Transcription
Maria Sainz 0:09
Well, thank you for the opportunity, we're going to be talking about near death experiences, which as we were kind of prepping last night for our discussion here, we talked about how, how much collective mistakes we have made over the course of careers that span 30 plus years for all of these distinguished panelists. So I'm actually very excited to be talking about this, we are going to take it into what I believe is the most constructive way, which is trying to share the lessons learned, what we wish we hadn't done. And what we would do all over again, if we had to face the same challenges. It is obvious that we learn a lot more from when we fail, and when we face challenges that were from when we succeed. So we hope this is going to be helpful for all of you. As we share, as I say, many, many years of collective experience here, we also have two sets of really interesting perspectives to put forward here. We do have two people that were down in the trenches, frontline sweating it and going home thinking this is maybe the last day of the rest of my life. Or maybe tomorrow is the first day of the rest of my life. And then we had two people. And those are, of course toward an end. And then we had two people that sat a little bit on the sidelines behind them on the one hand coaching them and mentoring them as board members and investors but also needing to make really tough decisions as to when to give up when to keep going, how to really sell the keep going if you kept going, which I know in some cases you did. So I'm very quickly going to turn it over to them to just say like two or three words on their background and their experience, and then I'll kick off the conversation. So Antoine, do you want to start?
Antoine Papiernik 1:53
Sure. Thank you, Maria. So Antoine Papiernik managing partner and chairman of sofinnova, which is a venture capital firm specialist of investing in medical technologies and life science in general. So I've had the real pleasure of working with three gentlemen over several companies, for most of them. So yeah, I look forward to the discussion.
Maria Sainz 2:18
Right, Jake.
Jay Watkins 2:19
I'm Jay Watkins. I am a partner at Sonder capital, which is a venture firm focused on very early stage. And I mean, sometimes before there's a name for the company, investment opportunities have I have had the pleasure to work truly with everyone here on the stage. I think some of some of the appeal of this session it sort of reminds me a little bit of car racing, where people watch it for the crashes. And this is this is a little bit about sort of the crashes, what they look like and how they unfold real time. I'm very happy to be here and participate in. Hey, Todd.
Todd Powell 3:06
Great. Thank you. I'm Todd Powell and CEO of Reflexion, I think, along with Andy representing the crashes today. But surviving those crashes as well excited to be here, spent most of my career in med tech over the last 30 or so years, early on as an engineer and then more recently, various levels of leadership, big companies and small alike. Good to be here.
Maria Sainz 3:28
Andy.
Andrew Weiss 3:29
Hi, I'm Andy Weiss, until January of this year, I was President CEO of ReCor Medical, the company that has been winning in the renal denervation space to treat hypertension. I spent about 10 years at GE medical, most of that at GE Healthcare. I was at Medtronic for five years and then saw the light and went to startups. So I've spent about half my career in startups, half in large cap. Antoine was an investor in my last two startups, ReCor, which is on the green side of the ledger and CO Axia. Before that, we failed and lost some money there. But we we've made it up at ReCor so far.
Maria Sainz 4:11
Oh, thank you guys. So as you see a lot of great experience. We were reflecting on near death. And it's interesting because the panel is here can talk about two levels of near death. We're very familiar with challenges that any of the companies that we all represent face, but it is a little more rare to talk about a category undergoing a near death experience. And there were two that came to mind when I was reflecting on it. And very recently there was one of those with scaffolds when the late thrombosis clinical data came and most programs shut down. But Andy was there firsthand and experience word, the HTN three data from Ardian slash Medtronic created a an A before And after for the highly promising initial run at renal denervation with an interventional procedures, and can you walk us through that?
