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GraftWorx Founder and CEO Dave Kuraguntla (DK) and VP Product, Marketing, and Business Development Amit Rushi (AR) recently spoke with ViVitro Lab and Interim General Manager Rob Fraser (RF) about their work on a family of patient monitoring devices that combine state-of-the-art sensors and algorithms with user-friendly design to enable precision medicine with real-time data.
RF: Dave and Amit, please tell me about your current work at GraftWorx.
DK: With GraftWorx we have created a remote monitoring platform that improves the management of patients with chronic conditions. Our beachhead market is in dialysis, where the patients have many co-morbidities and have complex care to manage. Comprehensively monitoring the dialysis patient, along with those additional issues, enables GraftWorx to enter into adjacent markets such as heart failure and peripheral arterial disease.
There is a clear need for both the patients and their care teams to have an end to end remote monitoring platform with a continuous sensing technology. But the real key feature is clinically actionable cardiovascular metrics. This is what really enables the care team to optimize patient care. Today we have built that entire system out and obtained about 120 patients worth of data. We are about to kick off the next phase of our pre-commercial activity.
RF: How are you physically measuring that pressure?
DK: We have a series of different metrics that we can generate. There are twelve sensors inside of the patch in four major groups: optical, acoustic, thermal and mechanical. We utilize sensor fusion to bring all of that to bear in generating our array of clinical metrics. ViVitro really helped us go from the bench top to the humans. In the human, we are currently able to get volumetric flow rate, percent stenosis, hemoglobin, hematocrit, SpO2, and heart rate. We are also looking at things like mean pressure, and we also have an ECG module in the patch as well. All of these hemodynamic metrics come together to give us a full picture of the patient.
RF: This patch is worn on the skin?
DK: Exactly. Typically, it’s placed on the skin over top of a vessel you are looking to interrogate. Dialysis is nice because patients have a fistula or graft for us to interrogate. Our exact same patch works over top of the radial artery for things like heart failure, or even on the carotid artery for stroke monitoring and even the posterior tibial artery for conditions like peripheral artery disease, etc.
SmartPatch
RF: How big is the patch?
DK: It’s pretty small and it’s getting smaller. Right now, it’s about the size of a Band-Aid – maybe a little bit thicker than a Band-Aid. We did a strategic partnership with W L Gore to utilize some of their material to make the patch even more flexible and more comfortable for the patients – effectively a “forgettable” form factor.
RF: What sort of reactions are you getting?
DK: We started off by interviewing about 500 patients and then spent about another week with about a dozen dialysis patients, several physicians and six vascular access nurses who were treating those patients as a nephrology team, in order to design the product. Our user-centered design process led to a terrific amount of feedback in terms of user needs and user experience. One of the most important lessons we took home from this exercise is these dialysis patients typically feel like they’ve lost the sense of control of their lives because of this condition.
In a lot of ways dialysis and end stage renal disease patients feel like they are on a conveyor belt to the end. When you place that patch on a patient and talk to them about what it does, they come back and say “Wow, I finally feel like I’m not on that conveyor belt. Someone’s given me some actual control and helping me live my best life from here on forward”. I think that’s a really exciting opportunity we get to create. That is the feedback we have gotten and appreciation we have heard from patients.
Hub And Interface
RF: That’s pretty powerful. Does the patient have access to this data in the same way that the caregiver does? Is that kind of the model?
DK: We have been focused on driving clinically actionable alerts, either through an electronic medical record or our own portal for the clinician. For the patient, the current feedback loop is they know something is wrong via our system, but they react in the care of their clinician. Over time, we plan on having a patient facing app so they can learn a little bit more to drive better care outside the clinic. At the same time, you want to really leave clinical care in the hands of the clinician and not have data overload on either side. That can lead to everyone getting frustrated with the product.
RF: Fair enough. How has ViVitro Labs helped you with this development?
