Tushar Sharma - Vivifi Medical

Tushar: 0:05
One of the downsides that we had early on was none of us were physicians. We were all biomedical engineers thinking that we can change the world. Having a urologist on your side makes a huge difference. In fact, I was talking to a urologist I was explaining the whole mechanism of action. And he was I don't know if this is going to work. I don't know if this science makes sense. And then the other urologist goes, Oh yeah, I've checked out the data. It makes perfect sense. That's all it took. It was 15 minutes of my convincing versus one statement from the other urologist. That's all it took!

Giovanni Lauricella: 0:43
Tushar, we are going to do the MedTech startup podcast today. You can see from my shirt. So I want to say thank you very much for joining us. And the purpose of what we're going to be doing is getting inside the minds, the heart and the gut of a medtech entrepreneur and I couldn't have thought of a better starting point than yourself starting Vivifi Medical. We're going to get that story. That's the purpose of today. But before we do that, I want to set the stage. Who are you? So I want to know who Tushar Sharma is. Where are you from and how did you build your life academically, professionally? And that click moment when you decided to found Vivifi Medical.

Tushar: 1:26
Thanks Giovanni. It's a pleasure to be here. I'm originally from India. born in the very north, the Himalayas, a very small town of about 10, 000 people. But grew up in different parts of the country. I did my undergraduate from Indian Institute of Technology, Madras in biotechnology with a minor in advanced chemistry. I was always inclined towards doing research, especially in the medical devices side. So I was one of the few undergraduates that graduated with two international peer reviewed publications. my work back then was on generating electricity out of sewage. And I thought, how can I apply this to humans? So when I came to the U. S. for my master's and PhD at UT Austin in biomedical engineering, my master's thesis topic was to make implantable biofuel cells that generate electricity out of blood glucose for powering the ICDs. I was working 80 hours a week doing teaching assistant to make money, and also doing this research work to get the project off the ground with a big impact journal publication and then I switched over my PhD topic to flexible pressure sensors for catheters. After that, once I graduated, I went to Intel up in Portland, Oregon, and worked over there for a couple of years. One was I realized that I was an amazing process engineer. I have this ability to do mental gymnastics with different steps in my mind and figure out in the entire process, a big process, how the different components interact with each other. And if I tweak one particular component, how it's going to affect the outcome. And that has helped me a lot, with medical devices. But besides that, I also happened to get my green card in a span of two years, which is really fast for especially Indian descent. And one of my PIs from my grad school who was a trauma care surgeon over here in UT Health. Had a startup and he wanted me to come work for him. So that made me move from Portland, Oregon to Houston. Worked on his technology and then another technology with a pediatric neurosurgeon. And then finally moved over to working over here in this facility with world famous cardiothoracic surgeon at J&J Center for Device Innovation. And while I was working over there we worked on all different areas, anywhere from mechanical thrombectomy for stroke through soft tissue balancer for robotic knee arthroplasty and everything in between. We came across this body of clinical evidence connecting varicocele to BPH and that was the genesis of Vivifi Medical.

Giovanni Lauricella: 4:09
Leading into Vivifi Medical, you went through numerous projects. You identified which one you wanted to own. How many years have you been at it now with Vivifi Medical?

Tushar: 4:18
Four years.

Giovanni Lauricella: 4:19
So four years ago, this click moment of you're going to run with this project. What was that like? One of the main questions I wanted to ask you, and then we'll get into Vivifi shortly, but you made this transition from being an engineer. To then founding a company and running a company. So before we get into Vivifi, tell us that transition story, like all these entrepreneurs or even want to be entrepreneurs that think they have a shower idea of a medical device and they have no idea what they're getting involved in And they don't know what that transition takes them from being an employee as an engineer to then taking an idea and making it their own from a business perspective. What is that transition from engineer to founder?

Tushar: 5:06
Yeah. I was not an employee of Johnson and Johnson. I was actually a contractor. And the area that I'm focusing on is urology, which is an area that J& J. did not operate at that time. So I had a clear path to pursue this on my own However, making the transition is hard and oftentimes nebulous at an early stage. So I had the fortune of getting a paycheck from my contracting and consulting work While I developed this startup eventually I was forced to go full time on this company which also happened to coincide with us getting phase two NSF SBIR award of a million dollars. So it was good timing and that was my transition full time into this company.

