Ventric Health Unveils Vivio^®, a Non-Invasive Revolutionary Device Designed to Detect Early Signs of Heart Failure

Please introduce yourself by stating your name, your title, your organization, and any professional background you want to share with the audience.

Sean Brady: I'm the CEO of Ventric Health. I've been with the company since 2014. Prior to Ventric, I was working as an attorney for early-stage companies that were spinning out of university labs. So, that's how I first started working with the team at Ventric, and I was involved in its founding. There was some interesting research that was coming out of the Gharib Laboratory at Caltech in the Bio-Inspired Engineering and Fluid Dynamics Laboratory.

There's Professor Mory Gharib, who's been involved in several cardiovascular medical devices over the years. He had a post-doc named Derek Rinderknecht, who's our CTO and co-founded the company.

And then there was a PhD student at the time named Niema Pahlevan, who's now a professor at USC.

Niema's PhD dissertation had won an award for best PhD dissertation in the physics department. So, we thought it seemed like a very interesting concept around which to develop a company.

That really culminated just recently (October 2023), with us receiving our clearance to noninvasively left ventricular end diastolic pressure (LVEDP) to help drive forward the diagnosis of heart failure.

For Vivio specifically, because it uses advanced algorithms for non-invasive heart failure detection, how does it work? What sets it apart from other devices in space like catheterization or echocardiograms?

Sean Brady: I think what's unique about Vivio is that we're able to accurately, non-invasively, and easily fit into existing workflows to measure this LVEDP which is really the gold standard—the diagnostic piece of information for diagnosing heart failure and finding it in any care setting. And what's unique about our solution is that, traditionally, to get an accurate measurement of LVEDP, you needed to have a patient go through cardiac catheterization, so, they would have to have a cardiac catheter placed either through their wrists or their groin, into their aorta, and then actually put a sensor inside of the left ventricle in [the] main pump of your heart.

It's extremely invasive. It's a means of last resort for patients who are even lucky enough to be able to find themselves with access to a cardiac cath lab.

As a result, most patients can’t get that type of diagnostic work up in any realistic time. So, what you have instead is you have other tools that are used at the point of care today, like echocardiogram which you mentioned, or blood tests like BNP. Or reliance on clinical signs and symptoms.

But the problem with all those other tests is, they really have poor correlation to this gold standard LVEDP invasive measurement. For us to come up with something that's point-of-care deployable, non-invasive, and easy for the patient to experience and get that quality of data, I think, is a big paradigm shift in how heart failure is being diagnosed.

Based on what you’ve shared, there's not many technologies out there like yours, correct?

Sean Brady: We're really in a class of one in terms of the device and our indication for LVEDP.

With the growing rate of heart failure cases and what we know about heart failure in general, how can Vivio improve early detection in patients? How is it able to accurately diagnose heart failure, which could potentially save lives?

Sean Brady: I think one of the areas we're most focused on is that today, if you look at the average Medicare patient who develops heart failure, 65% of heart failure is diagnosed in the ER or inpatient setting.

There is a delay from initial clinical suspicion to a diagnosis ending up in a patient's record. I think the median time is somewhere [around] 30 months. It’s this long-drawn-out process where patients must go through different types of diagnostic testing that may require multiple appointments that they may or may not go to. And that's all predicated on the idea that the physician, in the first place, had picked up on something suspicious, which patients oftentimes dismiss. Or they ascribe them to just getting older or some other condition. That’s what's particularly tragic about heart failure, isn’t it? It just continues to progress.

It's a chronic progressive disease. And you can't really get that quality of life back once it progresses to a certain stage. What we're really doing is helping to drive that diagnosis forward by empowering clinicians to get this information on their at-risk patients when they first become clinically suspicious that heart failure may be present.

It allows clinicians to use the device on patients where they think it's clinically reasonable to. For example, for elderly diabetics, other studies have shown about 30% of diabetics over the age of 65 have undiagnosed heart failure. If you can, take them through an extensive screen in a diagnostic program. But it's not feasible to do that for every patient. And so being able to find a quick and easy way to find those patients in the point of care setting really allows you to drive treatment earlier and get those patients into care management programs. Really maintain that state where they're not having progress to the place where they must end up in the ER or inpatient in the first place.

Do you see any difference in health care costs for patients using your method with Vivio rather than other treatment options with catheterization or echocardiogram?

