New Technology Promises Quick Sepsis Detection in Emergency Rooms with Ajay Shah, CEO and co-founder of CytoVale

[00:00:03] Hey, everybody, welcome back to the Outcomes Rocket. I'm so excited that you're joining us again today. Today I have the privilege of hosting Ajay Shah on the podcast. He is the CEO and co-founder of CytoVale. He's an expert in cell-based diagnostic technologies, as well as a serial entrepreneur

[00:00:24] leading his third company. After co-founding two life sciences companies, one of them which was acquired in 2012, he co-founded and serves this company, CytoVale. And I'm excited to help unpack the work that they're doing around early detection tests for sepsis. So really excited to have you

[00:00:42] here on the podcast, Ajay. Thanks for joining us. Ajay Shah Thanks for having me. Steven It's a pleasure. Now, diagnostics, it's a tough business, and technologies really need to be differentiated and add value. So I'm

[00:00:53] excited to really give you the stage today, Ajay, to share the value you guys are creating with your device and the assays and things that you do. Before we do, though, I'd love for our listeners

[00:01:04] and viewers to get to know you a little bit better. So talk to us about you and what inspired your work in healthcare. Ajay Shah Sure. So look, born and raised in Southern California, I grew up as the

[00:01:13] son of a critical care physician and spent my life immersed in and around the world of medicine. My wife's an anesthesiologist at UCSF, and through those experiences always had a curiosity about how technology can be used to improve care delivery and really help patients as well as

[00:01:32] physicians get to better outcomes. And so that's been an inspiration and a thread all throughout my career. Steven I love it. Yeah, it's a lifelong thing for you, and you decided to take the

[00:01:41] technology side of it. So definitely still a very impactful and oftentimes very scalable road to take. Talk to us about the company, SideAvail. What are you guys doing? Why is it different? And how are you adding value? Ajay Shah For sure. So what I'm really most excited about

[00:01:56] SideAvail is the impact that this company, I believe, can have. We've taken on a huge challenge in early sepsis detection in the emergency department. Sepsis is the leading cause of death in US hospitals and the most costly condition in US hospitals. Today, as patients

[00:02:14] walk through the front door of emergency departments, the key question is, are they experiencing a medical emergency? And clinicians and providers have objective tools to diagnose the other major emergent conditions such as STEMI and stroke. But even though there's twice

[00:02:29] as many cases of sepsis as STEMI and stroke combined, today until Intelicep, SideAvail's flagship diagnostic, clinicians have lacked a clear objective tool to identify and help risk stratify which patients really are at risk of sepsis and need aggressive care. The symptoms

[00:02:47] behind sepsis often mimic other conditions and there's symptoms like, you know, they're vague undifferentiated symptoms like elevated heart rate, respiratory rate, temperature. These are patients who walk in and say this is the worst flu of my life. You know, my loved one urged me to come in.

[00:03:03] Don't feel well today. But sadly, these are often the patients who could be left sitting in the corner of the waiting room because they're not coming in with those obvious signs of a heart

[00:03:12] attack or a knife wound or the like. Yet they're experiencing a similar medical emergency that needs aggressive care. And so today, triage nurses, providers and the entire healthcare ecosystem is forced to try and tease out what's behind this constellation of often vague signs and symptoms.

[00:03:30] And unfortunately, that leads to both meaningful undertreatment and delays in the aggressively needed treatment and poor outcomes for these patients or through their best intent, meaningful overtreatment, unnecessary CT scans, unnecessary costs and sometimes harmful treatment to patients

[00:03:48] who aren't going to benefit. And so ultimately what CytoVal brings to the table with Intelicep is a objective patient-specific diagnostic tool that in eight minutes identifies which patients sitting in that emergency department waiting room can benefit from aggressive sepsis

[00:04:05] focused care. And that's key because in sepsis, the real challenge is early identification. There's up to an 8% increase in mortality per hour of delayed diagnosis for patients experiencing septic shock. And we're here to help impact that.

