Jeff Pompeo Presents Caretaker Medical at LSI USA ‘23

Caretaker Medical’s VitalStream™ Wireless Hemodynamic Monitoring platform is FDA-cleared to Non-invasively measure Continuous Beat-by-Beat Blood Pressure, Cardiac Output, Fluid Response, and other Advanced Hemodynamic parameters for ICU-quality continuous Remote Patient Monitoring across the full care continuum.
Speakers
Jeff Pompeo
Jeff Pompeo
President & CEO, Caretaker

Transcription

Jeff Pompeo  0:04  

Thank you all for being here. My name is Jeff Pompeo on the president of Caretaker Medical in Charlottesville, Virginia. We are a commercial stage early commercial stage company. And I got to take a moment tell you how good it feels to say commercial stage after six years of r&d. But I want to talk to you about our flagship product called Vital Stream. vital stream is the world's only wireless wearable that already has FDA clearance for continuous beat by beat blood pressure, cardiac output, stroke volume, other vital signs and hemodynamics. And our whole goal at our company is to untether patients from bedside monitors and what we call boat anchors, and enable continuous and non evasive ICU grade hemodynamic monitoring at all points of care. So let's talk about the problem we're trying to solve here. If you look at the main points on the continuum of care, there are 5 million ICU admissions that happen every year in the US 10% of those people are going to die. What's interesting about these ICU patients is two thirds of these ICU patients don't have invasive a lines, they're not being monitored continuously. With regard to blood pressure, cardiac output and hemodynamics. Two thirds of these patients still rely on spot checks that require a nurse to take a productivity hid in an overcrowded ICU that look likely doesn't have enough staffing resources, and go do manual checking. There are 20 million ICU admissions that come out of the emergency room every year and 32% of those emergency room patients wait at least two hours for a bed to open up almost all of them in an unmonitored bed where bad things happen. There are over 100 million major surgeries in the US and 27% of those are going to have post operative hypoid hypotension, complications, that's hypertension, or hypertension, we like to joke about will kill you eventually with your high blood pressure. But hypotension is going to kill you right now. If it's not treated immediately, of those of those 100 million surgeries that happen and the 27% that have complications $30 billion is going to be spent each year in treating those complications. 75% of all adverse events that happen in a hospital happen in an unmonitored or an under monitored bed. In fact, if the 30 days after surgery was its own disease state, it would be the third largest third leading killer of humans in the United States. 50 50% of IV fluids don't work. And 80% of patients that are in a hospital get some form of IV fluids. They're either over infusing or under infusing. So the problem you can see can be framed here is clinicians need an early indication of hypertensive and hemodynamic decline that they largely don't have without invasive catheters and a lines. So they're stuck with blind spots, not knowing the status of the of their patients not being able to take an early intervention. So our mission is to change all that. Here's a great example. Let's dig deeper here. Here's a classic ICU patient being monitored in real time with lots and lots of stuff ECGs probes and leads, except for one thing in this particular case, well, two things in this particular case, blood pressure and cardiac output. This still relies on thermal dilution. So our goal is to detect these things early so that we can diagnose them quickly and take an early intervention. On the graph on the right here, see these blue dots. Those blue dots are that upper arm cuff waking up every four minutes, which is very fast, and taking a blood pressure reading. Unfortunately, this patient's one of the 9% of anesthetized patients that experience a hypertensive crash that requires an intervention vasopressor has to be pushed to bring the blood pressure back up. And you can see sure enough, that danger zone happened. See the black lines the black lines is the continuous beat by beat blood pressure of this patient. So notice two things. Notice the volatility of this blood pressure in between those, but during the blot what we call the blind spots in between those blue spot check readings. And notice obviously, if you're measure if you're measuring in real time, you see the decline as it happens. And in this case, you would have noticed the hypertensive decline. Two and a half minutes earlier, been able to take an earlier intervention to reduce the impact of perfusion loss on the body. That's Oregon's so early intervention really matters. There is a gold standard endured for continuous beat by beat blood pressure and hemodynamic monitoring. But it's invasive, it's a PA catheter, or it's an a line, it's actually a catheter that is inserted into the artery. But because it's got infection risk prone, sometimes it's very difficult, particularly in high BMI or low BMI patients. It's reserved for use in the or in the ICU. And in fact, in the overwhelming majority of hospitals in the US, you can't move a patient from an ICU bed to a lower cost bed until you remove these eight lines. Our goal at caretaker medical with vital stream is to enable a non invasive equivalent to this so that you can move patients to lower cost beds earlier, without sacrificing the continuous view, you need to keep that patient healthy. So what we've invented is the vital stream, which I'm wearing. And if you look closely, you can see my blood pressure is actually receding from the, the from the nervousness when I first got up here, caretaker is a wearable device that you clean and recharge with between each patient use a disposable finger sensor, which is where all the magic happens. And from that finger sensor all FDA cleared. Now with over 14 clinical validation studies, we measure all the things you see in blue here, most importantly, continuous beat by beat blood pressure, that's a blood pressure reading, every time the heart rejects. And by the way, your blood pressure changes constantly, even if you're healthy. And it better because if it doesn't, you've got arteries of steel, and you're gonna have some big problems. So to think that a single spot check blood pressure reading is a true indication of continuous health is living in the blind spots. This finger sensor delivers using our AI algorithms and a new model called Pulse decomposition analysis that we invented that I'll talk about in just a second. And from there and a completely wireless form factor that all that data that I mentioned is collected here can be sent to our cloud portal for remote patient monitoring inside the hospital for consults by another doctor at another hospital or post discharge for your high risk patients post discharge, or it can be streamed to our app, and can be tech and can be connected into EMRs and other patients other patient monitors like the Philips Intellivue because this is also a wearable Wi Fi and Bluetooth patient monitor. We can integrate other sensors into our platform, ECG patches, temperature patches, pulse oximeter and so forth. Well, you may say that's great continuous non evasive beat by beat monitoring is great, but only if it's accurate. Well, as I mentioned, we've have over 14 Clinical validations not on easy, you know, NBA players and Olympic athletes, but on tough patients sepsis patients, mitral clip procedures, arrhythmia patients, showing that we track those gold standards extremely well. The whole thing that we've built is based on a brand new technology that our CTO has developed over the last 10 years his life's work called Pulse decomposition analysis. In brief, the way it works is every time your ventricle injects blood into your aortic tree, there's a reflective wave that comes back up the tree at each impedance mismatch. Every time there's a change in diameter, where you're thorough, basically, at the renal arteries at the iliac arteries, where the where you're able to treat narrows, there's a reflective wave that comes back out to the periphery, we measure that in this low pressure doesn't include blood flow, where it all day sleep disorder, lab patients, oncology patients, critical care patients, that is digitized and that waveform is torn apart into its three constituent parts runs against our model and our AI. And that's how we're able to derive all of those things. PDA is covered by seven issued patents and three pending patents worldwide. So we see the world where we're changing the continuum of care to give better information in a low cost, intuitive, easy to use, patient compliant, comfortable form factor that untethered patients from beds and allows this critical ICU level monitoring across the full continuum of care to improve outcomes and reduce cost and improve productivity and are overburdened nursing staffs. Thank you very much.

 

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