01:30   Amir Gross shares how the pandemic gave him more time with his family

03:30    How does a lawyer end up in the world of MedTech and cardiology?

05:50  The story of the founding of Valtech.  

07:38    What is structural heart disease and what problems, challenges are there to meet in the field?

10:00   Are you seeing any impact or any change in the Cardiovascular market, due to the entry of digital health devices?

13:00  Amir shares about his investments as an angel investor and areas of interest.

15:30   Why is a company’s image so important even in the early stages?

19:00  What are some tips that you can give about managing stakeholder relationships – externally and internally and how to make sure that they're part of your journey as a CEO?

23:00   Do you have a moonshot and what is it for you personally and for the cardio space? What would be, a dream, change or technology that you would see coming 10 years from now?

24:30  Amir Gross shares “the why” - We're doing it for patients, we're doing it for humanity.

26:55  What are your 2, 3 biggest pieces of advice to an entrepreneur at the beginning of their journey and how to best prepare.

29:40  If you could go back to your 16-year-old self and tell yourself one thing. What would that be?

31:25 When are we going to hear a next substantial milestone for Cardiovalve?

Amir Gross is co-founder and CEO of Cardiovalve. Before co-founding and managing Cardiovalve, Amir founded and led Valtech Cardio from 2005 until its acquisition by Edwards Lifesciences. Amir is a serial entrepreneur, an angel, a visionary at heart.

This has been a very exceptional year. And we wanted to ask you what was the best thing that happened to you in this pandemic here?

Amir Gross :Okay, a bit difficult to answer that, because I lost some relatives as well. Far relatives are still relatives. But the best thing was that I gained a lot of time with my family. And I have a 10-year-old daughter, which basically, I met her 4 years ago. Her first six years, were total sacrifice for me and for her. I was traveling over 100 days a year. So, for me this year was a pause. A time to spend some time at home with my wife, with my daughter. I had a great time. I felt a bit like in some Italian family, we're having lunch together, dinner together on the porch, outside in the garden. So I felt a bit like some kind of an Italian family. So, this was the best thing happened this year. And I felt a bit in some kind of a vipassana mode, and let everything relax. But, you are also not totally relaxed, because you try sleep at night, but you wake up like a baby. You're still the CEO of the company. You still need to be worried about the employees, about the investors, about the plans. We lost basically a year of work. Nine months, we worked, we can say 70% to 80%. Three months are totally lost. It's a total loss of three months out of this last 12 months. Which for a startup. We were only burning money and we have no income.

You're a lawyer by training. How does the lawyer end up in the world of MedTech and cardiology, and cardiovascular and structural heart disease?

Amir Gross :Okay, so first of all, I'm fortunate enough to be born to the right guy. My father is a serial entrepreneur [Yossi Gross]. For the last 40-years he's in the business of medical devices. And initially, I went to study business management. And in my second year, I moved to law and I liked it. But still, all the time, I have some kind of wishful thinking of working with my father, to continue the heritage. I finished my University, finished my internship, the bar exam, and I became a lawyer. And I approached my father, 'Okay, I've done all my duties, I'm certified. I can start tomorrow to work as a lawyer but actually, I would like to work with you.' And he advised me to be a lawyer. And I did so for 18 months or so. I was a bit upset. I thought I would work with him but he had different plans. And then, one day he appeared and asked: 'You want a start up? I'll give you an idea for a startup.' So, then he came back with the idea of mitral valve repair. We saw in one of the meetings, the Edge-to-Edge, which is now with the Mitra clip, which is a huge success. Back then, everyone was skeptical. I myself was skeptical, 15 years ago. You know, the rest is history and we cannot ignore it. These devices in 2019 had sales of $800 million and is still growing. So, this is a huge market. These guys nailed it many years ago and have a CE Mark since 2009.

But my father is an aeronautical engineer. If we go back to the question. For him, it was counterintuitive to have the clip in the middle of the leaflets. We started from the ventricle, actually, do a retrograde approach with some kind of a nitinol band. This was the first IP.

But then after some preclinical work we got to the idea that we want to imitate the gold standard of the surgeons. Which basically, is the annuloplasty ring. You must be  naive to do it. Everyone thought it's impossible but it was my first project. So there was  naivete there.

I raised money from the Office of the Chief Scientist in Israel. Then I got money from investors from the US and the rest was history. Because when I raised the first $8 million, the rest was really history. We got a great team. I advocate you should always surround yourself by smarter people than you. I'm a simple lawyer. I'm the layman. But we got great engineers, great scientists, we teamed up with great physicians. The journey was an amazing journey for 11 years, a real roller coaster. I learned a lot. I'm still recovering. It's not easy. The sacrifice was huge and I’m still recovering. But now I'm in my second project. And it's not that you're learning something from the first and you can implement in the next. Whatever I learned and trying to implement but the startup life is a moving target. So, you need to adapt each and every time. So, what I learned in the previous endeavor, doesn't mean it will correlate with this endeavor. Even though it's in the same space.