Giovanni Lauricella: 5:54
So for all those entrepreneurs listening out there. You have to protect yourself on how you leap into an idea. you have to be financially secure. you're going from being an employee to pursuing your technology dream. And in your case, you were a consultant for a while and then transitioned full time, at least in the early days.

Tushar: 6:12
Yeah, and different people have different risk appetite. I had a family. I have a one and a half year old daughter. We could not afford to have a lot of pay check list days or months at end. So I had to buffer up or get enough amount of buffer. Savings so that I could make a full time transition and another person who is far more younger might have a higher risk appetite. They might be able to survive on lower amounts of funds the startup risk profile also might vary as well. I think what Vivifi. Where Vivifile lands right now, it's very high risk and early stage, So getting funding for their startup might be easier. So it varies on the risk appetite of the profile of the company and individual profile. for me, it made sense to take it slow and make sure that we have completely de risked on the clinical side and the technology side before making that leap into full time.

Giovanni Lauricella: 7:11
So then tell us about Vivifi. You mentioned urology, but what is the device? What are you building?

Tushar: 7:17
Yeah, so Vivifi started because we came across this clinical body of evidence connecting varicocele to BPH. Varicocele are the failure of spermatic vein one way valves. So when spermatic vein essentially goes varicose, it leads to increase in the pressure in the testicular area and start shuffling this 50 to 100 times testosterone rich blood that usually screened by the spermatic vein. Now it starts going towards the prostate and that leads to BPH over time. So there was a clinical study done out of Israel and then followed up by Germany where they treated the spermatic vein, which is done through ligation or closure of the spermatic vein. and showed natural reversal in BPH. So we dug up the literature and went all the way back to the late 1800s to Vivifi all of the basic pillars on which they were basing the theory of this varicoseal leading to BPH and everything checked out. The only thing that did not make logical sense to us was how varicocele are treated to this present day. We proposed another procedure instead of closing of the spermatic vein, what if it could connect it to an adjacent blood vessel to instantly drain the testicular venous blood into systemic circulation and prevent any of the testosterone rich blood going to the prostate whatsoever. And once we did that, we started talking to urologists. And soon after that, we found that somebody had already done this exact same procedure for varicocele in the late 1980s. Varicocele also happens to be the lead cause behind male infertility in younger adults. patients who had undergone ligation procedures and were not able to conceive, got the anastomosis procedure and were able to conceive. we got a chance to talk to the inventor of that procedure. And asked him like, if this was such an outstanding procedure, why is ligation still the standard of care? And so he mentioned three main reasons and we'll develop a technology that addresses all of those in summary, we are developing a laparoscopic and robotic surgical technology that enables vascular anastomosis through a small port.

Giovanni Lauricella: 9:21
You and I have known each other for a while. I've been along with this journey of you building Vivifi I want to touch on a unique topic, this space of BPH is a very mature in some ways space, but it's also a very crowded space in terms of innovation. And over time you have received feedback on pursuing alternative applications, So once again, for all those entrepreneurs and engineers listening right now. That have conviction of what they want to pursue. What's that journey of building KOL feedback or that network of KOLs and advisors that are either on board with what you're doing and believe you and back you? But what about, how do you handle all those other people who are pushing you in different application alternatives.

Tushar: 10:12
Yes. Going back to our initial story we came across this body of clinical evidence and then proposed this new procedure we started talking to urologists and I think I would have probably talked to 50 urologists or so before I got a first, maybe this might make sense. Most of them were like, you're crazy. Get out of here.

Giovanni Lauricella: 10:36
Okay. So most people who thought that they had a genius shower idea, they go out and they do a bit of testing, And they usually get some warmness, even in a sample size of 10. Talking to urologists who would be the end user of your device or application, and you had to go through 50 of them before you got an even maybe. What was your head or even your heart telling you, why are you pursuing this?