Andrew Weiss 5:10
Yep. For those of you in the audience who haven't followed the renal denervation space, the concept is by killing the nerves that are surrounding the renal arteries, you can interrupt the signals from the brain to the kidneys, which can cause high blood pressure. And we at ReCore felt very strongly that that mechanism of action could manage blood pressure by cutting those nerves or bleeding those nerves. And thanks to mono, who helps in the audience might my partner and the founder along with with Antoine and Jack, the founder of ReCore, they felt they had a unique technology that could uniquely and safely ablate the nerves and treat blood pressure. For those of you don't know there are about 150 million Americans with high blood pressure about 200 million Europeans. So it's a big indication, you may know that Ardian was one of the first companies in the field, Medtronic acquired them for about a billion dollars, they were in a very, very large trial, under an IDE for pivotal over 300 patients. And when the trial results were announced in January of 2014, their trial was negative. So there was basically no treatment effect. And there were many other firms that tried to get into this space alongside Medtronic and Ardian and ReCor. And within 30 days, everyone left the field, because the general sense was is Medtronic couldn't do this, then obviously, it didn't work, or it was undoable. And I'll say that that was sort of the inflection moment that we as a Board had to face. Antoine and his team had put a lot of money into ReCore. And was facing really a pivotal moment, which is, what do we do? Do we add more money do we try again. And so all of the lessons learned came from that. I don't know how far you want me to go. But the long story short, that was a little that was nine years ago. And what we had put together in there are a few lessons learned here. And then I'll stop. So first of all, face reality, the whole field was reset. The moment Medtronic was negative. It was basically the whole field was set ground back to zero. So we had to basically reprove all of the science, all of the clinical evidence from scratch. And so then we had to make sure we had the right team that was scaled, costed and ready to go reprove the science. So we had to create the best clinical trials with the best team and focus 100% of our efforts to do that. That was the value creation effort for the investors and for patients.
Maria Sainz 7:51
Andy, just because I know the story a little bit, how important was it to connect with thought leaders that were true believers?
Andrew Weiss 7:58
Yeah. So we believed in the science and in order to really reprove the fundamental science and efficacy, mono Helen, Lesley Neil and I went to the most critical thought leaders in the field, the physicians, and we spent a lot of time listening to them. How can you does this work? How can you design a trial? How can you implement it, and then we we follow the I hate to say one of the Jack Welch, you know, truisms from my years there, which was control your destiny or someone else will. So we worked with our board and investors to say, if we're going to run these trials, and make this actually valuable for patients and investors, we got to control every single aspect of them. So we ran the trials with our own team, no, CRO, we controlled every single site, we control the recruitment, the procedure, data collection, every single thing to make sure that if we're going to spend the time to run these trials, we were going to do it 100%, right. And I think that's what paid off. The other part along the way, is navigating everything else, like raising money, communicating with the team, you know, keeping the board informed and communicating transparently every single step of the way, for every high and low. And then it takes unbelievable resiliency for you and your team. And if there's one lesson I learned, get people that you can talk to truthfully, be 100% Transparent every day. Because if there's people on your team that can't handle the truth, they shouldn't be on your team. People that can deal with that. They're the people that will stick with you, and they will make you successful. So, you know, this was clearly a face reality. It was a sector reset, go back to the basics, realize what that is and go do it. And Jay and Antoine you lived through this whole time. You know, you guys have insights from the board and investor perspective, right.
Maria Sainz 9:54
And I was going to turn it over to Antoine because you are an investor the cat Gauri is is clearly publicly slaughtered it felt and and you take a chance on this crazy guy out there this crazy guy on stage and and you sell that to your LP's you look like, like you're on top of the world?
Antoine Papiernik 10:20
Well, there was some lonely moments because you'd go into a conference like this one it says, This is my investment in renal innovation and people would say I'm sorry. I'm so sorry. So this is I mean renal innovation became really a joke where it would Yeah, I mean, there were dozens of companies because everyone understood the the power of of finding a solution to hypertension. So, but then okay, we were there and you know, no choice is a choice. He's like, Okay, what do we do? Do we stop and pull the plug? Which is, you know, something you can do? Or do we believe that there is indeed something there. And, I mean, some of the we talked about some of the key guys, one of them was Michelle Azizi, actually, all the way from from Paris, and he was a hypertension clinician, most of a big part of the issue with the HCN three trial was that we were talking to the the interventional cardiologist and not to the hypertension specialist, if you ask him. What do you think? Do you think that works? And yeah, actually, I know, it works, because I've actually run my own study. And I know it works. Okay. So if if the clinicians are convinced to have conviction that this could work, we did exactly what, what Andy and Manu said to do, it's like, okay, let's just run that study, with the same sort of, you know, dedication that this clinician, this public hospital clinician in France had done proving that it worked. And that's, you know, the results were outstanding. I mean, I've rarely seen p values in the medtech space that were of the, of the, the 0.001, that that the,
Andrew Weiss 12:04
for those that don't know, we ran and completed three blinded randomized, Sham controlled trials, each one's positive, over 600 patients were enrolled, we recruited millions to get there. And we're now at the final stages in the FDA process. Hopefully, we'll have FDA approval on this this summer. So it's still that when it's not done,
Jay Watkins 12:27
yeah, I yeah, I I lived through this one, as chair of the board, trying to keep the investors and the management team from jumping over the cliff. You know, I sort of lead off with an analogy about car racing and crashes. But my my real view of startups is that they generally don't fail in a catastrophic, traumatic, you know, cloud of dust, they actually roll to a stop. And that process is the process, I think, that we experienced at ReCore. And when they roll to a stop, they usually roll to a stop because they're missing fuel of two kinds. One is capital, just pure capital. Okay. And in some senses, oddly, weirdly, that's the easiest thing to tap. The other piece is the hard piece of the fuel. And I think what, what happened at ReCor, in part was they kept the focus on the proof of potential. And it was those proofs like Michelle Azizi who came forward at a really fundamental level and addressed potential. And so that, that never really waned. And we were able to, to architect interest in continuing, which was a hard thing. I mean, you know, you look at the investors and in those circumstances are hard to imagine, okay, now I'm going to, I'm going to put some more money in here and, and, and expect great things following Medtronic. So I think those those elements of fuel that are commitment, because you have proof of potential, that's currency, that's real currency. It's like money in the bank. And so I believe that mono and Anandi did just an exceptional job of keeping that and elevating that to the front.
