Reimagining Compression Therapy for Lymphedema and Venous Disease with Andy Doraiswamy, Founder and CEO of Koya Medical: Audio automatically transcribed by Sonix

Reimagining Compression Therapy for Lymphedema and Venous Disease with Andy Doraiswamy, Founder and CEO of Koya Medical: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Paul Grand:
Hey everyone, thanks for tuning in. This is Paul Grand on the Outcomes Rocket MedTech podcast. I am super excited to have you back with us. If you haven’t heard me before, I’m the founder and CEO of MedTech Innovator, the world’s largest accelerator for medical devices. Learn more about us at medtechinnovator.org and look for the link in our show notes. In this podcast series, I interview medtech innovators and stakeholders working to improve outcomes. There’ll be a link in the show notes to a post about this episode on LinkedIn, and I invite you to join our conversation by clicking that link and sharing your thoughts. My guest today is Andy Doraiswamy, the CEO at Koya Medical. Andy was actually a finalist at MedTech Innovator in 2019, which makes me especially excited to interview him today. Let me tell you a little bit about Andy. Andy is the founder and CEO at Koya Medical. Koya is a transformative health care company, developing breakthrough treatments for lymphedema and venous diseases to increase movement mobility and personalized care that is unavailable with traditional compression therapy. Previously, Andy was the COO at Oculeve, the first-in-class health care startup funded by leading VCs like NEA, Kleiner Perkins, and Versant Ventures. Oculeve was acquired by Allergan and post-acquisition Andy was retained by Allergan to provide leadership for the program. Prior to Oculeve, Andy developed site restoring implants at AVS, which is acquired by Santon Pharmaceuticals, sublicense to Bausch & Lomb now Bausch Health, and as the enVista IOL, which to date has treated over six million patients worldwide. He has deep and wide experience in innovation technology and commercialization in health care, and he received his Ph.D. in Biomedical Engineering from the School of Medicine at the University of North Carolina, Chapel Hill. He has an MS in materials science, engineering from the University of Arizona, a bachelor’s degree in chemical engineering from the University of Madras, numerous patents and publications, presentations in health care, innovation, and leadership. And if that’s not enough, Andy also enjoys the benefits of meditation and the thrills of mountaineering. In his off-hours, he restores pre-World War II motorcycles. He’s also on a quest to climb the tallest mountains in the world. That is a lot. Welcome to the Outcomes Rocket MedTech, Andy.

Andy Doraiswamy:
Thank you, Paul. Happy to be here.

Paul Grand:
All right, so let’s start at the beginning. What inspires your work in the medtech industry, both personally and professionally?

Andy Doraiswamy:
So before we begin, Paul, I wanted to say thank you for everything you’ve done for the innovator ecosystem. Patients across the world benefit from all the work that you’ve done through your leadership, so I wanted to thank you first. My own journey within health care began through mountains and mountaineering. I was actually a mountaineering guide and training in Nepal when at the base camp, I saw a cataract surgery. For those who are not familiar with it, as we age, we slowly lose our vision to cataracts, so the crystalline lens clouds, and that is currently given sight through an artificial lens. It’s a two-minute surgery. I have the fortune of observing that when I was done with the mountaineering and so essentially that was my entry into med tech.

Paul Grand:
That’s a great way to get started. Not everybody in med tech can say they started in mountaineering. So that’s pretty exciting. So let’s talk a little bit about your company, Koya Medical. So let’s start with kind of the founding story. What made you want to start a company in the lymphedema space?

Andy Doraiswamy:
Yeah. So if you’d asked me three years ago, Paul, about lymphedema, I probably would have misspelled it, quite frankly. My background primarily was in eye care. Ophthalmology is where I focused and innovated, as you know in intraocular lenses, dry eye disease. As I was exiting one of the companies to pursue what was next, my dad turned 76, and unfortunately was diagnosed with prostatic cancer so he had his surgery, which is very common in both surgery and radiation. Subsequently, he ended up with an impairment of his lymph nodes and ended up with lymphedema. So that was my first introduction to lymphedema, and as I started learning more about the disease state, I wanted to do something about it.

Paul Grand:
You know, it’s really interesting, Andy, because I found in my experience a lot of founders at health care companies do have a personal connection. I think it helps in terms of passion and drive. It’s not a requirement but I definitely think that really does make a difference. I’m glad to hear you started a company to help with a problem with your father. We’ll dig more into that in a little bit. So let’s get into lymphoedema a little bit. You know, as you said, you started off, you probably couldn’t even spell it. Tell us what lymphedema is and what does your product do? How does it address this problem?