Tushar: 11:00
So I saw a clear application for our technology and for our procedure. the main benefit that I saw was if this works it will completely disrupt the way urology is today and going to be in the next decade or so. Right now, majority of the urology procedures, especially for BPH, are transurethral. we are proposing a procedure, we are proposing an entire paradigm shift. We are proposing to go vascular for these urologists. And all of the treatment options right now for BPH, result in severe side effects because they're just treating the symptoms. And if we can somehow treat the root cause. we can circumvent all of these side effects, which would be massive value and impact to the patient. And that was what was driving me even back then. So we saw the vision very clear up front that if this does work it could be revolutionary. Now when we go to urologists, we understand that they've been doing that ligation based procedure for decades. So they think that it works and proposing an alternative procedure to do the same thing or slightly better might not make sense at first. And we had a problem where we didn't articulate the value proposition of our procedure in terms of the benefits to the urologist and to the patients early on. And that was a continuous process of learning and development over time. So as we continue to start, continue to talk with multiple urologists over time, we realized if we position in an X, Y, and Z format. You're all just suddenly are very receptive to what we're doing, and that was a learning procedure for me as to how to speak to urologist in their language. One of the downsides that we had was none of us were physicians. We were all biomedical engineers And having a urologist on your side makes a huge difference. In fact, I was talking to a urologist and there was another urologist who we had sold on the idea that this could work. And then we were talking to a third urologist and I was explaining the whole mechanism of action. And he was going to, I don't know if this is going to work. I don't know if this science makes sense. And then the other urologist goes, Oh yeah, I've checked out the data. It makes perfect sense. That's all it took to convince that third urologist.

Giovanni Lauricella: 13:30
So mechanically speaking, Would you advise early stage entrepreneurs in medical device to have a champion or a co founder who is a physician in that space to champion their application?

Tushar: 13:43
Absolutely. That makes a world of difference. If there is no clinician on your team you should be looking for one. that was our goal too. To get the first champion and the clinician who would be, who would go along all the way along with us, but getting to that stage can also be challenging, especially when you're talking about something that is going to change the entire guidelines for how a treatment is done. So that was a learning aspect for our journey.

Giovanni Lauricella: 14:07
I want to go back, you mentioned earlier on that you had received an NSF grant. Talk about that. And I want to spend a little bit of time on the importance of grants in early stage medical device companies and that process of finding them, that process of writing them out and submitting them. What did it mean to you to get that grant and what was the process in order for you to get that grant?

Tushar: 14:30
Yeah, so we are primarily, funded by NSF grants, if we didn't have those, we wouldn't be here today part of my grad school job was to write research grant for the project that I came up with this crazy idea into the U. S. with to get funding for that project and in the meantime, my professor would also send me these other grants to review and part of those grants were SBIR grants. So I had the opportunity to go through SBIR grants So I had an understanding of what a good SBIR grant looks like and what does not. In 2019 or 2020 when we applied for the SBIR for Vivifi Medical. We put something together and thought that's never going to work. It is, we are not going to get funded, but this was just our initial application because the concept we proposed was so wild we didn't think the NSF was going to buy it, but somehow they did. And so it's great. Now we have to actually do it. So that was the first initiation of momentum on getting technical stuff done. And going with NSF as an initial one is actually phenomenal because they expect you to fail. They expect you to pivot. The whole goal is to do an initial analysis, talk to physicians, come up with a pivot. And if you haven't pivoted, then it's a failure. Essentially, you haven't learned anything. So that was a phenomenal aspect about NSF grant applications. And NIH grant applications come a little bit later. So we did the NSF grant application phase one, completed all the research objectives and then applied for a phase two grant application and then just recently received the phase two for a million dollars.

Giovanni Lauricella: 16:08
How long does that process take?

Tushar: 16:09
So once you submit the grant application, receiving feedback, whether you're going to get funded or not is roughly around six months time point. And once you get the notice of award, it's Within two to three weeks, you will have access to the funds.

Giovanni Lauricella: 16:24
Your device is a class 2 device, right? From a regulatory standpoint, you know that it's a 510k technology, according to the FDA. But yet, you're going to be tasked with doing a sizable clinical trial, Does that have anything to do with the fact that you're playing in a crowded space? Why do you have to do clinicals for a 510k device? Talk about your clinical strategy that you have been thinking about?