Maria Sainz 14:52
So thank you. There's something you guys have mentioned, which I had experienced as well. This idea of going to the clinician that understands the disease the best and champions did for their patients, is it's incredibly fundamental AF and we have developed tools that other clinicians can use, but they don't understand the disease, they don't understand some of that happens in the heart failure space. But it was phenomenal that there was someone that was so convincing and such an expert and, and was part of that, that potential sort of currency that you've you've mentioned. So I'm gonna, I'm gonna switch gears to the company. And I think at some point in time, Antoine, I want to make sure that you tell the audience what you call the near death experience, because I'm not going to use your words, but you can. But Todd, there, there's a little bit of an FDA induced near death experience that you have gone through and gone through during COVID years, as well, and through what is a very challenging healthcare access and financing time. So walk us a little bit through that, and then I'll have Jay partner with you on some of that as well. That sounds
Todd Powell 16:07
great. Thanks, Maria. And you're right, it was during COVID, which is amazingly, we almost forget, because it somehow made COVID seem a little less severe. And we were definitely in our own little storm, just a real quick bit of background might be useful about how our machine works. So we're a radiation therapy company. But we target the radiation to the cancer in a new way that no one has ever done before. The concept is actually really straightforward, even though there are a bunch of electromechanical miracles to make it happen. And what we do is we inject a pet tracer, that pet tracer, as I'm sure you all appreciate, collects in the cancer, and then begins to emit signals. And we've made a machine that is sensitive to that not too dissimilar from a PET scanner, which obviously, we collect multiple signals over time to form an image. That's not what we do. We collect those signals in real time, and then immediately send therapeutic radiation back to the source of those signals, which is the cancer. And of course, because we're locking on in a homing beacon like fashion to the cancer itself, and we light up all the cancer in the body starts to create opportunities to not only do a better job of targeting the cancer itself, but getting that same therapeutic benefit to metastatic disease in patients that are presently beyond the reach of existing radiation therapy. So as we started to go into this process, we had had multiple queue subs with the FDA. And we explained our rationale for the type of evidence we were going to produce, which was all going to be benchtop evidence, a lot of people are surprised to learn that that's how radiation therapy machines are cleared, they all have about 510K process pointing back to a prior machine. So we did a similar thing where we pointed back to a prior machine that was similar. And we also pointed to a PET CT. And we figured that the two those two devices coming together with novel software and capability in between them is what really what unlocks the potential of our device had FDA agreement on that submitted a 510 K that was sort of late 19. And then in sort of December of 19, we learned that they had changed their mind, they didn't believe that was the right approach any longer. And they actually wanted us to take two different approaches, the second of which was undetermined to address questions that weren't asked with evidence that was not defined. And other than that, the 510K was going great. So we wound up getting cleared in in q1 of 2020 for conventional radiation therapy, because our machine can support that to think of it kind of as the backward compatible mode. That puts us on a level playing field. But of course, none of us were there to be another conventional machine that that you know, it was, in some sense, comforting. But it was clearly not the value proposition of the company or the clinical indications that it would represent. So then we had to spend, and really just take a total reset, and go back and and unlearn everything that the FDA believed they understood about our machine because we learned through the process where they brought in the drug branch, which participated in our review time that the drug branch had no idea what we were really trying to do. And they were brought into the review team late in the process, and completely reset the opinions. And so we had to sort of unlearn 40 or 50 years of radiation therapy and how that was managed through the FDA is mines. Because we again, do things completely differently. No one does anything like we do. And we had to unlearn all that and then re educate them on that process. We had to invent a new clinical trial approach. We had to produce clinical data, we had to define endpoints that didn't exist in the industry. We wanted to finally an IP on that which which was maybe another little silver lining about the approach, defined all of that study through 2020. Ran the clinical study through 21 submitted a De Novo application after getting breakthrough device designation in 22. And then we're just cleared about a month ago and so now we're fighting for biology guided radiation therapy. Thank you. So that's sort of the story and in
Maria Sainz 19:56
How was the capital available through That time, how was the management of the team through that time?