Andy Doraiswamy:
Yeah, lymphedema, unfortunately, it’s all around us. So everybody’s heard of cancer and venous insufficiency. What most people may not realize is it’s a very common side effect of cancer treatment, a chronic side effect. Once the cancer is taken care of with treatment through surgery or radiation or chemo, unfortunately, a decent amount of patients end up with lymphedema, which is impairment of the lymph node. And then essentially what ends up happening is the lymph is not able to be cleared from the limb, which leads to edema, hence lymphedema, which is basically a protein-rich fluid that causes painful swelling in the arm or the leg, and in some cases, head and neck as well, torso, breast edema as well. It is a condition that is a slow accumulation of fluid. What is unfortunate about the condition is it’s a progressive chronic ailment where if not treated early and diagnosed and treated, it continues to progress further into fibrosis, which turns into a risk of infection, cellulitis, and ulceration, and in really severe cases, one could also lose their leg. Amputation is also fairly common on the lower extremity. A lot of comorbidity as well with diabetes and obesity. It’s a terrible condition. Nearly 20 million folks just in the U.S. suffer from it. One to two out of every five breast cancer survivors has lymphedema as well. It’s a very prevalent condition and with an aging population that continues to grow.

Paul Grand:
One in five breast cancer survivors has lymphedema. I mean, that is just a staggering number. And it’s something that I think, as you said, not a lot of people really have this on our radar. I think it’s probably because this is, you know, something that people are dealing with at home. And I know that’s what your product is designed to help address, right? So let’s talk about value propositions then. You know, there are compression systems that are available right now. What’s your primary value proposition? Sum it up for us a little bit.

Andy Doraiswamy:
Yes. It starts with the need. There are three key stakeholders in this ecosystem as with most ecosystems in health care. It starts with our patients. Unfortunately, since it’s a chronic condition, they have to manage this, they have to be on top of it. They have to make sure this doesn’t get worse. So it starts with the patient. What can we do? Innovation and Koya what can we do to make their lives easier? So it starts there. So the value proposition for us is we have come up with a wearable solution that allows them to be fully mobile and active while they live their life so they don’t have to pause for an hour or two every day to do the treatment. They can be out and about and use it. As far as the second stakeholder goes, it is the caregivers, whether it’s at home or the physical therapists that do the wonderful work of taking care of our patients, or even the MDs and the oncologists and the vascular surgeons. For them, it’s very important to understand how does it work for that individual patient? Everybody is different. They come in all shapes, sizes and forms, and different stages. So personalized care, being smart about what works, what doesn’t. Adherence is a big factor, too. All these come into play and we’re able to provide all these as part of the solution that we’ve developed. And the third equally important stakeholder is the payer. As you know, Paul, in the U.S., it’s a fairly complex ecosystem between Medicare, commercial payers, and the VA. So for them, it’s very important that whatever ultimately they’re paying for from a care path needs to work and needs to also be utilized. If it isn’t utilized then, unfortunately, it won’t work. One of the beauties of the solution we’ve come up with for Dayspring is the access to care is there when you need it. It’s with you. It travels with you. You can wear it any time you need. So really, we’re taking the friction out of the usage, and adherence is something that is so critical for a chronic condition, especially something that needs to be managed. So we’re able to look at these to address the unmet needs for all these three areas.

Paul Grand:
I can tell you from the experience I’ve had and working with your company, luckily, you know, we had a chance to get to know each other through Medtech Innovator for a while now. I could see from, you know, just the patients that you’ve been working with that it makes a huge difference in their mobility. You know, you have mentioned Dayspring, which is the product and, you know, certainly some of its advantages. But let’s talk about, you know, what’s available today. Again, you know, you mentioned being mobile. Does that mean that everything else is not mobile? How is this better than what’s available today?

Andy Doraiswamy:
Lymphedema and venous being a space has historically been ignored from an innovative standpoint. So there are only two real options today. We’re obviously seeing more activity in the work we’re doing at Koya, and we’re being welcomed with open arms for this entire ecosystem, which is lovely. But as far as the current care path goes, it’s primarily the therapists perform what’s called manual lymphatic drainage or MLD. So you need to be with the therapist for an office visit, which is very difficult for a lot of folks, especially for a chronic condition to do on an ongoing basis. The second treatment option that has shown a lot of improvement is the pneumatic compression pumps. So not too dissimilar from ventilators. They are basically large air palms that are plugged into the wall and generate air that’s inflating and deflating these garments that you wear. So it’s a fully tethered system. Unfortunately, it’s difficult for patients to be tied down to it for about one hour a day for the rest of their life. You know, one of our patients that reminds me mentioned that I’ll never forget, she said to me and our team. There’s a lot of life packed in an hour. But so that really sunk in deep with us to say, Wow, that’s quite powerful. It adds up quickly. And what we’re able to do with the innovation we have is we cut the cord literally and allow the patients, our patients to be mobile, be active. And one of the irony, Paul, is for anything that requires constant fluidic movement like venous and lymphatic movement, mobility is very essential. Exercise as part of the care path here, and they’re recommended to be active, very important especially with all the co-morbidities associated with it. So we’re able to enable that. We believe in an active treatment for an active life.