Tushar: 16:50
Absolutely. we are proposing a new vascular procedure that has never been done for BPH. though it's been done for male infertility, we are developing technology to enable that procedure for urologists. And so there's two aspects to your clinical and regulatory pathway. One is the technology itself and the procedure for the indication of BPH. So based on the primary assessment that we have received from some of our regulatory firms we believe that we would be a 510K technology based on the predicate device which open surgical vascular anastomosis is done but there's a lot of devices that exist out there to do that. So based on that, we should be a 510K technology. However, to get the indication of use for BPH we have to do clinical studies because that's the precedent set by other companies in the space. there's usually 200 to 300 patients that are required to do BPH. So our pathway like right now looks like we would be going for a 5 10K clearance of our technology then clinical studies and pivotal studies to expand the indication of use for our technology from just vascular anastomosis.

Giovanni Lauricella: 17:58
then coming up with the clinical trial studies that you've been thinking about that strategy. Where is that taking you now? and who Or what is helping you come up with those strategies?

Tushar: 18:08
Yeah amazing mentors such as yourself for connecting with other people as well. We have amazing folks in the world of urology as well, who have done pivotal studies for BPH. They understand what our sham control procedures or arm should look like. So getting feedback and taking all of that into account. But then a part of our clinical strategy is also coming from the fundraising aspect of it. We've talked to institutional investors and asked them for our series A round what would you like to see? And one of the feedbacks was we want to see that this procedure actually works. You're the first ones proposing this procedure, but there is no clinical evidence that this works. So as a result of that, what we are doing is we are right now targeting a pre seed round. Where we will start with just five patients of BPH and study all the different endpoints for BPH. So just demonstrating the procedure proof of concept, it won't be using our technology. And then in parallel, we'll be developing our technology, which we will de-risk through cadaver and animal studies.

Giovanni Lauricella: 19:13
Do you have a certain geography that you're looking at to entertain that?

Tushar: 19:17
Yeah, we are evaluating a couple of sites India being one of the lead ones. And we are also evaluating Panama and Australia as well.

Giovanni Lauricella: 19:25
You mentioned having a great board. I know on your board is Stan Rowe. Anyone in the medical device industry especially vascular or heart cardiovascular should know the name Stan Rowe, associated with the TAVI procedure, transcaptor aortic valve implants. You got to tell us a story. Early stage company and you landed this marquee name in medical device history. How did you, how did you get Stan?

Tushar: 19:51
Serendipity and vision and mission, I think Stan is a visionary. we are targeting a huge ambitious goal, it tends to attract a lot of visionaries and a lot of champions that, that believe in doing stuff greater than themselves. And Stan falls in one of those categories. We got introduced to him through CDI, Johnson and Johnson Center for Device Innovation. he used to visit over here and we just said, By the way, we are also working on this side project over here on Vivifi Medical. I would love to chat with you about that. And we had specific questions for him that we valued his feedback and his opinion, he has been phenomenal with regards to how we should be pivoting in terms of our marketing strategy, talking to urologists and how to go about conducting the clinical studies and de risking our value proposition making sure that there is a clear commercial pathway for us moving forward. It's just meeting all these visionaries and amazing mentors that I've had over my years. Another one is, for example Marshall Stoller. Who is a phenomenal person. He's the vice chair of urology at UCSF. we met him because you connected us through Mike Wallace. And Mike Wallace is like okay, this is interesting. I like what you're doing. Let me check. I have a urologist that I'm working with. Let me check if what he thinks about this so that was all like hey, what do you think about this? I just want to get a second opinion. Now he's an amazing champion for what we are doing. He's already sat on due diligence calls for us. He wants to to fly down to india or wherever we do our clinical studies to actually do the procedures we are working on cadaver studies with him. So just like that

Giovanni Lauricella: 21:43
Taking a pause for an educational plug to all those entrepreneurs listening in again. What is the importance of networking being an entrepreneur and what don't you have to think about when you're an engineer or a consultant or employee working for somebody else and you translate from engineer to founder, co founder, CEO of an early stage medical device company and what's that power of networking? You just talked about how things unfolded. Now that you have a really good grasp of it, what is that power?

Tushar: 22:14
Yeah, your network is your networth. The more number of people that you know and by knowing just not like on superficial level, but actually like having a relationship with them, the better the chances for success. Especially in the medtech world, it seems like a big community, but it is still very well interconnected. A lot of people know each other very well. And amazing thing about medtech community is that everybody's super helpful. They love connecting you with other people who they think would be a good person to connect with. Networking has been one of the most important aspects to move our company forward and just keep it alive, honestly.

