Practicing urologist and founder Jeremy Wiygul, MD believes millions of people are suffering needlessly due to the inadequate delivery of effective treatment, among these his own wife. Pelex aims to use new technology to integrate existing resources and greatly enhance patient outcomes for people with pelvic floor problems such as incontinence. A fun chat with a compelling founder.
Highlights:
Sal Daher Introduces Jeremy Wiygul, MD Founder of Pelex
“...up to 60 million Americans are affected by one form or another of pelvic floor disorders.”
Pelex Combines a Connected Device and a Telehealth Platform to Provide Effective Care
Pelex Intends to Bring Together the Right Provider, the Right Treatment and the Right Delivery of Care
Consumer-Grade Pelvic Floor Devices Are Hit or Miss
Parallels to Imago Rehab Which Delivers Physical Therapy Remotely via a Connected Device
Connected with Jeremy Wiygul via Chrissy Glover of Imago Rehab
Jeremy Wiygul’s Own Physical Rehab Informs His Work
Why Would a Urologist with a Practice in New Your City Found a Startup?
What’s the Innovation Pelex Is Bringing to Market?
The Regulatory Strategy to Build Value in the Long Run
“...we feel very strongly that our outcomes are going to be above, and significantly better than any other service that's out there.”
Strategy with Regards to Intellectual Property
The Combination of Practitioner, Care and Delivery Has the Potential to Build a Brand Based on Dramatic Improvements in Outcomes for Patients
If the Wife of an Urologist Struggles to Get the Right Care in Her Husband’s Specialty, There’s Obviously a Problem
Contact jeremy@pelex-med.com if You Have the Problem or Want to Help
Exit Strategy
The Power of Bringing the Right Technology to Market at the Right Time
Learn More at https://pelexhealth.com/
Thanks Chrissy Glover of Imago Rehab for the Introduction to Jeremy Wiygul
ANGEL INVEST BOSTON IS SPONSORED BY:
Transcript of “Pelvic Floor Connected Health”
Guest: Founder Jeremy Wiygul, MD
Sal Daher: I'm really proud to say that the Angel Invest Boston podcast is sponsored by Purdue University Entrepreneurship, and Peter Fasse, patent attorney at Fish & Richardson. Purdue is exceptional in its support of its faculty, faculty of its top five engineering school in helping them get their technology from the lab out to the market, out to industry, out to the clinic.
Peter Fasse is also a great support to entrepreneurs. He is a patent attorney specializing in microfluidics, and has been tremendously helpful with some of the startups which I'm involved, including a startup, came out of Purdue, Savran Technologies. I'm proud to have these two sponsors for my podcast.
Sal Daher Introduces Jeremy Wiygul, MD Founder of Pelex
Welcome to Angel Invest Boston conversations with Boston's most interesting angels and founders. Today, we have with us Jeremy Wiygul, MD, who is an urologist practicing in New York City, and who is the founder of Pelex, which has a connected device and a telehealth service for patients with pelvic floor problems such as incontinence. Welcome, Jeremy.
Jeremy Wiygul: Thank you so much for having me on your podcast, Sal. It's a real honor, I appreciate it. Excited to be here.
Sal Daher: It's great that you're here. I think you're addressing a very important problem which afflicts, for example, a lot of young women who have given birth recently. It afflicts a lot of people of different ages. It's a problem that's amenable to pretty accessible solutions. Why don't you describe the problem that you're addressing here? Why is it Pelex has come into being?
Jeremy Wiygul: Sure. Absolutely. It helps a little bit to understand what a urologist does, and how that influenced my identification of the problem at the beginning. A urologist is the type of person that folks who are suffering from these conditions come to once they've made the identification of the problem, but that's actually where the big issue lies in the first place. Pelvic floor problems or pelvic floor disorders actually encompass a bunch of different diagnoses. The most common one and the one that people can wrap their mind around the easiest are the incontinence issues. Urinary incontinence in particular.
“...up to 60 million Americans are affected by one form or another of pelvic floor disorders.”
But there are many more diagnoses, but more importantly, this is a very, very common problem. By certain calculations, up to 60 million Americans are affected by one form or another of pelvic floor disorders.