Paul Grand:
Well, activity is everything. You know, having people sitting around is never good and we know that it makes a difference in their outcomes if we can get them mobile and get them back to their activities. I know that has a huge impact so cutting the cord in this particular space is a huge thing so that sounds like a terrific benefit to me. Let’s talk a little bit about the journey here for a moment. Everything is not always roses. There are always issues, setbacks. What are some of the setbacks that you’ve experienced along the way in your journey here? And what were some key learnings that you took away from that?

Andy Doraiswamy:
Continuous learning. That’s one of the beauties and the allure of a startup is you constantly learn. No matter what you’ve seen before, every situation is different. For us I think that two things come to mind in terms of setbacks or challenges which we were able to overcome. One is, of course, COVID. That came out of nowhere. I think everybody clearly figured out a way to navigate and wasn’t easy at the beginning. We had to work remotely. We still have to build momentum, especially as a startup with limited funds. Initially, the clock still keeps ticking so that it doesn’t stop, right? So we have to figure out innovative ways to deal, collaborate still make progress. So that was quite challenging. I think the way we solve that was the trust with the team we have, and this team is unique in that they work before they’ve seen challenges together before. So there’s great camaraderie and trust that’s built with this team and that allowed us to quickly move through the challenges we see. The other challenge is interesting. So with wearable therapeutics, there are very few that actually focus on therapeutic applications with wearable technologies. As you know, most of them do diagnostic which is definitely commendable. Therapeutic adds another layer of difficulty because now you have to focus on solving a disease state. You’re actually treating a disease state, which is very, very challenging. You’re dealing with the physiology, the variation of the physiology, and you have to do some hard science there. Beyond that, the layer that is added is an electromechanical device that is weaved into a garment, which is very unique. And most folks in medtech deal with class three implants or catheters and those types of things. To deal with an actual wearable sort of meets the consumer meets health in that sense, which is definitely unique. And then you think you have to think about it in a different way in a conventional medtech approach won’t cut it. You have to collaborate with experts that come from a very different ecosystem. So those are some of the ways we sort of pass-through that challenge.

Paul Grand:
Well, that’s really impressive. As you mentioned before, trust in a team is huge. I know you’ve got the trust of your team. I know you’ve worked with them before, and that’s one of the things I know that excites a lot of people who continue to back you as an innovator because they know that they can trust you and something that I developed along the way working with you as well as understanding that you were going to tell it like it is. And I know we all appreciate that. You also mentioned that you had COVID as a little bit of a setback and that that trust enabled you to get through it. And not only did you get through it, but you’ve kind of thrived during COVID in many ways, the Dayspring system recently received another 510k clearance for the treatment of lymphedema and venous diseases and lower extremities, which complements the original one you had in the upper extremities, and you received a new CMS code, which was established for your device. So that’s huge. I mean, we talk all the time at MedTech Innovator about you’re going to start a company. Don’t start one thinking you’re going to go get a new CMS code, but somehow you manage to do that even during COVID and you raised the funding round, which we’ll talk about in a minute. But can you tell us a little about what these milestones in terms of the additional approvals and the new CMS code mean for people with lymphedema?

Andy Doraiswamy:
Once again, it goes back to the team. It’s all about the team, quite frankly, and the company is the people. In our case, we’ve got superstars in the team and they deeply care for one another and the mission of the company, which is to transform lymphatic and venous health. And we’ve been very fortunate even though COVID. As you said, we’ve been able to continue and build momentum with series A, you know, we have Arboretum as a great trusted partner in helping build this further and which is very exciting. Beyond that, yes, we’re very proud of our 510k approval. As you know Paul, it starts with, does it work? We’ve been able to check that box. The next box is, can you get it through the FDA and the regulation? We’ve checked that box and we’re happy to say we’ve got the best-in-class label and given the mobility that our product enables, so we’re able to able to absolutely market that to the stakeholders. The third milestone, which is the natural progression of building a health care company, is reimbursement. And the first step for that process, we’re excited that CMS Recognized this as its own category, which has two new codes, which allows us to enable market access for all the patients that are looking for a better solution.

Paul Grand:
It’s a very, very exciting thing that you were able to get that new code. I know reimbursement really is everything these days. Payment. Of course, it’s treating the patients and delivering great therapy in your case. But if people can’t buy it, if they can’t pay for it, then you know it’s a non-starter. And the fact that you’ve got this is a huge advantage. So congratulations on that. So you mentioned briefly, you know that Series A and Arboretum Ventures is one of the multiple venture funds that you brought in in your Series A, which again happened during COVID at $11 million Series A. That was really impressive. Having people like Arboretum and Scientific Health Development partners and others behind you, I think makes a huge difference. But let me ask you, how important is it to have experienced health care investors? You know, what do they bring to the party?

