Jun 16, 2021 Robert Fenton

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

 


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Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market.

Heather joined EvoEndo in 2019 after completing the Stanford Biodesign Fellowship for medical device innovation. She completed her PhD at the University of Colorado (CU) - Boulder's ATLAS program, where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship Grant and Gates Grand Challenges Grant to support her research. 

Heather has spent the past 10 years founding and leading medical device startups, non-profit life science organizations, and innovative academic initiatives, including co-founding Inworks at CU Denver.

EvoEndo was co-founded in 2017 by Dr. Joel Friedlander, a pediatric gastroenterologist, and the interdisciplinary aerodigestive medicine team at Children’s Hospital of Colorado. 

EvoEndo’s mission is to make endoscopies safer for patients by eliminating the need for general anesthesia while reducing the complexity and cost of endoscopy for physicians and hospitals. EvoEndo’s system combines sterile, single-use, flexible endoscopes with virtual reality (VR) based patient distraction to allow the procedure to be performed safely in children and adults without anesthesia or sedation. 

Key Takeaways:

  • How EvoEndo’s products allow for more frequent monitoring and faster results for patients and healthcare providers
  • Tips for the journey on FDA submissions
  • How to fundraise while building relationships and trust with your investors 

Show Notes: 

EvoEndo Website 

EvoEndo on LinkedIn 

Dr. Heather Underwood on LinkedIn 

EvoEndo Raises $10.1 Million to Make Unsedated Transnasal Endoscopy a Reality for Patients and Physicians 

FDA - 510(k) Submission Process

Application to be on the show: From Lab to Launch

Qualio

Music by keldez

 

Transcript

We seek to transcribe the audio as accurately as possible. Please excuse any minor grammatical or misspellings. 

Grant: Hi everybody, welcome to today’s show. I’m Grant and I help produce this podcast. Before we tune in with Robert and today’s guest, Dr. Heather Underwood, CEO of EvoEndo, I wanted to thank you for listening. 

We didn’t know what to expect when we started this podcast a few months ago, but we’ve had listeners on every continent. I guess except Antarctica, as far as we can tell. But from San Francisco to Dublin to Bengaluru, Cairo, Tel Aviv, and Abu Dhabi—we are part of a global community working together to save and improve lives through life sciences, so thank you for being part of that.

Dr. Heather Underwood and Qualio founder, Rob Fenton, discuss EvoEndo’s journey to bringing sterile single-use endoscopes without the use of anesthesia to the market. In this conversation, you’ll learn how EvoEndo’s products allow for more frequent monitoring and faster results for patients and healthcare providers, tips to the journey on FDA submissions, how to fundraise while building relationships and trust with your investors. You’ll learn that all that and a lot more between this discussion with Heather and Rob. 

That’s enough for me now, let’s get into the discussion. Enjoy.

Robert: I’d love to kick off with yourself and maybe you can share a bit of background as to what brought you here today. 

Heather: Thanks, Robert. It's been a pleasure to work with Qualio. It's been [...] year and I'll know. I joined EvoEndo back in 2019. Before that, I was at the Stanford Biodesign Fellowship program. I have always had a passion for working at this intersection of healthcare and technology. I did my Ph.D. here at the University of Colorado in Boulder. I was developing a clinical decision support system for midwives and nurses in Kenya. That was just an incredible project. It really got me very excited and very interested in working directly with patients in that healthcare setting.

Robert: EvoEndo then, tell me about the leap from that background, which is fascinating to the company.

Heather: EvoEndo was founded in 2017 by a group of interdisciplinary physicians here at the Children's Hospital in Colorado. It's gastroenterologists, pulmonologists, and ENT doctors here at Children's Colorado. They recognize the need to provide safer endoscopies for pediatric patients and their families. Currently, the standard of care is to put a pediatric patient under general anesthesia even to do a routine diagnostic upper endoscopy. This comes with a lot of risk and a lot of costs, obviously, for both the hospital and the patients. 

This interdisciplinary team, Joel Friedlander, who is our co-founder and chief medical officer, he is a pediatric gastroenterologist. He was looking at his ENT colleagues that were performing transnasal laryngoscopies—it's a very common procedure to go transnasally. His pulmonology colleagues had these really slim pediatric bronchoscopes that they were using for bronchoscopies. This group realized that they could use the transnasal procedure with the pediatric bronchoscopes to go transnasally to do GI exams without the use of general anesthesia.

