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Interview: Michael Nagy on implantable wireless pulmonary artery sensor for outpatient hemodynamic monitoring

August 23rd, 2016

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Mike Nagy

Michael L. Nagy

Founded by a cardiothoracic surgeon and a mechanical engineer whose family members suffered from CHF, Endotronix is developing a single platform digital health medtech solution that provides comprehensive health management tools for patients suffering from advanced heart failure. The solution includes a cloud-based disease management data system and outpatient hemodynamic monitoring with an implantable wireless pulmonary artery sensor for early detection of worsening heart failure. ViVitro’s Lab Manager, Rob Fraser (RF), recently spoke with Michael L. Nagy (MN), VP Engineering, about the Endotronix Care Management Solution, a recent $32m Series C funding for Heart Failure Solutions, and healthcare transformation in the Internet of Things and Digital Health world.

RF: What is unique about the work Endotronix is doing?

MN: We are focused on an end-to-end solution for patients with heart failure. It’s been known for a long time that daily measurement of pulmonary artery pressures (that are very different from your arterial pressure) allows a clinician to proactively manage heart failure much more effectively and avoid hospitalization. This exciting technology is combined with a comprehensive patient management system that includes individualized clinical care protocols and improves physician, patient, and caregiver communication. We’re on the cusp of a movement to transform healthcare from being clinic-based, that is, very reactive to symptoms to a home-based model that tests and treats these states before symptoms appear. And we’re doing it with heart failure, which is an enormous market.

RF: That certainly sounds appealing for a lot of reasons. How is Endotronix addressing this opportunity/challenge?

 

 

Sensor implant

Sensor implant

MN: We have an implantable pressure sensor. It’s very simple, but it has to be quite small because the sensor fits within the pulmonary artery via a catheter based, minimally invasive delivery procedure.  The procedure has to be cost-effective and safe. We designed a sensor that will exist for the lifetime of the patient in the pulmonary artery and is powered from the outside.  The patient picks up a reader approximately the size of a cell phone, holds it against their chest for 15-30 seconds each day.  And that’s all they have to do.  The reader records the pulmonary artery pressure, sends it up to the internet, and a clinician reviews the information. Trends in this data provide early detection of worsening heart failure that allows the clinician to intervene by adjusting the medications a patient is taking.  With the feedback data they can adjust meds more intelligently. It’s been shown that this can reduce hospitalization of heart failure patients by 40%.

RF: You just recently received another round of funding.  I assume that’s a good sign.  Do you want to give an update on how you are doing in the development of your device?

MN:  It’s going very well, but remains a big project. We’ve established the basic technology for our cloud-based patient management system and our sensor system, which includes the implant, the delivery system and the reader. Management of the data is a very important piece of the puzzle because it is a lot of data and the clinic staff often don’t have time to sort through and analyze all of it in great detail. Presenting the data in an organized and useful fashion is a big part of this job. We are now moving steadily towards commercialization. The C round funding really enables us to execute on the activities we need to do in order to verify and validate the system.

RF: I believe CardioMEMS™ HF System is the only predicate device on the market right now.  How do you differ from that product?

MN: We’re similar in many ways – the basic measurement and what we do with it is similar to CardioMEMS. For the sensor system, our main differentiator is our reader unit.  We have a different kind of reader technology that allows us to make a very small, handheld reader unit versus the CardioMEMS interrogator unit, which is built into a mattress and is a fairly large piece of capital equipment that has to go into a patient’s home.  We realize that a very important part of the process is designing a reader that people will want to use.  Our reader looks like a piece of consumer equipment that belongs in the home rather than a large piece of medical equipment that dominates the room and that you have to lay down on. That’s one big aspect of it.

 

 

Patient Management Care System

Patient Management Care System

We’ve also developed an entire care strategy, a care platform to simplify home based individualized care protocol management.  The care community includes the patient, their loved ones and the clinicians. They can work together in a way that is effective and doesn’t take a lot of anybody’s time, yet gets the therapy done correctly and gets the data managed in an efficient way. I think those are two of our biggest differentiators from CardioMEMS.

RF: There must be a fair amount of excitement about this new technology. What are reactions from colleagues/industry regarding those differentiators?

MN: Yes, we got a $32 million reaction that was very positive! The industry is behind our strategy and heart failure is such a pervasive disease state.  It’s an enormous market: 20 million people in just the United States and Europe with millions more elsewhere and several million new patients coming on the rolls every year. As a medical device engineer you might brag about a product you are working on that is going to help out 50,000 or 80,000 people. But 20 million people! Economically and from a personal level, it’s very satisfying.

