Medsider Radio: Learn from Medtech and Healthcare Experts

The Steady and Successful Climb of BAROnova

February 05, 2016 Scott Nelson
Medsider Radio: Learn from Medtech and Healthcare Experts
The Steady and Successful Climb of BAROnova
Medsider Radio: Learn from Medtech and Healthcare Experts
The Steady and Successful Climb of BAROnova
Feb 05, 2016
Scott Nelson

Henry Ford is famous for stating, “If I had asked people what they wanted, I would have built a faster horse.” Although it’s arguable whether he ever uttered those words, the statement is still very powerful. And it’s one that Hugh Narciso has taken to heart. In fact, in the early days of BAROnova, when...[read more]

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Show Notes Transcript

Henry Ford is famous for stating, “If I had asked people what they wanted, I would have built a faster horse.” Although it’s arguable whether he ever uttered those words, the statement is still very powerful. And it’s one that Hugh Narciso has taken to heart. In fact, in the early days of BAROnova, when...[read more]

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Scott Nelson:   0:08
Welcome to Med Cider, where you can learn from experienced medical device and med tech experts through uncut and unedited interviews. Now here's your host, Scott Nelson. Hello, everyone is Scott Nelson. And welcome to another episode of Insider, the show where I interview Met Check and Medical Device Thought leaders on today's program We've Got You Narcissus, who is the founder and president of Barrow Nova. Let me tell you a little bit more about you before we dig into the interview. Uh, prior to founding Baranova back in 2006 you have held several senior executive positions or served on the board of directors have right of companies. Some of those, including left. Oh, spiral Medical Landa Pharmaceuticals. I hope I'm pronouncing that right Core macular surgical symptoms, uh, near Avants Medical Technologies. She also is unnamed inventor on more than 30 U. S. Patents. So pretty impressive resume. Thanks for coming on the program. You appreciate it. Well,

Hugh Narciso:   1:15
thanks for having me, Scott.

Scott Nelson:   1:17
All right, so we'll dig in here in a second, but I don't want to let everyone know that this interview is sponsored by touch surgery. Now on full disclosure, I'm employee of touch surgery. Um, and I'll tell you a little bit more about that as we as we progress here in the interview with you. But in short, that surgery is a company that makes an app that it's free to download on the APP store or the Google Play Store completely free. And it's designed for position surgeons, healthcare providers to learn and practice procedure, surgical procedures anytime, anywhere. So if you're interested, just go to touch surgery dot com and you'll find a link to download the free app. Um, all right, so phew, let's get started. You found another mission just now. You found it. Ah, Baranova back in 2006. It's now early 2016 full 10 years later. It's a long time, I think, from anyone's perspective. Uh, so So let's let's start with how you're feeling about how your position now, especially against, you know, sort of entrance incumbents like like our game with the with the lap band procedure is, well, just other other startups, and they're kind of in that in that safe space like G. I dynamics and paramedics start there. Okay, Well,

Hugh Narciso:   2:36
um, you know, we're pretty happy about where we are. A company Like you said, We've founded the company in 2006 and we've accomplished quite a bit. We've been through a couple of human clinical trials, including our most recent one, which we conducted in Sydney, Australia. Now, in that trial, we demonstrated the fairly significant level of weight loss in those patients. And, uh, you know, just to give you an example at at the six month time point, the average weight loss or our patients who had bm eyes between 30 and 40 was about 14.9% total body weight loss. So if you take the weight of the patient and you subtract about 15% of their weight, that's what they achieved in six months. And if you look at comparable obesity trials, that's, ah pretty large number. So, you know, we're very happy where we are in. Our clinical results were continuing to develop the the product that transpire. Lord Shuttle is the name of our device, and, uh, you know, compared to companies like reshape Apollo G I dynamics and aromatics, you know, those guys are all Trailblazers and, you know, they they've, ah, set the standard with their regulatory approvals. And, you know, we appreciate all that they've done for the space of obesity. And, uh, you know, we're just gonna follow in their wake and hopefully have a successful, pivotal trial. And then we look forward to competing with them in in the market once we get those.

Scott Nelson:   4:10
Well, yes, certainly helped. Thio. I'm not sure if you consider yourself a fast follower, but, uh certainly helps to follow in the, uh, you know, a lot of path that other other folks have helped place. That certainly can appreciate that. But I know you mentioned a couple of things that I wanna I wanna discuss the trial in Australia, a swell of your pivotal trial that you're starting on that show entirely. How much you could discuss with your your US pivotal trial. But let's let's start with the actual device. You mentioned that I think it's often often referred to as the T. P s device. Um, give us give us a hike through the high level overview of the device as well as, um, sort of the disease that you're trying you're aiming to treat. I know you mentioned it. It's an obesity viewing device, Um, and how it may be compared to other other devices that physicians would would use in today's market, sir, So are our