Sal Daher: Wow.
Jeremy Wiygul: It's a huge issue, and with huge issues, as you alluded to, there are definitely treatments out there, but the problem is, is this isn't a one plus two equals three scenario where you have a hernia, you go to the hernia surgeon, and you fix it. There are multiple people that you end up having to see to get the right treatment. It requires a whole lot of sophistication to navigate that. That's really where Pelex...where we feel we really offer the value for patients dealing with these issues, is that we are really simplifying and shortening that patient journey to wellness.
Pelex Combines a Connected Device and a Telehealth Platform to Provide Effective Care
Sal Daher: Can you tell us what your device does, how it helps in that to integrate this multidisciplinary approach that's necessary to resolve urinary problems?
Interviewee: Absolutely. To understand why it's important to have this device, and why it works the way it does, it's also helpful a little bit to understand a little bit more, what are the actual barriers that people are running into? Really, [there are] three things people need to get good outcomes. You need access to the right doctor, because not all doctors can treat this. You need access to the right treatment, meaning that even if you find the right doctor, if you can't get the right type of treatment, you're still not going to get the right outcome.
Then finally, you need the right delivery of treatment. What I mean by that is, because of the body issues that are associated, a lot of these treatments can be really invasive. Finding something that isn't overwhelming and scary, that's intuitive to use is also really key in getting folks to pursue treatment. That's really where our solution comes in, is solving for all those barriers. We are a connected device and telehealth platform.
The way that the device works is that we're actually taking clinic-proven therapies out of the office and bringing them into the home. All of this treatment can be done in the home rather than having to make these trips to treatment providers. Specifically, we have two technologies. One is a physical therapy that is augmented by a form of biofeedback. This also allows for diagnosis for a lot of pelvic floor disorders. We also have a neurostimulation technology as well.
Now, with those two together, we actually can treat up to 90% of all pelvic floor disorders. The other 10% are really surgical remedies. Because we're able to do that, and we're able to do it in a non-invasive manner, we can take all that treatment where folks are traveling to a physical therapist for pelvic floor physical therapy where they're going to potentially a urogynecologist or a specialized urologist like myself, and they're able to do this all in the home.
Pelex Intends to Bring Together the Right Provider, the Right Treatment and the Right Delivery of Care
Sal Daher: Basically, the device is to help empower remote delivery of care, and therefore, substantially increase access, which solves one of the problems of access to the right type of care.
Jeremy Wiygul: Exactly.
Sal Daher: Removes the friction.
Jeremy Wiygul: Exactly. Then the other component to that is the telehealth platform, and if you look at current products in the market that are trying to address these issues, and there's actually quite a few, everyone's trying to do the right thing. They're trying to make sure that they're getting the care out there, but you can make the best device in the world, but if it's not being used appropriately, you can actually do as much harm as good. That's really why the telehealth platform is so important, because you need that care with a specialized provider to make sure that you're doing the right thing.
Consumer-Grade Pelvic Floor Devices Are Hit or Miss
If you just buy something off of Amazon, which is what a lot of people end up doing, it's just random chance whether or not you're actually going to get the right treatment for your condition, because, it's not all just Kegel exercise. There's all types of different types of therapy that's needed, and you need the right treatment provider for that. That's why the telehealth platform is absolutely key to this. Again, because telehealth is here to stay in terms of medical care, it only makes sense that we build the device into a telehealth platform to improve connectivity, and to be able to allow patients to have their care personalized by their treatment provider as well, because the device will have a data tracking component as well.
Parallels to Imago Rehab Which Delivers Physical Therapy Remotely via a Connected Device
Sal Daher: Well, at this point, I think we should recognize that we connected via Chrissy Glover of Imago Rehab, a company which has a device, and is using a telehealth delivery of care in that case for helping patients who have had stroke to help their hands recover. It's a robotic glove. In a way, there are a lot of similarities between Imago Rehab and Pelex in a sense that you're taking advantage of this opportunity, this moment that we have now that telehealth has been broadly accepted. There is also the case of Imago Rehab. It's not just the device. It's also the fact that they're just getting reps.