You're very humble. I don't know many people will work as hard as you do. For those who are not familiar with the field, could you maybe give a little small introduction about what is structural heart disease and what problems, challenges are there to meet in the field?

Amir Gross: Sure, so I call it [cardiology] the engine. The big engine of the medical device industry was in the 90s with the stents. Everybody had stents, everyone wanted stents, but now stents are a commodity. But really, the companies made a fortune out of stents. Now the next engine for those companies, big companies, is structural heart. The structural heart business is basically everything in the heart, which is not electrophysiology and does not touch the coronaries. Basically, in the functionality of the heart valves, left atrial appendage. This is the main technology, also some ASD closures and paravalvular leaks; This covers the whole inside of the four chambers of the heart, trying to repair or replace defects.

This market is huge for two reasons. First reason because its huge to begin with. And second, we sell today repair and replacement devices for between $20,000 to $30,000. And the gross margin is high. Even in the days of the stents, you would sell stands for $1,500 , $2,000, or  $3,000. But selling devices for $20,000 to $30,000 is huge in a huge market. his is why this market is so huge. We're talking about a $7 billion market today, but in less than 5 years it's going to be doubled with a target of more than 10% annual growth rate. So, this is really a huge market which drives and going to drive the big companies. The big companies made all of the acquisitions, but will continue to make acquisitions. And even second tiers are interested, now in the structural heart market, because they understand everyone is moving there and there's big (a lot of) money to be made.

We're seeing a lot of shifts in the market with the entry of digital health. Are you seeing any impact or any change in the market, due to the entry of digital health devices? Whether it's in prevention, in monitoring, in perhaps, remote surgery?

Amir Gross: Sure, we see impact. I think it's a good impact. But there is a huge 'BUT'. I don't think I will see in my lifetime any electronic device or any application that will fix or repair a valve. So, in this segment is still going to use the mechanical stuff. We use nitinol, cobalt-chrome, catheters, interventional cardiologists. We will still need to do the mechanics. Tesla now will not need mechanics because they have basically a battery, no engine. So, no radiator, no carburetor, none of the above. But we are still treating the human being, human being's heart is like an engine. As long as we have this engine working, we need mechanics. And we're the mechanics at the moment.

Of course, all the digital health is amazing. I'm envious of all those companies. I have different issues, they have different issues. But always you know, the neighbor's grass looks greener. For me, you know everything with AI today, it's easier to catch the money. With digital health, seems to me easier. Some nice guys with laptops working, and I see my crew guys running around with the 1.5-meter catheters running to the animal lab. And blood is splashing on the right side, pig is running from the left side. And those guys working only with nice laptops in a clean, nice environment and producing some applications or AI in those family (IT group).

This is a different breed and I envy them. I understand what is the need is. I understand the future is going there. But unfortunately, we're still working in the mechanics of the heart, we're not yet into the digital world. But I'm sure we'll get there. I made, also, some personal investment. I was blessed after Valtech and so, I invested as an Angel, a few Israeli startups. And basically, one of them which intrigued me is using AI because I was envious. Also, I wanted to help. All my investments by the way, were to young intrapreneurs. None of my investments went to, already, a serial entrepreneur or someone who is already experienced. All my investments went to green, totally green people, who are still naive. And I believe some kind of naivete is a big factor in the success. Because if they will tell me I can't do it, probably I wouldn't do it. And if they will tell us we can't get to the moon, we wouldn't get to the moon.

Amir Gross 14:22             So, I think this is the part that made me intrigued in investment in green people. Like I was totally with green. Although I came from a heritage but personally, I was totally with green. And it makes the endeavor was very much easier. I can tell you today I'm not naive, but it made makes things more difficult. I think more from my brain rather than from my gut.

In case somebody is listening, who's out there for funding and is at the pre-seed, seed-stage. What kinds of areas are you looking to invest in? Is it only structural heart and cardiology, are you looking to expand?

Amir Gross: No, not at all. First of all, I placed all my bets already. Now I need to wait for some exits. And then I can continue to place my bets. So, now basically, I'm sitting on all the investments to see what the day will bring. But whoever is out there and searching for money can contact me, I'll be happy to share my experience. I'll be happy to share my contact list. I'll be happy to mentor on a successful way to raise funds. I think it's very important, because it's always what comes first, 'the Chicken or the egg?' And you need money to make the project. But if you don't have a project, you cannot get the money. So, it's a very fine line of how to raise the funds when you're in the early stage. It is a very delicate, fine line.