Robert: Okay, so able to modify or repurpose an existing product?

Heather: Yeah. They really cobbled together the pieces of equipment to try this procedure and really proved out the feasibility of doing unsedated transnasal endoscopy in kids. Then what EvoEndo has really done is innovated and created a specifically designed single-use sterile endoscope for transnasal endoscopy in pediatric patients.

Robert: I'd love to ask, how did that happen? You mentioned cobbled together. It's a common story. People are in a situation—you see a problem, you end up building something that solves it. Clearly, there's been a lot of success for you and a lot of momentum. Can you talk a little bit about that process of cobbling together the first product and how that goes? Because that's the part that people often wonder about is, well, of course, it works great now, but how did it get there?

Heather: The procedure of transnasal endoscopy has been around for a long time, almost exclusively in adults. Even then, if you think about a drinking straw, most of the endoscopes on the market are a little bit bigger than a drinking straw. That goes into your nose and down your esophagus, into your stomach, and your small intestine. Even for adults, the procedure is not historically very comfortable. That made the procedure pretty much impossible to perform in a child with smaller nasal anatomy, which is where those pediatric bronchoscopes that Joel saw his colleagues using in pulmonology, they were small enough to go through the nose in a child. 

They use the reusable pediatric bronchoscopes, they use the TNE procedure that has been around for a while, and then Joel added the patient distraction. The patient actually wears virtual reality goggles during the procedure. I don't know if you have kids, but you sit them in front of a video or a movie and they're pretty distracted. He was able to perform this procedure in an awake patient by putting these three pieces together. 

The pediatric bronchoscopes, they're not meant for a GI exam. They're reusable scopes so that introduces infection risk, creates a lot of costs for the hospital around reprocessing and cleaning those scopes. It also comes with a lot of breakage and maintenance. When these scopes get really, really tiny, they break more often. 

Like I said, cobbled these pieces together and proved out the feasibility of doing unsedated TNE in kids. Then EvoEndo, we saw the need for more of a turnkey system, so we did a lot of R&D over the last four years to design a specific transnasal gastroscope that will be the first and only scope in the market with a specific pediatric and adult indication for use. It's a single-use scope designed for the TNE procedure. 

Robert: That's such an interesting application of multiple technologies to solve the problem. It's amazing to hear that. With this, doing some research beforehand, your folks are now pending 510(k) clearance, which is really exciting to get that across the line. Can you walk through what the process was like because we already mentioned that, okay, there were existing products that were similar on the market for different applications? Could you tell us a little bit about that journey? Because there's a lot of learning there. A lot of companies, this is where they fall down often. You have something that might work, but it's different to develop something that might work versus something that might work and you can get approval for.

Heather: The 510(k) process is long. That's all at a high level.

Robert: One of the shorter processes is all the same. 

Heather: That's true. We've been working towards our FDA submission basically since the company was founded, I suppose. Really, for the last year and a half, we kept having deadlines for submission, and then that kept getting pushed out. It just takes a lot of time and a lot of effort to understand the standards and find the right people to assist with the testing, the report writing, and finding qualified vendors to get everything that you need done to actually get that submission in a good spot to send to the FDA. 

Another key piece is really to develop a relationship with the FDA. We had several conversations with the FDA and reviewers in the department prior to submission, which was very helpful. We got some insight into the process and what they were looking for, and we were finally able to submit our 510(k) in March to the FDA.

Robert: I'm curious about your product. What are the trends driving products? What are you doing? I think you are an example of a combination of existing technologies, but also looking towards these new avenues to be able to provide value to the patients. VR goggles and those immersive experiences aren't traditionally thought of in the maybe more clinical setting that they've been using now. 

What do you think are the trends driving companies like yourselves? This new way or these new ideas can be brought into healthcare? I'm sure this is just a lot of the investor discussions you've had. I'd love to understand how you look at this.

Heather: For the VR components specifically, there are a lot of interesting technologies. Not a lot of them have really found a specific market. VR and AR have had a little bit of a slow start just in terms of a consumer application. Healthcare is one of those markets where VR could have a really big impact, especially for pediatric patients. Although we've talked with a lot of adults that are like, where can I get my VR for my next procedure? It just makes the procedure a little less intimidating. You can be really dissociated from the procedure room and from what's happening.