Todd Powell 20:03
I mean, it was just an amazing journey, honestly. I mean, I'm so you know, and I think you said it as well. I mean, I think we're all saying it here. And I think this panel represents the notion that you've got to be transparent, you got to keep everybody close. It's it is all about the management team and the board relationships, making sure that you don't run out of the fuel along the ways you get what was effectively $150 million reset for the company, right to two and a half years, a lot of capital, we didn't lose a single member of the management team through that process. And every blow that we would have with the FDA to kind of realize just how much they didn't know or misunderstood, where we we got kind of comforting, yeses early on, turned into very uncomfortable no's very quickly. That was tough, it was really tough. But it was that transparency was bringing in the KOL, as you mentioned yourself, Maria and others, to backstop the story and to talk about the patience and the opportunity. It was an incredible journey. And we did raise a lot of capital during that time. And it was all about keeping our eye on the ball, right? It wasn't about all of this is just the noise in the way. And if you believe you have something new that no one else can do. And it's different, it's clinically valuable. You've just got to keep the faith and keep chugging along, provided you can have people that also believe and will pay for that journey.
Maria Sainz 21:26
So So Jay was there before you. And he was there when the promise was huge. But it had to be proven. And I know that you needed to raise not an insignificant amount of money for that time on a very binary outcome. Do you want to tell a little bit about how that went? financing
Jay Watkins 21:48
Yeah, I mean, the the first, finance, first financing. So Reflexion, in some ways has been a long series of impossible financings, starting with the first one, which was which was summed up as we need to raise $13 million to build a prototype. And it'll take us a year and a half. And if we build this prototype on one day, we're going to learn one of two things. It looks pretty good and promising or you lost $13 million. Okay. And so it was a completely binary $13 million bet. And you can imagine walking into venture capitalists in 2009. With that value proposition was a little tough. So we we failed spectacularly. It took us two years of conversations to accumulate 50 turndowns. From investors. So we had we kept like we all do, right, we kept a spreadsheet. And we color coded it. And so sharing shades of red. Yeah, share it. Well, it was read. I mean, every block on this spreadsheet was read because we had been turned down by pick your venture people. Okay. And so, accidentally, we ended up in a conversation with Pfizer trying to learn more about Pet tracers, because we didn't know a lot about pet tracers, at the time. And they called up a couple of weeks later and said, we'll fund the whole thing. And, and we were kinda like our phones broken or something. And so we were, we were we were not actually expecting capital from them. And yet they stepped up in this is Bill birkoff. And offered to fund $13 million, and send us a term sheet. So
Maria Sainz 23:46
what did you realize had happened?
Jay Watkins 23:47
Yeah, and this, this goes a little bit to the point I was trying to make about keeping the focus on, on the proof of potential what what Bill had done was, was socialized the the visit we had made to the drug side, and the drug folks had come back to Bill and said, You mean that if we had a patient with multiple tumors, we could potentially scan that patient with radiation, have all those tumors signal where they were and get and get radiation therapy. And we could do that in a sort of traditional one tumor setting. Their reaction was, we don't know if this will work, but we need to know whether it'll work because imagine that we could default those patients, those advanced state patients, to to whom and for whom there's a whole generation of drugs coming. We can have less cancer between us and total success with the drugs and so it became a story about the the many facets of cancer therapy that have to come together to really you know, to relegate cancer to us, as Sam amazing, the founder says to a chronic condition that's treatable. That potential, I mean, it, we had sort of had a sense of it, but we really didn't have it in focus until that conversation with, with Bill Birkhoff. And then Antoine and I had had conversations over time about this opportunity, and Antoine said, you know, he was interested in taking another look, and, and that's what led to our closing a Series A round with 13 dollars led by sofinnova partners, with Pfizer, and Venrock on a binary outcome where we had to spin this thing 60 rpm and hope it stayed in the parking lot.