There are many entrepreneurs or CEOs of companies, who think that if they have technology, it's enough. If you have great technologies, investors and partners will come. But you're a very strong believer is that it's not only about technology, it's about image. The way the company looks, feels and projects, are key to its success. And because of that, you as investors believe in effective communication materials. Why is that?

Amir Gross:      

First of all, I believe that if you want to be treated in a certain way, first treat yourself. There are five potential buyers and everyone wants to get a fat cheque. You cannot ask for a fat cheque if you are lean. If you are lean, it's okay, but then you cannot ask for a fat cheque. So, you need to build your company to last for long-term. That's my premise. Some are advocating lean. And I do believe you need build the company for the long run. You need to have a team. You need to have the core technologies in-house. You need to advocate yourself properly to the physicians. And we noticed in Valtech Cardio, and also, we noticed in Cardiovalve: When you invite the physician to your facility and they see it's a serious facility with in-house manufacturing. And they see how you are going from A - Z, all within the highest quality. They're more engaged with providing and participating in a clinical study. We're not talking here on implementing another AI, digital health technology. We're talking about implementing implants into the human body. So, you want to make sure that the physician who is going to be your partner in the clinical study, trusts you. And the best way to gain the trust from the physician is of course, above and beyond, good clinical results. But again, it's the chicken or the egg. What comes first? To get the good clinical results, you still need to do the first few cases. You get the confidence of the physicians that the technology makes sense, looks good, works good. The physician can get the impression that you have all the functions, that you're not some kind of a garage startup.

We do the trials in the US and Europe, and we tell them we’re a startup from Israel. They first say, 'Okay, working in your parent's garage?' You cannot afford this image that you're working in some kind of a parent's garage. So, that's why I educate my investors and my team, that you need to be able to at least like the big guys, if we want the big guys to acquire us. So, whatever the big guys are doing and have, we should have. That's my philosophy.

You bring up the relationship with physicians. You're not the only one to say how central that is in the relationships of the company and how much time you should spend on that. Are you the only one that sits with the stakeholders as the CEO? Are there other people in the company that have to manage those relationships? And what kind of tips can you give companies that are creating a KOL advisory board or in contact with stakeholders? What are some tips that you can give about managing those relationships and how to make sure that they're part of your journey as a CEO?

Amir Gross: First of all, there are more stakeholders in the company, which are working very closely with the KOLs: the clinical department, the engineers. The engineers must work hand in hand with the physicians. They need to have a common trust. They need to trust each other. Basically, when they enter into a procedure, they need to know that each one watches the other's back. They know that they have the full support from the physician to what they're doing, the physician knows that he has the full support of the engineers of what he is saying on all the quality side and the regulatory side. When we bring a product to a physician, he knows that we tested it to the fullest. He knows that we are in compliance to all quality, and regulatory parameters. So, he trusts us. So, you need to build the trust to show him all the processes and to work hand in hand from A to Z. Tips of managing the KOLs. I don't really have any strong tip on that. I just think that competence bring confidence to the physician. Show a lot of competency, we show a lot of confidence. Be very close with the physician. Speak to him often, visit him often, engage with him often, invite him often. And as more you engage with him, he will be engaged with you. And of course, you need the other side to be committed. It 'takes two to tango,' as we know it so. It's not enough that your physician is engaged. And we need to, probably, meet with few physicians till we feel the right click, the right cues trait. Many physicians also promised to deliver but they're so busy. You need to find the guy that already have some reputation, but he's still not that busy. He's still not too busy with so many technologies. That he's still not over-using all the technology. So, you have someone that you can really have the journey with together.

There are two main schools of thought that I hear from different entrepreneurs and managers. There are the physicians that are the shining light, the Northern Star, the big names, but they tend to be very busy. And they often give their names to many different companies.  There are the second types of physicians that are up and coming and are very hungry, and may have a little bit more time on their hands. And they may be able to commit a little more, in terms of their own time and partner with you in the long-term. So, I guess that you have this perfect mix in the companies that you manage.

Amir Gross: You need to take care of them, be respectful, they have their names. They will represent you on the podiums with the regulatory bodies and you need to run, 'schlepping' around with them to the animal lab, to the clinical trials. You need both, a mixture of both.

You need it but you basically need believers. Dreamers and believers.

Do you have a moonshot and what is it for you personally and for the cardio space? What would be you know, a dream, change or technology that you would see coming in, you know, 10 years from now?