Having a physical therapist interact with the patient remotely, and the physical therapist might see the patient in person one time or two to help them put the glove on and all that thing, but then they can capture information remotely and so forth. This is like cutting edge of development of this combination of some connected device, and then telehealth. Very interesting. Actually, how did you connect with Chrissy?
Connected with Jeremy Wiygul via Chrissy Glover of Imago Rehab
Jeremy Wiygul: I actually met her through another friend of mine, or actually, another connection that I had made, a friend of mine from residency. There was a couple of touchpoints there. I really want to definitely give a shout-out to Chrissy. She has been nothing but incredibly helpful this whole time. Aside from being just a really nice person, it's obvious that they're going places. Again, want to give her a shout-out for that.
Jeremy Wiygul’s Own Physical Rehab Informs His Work
Also, to your point, Sal, and just following up, when I was in college, I broke my hand, and I needed to go to physical therapy. I had a pin put in it, and I went to physical therapy. I remember, I saw the physical therapist a couple of times. I went home and did my own treatment that was prescribed to me. I was so motivated because, I was thinking I wanted to be a surgeon at that point.
[laughter]
Jeremy Wiygul: I got to make sure that my hand works. I went home, and I just went nuts on it. I remember one of the things that stuck with me from that interaction that echoes even now, and goes to your point about this idea of reps. When I came back and I saw her, and she saw the advances I had made, she was like, "You've been working on this a lot. Haven't you?" I was like, "Yes, absolutely. I'm super motivated to do this." She was like, "Well, that would be ideal for everyone," but obviously, if you don't have something pushing you along in terms of care, and especially if you are like most people these days, I was a college student, and I was in my senior year.
All I had to do was do this, and finish up a couple of exams, so I was hyper-focused on this. If you're someone who has a full life like most people do, you need something that's pushing you along that path for rehabilitation. That's another reason why there's such a value add to this type of model.
Sal Daher: Yes. Chrissy, I think she was getting something like one or two orders of magnitude increase in the numbers of rep effectively. The old model is, a physical therapist goes to the home of the patient, and then works with the patient one on one, or sometimes the patient comes into a therapist's office. Many times, appointments are missed, so it's once a week and so forth. They're doing reps every day with the glove. I think there's a whole class of problems that will be solved with the integration of connected devices, and these telehealth platforms.
Jeremy Wiygul: Yes, absolutely.
Why Would a Urologist with a Practice in New Your City Found a Startup?
Sal Daher: I'm curious, a practicing urologist in New York City has all the work that he or she could want, why start a company? Why do something as crazy as start a company? Where does this come from? You have entrepreneurship in your family, or where do you get this idea of becoming an entrepreneur?
Jeremy Wiygul: Well, the idea of the company, it's something I've been playing around with for a while. I think, and I know that you've interacted with a bunch of entrepreneurs, and you likely a lot of insight into this as well. There's something when you're confronted with a problem, that you just feel, there's almost a sense of injustice associated with it. You're like, "This should be better. This, there's no reason why this shouldn't be improved."
Sal Daher: Yes. It's outrageous that so many people are suffering so much from this problem that has a solution, I can see it, and it's not getting done.
Jeremy Wiygul: Right, exactly. I think that's really the impetus, at least in the entrepreneurial community that I've come in contact with, is there's almost, I don't want to call it a righteous indignation, but there really this, "This is silly. We should be able to do this better." Now, I also like to tell people that you have to pain as well, because there is a lot of work associated with this. Listen, if we can do something that really moves the needle in terms of care, who wouldn't want to do that? Who wouldn't want to be involved in that?
Sal Daher: I asked the question knowing what the answer is likely to be, you've got an itch you have to scratch. That's the drive, you see this thing and you got to do it, and it's not a rational thing, and it is to the great benefit of humanity that people take on these very difficult, painful things, because it is a very painful thing. It's much easier just to continue growing your practice, and just go along.
What’s the Innovation Pelex Is Bringing to Market?
Where are you in terms of developing? I understand you have some new technology; would you care to explain what's new, and what's just coordinating existing resources?