Giovanni Lauricella: 22:52
I want to go into fundraising. you've been predominantly funded by grants to date, but you have been fundraising and. depending on who you're talking to right now, we're either warming up and coming into a better place than we have been. For others, they still say it's hard right now to fundraise. What has been your experience fundraising outside of grants? Who are you calling on? Who are you pitching to? What have you tried to pitch to that didn't work? What have you learned along your capital raising experience What has that process looked and felt like?

Tushar: 23:27
It's been a crazy roller coaster ride, especially with the macroeconomic climate of 2022 and coming into 2023 We officially started our fundraising in 2022, So needless to say, we did not make any traction. through the summer of 2023. We had one potential investor who was interested in us, but that fund did not survive. And right now, the biggest traction that we have seen is through our advisors and other clinical folks that are interested in our technology. They have committed 200 or almost half of our pre seed round we are in due diligence with two funds. One based out of Texas and the other based out of Oregon. And we might be looking at hopefully closing the pre seed round by the end of this year.

Giovanni Lauricella: 24:17
When you say funds, are you talking about venture capital funds or what kind of funds?

Tushar: 24:22
Both venture capital and angel groups.

Giovanni Lauricella: 24:25
Oh, okay. So venture capital, interestingly enough, is looking this early on. First time fundraiser and capital raiser did you have to make trial and error to figure that out? Did you travel all through Texas and coast to coast pitching to VCs to constantly hear that you're too early, and then had to change your strategy? towards those angels, family offices, and other sorts of funds.

Tushar: 24:46
Yes, absolutely. In fact, we got rejected by a lot of angel groups as well. they wanted to see clinical data and that was probably part of the economic climate and the fact that there's a lot of other startups further along. And so they are seeing much richer deal flow coming their way. the early, super early stage that did not have any clinical data on hand. but yeah, just looking at individual checks and having our pre seed, what we realized is once we hit a critical milestone on our precede round in terms of we have X amount of money in the bank or committed in commitments forward towards a pre seed round, then it starts to pick up momentum and then it gets, starts to get a little bit easier to communicate that story and close out the pre seed round. So that's way much more easier than getting that initial checks in.

Giovanni Lauricella: 25:38
Throughout this either lifetime journey or entrepreneurial journey that's been going on for four years now. Do you have an identifiable mentor that you would want to call out and thank to be able to help get you where you are today?

Tushar: 25:53
Oh boy, where do I start?

Giovanni Lauricella: 25:55
So it takes a village.

Tushar: 25:57
It does. And here's the thing about mentorship. There won't be one specific mentor who can address all of your concerns or all of your questions, right? Ideally, you have a specific mentor for a specific area. That's what they specialize in or that's what they have the most experience in I have a mentor specific for metric related stuff. I have a mentor for philosophy, general philosophy in life general how to go about your daily daily life. And I have a lot of other mentors that have guided me along the way. Based on the different stages of my life, One thing that I realized is not really looking for mentors specifically. It just has happened serendipitously And I just seeked out people who I thought would be able to help me out. And that's resulted into these long lasting mentorship relationships for me.

Giovanni Lauricella: 26:51
Very cool. When it comes to where you are now, what you've succeeded at. Do you believe being a medtech innovator involves a lot of luck or effort, or is it a combination of both?

Tushar: 27:07
Yeah, I don't think either of those are exclusive. If you ask Billy Cohn, he will quote Michael DeBakey's statement, which is, I find the harder I work, the luckier I get. And I think that's true. Even though it's in biomedical engineering oftentimes we, when we fail, we know exactly why we fail and we talk about it. But when we succeed, we don't understand what are the other ways it could have gone, how we could have failed. When we are successful, we don't really reflect back And I feel the more number of times you try, the harder you try, you're eventually going to figure out the one of the many possibilities or pathways how it's going to succeed and call it luck on how you land over there or call it hard work. It's just numbers at the end of the day.

Giovanni Lauricella: 27:58
Now we're in Texas Medical Center Innovation in Houston. And there's this notion that's been thrown around the third coast. Texas is on the up and up. What's your thoughts on what Houston and then as a whole, Texas offers innovators in medtech where do we see the future going for Texas, Houston, Tell us about Texas and Houston.