Andy Doraiswamy:
Yeah, I think we’re very, very, very fortunate. It’s never a dull moment there. I think it’s very important to have the right investors, without a doubt. I think it starts with the people within your team and also within the operating team and the investors that back you. Obviously beyond the capital, it’s really the strategic outlook in how to build a company that they bring. They’ve seen so many go through, they’re on their fifth fund, I believe, now. So I think the collective experience that the investment community brings is incredibly powerful for us. We know which path to navigate depending on the challenges we face.

Paul Grand:
Well, you’re very lucky. You know, I told many, many people to pitch Jan Garfinkel and others over at Arboretum Ventures over the years because it is such a great fund and with such a great track record of helping companies. I actually got lucky enough to spend some time on a board with Jan many years ago, and I can tell, you know personally as well that they do add a huge amount of value. So again, congratulations on that. We’ve talked about a lot. I want to just go back to something, said the very beginning again. You know, you talked about being inspired by your own father. So is he continuing to use some or has he used those older school products for lymphedema treatment? Those ones that that had a cord that was tethered and is he using, you know, your new Dayspring system?

Andy Doraiswamy:
Interesting. You ask if you get to know my father, I think one of these days you’ll get to meet him. You’ll see that he is always on the go. He doesn’t like to sit around and he probably will be listening to this and nodding his head I think in agreement. For someone like him, he likes to garden, he likes to be outdoors. He likes to help out in every way possible, constantly on the move. He doesn’t like to sit still and quite frankly, his waking hours are always active. So he has tried the prototype and he loves it, and he wants to be part of the clinical study, et cetera, as we build that thing further. But he is in India, so we cannot enroll at this stage. When ready, I think we will get him the new one.

Paul Grand:
Well, I’m glad. I’m glad to hear that when you have the opportunity, you’ll get it to him. So, you know, again, we’ve covered a ton of things here today and be thrilled to get this update from you. So before we conclude, if there’s any closing thoughts you want to share regarding the space for innovators advice, anything you want to share with us and also let us know where the Outcomes Rocket listeners can get in touch with you.

Andy Doraiswamy:
Yes. No. Thank you again, Paul, for everything you have done and what you continue to do. Health care is unique. You know, we live in a time when it’s arguably one of the greatest needs. It starts with health before you live your life, no matter what you’re pursuing. So it’s very important that we move from treating a disease to really taking care of health. And to start with, right? I think it’s an area that I am deeply passionate about and our team is very passionate about, and we’re able to make our mark in the lymphatic and venous space, and there’s more to come. It’s an innovative group. There’s a lot more that we’re working on as we speak. As far as getting in touch with KoyaMedical.com. You can hit us up through email or if you’d like to talk to us, give us a call.

Paul Grand:
Terrific. Well, listen, Andy, it’s been a pleasure. As I said, Outcomes Rocket listeners. I hope you guys have taken some deep notes here because Andy has shared a number of pearls of wisdom not only about their technology but as an innovator about some of the things that are really important. Things like having the right backers behind your company between having a fantastic team who is aligned and who understands what your mission is and being transparent with them having trust. We talked about so many different things, and importantly, you know, as I mentioned before, having that personal connection doesn’t hurt because it really does motivate you. And for all of us, you know, we talk about mobility all the time as being something that is just so important in health care, and it’s something that I think not a lot of people pay attention to as well. As you mentioned the caregiver in the equation, you know, we talked about payment, but that caregiver and how impactful a great technology like this can be on their lives about freeing them up to not do a difficult procedure where they have to manually drain someone’s leg and compress and all these things, I mean, there’s just so many, so many freedoms involved. If you were taking care of your father or your mother and they had, unfortunately, lymphedema, you wouldn’t want to, you know, have to sit there with them at home. Now you know that they can be mobile with this technology. So again, all sorts of great things. The listeners are hopefully again, you’ve taken some notes, you do reach out to Andy because he, I can tell you, is a terrific guy and someone who does love to help innovators. He’s been on the boards of other companies and foundations and is just a terrific guy to get to know. So thanks again to Andy for being with us today and looking forward to spending some more time talking with you again.

Andy Doraiswamy:
Thank you, Paul. Thanks for having me.

Paul Grand:
All right, everybody. So you’ve heard a great interview today. If you like what you heard, make sure you subscribe to us here on the Outcomes Rocket MedTech Podcast. In addition to medtech, you can also learn other things on the Outcomes Rocket channel here. We’ll have discussions about pharma technology, health technology, also nursing. There’s a lot of different great things to learn, and then just in general, we talked to lots of health care leaders, so please continue to tune in. Subscribe to the Outcomes Rocket. We’ll have a lot more great things to talk about. Thanks for joining us here today.

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