Jeremy Wiygul: Sure. Our device, again, it's important to know that our advice has two separate technologies, both of which in broad terms have been proven out clinically in the past. One is that, again, it's the biofeedback physical therapy. Now, what's novel about what we're doing is actually how we're accomplishing that biofeedback. Up to this point, everything has required, as I alluded to before, some type of the device that's invasive to be able to do this.
Sal Daher: Like a needle or electrode or something.
Jeremy Wiygul: Exactly, something that either pierces the skin, or actually goes inside the body. Obviously, that turns a lot of people off. We are actually able to accomplish that non-invasively. In addition, our neuro stimulation therapy is actually targeting a nerve transcutaneously, so that means through intact skin, so nothing that needs to be inserted into the body with a nerve that's only been accessed percutaneously, so through this, a needle placed through the skin. The novelty is both in the noninvasiveness as well as the way that we're addressing the nerve stimulation.
Again, in addition to all this, the device has the ability to track responses. That's going to be really important, because the Grail of pelvic floor research is being able to get granular data on responses to interventions, because, as you can imagine, once a physician who's taking care of these patients refers them out to a physical therapist, for instance, that physical therapist a lot of times, potentially they're using devices, potentially they're not. That data isn't going back to the doctor who would be doing most of the research.
Assuming that we're able to accomplish scale, we'll be able to have data that doctors can look at for hundreds of their patients and make decisions based on what their interventions are being recommended. There's multiple parts to the device.
Sal Daher: You're saying that the device also lends itself to population-scale data that might shed light on improvements. There're possible two ways of treatment?
Jeremy Wiygul: Yes. It can be a pure research tool in that sense, but it also can help for personalized care on a patient-by-patient level.
Sal Daher: Benchmarking.
Jeremy Wiygul: Exactly.
Sal Daher: How a patient is doing.
Jeremy Wiygul: Exactly. Does this treatment affect this parameter, and how does it? Then, how do I fine-tune that, from the physician standpoint, or from the treatment provider standpoint?
Sal Daher: When the patient sees the therapist, they'll be wearing a device, and the device provides feedback that then the treating physician can keep track of and understand.
Jeremy Wiygul: Right.
Sal Daher: That is a way that integrates these different siloed service providers?
Jeremy Wiygul: Yes, absolutely. Also, again, just to re-emphasize that, because there's a wealth of data that shows that having this ability for biofeedback, above and beyond just interaction with the treatment provider, improves both short-term and long-term outcomes literally by orders of magnitude at times. It's really crucial to be able to have this for the best outcomes.
The Regulatory Strategy to Build Value in the Long Run
Sal Daher: Very good. Perhaps we could talk a little bit about regulatory strategy, and also, intellectual property strategy. First, regulatory strategy. What are your plans in terms of, are going to seek FDA clearance? Explain your approach to the regulatory side of things.
Jeremy Wiygul: No, absolutely. With everything, a part of our regulatory strategy is influenced by what we see will be the best way to drive adoption, right? I alluded to it earlier that there's a lot of devices already out there, and they've already pursued the exempt status. We think that is a mistake, and it's because of this idea of not being able to differentiate what's a clinical-grade device versus something that is out there to help with Pelex for "wellness".
I definitely think there is a role for that type of product as well. In terms of what we see our long-term strategy is, we are pursuing a 510K designation for the first technology. Again, that's the biofeedback. That actually is for two reasons. Number one, we're actually going to be pursuing specific claims on the device. Whenever you do that, you at least need a 510K. Then, also, that actually helps when the initial physician recommendation, we feel very strongly, and again, this is based on all of the interviews that we've done with end users and other physicians. I can tell you, I feel this in my heart as a physician who takes care of these conditions, to be able to make that differentiation with doctors, you need to be able to show that you have the imprimatur, as they say, of the FDA.
It's really important in terms of winning market share, we feel, to do the regulatory strategy that we're talking about. Now, initially, we are planning on doing, potentially, an exempt test case just to show that there's demand for the device, but the long-term strategy will be the 510K. That's also because we are pursuing a third-party reimbursement strategy for our business model long-term.
Sal Daher: Very good. Very good. You expect it's going to be a reimbursable service to device?
