Medsider: Learn from Medtech and Healthtech Founders and CEOs - De-Risk and Execute to Create Value: Interview with Supira Medical CEO Nitin Salunke, PhD

Episode Date: February 26, 2025

In this episode of Medsider Radio, we had an insightful chat with Nitin Salunke, President and CEO of Supira Medical, a Shifamed portfolio company. Supira is developing a catheter-based heart pump that provides hemodynamic support for patients undergoing high-risk heart procedures. Before Supira, Nitin was Vice President of R&D at Medtronic Neurovascular, overseeing global product development. He has also held leadership roles at Altura Medical, Cordis Corp (then a Johnson & Johnson company), and W.L. Gore & Associates. Nitin holds a PhD in Mechanical Engineering and is an inventor and co-author on many patents and publications.In this interview, Nitin shares the philosophy that guided his journey as CEO of Supira, his strategy to evaluate and address major risk factors in medtech, how to generate value for all stakeholders—patients, physicians, and investors, and his formula for creating a next-gen medical device.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Nitin Salunke.

Once you are a clinical stage company, my currency is the clinical data. The more you generate and the more you offer to your investors and your other stakeholders, the more value you generate in their eyes. So having these additional patient experiences that you can present from the podiums that you can share at the scientific meetings, that's one way to indicate that you are clinically derisks the concept and you are clinically de-risk company. Welcome to Medsider, where you can learn from the brightest founders and CEO,

in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now here's your host, Scott Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Nitton, Salunke, president, and CEO of Supira Medical, a shefamid portfolio company. Before Superior, he was vice president of R&D at Medtronic Neuovascular overseeing global product development. Nitten has also held leadership roles at Altura Medical. Cortis and W. L. Gore. He holds a PhD in mechanical engineering as an inventor and co-author on many patents and publications. Here for you the key things that we discussed in this conversation.

First, developing novel technology without predicates carries clinical risk. On the other hand, improving existing tech or creating a next-gen device comes with technical and or commercial risk. Therefore, decide which risk you want to tackle and prioritize them appropriately to avoid overwhelm. Second, create value that resonates with all stakeholders, patients, physicians, and investors. Address risk step by step, keeping value creation at the core of every decision. If you can, choose clinical paths that give you more options, demonstrate progress, and use data to build credibility and attract investment. Third, start with a clear end goal and focus on creating value that aligns with the needs of your customers, strategics, and investors. Be efficient with capital by ensuring your returns far outweigh your cash burn.

Build trust, improve your ability to execute by consistently hitting milestones and keeping stakeholders informed. And don't hesitate to engage with strategics. You can't expect to come out of stealth and suddenly be a priority for potential acquires. All right, before we dive into this episode, I'm pumped to share that volume 7 of Medsider mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lour, CEO of Pristine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health and other proven

medtech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created MedSider. mentors. These e-book volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to medsider radio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely

consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of Medsider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider Playbooks, curated guides, path with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more. And if you're fundraising, don't miss our exclusive investor database, featuring over 750 life science VCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right,

without further ado, let's dive in the interview. All right, Nitton, welcome to Medsider Radio. Appreciate you coming on. Hey, always pleasure to join you, Scott. I know things are hopping at Superior. I know I do appreciate your willingness to cover out some time and share not only your story, but also what you're building at Superior, at least over the past handful of years now. With that said, I recorded a short bio at the outset of this episode, but let's start there.

You know, over two decades of MedTech leadership experience. I think you've been at the helm of Superior now since early 2020, if my notes are correct. So give us like an elevator style kind of pitch on your background leading up to starting the company. Yeah, no, as you mentioned, Scott, it's been an almost five years journey coming here at Supera and a really very enjoyable journey. I started my educational background as engineer. I did my mechanical engineering with research focus on biomechanics. So it was very unusual back in the 90s to have a specialized area of biomedical engineering. So there were schools where they will study biomedical applications of engineering.

And that's how I started and I stumbled upon that. And after completing my PhD in cardiovascular biomechanics, I've been really fortunate to continue to work in medical device sector and that too, in cardiovascular medical devices. So that's my journey of 25 years in cardiovascular medical devices after finishing my engineering grad school. I get to work with both large and small companies. I put my first 15 years with WL. GOR, they were transitioning from a vascular graph company to an endovascular company. So I get to write that way. Subsequently, work for large and small companies for J&J,

and more recently at Metronic Neuovascular, where I get to work on building the neurovascular stroke portfolio before coming to Super 5 years ago. Got it. That's great. And to your point about right of the way, you certainly rode that out in some pretty high growth categories. We'll get into this in more detail, but speaking of Sapira, you're working in a pretty attractive category, right? Especially after the acquisition of J's acquisition of AbioMed. So it gives us a sense for kind of what you're, like the big problem your device is trying to solve for, and then maybe give us a glimpse into where you're currently at in terms of life cycle of the company. Yeah. So Supera Medical,

we are in the business of developing a heart pump that we can deliver using a catheter or interventional technique. So this is the heart pump or cardiac pump that gets used in two different type of indications or patient. In one patient population where the patient is going through high-risk percutaneous coronary intervention or high-risk coronary procedure where the patient needs some kind of hemodynamic support. And that's where the supera pump comes into action by providing that hemodynamic support in

those high-risk PCI patient so that the phympic. so that the physician can conduct the procedure without having to rush through it and taking unnecessary risk. So that's the first application or one application. Other application is for cardiogenic shock or heart failure patient. Those are the patients who have been through several episodes or events of cardiac-related issues and now their ventricle is not capable of pumping enough blood. And that's where supera catheter pump can come into play.

