring safely at home, this sounds like a win-win.
|
| Also, I didn't realize that Phase I trials didn't have to be
| registered on clinicaltrials.gov! But you're right, they're
| specifically exempted[1].
|
| 1 = https://clinicaltrials.gov/ct2/manage-
| recs/fdaaa#WhichTrials...
| Shank wrote:
| > We've done a 103 patient pilot study, which showed that our
| software successfully interpreted 100% of ECGs and could even
| replicate doctors' clinical decisions.
|
| Do you have a link to the study? Isn't that a relatively low
| number of patients to validate against?
| rnavara wrote:
| Great question, our training data involves thousands of ECGs to
| validate the software performance of the algorithm itself. As
| far as in-human data, 100 patients is well-powered for Phase I
| software validation, in preparation for our upcoming
| prospective clinical trial (Phase II). These results are hot
| off the press so we don't have a public link yet - more to
| come!
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(page generated 2021-08-24 23:00 UTC)