Hugh Narciso:   5:04
TPS is an endoscopic device, and so that means that there's no surgery required to deliver or retrieve the device. So it's a completely endoscopic procedure, both on delivery and retrieval. And what we demonstrated in that Australian study was that the level of weight loss that I previously referred to was actually superior to the weight loss that you see in a similar study conducted by elegant for when they did their low b M. I trial. Um, now you know your audience Mayor may not know, but the Lap band is a surgical procedure, so there's surgery involved in that procedure. So since there's no surgery involved in our procedure, if you can get surgical levels of weight loss without the need for surgery, we think we've got a pretty good competitive advantage. Once we we get to market with our device, now we get Maybe we could talk a little bit mechanistic Lee how we're working. So this device that we deliver endoscopic lee, we, in effect, we build it in your stomach So we send it down in a deconstructed fashion and then, by engaging a few, um, levers and pulleys and in the delivery system, we're able to construct it in the stomach. And and what you end up with is it's a ball, uh, probably a little bit smaller than a tennis ball with a tail on the end of it. And the way that it functions is because of its shape and its size. That tail wants to go across the outflow of the stomach, which is the pilot, Um, so it crosses that valve and the tail sits in the in the intestine. The duodenum and the ball will sit in the stomach, and so our device was designed to work in concert with your own physiology. So a lot of technologies try to fight the physiology. Hearts was designed to work with your physiology, so there's a thing called Paracelsus, which it it's a series of contractions and relax ation of muscle that forces food from the stomach into the intestine and then down the intestinal track. And so when that wave, which starts at the top of the stomach, starts to squeeze down on the stomach, it'll actually push our device down into the outflow stomach the pilot and it'll intermittently blocked that valve. So the wave pushes our device into place. And when the wave passes over our device, it'll it'll pop it out, pops up a little bit out of the pile hours, kind of like a watermelon seed will pop. Uh uh, when you squeeze it between your fingers. And so once that device pops up, it allows food to pass around it, and then the next wave comes along. It pushes our device back in place. So what? Your own physiology, this parasol, which creates the shuttling motion of our devices. And that's what we call it a trans pilot, a shuttle. And by shuttling back and forth, we intermittently blocked the outflow of your stomach so the patient will fill up quicker and stay full longer. And it's really that simple. That's that's the mechanism that we think we're operating under.

Scott Nelson:   8:08
I got it, and that's delivered entirely through an endoscopic approach, right? I got it and you said it's sort of constructed in place, so sort of my writing thing. The parts are delivered through an endoscope, and then the position would actually build it. Sort of in place within the within the stomach.

Hugh Narciso:   8:26
So they're not delivered through the endoscope. The endoscope is there to visualize the process at various points in the in the delivery procedure. But we've got our own catheter that is delivered through the mouth down the esophagus and into the stomach. And, like I alluded to earlier, you know, by turning a couple of cranks, what you end up doing is you engaged some strings, which then engaged some locks. Ah, and ultimately, you locked the device in place and by locking it, that's what I call constructing the device in your stomach.

Scott Nelson:   9:01
Okay, um and this question actually came from our audience. Uh, you know, someone from the med center audience? Ted Jordan, with stellar technology's not overly familiar with stellar technologies. But he asked he wanted that he wanted to ask you Ah, in preparation for this interview, how did the physician then remove the implant after the patient loses the desired amount of weight? Can you answer that question?

Hugh Narciso:   9:26
Sure. So again, it's an endoscopic procedure. So there's no surgery involved in either aspect delivery or retrieval of our product. So the position would go down with a normal endoscope and typically endoscopes have working channels. So we use devices that go through those channels that are well known to gastroenterologists and surgical and ask a bit things like, you know, snares or grass spurs. And what we do is we put ah, grasshopper down the central channel of the scope and with scope allows you to visualize where the devices and right on the top of that ball that I earlier described, there's a release mechanism. So what you do is you grab onto that release mechanism. You pull that back up against the the, uh well, we we retrieve it through and over tube. You pull that that device up to the over tube and apply a little pressure. And what that does is it releases the therefore, locks in the device releases all four of those locks. And once the locks are released, the device could be deconstructed, basically the opposite of what we do when we construct it. And that silicone is then pulled out through the over too.

Scott Nelson:   10:41
Okay, cool. Cool that as you describe that, I'm, uh, thinking air. It sounds very familiar to you. like an I d c filter removal. And, you know, maybe that's because I said most of mine my career in the in the vascular space. But that concept is sort of ah, grafting on thio looking sort of retrieving the implant out of out of a, you know, out of a vessel, or in this case, the stomach sounds sounds fairly familiar, right? You got it. Cool. All right. Good. And, uh, um said if you're listening thanks for thanks for sending that question. It's the other Folks want to ask questions in advance of the interviews. Just just go home. Insiders described the email newsletter typically typically send out, um, information in advance of who I who will be interviewing next? That when you have a chance to ask any questions that, uh, that you, uh, you have for the guest here on the program. So you thanks for the overview of advice. It'll give everyone a good you know, at least somewhat of a feeling for what? You're what You're what you're building their Baranova. Let's go back to that kind of pre 2006 Before before he founded founded the company, you said time with some of the other start ups that I mentioned in the intro Miramonte Medical Corps. Vascular lactose biomedical. You know, when you think about your early time there, um, you know that this is well over 10 years ago now, but, uh, I got to think that there's probably some mentors that you had some folks that in place that you are Ah, you know, that you learned quite a bit from, um can you speak to some of those experiences that you learned along the way that it would be helpful for Phyllis Folks listening that are utterly in there and there met careers.