“...we feel very strongly that our outcomes are going to be above, and significantly better than any other service that's out there.”
Jeremy Wiygul: Yes. That's because we feel very strongly that our outcomes are going to be above, and significantly better than any other service that's out there. Because, we have both that combined device, and an engagement platform. Because we're going to have people who are going to be able to access care in a way that they weren't in the past, we're actually going to be bringing more people into the treatment funnel, essentially.
Sal Daher: Interesting. When I spoke with you offline, we had talked about how your telehealth side of things, you're not building a platform, de novo, you're using existing resources, so your focus on innovation is on the side of the device. It's putting the device into a situation where it can add value of bringing things together. It's integration of services. It's not creating services anew.
Jeremy Wiygul: All right. A good analogy is, as a hobby, a few years ago, I started working with an Arduino. I don't know if you know what that is, the prototyping platform. The reason why I bring it up is that, if you just have the desire to try to figure things out, there's so many off-the-shelf sorts of products that are out there that if you're just looking at it from a very scrappy, "How do I do this for, if not $0, for as close to $0 as possible, what does that look like? What are the basic components, and then, how do I build it from there?" That's definitely the attitude we're taking towards building the telehealth component.
Coming from a pure clinical background, the question that was always in the back of my mind is like, "How are we going to deal with HIPAA?" Actually, almost every telehealth platform has a HIPAA compliant component built into, so you can literally just check a box on your service, and you're now fully HIPAA compliant. Then, there's tons of lightweight EHR systems out there, so just plugging those together, and just building a very simple, bootstrapped prototype together.
Number one, it minimizes, obviously, financial investment on that side, but also, again, going back to this idea of scratching an itch of mine, of just being able to bring these pieces that are lying around, and just building them into something that you want it to do a certain thing, like building an Arduino, using an Arduino to build a robot.
Strategy with Regards to Intellectual Property
Sal Daher: That is really interesting. Now, intellectual property. If you begin to get traction, how is it that you keep competitors from just copying what you're doing?
Jeremy Wiygul: Our IP is based on two things. It's specifically the patient interface, so the way that the actual patient interface is with the device, and it's also built on some signal processing for the neurostimulation. Now, what we're really excited about in terms of our IP is that because of the way that our patient interface works, it's hard to get into too much detail, obviously, but it allows us to target this nerve that we're targeting for stimulation in a unique way. It's actually the only nerve that can be addressed transcutaneously through intact skin in the pelvis.
Because of that, that essentially draws a very big fence around what we're doing. People can build pelvic floor physical therapy devices, they can definitely do that, but they can't do it non-invasively because of our patient interface. They also can't do neurostimulation at all transcutaneously because of our IP around that. We feel very good about our IP situation. As I told you, when we spoke offline, we just got our notice of allowance on part of the patent application. So, we should be getting awarded that later this year. We're very excited about that too.
It's a very important part of what we're doing, and you're right, if it was something that someone could come in and engineer around relatively easily, we would still have value, but it obviously helps a lot that that's not something that anyone can do in the way that we're doing it.
The Combination of Practitioner, Care and Delivery Has the Potential to Build a Brand Based on Dramatic Improvements in Outcomes for Patients
Sal Daher: Okay. Very good. I guess also, if you are the platform approach to this, integration, if that works well, I think it will also have the benefit of practitioners of various types using it because it's convenient. It gives good results, and it's convenient, and that also serves to create a barrier, the competitors who are unable to bring together all the pieces the same way. It just is really, in the end of the day, how well it's done. If it's done well, it is very difficult for someone to compete.
Jeremy Wiygul: Right. That's part of the reason, again, we see our long-term development strategy the way we do. Is, if we can win this, the brand-name recognition, if any time this condition comes up in a clinical scenario, and our name is top of mind, we've won. That's what we're aiming for. I mean, we're not bashful about what we're trying to accomplish going back to what we said before like, I can just focus on my practice, but if I'm going to do something like this, I want to do something that has a lot of impact. That's what we're aiming to do.
Sal Daher: Excellent. Excellent. Jeremy Wiygul, are there any other thoughts that you would like to leave with our audience, founders, angel investors, people who work at startups? What would you like to communicate?