[00:04:19] Yeah, no, that's a big problem, Ajay. And like you said, I mean, let's just face it, most are flying in the dark on this. Elevated respirate, elevated temp is an indicator but not necessarily

[00:04:33] a true yes, you have it. So talk to us about the product and how exactly it works. That's absolutely right. You know, I think one in every five patients who walks through the door

[00:04:45] of US emergency department has those signs and symptoms, yet only a small fraction of those actually have sepsis. And so what's behind Intelicep is the ability to directly see the innate immune system. Sepsis is not an infection. Sepsis is your body's dysregulated

[00:05:05] response to that infection. It's when instead of targeting the pathogen and specifically attacking it, the body instead has an overwhelming kind of carpet bombing type response, if you will, and attacks everything in sight. And so what our novel diagnostic Intelicep does is actually

[00:05:24] looks at those white blood cells and looks in just a few seconds, assesses over 50,000 individual white blood cells, physically squeezes them and asks the question, is this particular cell highly activated? And by taking ultra high speed video data from those 50,000 cells and applying a layer

[00:05:42] of computer vision to it within just eight minutes from whole blood provides back result to the provider of is this patient, you know, a low risk patient, a band two patient or high risk band three patient, which shares that patient's risk of having or developing sepsis

[00:06:00] within the next three days. That's impactful. And Jay, you know, I'm not as familiar about the workflow in the ER, but how often are blood draws done? Is it a common thing? Yeah. So the patients that we're focused on helping are those who are presenting with

[00:06:15] signs and symptoms of infection that kind of one in every five patients who I mentioned earlier, about 30 million Americans a year for those patients who are coming in with those complaints,

[00:06:24] a standard blood draws that's used for tests like a CBC is quite common. And in fact, our test runs off of just a tenth of a CC from that same sample that's used for that stat CBC.

[00:06:36] Love it. Now that's really great to know, right? I mean, oftentimes it's fitting into a workflow. And then the second thing is reimbursement, right? So that's the other factor. And so as something like this, does it layer into a CPT code or anything like that,

[00:06:51] that providers could leverage for additional billing? So happy to share that we just received for Intellisep in our own CPT code and so certainly headed down that journey. Congratulations. That's a big move. What's really important here is the economic benefit to the overall hospital. Hospitals

[00:07:08] lose over $900 per sepsis patient, and this is a very costly condition for the institution. And so helping them identify which are the patients who are sitting in that waiting room who need the aggressive care so that they deliver the right care to those patients

[00:07:24] and yet can use their broader resources more efficiently and effectively is really at the heart of the economic story here. Yeah, for sure. Jay, you know, both sides matter and I appreciate you commenting on that. That's the big picture, no doubt. So you've shared with us, right,

[00:07:40] what happens today is inefficient. Anything else you'd like to add around what's different or better than what's out there today? I think the key, Saul, is in that really fast turnaround time, right? So our test is,

[00:07:51] as I said earlier, eight minutes from blood to insert. What that means from a workflow perspective is that as the test is drawn right alongside that very first set of labs the patients get,

[00:08:03] the result comes back before the provider has been forced to make decisions about what pathway this patient goes down. And so that likelihood of having sepsis result is in their hands to help inform their very first actions and decision making because for the patient who

[00:08:20] doesn't have sepsis, who really just needs some rest and kind of old-fashioned chicken soup, that gets them out of the emergency department faster, which is what the patient wants. And for the patient who really needs that admission and aggressive care,

[00:08:31] it also gets them upstairs faster. And maybe to tie back to the economic story, happy to share that our launch customer, Our Lady of the Lake, which is a large medical center in Baton Rouge, Louisiana, just published some data actually sharing that they've seen savings of

[00:08:45] over $1,400 per patient tested. And so we really believe this technology has the ability to improve both patient outcomes as well as hospital outcomes. Well, no, I think that's really impactful. And just to kind of get a capture of a level

[00:09:00] three trauma center somewhere, you know, like how many of these would they need for it to make sense in the workload? So what we've heard from some of the early customer conversations we've had is that

[00:09:11] the right way to use this technology really is in a protocolized driven environment, right? Such that the triage nurse is able to identify, hey, these are the patients who present with some potential signs and symptoms of infection and identify those. About 15 to 20%

[00:09:27] of the emergency department visits, you know, who meet those criteria, get that rapid testing done to then inform the physician's next decision. And so it's pretty meaningful, you know, for a busy emergency department that sees 50,000 plus patients a year, that's about 10,000 tests a year.