Hugh Narciso:   12:27
So, uh, well, you know, more than 10 years ago, I had a lot less gray hairs. So I miss those days. I've had the good fortune to work with some, uh, you know, some very knowledgeable and, you know, great, great mentors. And, uh, you know, they know the medical device industry. They know the the pharma industry. And I've spent some time doing both the med tech and biotech. And, you know, I've had the good fortune of of, you know, being under the tutelage of people who are willing to allow me Thio to expand my capabilities. But while also doing that to instill the passion that obviously required to succeed in any business. So, you know, I think a lot of his luck. So I said I had the good fortune to work with people who, you know, took an interest in my career and allowed me to, uh, you know, expand and learn from my mistakes and my successes. So, uh, hopefully that answers the question.

Scott Nelson:   13:31
Yeah, in a desert. Is there anything that you that you remember that you specifically did sort of foster that type of relationship where you were some of these? Some of these industry veterans that helped you along. They were, you know, that where they became a little bit more open and willing. Thio Investing time. And you, Well, I

Hugh Narciso:   13:52
mean, I always compare to my manager's on dhe, my mentors that you know what I was doing and I enjoyed learning what I was doing. But, you know, once I had gotten proficient in that area that I always wanted to take on more, and so they were always willing to, you know, uh, feed me as fast as I could. Could could take out new things on do you know, do it responsibly. But, you know, do it successfully. So, you know, it's really just kind of pushing the envelope throughout your career. You know, when I mentioned in the last question, you've got a passion for what you're doing. And so you know, if you have that passion, then you're willing toe work. The extra hours, you know, kind of accomplish what you need to accomplish and learn what you need to learn.

Scott Nelson:   14:36
I got it. And I think, uh, you know, and I'm making a hunch here, but I'm guessing your passion. You know, 10 plus years ago, it was probably fairly contagious, which, which probably opened, opened open the doors to relationships with those those around you. So you think? I guess. But I feel my touch is probably right. So I'm glad you mentioned that because, you know, like like we like we discussed here earlier in the conversation. You, but at, you know, you know, one of 10 years. But Baranova specifically 10 years. I mean, you've gotta have you gotta have a lot of passion for what you're doing in order to make that work. So very cool. So on that same sort of note. Speaking of kind of the early days of Baranova. What what's what drew you to the to the gastroenterology or sort of the obesity market? Was there something in particular?

Hugh Narciso:   15:27
Well, before we founded Baranova, I had spent some time with leftover biomedical and left toast. Was the company developing a neuro stim technology to treat obesity? So that was my introduction to obesity. You know, obviously, everyone knows it's a very large market, probably, if not the biggest, one of the biggest medical opportunities that that's out there and there are a lot of ways to attack it. So Neurosurgeon was one way to attack it. But, um, you know, when my time was coming to a close, that left toes, they decided Thio relocate the company. I was approached by my co founder in Baranova. Uh, Dr Dan Burnett and Dan Burnett is one of these serial entrepreneurs, and actually probably a better description is he's a parallel entrepreneur because he's probably got, you know, five or six or seven venture backed companies that have started up are in operation right now. And, ah, you know, Dan had this concept that he had developed while he was still a Duke Med school of the transpire lark shuttle and you know, his his early prototype ings quite different from what we have in the clinic right now. But the basic concept is still there. And, you know, I just thought it was the fantastic cop concept in that the simplicity of the approach is what makes it elegant, right? So it's easier to tell people whether it's an investor or a doctor or patient. You know how this thing works. It basically works as as, ah, ball valve, an intermittent valve that we put in the outflow of your stomach that causes you to Philip quicker and stay full longer. So it's an easy story to tell, but it's an elegant story to tell. And when we took it into the clinic, you know, what we discovered was that these patients I lost a lot of weight. And so, you know, we knew we had something there when, when these early patients would lose a significant amount of weight and again we could do it all without the need for surgery. So you know, the Godric's in time

Scott Nelson:   17:34
you got it. And, you know, speaking of you kind of hint at it earlier with with respect to the fact that the first, the first prototype probably looked a lot a lot different than, you know, the device that was that was studied in your your study in Australia. And then probably that may be may be different than the even the one in your pitiful trial here in the U. S. But, um, can you talk a little bit about how how you went from sort of initial initial idea or initial prototype generating on that idea based on on the feedback that you got in the trenches or in the market? Yeah,

Hugh Narciso:   18:09
sure. So you know, obesity's is, uh, you know, it's a challenging field. It's also relatively new field. So it's not like cardiovascular disease where, you know, people have been not only developing products for cardiovascular disease, but they've been, you know, in inventing animal models that will mimic what you see in the clinic. And I think one of the major Achilles heel for obesity right now is there's no large animal model that is very is predictive of what you will see once you take your device from animal testing into the clinic. And so, you know, we can do all the testing and, you know, we did do a series of bench top and animal testing on our device, but you never really know how it's gonna work until the rubber hits the road. You know, you take it into the human cliff. Excuse me, The human clinic. And you know what we learned in those early trials? Hey, it's functioning as we designed it to function. So you know that that's kind of the exciting point that, you know, there's there's the the the anticipation and then the nervousness about taking it into the clinic. You know, you've done all you can to make sure it's safe device, but now I've got to find out if it's gonna be an efficacious device. And so when we did that in our early trial on, got the results that we got, you know, we were excited and what that allowed to do. It allowed us to attract ah, an investor in our Series B, which was Al Ergen, who at the time was, you know, the world leader in devices for for weight loss and obesity.