If the Wife of an Urologist Struggles to Get the Right Care in Her Husband’s Specialty, There’s Obviously a Problem
Jeremy Wiygul: What I would like everyone to know more than anything else is that, we are absolutely dedicated to fixing this problem. Some of it comes from a very personal place. I've seen my own wife struggle with these conditions, and struggle to find care, and she's married to a urologist that treats these conditions. So, if she's having problems, the difficulty that the other folks are running into is obviously several, its magnitudes of order are greater than that.
Contact jeremy@pelex-med.com if You Have the Problem or Want to Help
What I would say is that anyone who is listening to this podcast, if this is something that you're interested in in any form, if you are a patient affected by this condition, if you are someone who has a loved one who is affected by this condition, if you are an operator in any way who has worked in this space, and would love to talk to me about, or talk to my team about this, love to hear from you. Investors, obviously, would always love to hear from anyone who really wants to get involved with us, and really push this forward because, every once in a while, I'll have this moment where I'm like, "This is a huge opportunity, and there's no way we're going to let this get away from us. This has to happen." If it's not us, it's going to be someone else, and I want it to be us.
If you are interested at all in what we're working on, please reach out. You can reach me at my email address. It's jeremy@pelex-med.com. Take a look at our website. It's pelexhealth.com, and you can also see us on LinkedIn. You can reach out anyway, would love to hear from anyone who's interested in this, so please, please, please, reach out.
Exit Strategy
Sal Daher: That is tremendous. It gets me thinking, for an investor, what is the exit in a company like this? Have you given any thoughts to that? You have comparable.
Jeremy Wiygul: We've thought about exits, and like I said, so, I always say this with a caveat that, I want this in the world right? However that looks, I'm for, but, because we feel so strongly that this is an opportunity that is very rare when it comes to startups, and I know everyone comes into this, I imagine everyone comes into this saying, "Yes, we're going to be huge, et cetera," but no one has tried what we're doing before, and it just makes logical sense.
Whenever we explain this to anyone who's even halfway aware of this problem, everyone's like, "Yes, absolutely. That makes total sense." Whenever we talk to patients or people like new moms for instance, the response that we get when we talk to people is just, it's just very compelling. I'm saying all that because, we feel that we can get to an IPO. We feel that we can be that company that becomes a sustainable business on its own long-term. That being said, we've also explored exit options. There are strategic investors or strategic partners that could potentially be interested enquiring us.
I won't comment on who those are. I just don't know if they want their names associated with what we're doing right now, but we've definitely identified those people, but we're swinging for the rafters, as they say.
The Power of Bringing the Right Technology to Market at the Right Time
Sal Daher: That brings to mind, one of the qualities in a founder, the technical founder is someone who has a sense that it's the moment for the technology to be brought to the market. Timing in that sense is a very, very important component of success in a startup. If you're bringing to market the thing at the right moment where the technology has created the possibility of delivering something that has a huge value and no one else is doing it. The first person to market with that can indeed be very successful.
Learn More at https://pelexhealth.com/
Jeremy Wiygul: Like I said, we were chomping at the bit about this. We feel this is a huge opportunity to have a really, really significant impact on people's lives. Yes, we're super excited about this.
[music]
Sal Daher: Tremendous, tremendous. Jeremy Wiygul, MD, urologist of Pelexhealth.com, P- E-L-E-X health. Was there a hyphen there, or was just?
Jeremy Wiygul: No.
Thanks Chrissy Glover of Imago Rehab for the Introduction to Jeremy Wiygul
Sal Daher: Well, I thank you for being on the podcast, and talking about a very important problem. As I say, I'm very grateful to Chrissy for the introduction. Let's move this ball forward.
Jeremy Wiygul: Absolutely. Thank you so much for having me on. It's been a real pleasure, and it's been great meeting you.
Sal Daher: Well, it's my pleasure. This is Angel Invest Boston, I'm Sal Daher. [music]
I'm Glad you were able to join us. Our engineer is Raul Rosa. Our theme was composed by John McKusick. Our graphic design is by Katharine Woodman Maynard. Our host is coached by Grace Daher.