DK: I’ll walk you through a little bit of our product development process. We typically start by simulating this with a Monte Carlo simulation in the cloud. We utilize optical sensors and do a lot of simulation of what’s happening. What has really been neat is there is typically a big leap between what you simulate in the cloud and what is actually happening in the clinic. That’s where working with ViVitro and having a ViVitro pump has really helped us out. We are able to really mimic the physiologic phenomena with the ViVitro pump. I think the capabilities allow us to not only mimic what we see in the clinic from a human matter perspective but also from a cardiac waveform perspective. We’re able to really take our algorithms from the cloud to the bench, analyze them, make them better and then go to the clinic and really make sure that there is a lot of accuracy. We found ourselves being very accurate with our initial clinical data. We’re already able to measure hemoglobin or hematocrit and meet or exceed the current standard of care that’s out there.
RF: Were there any surprises you noticed going from the bench to the clinic?
DK: We can get a lot more data than we thought we could. The raw data is really powerful. That’s an exciting opportunity and helped us move forward. Using the ViVitro system really gave us a lot of confidence. We were very excited about what we could already see on the benchtop. We did interesting things, such as, utilizing cadaver skin to simulate different skin colors. Because of the consistent underlying wave form created by the ViVitro pump, we could then change and modulate what we needed to see consistent data. We were able to mimic almost every patient population. It was really, really meaningful to not be surprised by outliers in the clinic.
RF: I’m glad to hear that. Will you share a little more about your plans for the future?
DK: Once we got that first set of clinical data, we wanted to build partnerships. I mentioned working with WL Gore to make the product even more patient-friendly than it already is. In addition, we’ve now secured four clinical partnerships in dialysis that enable us to execute a series of studies and ultimately launch our product into their patient populations with about 50,000 patients. These are patients on dialysis, and a lot of them are diagnosed with heart failure, and a lot of them have an arterial disease. It’s really an exciting phase that we’re entering. We’re building on our ecosystem of partners and investment that should continue driving our mission.
RF: Getting up to 50,000 patients is going to be a change in volume for production.
DK: What’s interesting is we are ISO13485 in-house. We currently these in-house, so there will be a step function change from building a thousand patches a month in-house to needing to build a lot more. We are exploring working with others to help us out.
RF: Very cool. You are on the cutting edge of technology. Is there anything you’d want to share or just advice that you’ve learned along the way?
DK: First and foremost, if you want people to use your products, the incentives have to really be in line. Internally, for any product we want to create or bring to market, we make sure the four P’s are aligned. Those four P’s are the Patient, the Physician, the Provider and the Payer. If they’re not all aligned, if the incentives are not pointed in the right direction, then no one is going to use the product and you’re not going to have the patient impact that you want. That’s really one of the key requirements of chronic care management which is incredibly critical.
On the other side, you can’t just give health and wellness data. You have to provide clinically actionable insights. The third thing is understanding what workflow changes do you trigger for the clinical team?
The best thing you can do, and I think what we’ve tried to focus on, is aligning incentives leading to clinically actionable metrics that don’t change current clinical workflow and everybody wins. That’s really the key feature at the end of the day.
Hearing the feedback from patients about how this product can give them their power back, or help them live their best lives, and never losing sight of our goal of impacting patients’ lives. It’s really important because the journey is incredibly challenging as you know.
RF: That’s great advice. Is there anything else that you want to share with readers?
DK: Maybe one thing, you asked previously how we differ from other products. I’ll answer in two ways. One was to make sure we had a scalable platform capable of not only treating patients in dialysis, but can also treat our additional pipeline indications. Thinking ahead was really important. Second, making sure our end users, i.e. the patient, has a really approachable way to utilize our product. We made it as plug and play and forgettable as possible.
The Hub seamlessly and securely captures data from any smartpatch in range and transmits it to the GraftWorx cloud. The Carousel holds about a year’s supply of smartpatches & adhesives,
For example, simple things like a patch relaying data to the cloud. There’s no Wi-Fi setup, nothing that makes their life complicated. They literally get a box from their dialysis clinic, then they go home and plug it in, and it’s automatically connected, and data is flowing. They put the patch on and when that patch comes within 100 feet of any of our hubs, raw data is going to the cloud. It is HIPAA-compliant and secure. There are lot of ways we thought about protecting PHI along the way. Ensuring ease of use really brings down barriers for patients being involved in their own care.
RF: Yes, that’s not the kind of thing you want to worry about – the Bluetooth isn’t connected or you’re troubling with a Wi-Fi network. You definitely want it to be as simple as possible.
DK: Indeed.
Read about other Cardiovascular Pioneers here.