Scott Nelson:   19:43
I gotta be back in 2008. Is that right? Correct. Okay. Got it. And at that point in time, I am not overly familiar with with space. But he was a lap band. The last man was on the market at that point in time. Yeah,

Hugh Narciso:   19:59
The lap band had probably been on the market for about five years by that point.

Scott Nelson:   20:05
Okay, a lot, man. Maybe if I've got my timing right was maybe early two thousands and then, you know, fast board and she ate an allergy. And because of the strategic investor, very good. Before we move on to sort of how you begin to build out your team and Baranova um, what is there a certain methodology that you typically utilize our framework that utilize you personally your lives or your team utilizes when it comes to making the device generations, based on the feedback that you that you see in in animal abs or in, you know, in actual human human trials, well,

Hugh Narciso:   20:42
it's important to have a stable of, uh, you know, key opinion leaders. So, uh, you know, we surrounded ourselves with some of the best and some world famous gastroenterologists and surgical endoscopy is to help us with that process. Now, Part of the problem is you go to these Ko Wells and say, you know, um, what should we develop? And if you're too broad and when you approach these people, you're you're not going to get the answer that you're looking for because basically what they want to do is they want to make, you know, a technology that they're familiar with. They want to make it a little bit better. And when we're talking about the TPS, we're talking about a technology that is very different than everything else is out there. So they don't even know what's possible until you show them what's what's possible. And when we went them to them with the you know, the original concept of the TPS, then the light bulb goes up in their head and because they're very experienced clinicians, they say, Okay, well, you needed to do a, B, C and D. And then, you know, we put our engineers in the room with the with the ko l's, and hopefully some magic happens.

Scott Nelson:   21:57
I got it. That's interesting that you said to me when you initially maybe that a piece of advice for other other med tech entrepreneurs or just other other folks that serving some sort of R and D capacity, that you're getting feedback from thought leaders or K Wells within a certain therapeutic arena that the goal is to get to go to them with a very specific sort of problem. River specific need that be accurate? Yeah, So

Hugh Narciso:   22:22
it could come back to you. I don't know if you've ever heard the quote by Henry Ford, but Henry Ford that if I had listened to what the people wanted, I would have built a faster horse, right? So we didn't build a faster horse we built, you know, the first car. So it was a very different concept, and it wasn't an improvement on something else that existed. It was a whole new concept.

Scott Nelson:   22:46
You know, I'm reminded also of the ski jobs quote as well, and I'm gonna paraphrase your account of the court in front of me. But it's something to that same sort of effect where I think the theme of the top of the scene. The quote was around focus groups, and he said, You know, you can't focus groups aren't necessarily, you know, worth it, you know, because people don't always know what they want. You know, it's probably fair facing. I probably murdered that quote, but I think I think I think we're on the same, you know, you know, kind of that at the same sort of, Ah, same street content there, right? I think so. Cool. So let's not Let's let's let's passport team now. So you it's you and Dan in the early days. Uh, Baranova, how quickly did you begin to build out a team? And when that looked like And I am asking it because I remember an interview several years ago I did with Rudy Masaki he was probably could be described as maybe one of those parallel entrepreneurs as you as you mentioned, um, but he mentioned how his team only on um I think was in the car and sort of in the context of what would you do? What would he have done differently? And I think he said that now, with his team, he almost entirely almost entirely a contract based team in the early stages of ah, med tech start up. So I'm curious when you look at kind of those those early days and beginning to form out a team of Terra Nova. Is that is that Is that what you followed or what? What does it look like? Yes.

Hugh Narciso:   24:12
Oh, my philosophy Throw. My career has always been to, uh, you know, to be capital efficient. So, you know, we were capital efficient before it was involved to be so. And what that means is, you know, you want to bring on core competency. I mean, you have to have some internal expertise because, like I said, the TPS was a new concept and, you know, we needed people inside the company that could develop that That concept you're never going to get the attention on and the dedication that you need to develop a new product by outsourcing that. But that being said, I think a lot of the other peripheral activities within a company, especially early on, can be outsourced. There's enough excess capacity out there to do that, and that allows you to use a certain function when you need it, and then, you know, avoid paying for when you don't need it. And, you know, one example would be you know, our manufacturing. So we took our Siri's $8. We raised enough money to, you know, developed the product tested on animals, and then do a handful of patients in our first in man trial. Well, to do all that. I mean, after we got through the prototyping and we, uh, we froze the design. You probably need less than 100 devices to support your clinical trial to support your your V N v testing. Ah, and any other thing any other needs for devices? Well, to build up a huge manufacturing facility in operation to build 100 devices that you're gonna need over the next two years makes absolutely no sense. And there's plenty of capacity out there to access. You know, people who have those skills to do that work for you. And, you know, I could probably come up with another five or six examples of functions within an early company that you can outsource. So, yeah, I mean, I would agree with with with your initial statement that you want to be. I won't call it virtual because, like I said, you do want that core competency. But being in a semi virtual.