Amir Gross: Actually, I never thought about it. Good question. But probably if we could have an artificial heart, which will be easy to tolerate by the human being. Maybe we could save all the other procedures. And so, there are already companies working on it. And then maybe really, we don't need the mechanics anymore. Maybe it will be so reliable that you just carve out the human being’s heart placing a total artificial heart and that's all. No need for repair replacement valves. No need for stents. No need for Cabage bypass. No need for open heart procedures. No need for ablations. No need for anything. But at the end of the day, what we're doing here, there are patients out there. We're doing it for patients, we're doing it for humanity. The best thing is that the patient can, basically, come and to visit the physician with a chocolate box. Regardless, if the procedure we could get it at a 100% success. Sometimes the procedure is an 80% success. But still, the patient feels very good, comes to the physician with a bouquet of flowers and chocolate box. So, this is the best present that the physician can get and we as a team can get. Because when a physician tells us that the patient is so happy, we get a lot of satisfaction from that. At the end of the day, there are patients out there that we sometimes forget it. But there are patients out there.

We're so busy in what we're doing. So busy in day-to-day life, day to day-fight to make the company successful, the product successful, the investors successful, the employees successful, the physician successful. We want everyone to be successful but we forget, that number one is the patient to be happy.

Healthy and happy. It is easy to forget.

Really is amazing that the day-to-day involvement is in the cleanroom and in the labs and then getting money. But at the end of the day, when you show that 2-minute video of the patient from Lithuania, after he got a replacement valve. When you even see him walking, talking to his wife beside him, while she is totally delighted and grateful that her husband is still there. I think that's the ultimate reward.

Amir Gross:  It is easy to forget. That's the same reward I had in my investment in BrainQ, which they are treating the spinal cord. And when you see a patient able to move their legs, able to basically stop using diapers, that's a win. You don't care about the business, you care about what you just saw, and it's a huge win at the end of the day.

Let's say there is an entrepreneur at the beginning of his journey, maybe a younger you who's about to start his journey. Give me your two or three biggest pieces of advice for them to be better prepared for what's up and coming?

Amir Gross: You cannot be prepared for it. It's a roller coaster. Everybody says it's a roller coaster. It's a true roller coaster. I wake up every day with a dream, with vision, with happiness to start my day. But most of the nights, I'm going to sleep while cursing or being very worried. So every day that starts, really, with the sunshine with a lot of hopes, good vibes, but most of the nights he will go to sleep it's very uneasy. Okay, you have responsibility for the patients, for the investors, for the employees, for the physicians, but the entrepreneur must be optimistic. And therefore, you wake up every day to the journey with a smile and trying to achieve his dream. So, I wake up every morning with the vision, passion and dream. Although not all nights are ending like that.

[There is] a lot of sacrifice. I don't believe the guys who made it without sacrifice. This is like winning the lottery. You must sacrifice family friends. It will not work otherwise. I want to see it happen. Unfortunately, I wish it would not be like that. But I don't see how it could happen. And naivete, as I mentioned few times, would be nice. Really, to be humble, surround yourself with smarter people than you. Always make sure you're the least in the room. Make sure everyone in the room is smarter than you, then you know that you have a good team. If you're smarter than others, it means you don't have a good team. That's my way of thinking. It's nothing I invented. It's tips that I've heard, I've seen, I learned myself. Some of the good ways, some of the bad ways.

That's life.

Being hungry is very important. Very important.

If you could go back to your 16-year-old self and tell yourself one thing. What would that be?

Amir Gross: Wow, be careful for what you wish for. Be careful for what you wish for. I have a friend he was in the army, a paratrooper. He said the first-time jumps are very easy from the plane, really easy. You don't know what to expect. The second time was much more difficult and the sergeant had to push him out. So, I think it's the same. Your first time, you don't know what to expect. You jump. You sacrifice your life. You sacrifice your friends. You sacrifice everything. The second time is much more difficult. You know already what it takes to make it. So, I'm there in this zone now that, I know what it takes to make it and it's not easy. It’s much easier to be naive.

11 years of a really like a solitary life. It's 11 years that passed overnight. There was no dull moment, but it was fun. I have no regrets and it was fun. It's a once in a lifetime experience. I hope to repeat it. I'm trying to implement better ways to repeat it, to sacrifice less. I hope I will be able to do it, sacrifice less, but can see still be successful.

Amir, can we end with, you know, when are we going to hear a next substantial milestone for Cardiovalve?

Amir Gross: Cardiovalve's, the next substantial milestone is to complete the first in many trials, for the tricuspid valve. We've just initiated it. So, this is the next milestone. And to continue to enroll patients in Europe and US. The journey has just started. You know, even if you think it's the end, it's only the beginning. So, still a long way to recruit many patients, help many patients, showing good results, improving the technology.

We're very confident. So far, the results are good, the technology works. First patients are more than three years out with great results. So, we are confident in what we have. Some bumps on the way but we need to continue. We wake up every day with a mission. We were planning on doing 40 cases, we did 4. So, we just miss the zero. So, it was quite difficult this year. We already see [change] in the last two months. We already see the last two months, daily calls from physicians. So, we see that the world is starting to get back to itself in the last two months.

Amir Gross's Profile on LinkedIn

Cardiovalve's Website

Cardiovalve's clinical study website.