Tushar: 28:24
Texas is phenomenal for early stage medtech or healthcare and biosciences There's clearly developing hubs within Texas. Houston is great for medtech and life sciences Austin is great for digital healthcare Dallas is great for general biosciences. San Antonio is amazing for anything related to, with the defense or the government aspect of stuff. So there's definitely strengths to which all of these cities and hubs play to. Houston in specific is amazing if you are in the growth stage as a med tech company and you want to run pilots because there's more than 40 institutional hospitals over here. And you can just run your pilot in any one of those institution and also amazing network of clinicians. In certain areas, such as cancer MD Anderson has his headquarters and home over here if you're a cancer related company and also if you're in cardiovascular, Michael DeBakey, Denton Cooley, Billy Cohn, legends of the cardiovascular space Frazier as well. it is an amazing place to be at.

Giovanni Lauricella: 29:34
The counter argument, what areas, so if this is a great place for innovation, as you mentioned growth, there's hospital systems here. There's obviously engineers and an innovator base who wants to create technology. What about the investor base? So yes, you can create technologies, but are you feeding only off of grants and then have to look outside of Texas for money? does Houston offer a good investor base for good or for bad? Talk about that. If you're going to be based here and innovate here, is there also a good enough investor base to support that? Or does it force you to look outward?

Tushar: 30:10
before I address that question I wanted to mention ARPA H. the health version of DARPA. DARPA net was created back in several decades ago and had phenomenal success in terms of creating some really amazing revolutionary platform technologies. Internet came out of, from DARPA. That was one of their contributions to the mankind. And so they actually started ARPA, the health version of And the team for ARPA H went all across the country. Looking at all the different places to decide land on three sites. That would be their main hub and spoke model. And they landed on Cambridge Massachusetts for investor Washington, D. C. for their strategy and policy. And. On Dallas in Texas for their customer. out of all the sites they explored on the east coast, west coast, south and in the middle they landed on these three locations. that also communicates about the infrastructure that's available here and the potential for the ecosystem to grow and get to the third course that you were asking about. In terms of the early stage funding for specifically for MedTech there's no dearth of money in Houston A lot of it is fueled by other companies or other areas, sectors, which are not medical and

Giovanni Lauricella: 31:32
Like energy!

Tushar: 31:34
Energy. It's the biggest one, especially in Houston. There's a lot of ID related companies as well especially with HP establishing their headquarters and then a couple of other areas as well. But energy it's the biggest one. And then there's a huge presence of physicians over here. So that can also potentially be an early stage investor community where physicians would come in and they'd be the first check in into the company because they believe in your idea and the potential of the company. Investors as you would find on the East coast of the West coast. There's a growing awareness of that. And there's a lot of investors and investor groups then starting to look at this area specifically for that purpose. There's a lot of technologies that are coming out of MD Anderson, a lot of from Baylor College of Medicine, UT Health, and all of these institutions as well. And there's a lot of startups that are specifically coming to Houston to run their pilots or take the technology or the company to the next level. So there's a growing awareness and focus on bringing more investors to this ecosystem. a decade from now. there will be a ton of investors here looking at the early stage startups coming out of Houston.

Giovanni Lauricella: 32:44
I want to wrap up, speaking to a room of entrepreneurs, going back to that transition from engineer to entrepreneurship, reflect on the personal, the psychological, the financial, the physical aspects of running a company when you've never done it before, like a few bullet points of what have you learned as an entrepreneur, as a businessman at this point, versus a engineer on the bench And running a company, what would you tell a room of entrepreneurs to expect when they make that leap?

Tushar: 33:15
If you're willing to leave your nine to five, job and work for a hundred hours a week at half the salary, or maybe even no salary for a couple of years, This is an amazing journey no regrets at all. Amazing. Tushar Sharma, founder and CEO of Vivifi Medical. This is the MedTech startup podcast where we get into the minds, the hearts and the guts of innovation in MedTech and entrepreneurs that follow it. Thank you. mad. Thanks. Pleasure is all mine. You that? Yes. He did that. Oh maybe, yeah, I sit here. Absolutely. Stand up and hug. So we are going for another hour round session. was, that was my flavor. Let's do another hour round session.

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