Scott Nelson:   26:15
Sure. That's a good example. Uh, and, uh, I think that definitely a lesson. The lesson learned in an area where you would know this much more than I I would preserve. But, you know, we're an era where, you know, we're med techs. Venture capital is not easy to raise. And capital efficiency is certainly a certainly incredibly important. I wanna ask you a little bit about that here in a second. The first let's let's talk a little bit more about the FDA, the regulatory environment as well as well, as you know, insurance coverage. And, uh, and reimbursement. You know, I think I think you would probably correct me if my mom, But you probably agree that the FDA does tend to take a lot of criticism when it comes to, you know, slow regulatory times. Although it seems like those are improving as of late. Um, no. It looks like based on 2015 of media may have improved a little bit. Um, but, you know, you're dealing with a p. M. A type of device, right? Even gonna require even more regulatory scrutiny. Not to mention the fact that, um, you know, uh, insurance coverage and then insurance reimbursement is a whole nother, you know, represents a whole another set of, uh, challenges. So, you know, when you think about positioning the GPS device for eventual commercialization in the U. S. You know the things that you're doing now to help you, um, sort of fast track those types of, ah, healthy overcome from some of the challenges, you know, when it when it comes to us. Commercial vision. Uh,

Hugh Narciso:   27:42
yeah, let me start by by, uh, agreeing with you. Over the 10 years that Baranov has been around, there's definitely been headwinds. Ah, and tail winds from the FDA. So, you know, probably within the last. I don't know, three or four years, I would say that our group at the FDA has has modified their way of thinking and their very supportive to companies like Baranova. I think a lot of that has to do with the leadership in the group that reviews are technology. It's Dr Herb Learner who has done a phenomenal job with with that group at the FDA, and I think the FDA is using that as a model to extend to to other areas of specialty So, um you know, but getting back to your question, You know, I have established a relationship with her, uh, over the years, and you know, I have the ability to pick up the phone and and give him a call and say, Look, this is what's going on within either our development area or within the clinic and and, you know, how can we We work through this process so it's It's become a very intuitive process. Onda Very cooperative process with the FDA. Where if you would ask me this question six or seven years ago, I would have said that, You know, the FDA is putting up barriers that are so high that even the approved devices that were out of the time couldn't be approved that day. So hurt. You know, your point is well taken, the regulatory environment, the pendulum swings, and right now it's it's slung to a cooperative direction. But, you know, getting approval and not having reimbursement or not addressing the you know how people are gonna pay for this technology is just as important. It's almost like you can't take one without the other. They're they're inextricably intertwined. So, um, you know what I would say about reimbursement is because Baranova is an endoscopic procedure performed on an outpatient basis, and the cost of the devices is relatively low compared to other technologies. For example, neuro stimulation for obesity that, you know, we have the ability to, uh, you know, once we get our approval from the FDA to support a self pay market so you know, it's it's probably similar toe LASIK therapy, which which your audience may be familiar with. When you know Lacey first came out. It was something that you know people would go in. Insurance wouldn't cover it. But, you know, they would pay for it, and the companies would arrange for financing for support that approach now. That being said, I think that's a short term approach for us because while initially when we when after we get approval and we launch our product it it'll probably be into self pay market. I think there there is incentive for the third party payers to pick up the cost of our device and procedure, because if we can produce surgical levels of weight loss without the need for surgery, you know, that's kind of code for we could get surgical levels of weight loss with all the costs associated with surgery. I think the third party payers are gonna be open to this approach. And so I think we we take a dual track that while we're gaining that no reimbursement approvals that we will pursue a self pay approach.

Scott Nelson:   31:17
I got it so that nothing interesting at an interesting path for certain, it seems like more and more med tech companies are are sort of keeping that sort of, ah sort of idea that sort of that sort of path on the table. That's self pay approach. Where you going to initially launch device into a market? Expect patients to pay forward, especially as co pays and tell insurance, you know, in deductibles and more than increase over time. The more and more patients are paying out of pocket for certain procedures, for sure so. But on that note, I want to ask you a follow up question, even though that you you maybe expect tow launch into a South pay market where patients are paying for this procedure with, you know, with cash. Are you other activities that you're doing now? Uh, conversations. You're having to help with an eventual eventual code or or maybe more specifically, to help with coverage or reimbursement with third party pears. Or do you see that happening down the road? Well,

Hugh Narciso:   32:19
it's it's it's not that black and white. So you know, we've tried to have the discussion with the third party payers, and it's really not a fruitful discussion until, you know, you're you're looking at at that data, right? Got it. And so I think we're gonna talk about a little bit later. But, you know, we've just initiated rus pivotal trial, which is a randomized control, double blinded trial. And so those data are gonna be very pivotal in in, uh, the assessment of the third party payers on whether there's they're there. Right? But I think what we can do right now is we're establishing the relationships with are, you know, obesity society heads, which you really need toe find people to carry your banner to the A m A. Ultimately get the the reimbursement codes that you're looking for. So right now, the ABC societies are very aware of what we're doing there, keeping an eye on what we're doing. We make sure we share our data with the society's. So when it's time for them to pick up the banner and, you know, sing our song to the people that are responsible for coding, I think we'll be prepared.