Robert: I would imagine a lot of people going through various procedures or local anesthetic procedures. A lot of people getting vaccines right now would probably like to get a set of VR goggles. 

Heather: The needle here is a big one. Kids and needle fear pretty much go hand in hand a lot of the time. That's one of the great things about our system and about being able to do an unsedated TNE on a kid. If there are no needles, there's no pre-op, there's no post-op. It's not a surgical procedure. It's fun in the clinic space now.

Robert: Which is really awesome. There are some data supporting these early experiences that have a huge role in shaping overall fear or willingness to undergo these things in the future. Creating a positive environment for people that are really young has a lifelong impact in terms of their ability to access healthcare. It’s really awesome

Heather: With some of the more chronic GI conditions—EoE, celiac, ulcers—it requires really frequent monitoring. EoE in particular is a food allergy. They do these food challenges six weeks apart. In order to monitor the progression or the treatment, they have to do another sedated endoscopy right now. What our system will enable is actually more frequent monitoring and faster time to treatment in these patients with these chronic diseases that require regular endoscopy. 

Robert: With that, maybe let's move on to the fundraising. I read the press release, the big announcement yesterday. I'm really excited to watch you folks on that journey. Maybe tell us about the process. I'd be curious to whatever you can share about where the company was at. How it was like to raise that? It's a lot of capital and it should be healthy to really move to that next level. Could you walk us through the steps and process as to what made you decide now was the time? How did you do that? What was that going to unlock for you?

Heather: Great question. Fundraising is an ongoing job, an ongoing process. We have had a number of incredible investors, mostly family offices and individuals from the beginning who are really passionate about our mission and just very supportive to bring this technology to market, to really help the patient. 

We have raised a number of convertible note rounds over the last four years. They're all converted in this equity round. The funds are really going to go towards the commercialization of our product this year, hoping to do a limited market release after we receive that FDA clearance later in 2021.

Robert: It sounds like you raised from private individuals [...] than traditional venture capital or other groups like that. I'm curious, looking back on the experience, any lessons learned you'd like to share with other people who might be thinking about going down that path right now?

Heather: Any fundraising, it takes a lot of resilience and it takes a lot of persistence. We talked with many, many VCs before we were able to actually close this round. It's interesting here with fundraising. We saw a lot of conservatism at first. People are holding on to their funds, not knowing what was going to happen next with COVID. Then we saw this influx of capital to certain sectors in the life science and healthcare space. 

It was just a matter of continuing to have those conversations with people, developing those relationships with investors, and showing them progress consistently over all of the last 12 months.

Robert: The hard part—showing consistent progress over time. It's often that people don't realize that rarely are these single data points, and in a lot of cases, people know people that had a chance to both build a relationship. More importantly, the things that we say we do, have we done those to [...] degree so that they can believe—when we’re talking about the future—that there's a possibility or likelihood that we'll be able to deliver on those milestones we raised on. I think that's a valuable lesson. 

I know we're coming to the end of our time here, Heather. There's one question I'd love to ask you, and it's really focused on that idea of sharing advice and helping other founders, other CEOs, and companies doing things like you're doing. If you could leave a voicemail to everybody in the industry, what would it be?

Heather: One of my favorite quotes is, failure isn't fatal and success isn't final. The only thing that matters is the willingness to continue. I think I'd probably put that on a voicemail to give everyone who feels a little stuck right now in whatever aspect of the journey they're on, whether that's fundraising or regulatory. A little bit of hope. If we just keep at it, stay curious, and keep learning. Also just to surround yourself with amazing people who are smarter than you and you really trust, then I definitely couldn't have done that without them. That's what's going to get us through and help us get on the market this year.

Robert: I really love that quote. I've got to find the scores for them and keep a copy for myself. Thank you for sharing that one, Heather. This has been really awesome. I'd love to chat more, but I know we're coming up near the end of time. Is there anything else that you'd like to share or chat about before we finish up for the day? 

Heather: I just want to stress, EvoEndo is on the cutting edge of single-use endoscopy technologies, and the market is moving in that direction. We're really excited to move forward after we get our FDA clearance and bring this technology to pediatric patients and their families, and hopefully, really make a difference in the quality of care.

Robert: Well, I'm excited that we're able to support you. I'm looking forward to keeping in touch, Heather. Have a great day. Thank you for taking the time today. I really appreciate it.

Heather: Thank you so much.

 

 

 

 

 

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Published by Robert Fenton June 16, 2021