providing hemodynamic support for extended duration to bridge them to artificial heart transplant or heart transplant. And in some cases, by providing the hemodynamic support, some of these patients do recover and go home to the native heart. So those are the two different indications. Those we are going to pursue. Of course, first thing first, we are going with a high-risk PCI indication. Got it.

Got it. Makes sense. And I'm looking at the website now, superiormedical.com, just as it sounds, S-U-P-I-R-A-M-M-M-E. Medical.com. We'll link to it in the full write-off on Medsider, but superiormedical.com is the website where you can learn a little bit more about the technology and the patients that the company is aiming to serve. And in terms of lifecycle, you've had a couple of recent, we're recording this in late 2024 here, a couple of recent announcements around some key clinical initiatives. So give us a sense to where the company's at in as a late Q4, 2004. Yeah. So as I mentioned, Supera Medical,

we started around six years ago as part of the Shifa made incubator, where we start companies and build the companies. Our founder typically starts the company. His name is Amar Sallier, serial entrepreneur. And after getting the company started, he hires someone like me to come in and really take the company to the next level. So after a year or so of starting Supera, I came on board and for the last five years, then we took the company from early concept stage to today. We are a clinical stage company. We have so far treated 71 patient in our both South America's study and we just started our U.S. early feasibility study. Very exciting milestone. So as of this quarter, we initiated our journey of getting FDA commercial approval through series of clinical

studies. The first study just got started and enrollment is doing very well. Got it. And the number of patients that you're aiming to, as of right now anyway, caveats aside that you're aiming to treat in this early feasibility study? Yeah. So we are talking up to a 15 patient that we're treating through this early feasibility study that will allow us to then go back to FDA and request for our pivotal study ID approval. Got it. And you started your first inhuman work in South America, you mentioned? Yeah. So our first in human milestone happened in South America. That then got expanded into additional countries and hospitals in Brazil and South American locations. So that's how we

continue our clinical journey in South America as we were working with. FTA to get the U.S. study started, that Scott gave us the confidence that our product is clinically ready for initiating our U.S. studies and that clinical derisking along with technical derisking in my books is very critical. So that way, once we initiate the clinical studies, we can complete those without unnecessary risk and our interruptions. Yeah, no doubt. I'm sure we're getting into this and a little bit more detail later on in the discussion, but I couldn't agree more. In fact, for other entrepreneurs that are working on their own startups and are staring down a clinical path that maybe doesn't require an OUS kind of first in human type of experience, there tends to be a lot of value in not only derisking the technology, but also de-risking a lot of those IDE studies, right, in the U.S. as well. With that said, let's spend the next 20 minutes or so running through some sort of cross-functional topics that any startup that is going to probably have to encounter hurdles that are going to have to be crossed if you're going to expect any sort of success in the METTech space.

And the first one I wanted to tackle was really just ideation, right? Like you mentioned a lot of these R&D roles, senior R&D roles that you've had at both large strategics like W.O. Gore and Cordes and Metronic as well as startups, you've probably seen a ton of ideas, right, come across your desk over the years. And so when you think about evaluating various concepts, various ideas, do you have a framework that you typically follow when choosing whether or not to work on something? Maybe I'll use Shifarmid as a case study again, being part of the Shifamid portfolio company, so Peramedical. Typically, when you are going into a new therapy space or new technology space, you can take either the technical risk or clinical risk

or both risks. So if you go into a brand new therapy, now you are taking on that, I call the therapy or the clinical risk, where you have no previous precedent about how the therapy may work. Sometimes you go with a new existing therapy space and you use a new technology. You use a technological advancement to come up with a better next generation device for existing therapy space. And sometimes both of those may coincide. So that's how the risk levels can exponentially go up. So typically my preference is if I have a choice to take one of the two risks and not take both the risks simultaneously. I just happened that not by choice, but I think by coincidence that most of the time I go into the existing therapy spaces where there is a true

need for next generation. And what happens, Scott, in the interventional endovascular therapy areas, where I spend most of my career, if not all of my career, the therapy next generation needs are somewhat, I will say, easily defined. If you can reduce the size or a profile of the delivery of this therapy or the product, that gives immediate patient and physician benefit. While reducing the profile or a delivery size of your device, if you can enhance the efficacy, i.e., if you can make the product work that much better, combination of lower or smaller delivery profile with enhanced therapy or efficacy usually leads to the next generation product. So that's the framework is easy to operate within once you put it in that way for endovascular interventional product.