Scott Nelson:   33:34
I got it. Get get what I want. I want to talk about your recent Syria D and as well as kind of the You know, the pivotal trial really touch on the pitiful trial, you know, share what you can I know it's gonna be somewhat limited in what you can share. But before going, I did mention that this interview is sponsored by my cut surgery again in full disclosure, I'm an employee of touch surgery. Ah, but really, for anyone listening, you should really, really check it, check it out, go to touch her you're toucher to dot com and really encourage you to take the next step and download the free app. Um, completely free to register with your email address. And really, it's very cool. I mean, what we're doing is we're building out. Um uh, surgical procedures were really any type of procedure. Interventional surgical, open surgical, etcetera. Building those out in on a mobile platform, a truly mobile platform. So the concept is that, um, a position and he's eating any health care provider for that matter, instead of having to, you know, the fly to a course, Uh, you re to some sort of power point deck, et cetera. They could instead they can learn and in practice, through interactive procedures on their on their mobile device. So whether it's an iPhone and iPad android, android based travel, etcetera, you can pull it out any you know, any time anywhere. 24 7 and learning practice, uh, procedures. And then what? What's even more unique? You could test yourself against you against what you know or what you practiced as well. So very collapse. Encourage everyone to check it out. So again, touch surgery dot com. Just, uh, just click on the links to download the android, uh, the android version or the version that said that the phone on top by a less so anywhere, uh, actually, back in our discussions. You You Recently, I Can I mention this earlier in the interview recently raised your Syrian be so congrats on that, I think was a 30 minute was reported, at least to be a over $30 million. So very cool to see. Um, very cool that you guys do that before we get into into into what you're doing with the clinical trial here in the US Let's talk about your experiences with fundraising. I know you're serious. B was back in 2008. Syria D No, late 2015 ET cetera are There's a major lesson that you learn, you know, may be with respect. You know, you're early fundraising versus you kind of late stage fund raising. And then also, uh, I want your take on that and also, you know, you got you got you know, you were able to raise money with both corporate corporate entities as well as private credit, eventual capital firm, someone to get your take on that. So maybe let's start with the you know, the differences between your early and late stays around and also get into the kind of the corporate versus private PC topic as well. Yeah,

Hugh Narciso:   36:22
so you know, I would say that, you know, a series a Series B is more about the promise of the technology, I think seriously and serious, he's more about executions. So you know, by the time you get serious, E, you have to prove that you've used the previous dollars raise in a responsible way, hopefully efficient and effective way. Uh, you know, Baranova has, uh we've had the good fortune to Babel attract, uh, many of the blue chip healthcare venture groups to invest in A And we've also received investments both from Al Ergen. Who I think I mentioned earlier was at the time of the investment. They were the world leader in devices, medical devices for weight loss. Uh, since then, they sold their obesity franchise to hollow on. We've also received investment from Boston Scientific, and you know, Boston, while they're not actively involved in obesity, you know, they've got, you know, a pretty mature endoscopic group where, you know, this white space technology could fit into that group at some point. So, you know, I think our clinical data has been validated by, uh, by these, you know, these professional medical device manufacturers, Uh, so, uh, you know, kind of getting back to your point. There's little difference between early fundraising, late fundraising, but, uh, you know, the time you get to see you gotta have a track record that yeah, people can invest in.

Scott Nelson:   37:57
Yeah, I like What was the analogy? You used the differences between being and like, you know, maybe d N A. Is, you know, Andy's A and B rounds are based on the promise and see the browser based on the data. That's a pretty helpful description. Thanks for sure. So you can you discuss, you know the difference, your experiences dealing with private venture capital firms as well as well as corporate venture. Because certainly there's there's been, ah, you know, I'm sure, you know, you'll get a different opinion sitting on who you talk to with respect, working with both both parties especially especially with corporate corporate venture venture arms. So maybe talk a little bit about that. Yes. I

Hugh Narciso:   38:39
mean, if you probably interviewed 10 CEO, you get five that fully support corporate partnerships, and five that absolutely hate them. So, you know, I come from the experience of, uh, I've had very good relationships with corporate partners, and that's those from the med tech world banned from pharma. So I think that, you know, if you get the right person that is your champion within the company and the company values the, uh, the indication and the approach that you're taking to to deal with that unmet medical needs. Uh, you know, I think the motivations are all in the right place on, you know, I've had the good fortune to work with some great BT people from great corporate development people. And, you know, I could give you an example. When our gang made their investment, they put the gentleman David Lawrence on our on our on our board. And David was great. David understands obesity. He, uh, obesity can be a nuanced specialty, and he really understood the do want of obesity. He also understood the challenges of operational issues even with the development stage company. And having that voice kind of balance out the, uh the approach of the venture capitalists was very valuable toe Baranova. And I think we had a very functional value added board toe have both the corporate perspective and the venture perspective sitting in the same room.