Everybody in the world has been affected by heart failure: if not yourself, then a loved one, a relative, a colleague, or a neighbor. This makes my work very personal. To be on a project where we have the opportunity to improve the lives of millions of people in such a big way is a once in a lifetime experience for a lot of engineers. I think of all the heart failure victims I’ve known in my life and it’s a real motivator to get this out to the market. It’s going to be something that’s affordable for payers and easy to use for patients and clinicians.

RF: You’re totally right. There are a lot of people in this industry that are here to help others. Helping with heart failure is a great way to serve the masses. Have ViVitro Labs and services helped in your efforts?

MN: Our implant is held in the pulmonary artery for the lifetime of the patient by nitinol anchors. It has to remain safe and function all of that time. We have to validate safety and efficacy long-term over many years of exposure to the endovascular environment, but we have to get that done quickly to get the development done quickly. Testing in an endovascular simulator is the way to go. Originally we planned to build our own test stand, but I have to tell you it is not trivial. For any new test stand, there’s a debug and a test stand qualification period before you can really believe the results, and that impacts project schedule. Having a ViVitro test stand that has already gone through this, and the turnkey solutions you offer, we believe are going to be a great timesaver and a quick, efficient way to get to that confidence level.

RF: You echo what a lot of people say.  What are your future plans/goals beyond this project? What’s next for you and Endotronix?

MN: We patented a wireless technology that allows us to interrogate a very small sensor with an external wireless reader, across large distances deep in the body (i.e. the pulmonary artery), not just a centimeter or two. That technology has a lot of other potential applications across medicine. This technology will give clinicians the ability to take a daily reading and understand what’s going on in many areas of the body. Real-time, frequent, home-based information versus occasional readings in a clinical setting where the patient may not be feeling or reacting in a normal way, is going to open up vast new worlds in medical and pharmaceutical research.

RF: In other words, you can measure anything of clinical relevance?

MN: That’s right. Our sensor converts the measurement into a resonant frequency.  It’s a pretty basic idea.  If you can create a resonator that transduces whatever parameter you’re measuring into frequency, we can read it wirelessly.  The measured parameter can be, for example, pressure, temperature, chemical presence, acceleration, strain, and there may be some applications for simple actuators as well.

RF: That’s very exciting. Hopefully those will be coming down the pipeline soon.

MN: We’re starting in what we believe is our biggest and most important market.  But there are many more markets that might follow.

RF: Do you have any advice for cardiovascular researchers and start-ups that are just about to make it big?

MN: Yes.  I’d love to see a wave of researchers and start-ups follow the effort that we’re spearheading. I think we need to stop thinking of healthcare as something that exclusively happens reactively and start proactively managing disease states. That care can be guided by frequent measurements of all kinds of data that matter- data from deep in the body that comes on a daily or hourly basis.  We’ve got this great thing called the internet that can get data from people’s homes to the clinic and organize it well. Now let’s make some devices that get the data we really need.  Let’s move beyond the systems out there now where you are just putting Bluetooth capability into a weigh scale, blood pressure cuff, or a glucometer.  That’s almost a commodity now. Let’s get deep in the body and start measuring pressures and temperatures in all of the organs that matter. This opens up a new treatment paradigm for medicine.

RF: It’s great to see that people are finally getting treated in the home and that you are delivering an elegant example of personalized medicine.

 

 

Reader on nightstand

Reader on nightstand

MN: That’s what we’re all about. There are also ergonomic and economic factors.  Home based equipment has to be very user-friendly and unobtrusive as well as cost effective.  That’s something researchers are going to have to think more and more about as this shift occurs.

RF: That raises another question.  Does the patient have any access to the data?

MN: Our plan is to make the data accessible to the patient via their own personalized website. How you present medical information to the patient and their family caregivers is very important. You want to present it in a way that they will understand it but not misinterpret it or overreact to it. You also want to make it effective. A lot of our job is to do the ergonomic studies and consult with front line clinicians – doctors and nurses who work with these people, to try to get that right.

RF: We know of the white coat syndrome where blood pressures increase because patients are stressed out.  Have you noticed anything like that when patients conduct their own data collection? Are they more relaxed or is there a similar effect?

MN: I’ve read the research others have done, and I believe it is a real effect.  I also believe that what the patient is doing when they take their measurement is important. There is a certain amount of training needed —everything from positioning the patient to did they just run up a flight of stairs? That is something we have to pay attention to. We do believe there will be a difference between getting measurements once or twice a year in the cath lab when they are laying down on the table with a catheter inserted versus each day at home in their normal routine.

RF: This was great.  Thank you very much for the interview. We really appreciate you taking the time.  I know our readers will be interested in your activities.

MN: Thank you. It’s nice talking to someone who is as much into this stuff as we are!

Read more interviews with Cardiovascular Pioneers.

 


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