[00:09:42] That's significant. And could one machine do it or do they need a couple? How does that work? Yeah. So, you know, we've seen hospitals really view this as a critical lab test, kind of akin to that troponin or that CT scan, for example, for the stroke patient.

[00:09:57] And so we're setting up our early customers with two systems to make sure that they're up 100% of the time, even as we're doing a maintenance visit or the like, always able,

[00:10:06] you know, night or day, rain or shine to be able to get a result back to their patients. And that's more than sufficient given how fast the test is. Love it. Folks, you're listening to this and you're thinking, wow,

[00:10:16] this is an issue for us or we've seen it. And, you know, even things that we have loaded in EPIC or Cerner aren't really giving us the early warnings that we need. It's technologies like these,

[00:10:29] the one that Ajay is telling us about, and Telicep that can help bridge that gap. And very exciting to hear that this is FDA approved and available. If you had to sort of

[00:10:41] point to the thing that makes you so fast, like eight minutes, you know, what's that technology that you're most proud of or, you know, that you want to share with us? I appreciate you asking that. What's really cool about this technology, unlike, for example,

[00:10:55] some of the algorithms you referred to a moment ago, is that we're directly looking at the actual bad actors that drive sepsis. We actually physically look at those individual white blood cells from an individual patient. And so rather than trying to put together

[00:11:08] a bunch of disparate data points or taking a number of different vital signs and other lagging indicators and trying to build a picture of what's happening, we're actually just directly looking and saying, hey, is this cell activated in this patient? And so we're able to, through that

[00:11:24] kind of direct technology approach, assess the unique patient biology and the unique patient kind of cellular pathophysiology to then guide patient level result. That's fantastic. Now, I appreciate you highlighting that. Ajay, it's always great to

[00:11:38] know how these things work and the opportunity is big because with a lot of these algorithms, it's garbage in, garbage out. And that's why so many of them get missed. So really, really appreciate you highlighting that. Thank you so much for visiting with us today and

[00:11:52] highlighting these things that are making a big difference with your company. For anybody listening, what call to action would you leave with them? And where can they reach out to you or your team to learn more? You know, I think the call to action

[00:12:04] would be, you know, the next time you walk through your emergency department or talk to one of your ED providers, ask them, hey, if you could look out across all the beds in your ED and all

[00:12:12] the patients sitting in the waiting room and just identify right away who are the ones who are at high risk who need that aggressive care akin to the EKG or the CT scan for a STEMI or stroke.

[00:12:25] Intellisub is that tool. And we'd love to have the chance to have the conversation and share more with you. Amazing. Hey, you know, I just had a thought, Ajay. We've been trained right here in this country to avoid the ED and a lot of that traffic tends

[00:12:39] to go to urgent care centers. What play is there for this technology in an urgent care center? So the technology is currently FDA cleared for use in the emergency department specifically. Got it. Certainly as we look down the road, you know, I think the opportunity here is for

[00:12:54] urgent carers who see patients who might have similar symptoms to be able to say you should go to the ED and get checked out. And the hospital in the urgent care should have confidence that

[00:13:03] because of how quick the test is, that patient will be able to get in and out hopefully quickly. Love it. Yeah. Hey, look, love the vision on the pipeline as well. But exciting that you guys are where you're at. So congratulations on all the excellent work.

[00:13:16] And listeners in the show notes, we'll leave ways to get in touch with Ajay and the team at Saddlevale so that you too could take advantage of Intellisub and learn more about it. So Ajay, thank you so much for being with us today. This has been very interesting.

[00:13:29] Awesome. Thanks for having me.