Scott Nelson:   40:14
That's that's helpful. That help on, um certainly very, uh, very cool that worked out so well with you. Um, I I got it. I got to think that you just mentioned uh, you know, uh, gentleman by the name of David Lawrence at Alabama. Sure if he's still there, but, um, that the fact that he knew so much there was, you know, he understood the space that you were. You're operating within. I gotta think that helps. That helps a lot for sure. Absolutely. Before we get into that kind of the last three questions probably one of my favorite favorite part of the interview with a little bit more personal nature. Let's talk about you know what's next for Baranova. You know, you mentioned the pivotal study that that, uh, that that you're working on for the U. S. When you talk about that, and then you finish it up with, you know, for positions that are wanting toe learn more about the device are considering, you know, you know, ways to treat treat this, er patients upset, you know, in the future. Why, you know, why should they consider? Consider TPS the TPS, Right. Um so the first part you want me to cover is Yeah, sure. So maybe just talk about the U. S. Trial first for anything that you can share. Um And then and then just kind of finish it up with with, you know, maybe the unique things that are making t p i g p s device different. Okay,

Hugh Narciso:   41:42
so the we just initiated our US civil trial, and I think your audience probably knows that the civil trial is, you know, the final trial that you conduct to gain FDA approval. Um, I can't say much about it. Uh, I can't say much about it, mostly because it's a double blind trial, and I don't know much information about it. So I'm blinded Thio to the trial also So But I can tell you how it was structured. So, uh, as I mentioned the randomized controlled trial. So we've got some patients receiving our device. Some patients that receive a sham procedure so they think they have the device. And, uh, it was randomized 2 to 1 treatment of control group. Um, the goal is to put the device into, uh, about the 270 patients. So that means 180 will get the device newbie in the control group. And thio leave the device in for one year. So we wanted to differentiate ourselves from, uh, some balloon technology where do two materials They need to remove the device. After about six months, we're gonna leave our device in for one year. Now it should be noted that there's nothing in the materials of the mechanics of our device that would prevent it from living in the stomach for 235 years. We just need to prove that And for a start up company to bite off a three year or five year clinical trial right right out of the chute just doesn't make sense. So the plan would be to get the approval at one year of residents time in the patient and then get subsequent approvals to expand that indication out to two years and multiple years after that. But it should also be noted that in that trial were treating patients that are 30 to 40 b m I, which is considered the you know, a lo bm I, uh clinical trial. Uh, but that doesn't mean that we couldn't ultimately treat patients that are above 40. What we saw in our Sydney trial was that patients above 40 lost the same percentage of weight as the patients between 30 and 40. So, you know If you're in above 40 b m my patient and you lose 15% of your total weight. You're gonna lose a lot more weight than someone who's a 32 b m I. But on a percentage basis, it seems to work the same independent of the M I. Now, once we expand north on the B m I scale, there's nothing preventing us from expanding south on the B. M. I scale for overweight patients. There's a cosmetic indication that that we could pursue where you know, people who are overweight and want to lose weight for some specific reason. Such a You know, they've got a wedding coming up for. You know, they wanna look, look good on the beach in the summertime, there's there's the opportunity to, you know, treat those, uh, those subjects with, ah, shorter term device. You know, maybe put it in in January and take it out in April. Um, you know, there's that opportunity for patients for overweight patients. Cosmetic indications, you know, want want that that benefit. There's also the diabetes indications. So you know people are familiar with the weight loss associating associated with improving your Type two diabetes So just by losing weight, you get the secondary effect of improving your your your diabetic condition, either eliminating the meds you're on or at least reducing the dosage. We think that in addition to the secondary effect of diabetes, we're going have a primary effect on on diabetes. So remember early in our conversation we we said that the mechanism that we think we're operating under his slowed gastric emptying so the food moves from the stomach into the intestine in a slower manner. So if you think about that, if if the calories air moving from the stomach into the intestine slower, you aren't necessarily changing the amount of glucose that gets released into the bloodstream. But you're doing it over a longer period of time, and when you stretch that time out, the effect is you reduce the glucose peaks. And if you reduce the glucose peaks, that's exactly what you want to do in a diabetic patient. So we think there's a primary, uh uh, effect. There's the potential least of the primary effect of our device for the diabetic patients, so we're very excited about pursuing a trial in that area once we get our initial approvals and, lastly, another E. We're very excited about his adolescent obesity. There really is nothing for the adolescent obese population right now. And, you know, you just have to open up the New York Times, probably daily to see an article on the you know, the the effects of adolescent obesity. So because that device is completely reversible, you can put it in and take it out. You don't have to worry about the effects of the device on a growing individual, whereas if you were tutoring something in place, you are changing the plumbing like you do with some of the more radical bariatric surgeries. You know, you'd have to worry about that. So in our case, we can get the effect of our device, remove it, and then the adolescent can can move into adulthood and either, you know, maintain their weight loss or if they need some intervention, whether it's another one of our devices or surgery. When they become adults, they've got all the options in problem that they had before. So I think all those reasons together, you know, make physicians very interested in what we're doing because we can treat a broad band of their population because they get, you know, all types of of obese patients and their practices. And I think they're very excited when we talk about these potentials.