Sean Brady: I think what's particularly promising about the Vivio System^TM is that it's able to detect both subtypes of heart failure. About 40% of all heart failure patients have what's called heart failure with reduced ejection fraction. Then, about 60% have what's called heart failure with preserve ejection fraction, and in general, the reduced category, that is the smaller of the 2 is easier to diagnose. So, if you do take a patient through, for example, an ultrasound, you've got a pretty good chance of detecting that reduced ejection fraction. However, the preserved ejection fraction patients often require routine or a serial number of tests to even arrive at a diagnosis if possible. So, these patients tend to fall through the cracks, and you end up not having just one echocardiogram, but you might need two. Then do a stress echo to use some other information like BNP, blood tests, or EKG to try and arrive at a diagnosis of HFpEF. But, usually, it's a diagnosis of exclusion and so, being able to have a device that has adequate sensitivity and specificity to give you the gold standard on the left ventricular end, diastolic pressure, (LVEDP) at the point of care helps save on those downstream costs.

The other thing is that echo and BNP are the current standard of care. And that's what's currently really failing, the system where 2/3s to 3/4s of patients are first diagnosed in the ER or in-patient setting. Each time that a patient is diagnosed in the ER in-patient setting, you've got the upfront cost associated with that with that visit, which is about $17,000 or so, and then those patients end up doing worse.

So, they have a worse 1 year and 30-day mortality. They have higher 1-year all-cause hospitalization, and they have a lower quality of life. The 12-month cost of that patient is estimated to be about $22,000.

And that’s a patient who's doing worse, has a worse quality of life, and that costs the health system a lot more money, because all these resources had to be used. Whereas, if you shifted that diagnosis to the outpatient setting to the point of care, you're going to save on those downstream costs. I think there's a significant impact to finding heart failure earlier in the outpatient setting.

Based on what we've read, heart failure is predicted to reach $70 billion by 2030. With the introduction of Vivio, patients will be able to save on health care costs.

When we think about social determinants of health and patient access, how does this technology address those barriers?

Sean Brady: I think 1 item that you just brought up is the is the co-pays. And that is in addition to a number of patients who may have difficulty even getting to multiple appointments and sitting down with a specialist. Then, having to go to additional appointments after that, if the diagnosis isn't yet clear, and I think that that contributes to these patients falling through the cracks. We particularly see this shift of the in-patient ER setting for diagnosis among patients with lower socioeconomic status.

75% of patients with lower socioeconomic status are diagnosed in the ER or in-patient setting, and the reasons for that can be anything from transportation issues, financial issues, health literacy issues, maybe not understanding signs and symptoms until it's far too late. And the cost to a patient once they've progressed to that stage is much higher than if you had found them earlier. And I think that's surprising given where we're focusing. There seems to be a ton of focus within the health care system today on addressing readmissions. But that's after a patient has already been admitted to the hospital for heart failure in the first place. If 2/3s to 3/4s of your patients are first diagnosed in that setting, then you've got this big readmission problem. It seems like the smart answer is to move upstream in the pathway and keep those patients out of the ER in-patient setting in the first place. That’s going to significantly help the patients who are most at risk in our society who face the problems with following up with care.

If there are language barriers or other issues that they're facing as well, it behooves everyone to move the diagnosis earlier and avoid a catastrophic reactive system we have with respect to heart failure today.

It sounds like what you're hoping to achieve is a more proactive response rather than how you put it, reactive. Do you know what the readmission rates are in the US given the system’s reactive approach?

Sean Brady: With the 30-day readmit, as of a few years goes, it is somewhere around 15 to 20%. And if you look at the 90-day readmit, it was even higher. It's a problem that Medicare has been aware of for a while. And one that hospital systems can face penalties for if patients are readmitted.

There's a huge focus there. But it's almost like too little too late, right? Because heart failure is chronic and progressive. You're now dealing with a much sicker patient, and the level of care that it takes for them to maintain a decent quality of life is so much higher. Your patients will benefit if you can just find them at the earlier stage of the disease when a lighter touch is needed to maintain that state.

Although 20% does not seem like a high number, when you look at total patient population, it impacts a large volume of patients. And, I believe, you said this rate is only within the first 60 days or the first 30 days, and then it increases after 3 months.

Thinking of the patient's experience, it is likely overwhelming.

Sean Brady: For a patient’s first in-patient visit for heart failure, that's already emotionally and physically taxing. And then you must get them home, and then they're supposed to now understand this entire new disease, manage it, and recognize symptoms for the first time. It's like trying to study for an exam in a tornado.

If you can find patients when they're in a more stable state earlier in the disease, it's a lot easier for them to understand what's going on than in this chaotic environment of readmissions.

Now that we know this device exists, we know how it works, we know what it can do to benefit patients who have heart failure symptoms or on their way to being fully diagnosed with heart failure—How is this device accessible to health care professionals and hospitals alike?

Sean Brady: We are actively in the market now. We're working with several value-based care providers focusing on physician groups who have the holistic long-term cost of care mentality and are caring for patients. We’re going to continue to work with those types of providers and, soon, expect significant growth into 2024.

Is there anything else you wanted to share about the device or the company?

Sean Brady: We have a unique team that put this together. I think it’s a good combination of smart and compassionate people who are driving this. We’re excited to get the product out into the world and really see the impact that it can have.