And that's one of the ways we started supera medical at Shepamad. When we looked at existing therapy where there was a market monopoly by a commercial layer and that player abuomede has done a wonderful job not only establishing the therapy but also generating clinical evidence but being the first generation product the product was slightly bigger in the delivery profile and had a performance that could be further improved and that's how we came up with the idea of supera medical to reduce the delivery system size while enhancing the product performance so as a case study, that's usually what I recommend, either for the entrepreneurs and or in the project selection discussion that we used to have in the larger companies in my previous experiences,

where we look at, are we taking both risks or one of the two risks or is there a way to stage the risks so that we don't take all of those simultaneously? Yeah, it's a great, it's a great way to put it. It's not necessarily the end of the world if you have to take them on both risks, but staging them gives you an added advantage potentially if you're willing to take on both sides of that risk equation, so to speak. You mentioned, I want to make a great way. I want to make sure I mention that as well because the portfolio of companies under kind of the Shifa Med umbrella is quite impressive. And so if you're interested in learning a little bit more, ShifaMed, exactly as it sounds, S-H-I-F-A-M-D dot com, S-H-I-F-A-M-D dot com. We'll link to it again

in the full write-up on Medsider for this particular conversation with Ninton. But I encourage everyone to check out the Shepa-M-M-M-Brand. It's pretty cool collection of companies that are building some pretty innovative stuff. So with that said, let's presume you did, you choose to work on an idea, whether or not, maybe it's the, the superior example or another one that comes to mind. Let's presume you've chosen to take on one of those risks, right? Whether it's clinical or technical, you maybe chose to take on one of them, not both. Most entrepreneurs in that stage are usually working with a pretty limited amount of capital, maybe some seed money, some friends and family. And you're just trying to get to

that next inflection point, right, from a technology perspective. Are there a couple pieces of advice that you'd give to that physician entrepreneur, maybe that engineer entrepreneur that's trying to take a swing at their idea, but trying to be as efficient as possible in those early phases? Yeah, of course, as you walk the journey of starting a company, building the company, your end objective is to create a value. And that value creation has to coincide with your own objective of value creation versus what investors may think about value creation. And that also then coincides with the ability to de-risk that company and that solution

along the way. So typically when someone is especially starting a company as a founder of entrepreneurship, or in my case, someone who comes in and takes on the responsibility to build the company, typically keep those two value creation opportunities or requirement in mind, front and center. What is value creation in terms of derisking the company? What are my biggest risk? And am I burning those down systematically, step by step? And that way, also creating a value in the eyes of my physician and my end customer,

but also in the eyes of my investors. because you always have to be fundraising mode continuously. And one of the ways to keep investors attracted towards your company is to show them that one, you execute your plan and two, you continue to de-risk the company and hence create the value. So that value creation has to be front and center instead of making a company and a project as a science project. Yeah, that's a great way to think about value creation, right?

Because oftentimes that looks different to investors, right, versus maybe a peer in the space, right, that thinks you've iterated on your idea and it's their idea of adding value to this concept that may look a lot different than an investor. And Brian Fahy, who you well know runs Adana, another chief of med company. He mentioned something similar when he was on the program and that a lot of times you may have, you may feel quite confident about whether you've addressed technical risk or some political risk, right, or both. But oftentimes you won't really know exactly what investors are looking for until you actually

engage them, right? And addressing this idea that oftentimes those are the, Ultimately, the stakeholders you need to win over at those early stages because you're going to need ultimately more capital in the company. And knowing what they're looking for and addressing those issues front and centers could be really critical at those early stages. Let's segue into kind of the clinical roadmap, which you touched on earlier, right? Your initial kind of first in human work was done in South America and you use that as a lever to get into these IDEE-EFS studies, which is huge. You also have breakthrough designation, which is there's a lot of devices that make it this far with that sort of designation. And with that said, when you think about navigating kind of the ClinReg process, even though you've got maybe some sort of predicate, some sort of trail that's been blazed with AbnewMed in your case and the Impela, how do you think about approaching the reg clinical roadmap? And maybe more specifically, are there a few key learnings that you've picked up on over the two plus decades of doing this type of work?

Hey there, it's Scott. Thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider premium members. If you're not a premium member yet, you should definitely consider signing up. here's why. First, Medsider Premium members get access to every single interview dating back to 2010. That's over 200 episodes packed with expert insights from proven founders and CEOs. Second, premium members also get free access to Medsider Playbooks. These are thematic collections of hard-won insights covering topics like fundraising, risk management, regulatory, reimbursement, you name it. Next is Medsider mentors. These are e-book volumes full of best practices and insider secrets from the same top-notch founders and CEOs that join a program, all downloadable for easy access. Then there's the popular investor database that now includes over 750 life science VCs, family offices, corporate investors, and angels.

So if you're ready to level up your game and check out premium memberships at medsider.com forward slash subscribe. Again, that's medsider.com forward slash subscribe.