Scott Nelson:   47:36
Okay, I I really didn't have any idea. I'm glad you mentioned the three other sort of ah avenues that you could pursue. Um, as well. You know, they cousin uses avenue. It's certainly interesting. You know, we're, uh because your devices removable someone could realistically happen, you know, continue any pretty beach weather. I don't know. I think that sort of fucking cheek, you know, it could be a market, but that you know that the dive, Yes, uh, the ability to treat diabetic patients as well. That's that's very cool. When I get anyone familiar with I understand what you're what you how you were describing sort of the way your device functions. That being the equivalent of you know why it's more healthy to eat a long chain carbohydrate because your body that Jesse's little are thereby preventing you know, those does those glucose Peco's insulin peaks, which can be dangerous for diabetic patients. Very cool. It's well, the reasons I love my attack so much. You know. You know, you kind of put yourself in the shoes of the patient. I'm sure you do this, you know quite a bit. But But you know that patient being on some sort of lifelong or prolonged, You know, you're taking a a drug for a prolonged period of time. Or maybe in some cases, you know, you know, for the course of the life, you know, they could take the can utilize that. You know, the bikes like like yours, you know, for a temporary period of time. So it's one of the reasons I I like med tech. Very cool from that perspective. So, um, very good. You

Hugh Narciso:   49:02
know, I could just make for obesity. I think that this is really a disease that is best treated with the device is about to drugs because what we've seen with the drug studies is not only do you have the effects of, ah, systemic drug on all the systems within the body, so you've got all these, you know, cardiac effects on you go down the list of the drugs. But what you see with drug studies is even the ones that are fairly effective. The body habituated to him within the first, you know, 9 to 12 months. And once the body habituate sit is the body is an amazing thing. It find another pathway around it and you'll see that the patients regain their weight. So I think with a device like ours where you can leave the device in place for a relatively long period of time, get some success, pull the device out if you fall off the wagon. Like I said earlier, you've got all the options in front of you. But you can get surgery. You can get another one of our devices, even get one of the competitive devices put in. Because you you haven't changed anything about your anatomy. You're not all in like you would be with ruin. Why surgery?

Scott Nelson:   50:12
Yeah, it is very, very cool. The way that you leave, your options are open. Certainly himself. Um, very, very exciting. Very exciting for for Ah Baranova. Congrats on all the work you work. You, you guys have done your team have done their very sometimes it's always good to hear some success stories, you know, in the attack. Like like Baranova. So before he is your last three questions. Very short questions that little bit more, more personal nature. Uh, first, you, What's your What's your favorite nonfiction business book? Um, I'm a bit

Hugh Narciso:   50:48
of a dinosaur, so my my favorite nonfiction business book, is an oldie but a goodie. It's built to last a few. You're familiar with that book. But yeah, it was written by some guys out of Stanford and and what they did is they did this comparative analysis of a series of, uh, competitive company pairs So they would take, you know, to two companies within an industry and go through their history and find out why one was successful and why or why one was more successful than the other one. And it's, uh, it's pretty informative on you know what works and what doesn't work and how you do build something less.

Scott Nelson:   51:25
Go so built to last night's question. Is there a business leader or maybe a another founder CEO that you're following right now are maybe one that really inspires you? Uh, well,

Hugh Narciso:   51:38
maybe not necessarily a business leader, but I would say closely related, a political leader who inspired me and still inspires me to this day is Ronald Reagan. This was a man with clear, critically formed ideas, plainly communicated, who had the ability to persuade his opponent, Thio, to support his policies. You know, it's easy, Thio. Convince your own troops, uh, people that are on your side to go your way. But you know, a true leader can get the people from the other side of the pull of you in the same direction. So, um, Reagan's Reagan's my hero.

Scott Nelson:   52:17
Very cool. Good answer. Ah, And then last week, uh, when thinking about your met career and then even even even what you even the successes that you've experienced here, Baranova especially a place. What's the one piece of advice that you tell your your 30 year old self? If I could talk to my 30

Hugh Narciso:   52:35
year old self, I would tell myself, Go into software development.

Scott Nelson:   52:39
Uh, good answer. Ah, good answer. Uh, we'll leave it at that. Uh, let's, uh, let's let the audience sort of, you know, take that for what it's worth, but I've been in a really enjoyable conversation. Q is the best place to direct people. If you want to learn more about about Baranova is your website that

Hugh Narciso:   53:00
would be great. W did like heavy Baranova dot com

Scott Nelson:   53:04
Spirit of a b a r o N o v a and enforceable link to that in the in the show notes, uh, this this interview in med center dot com So, again, you think I think the time for doing this? I'll ask you to hold on here before Before I, uh, people way hang up. But again, thanks for thanks for taking some time and sharing your, uh, your experiences over the course of your career as well with Founding Baranova. Well, I appreciate the time, and I appreciate you, uh, you know, reaching out the Baranova. All right, Uh, hope until the next episode of Meds. Cider Everyone here. Good.