Antoine Papiernik 25:51
You didn't tell me was binary? I did. You told me nine. It's gonna work. Don't worry. It's gonna work. And you know what the thing that was the most convincing was because we did our diligence. And yeah, I mean, the engineer said you could turn that thing at 60 RPM here. And then the other thing was, but
Jay Watkins 26:12
We haven't done that yet. By the way. Yeah.
Antoine Papiernik 26:15
No, we had to buy two old machines at half a million each or something to undo them and check that this was going to work. And it did. So you were right. It worked. So that part was good. The other part was the FDA, the FDA was clear cut, that this was a 510 K with no clinical with a major reason to invest. Yeah, we learned the hard way, a few years later, that was not exactly the case. But today, we have an amazing machine that works. And that is approved by the FDA that many patients are now, you know, benefiting from so.
Jay Watkins 26:53
Yeah. And I think what Antoine is describing there is that the the venture community did its due diligence on the FDA, this wasn't this. This wasn't like, Oh, yeah. And gosh, golly, we got to get this thing approved. So Well, I wonder what the it was. This is a big bet. We were at the time period, when Todd's referencing there were what probably a couple 100 million in the company, I would say at that point in time. So this is not like we're, you know, three guys in a dog trying to market a business plan. I mean, this thing's running. Okay. And it's, it's it's big dollar running. And so when when that event occurred, when there was a change, in course, from the from the FDA, it was against everything the investors knew and expected. Think about that. You thought it was a five to I thought it was it wasn't a 510K, it was it was a it was a as Todd described, it was another year and a half, two years, and $150 million dollars of capital. So So one of the questions you can ask yourself as well. Okay, so why didn't the company die? Right there? Okay. Two things. One is they didn't stop turning over the cards on what the proof of the potential of the technology was. We started actually talking a lot more to drug companies, for example, other drug companies, not just Pfizer, so And ultimately, today, have some very strong relationships as a result in into the pharma community, again, kind of keeping that potential kind of data stream conch, developing and sort of convincing people that there's something out there, that was worth it. The other thing we did, which was referenced from this stage, I think, in a conversation yesterday about raising capital, and and I think it's a really important message for folks who are, who are trying to avoid near death experiences, is we didn't let the valuation get ahead of where we actually were. And I know that's, that's a controversial sort of statement in the context of entrepreneurship. And in full disclosure, you know, I started into this field as an entrepreneur raising money from venture capitalists, so I get it. That said, if you if you want to have a really traumatic experience, with your investor base, it's it's going to be around encountering a problem where there's not enough headroom left, and you've used all of it up. Okay. And so I you know, it's always hard to find that set point. But there is there is a right way to balance risk and return as you raise successive rounds and tranches of capital and so many companies and particularly true in this environment today, get in trouble because we we just Don't pay attention to the guideposts.
Antoine Papiernik 30:02
It may be a comment more on the on the people side because having going through a near death experience is almost okay. If you're with people that you think you can, you can die with. It sounds silly, but because there are many other near death experience, because you really hate the people with whom you are. And were in fact in towards a near death experience. You start arguing, and so here, okay, sometimes you you are you can see the war, you accelerating towards the war. But if you think, okay, we all going to die together, you know, sorry to be to be saying those words, but that's the truth. Because the only way to survive those type of things is if you are with people with whom, you know, you feel okay. It might be our last moments, but you know, and we did go through that with Coaxia. We died together in coaxial well, okay, we sold the company for a pitiful amount to dissolve. But in the end, when I was on the other side of this, we lost the money. And I thought management had done an amazing job. Yeah, we opened we, you know, we sort of opened the box and the study was negative. But management did an amazing job. And then when I had to pick a new CEO, to read operational ReCor from the US, I thought, Okay, this guy, you know, I went to war, he went to war for us. And he is someone I want to back. So it's, I know, it's cheesy, but it's it is all about for people, it's okay, to live through. I mean, the best way to live through a near death experience is with people, and I'm repeating myself, that you can actually die with,
Andrew Weiss 31:45
you know, for those in the audience, you know, they're their CEOs or investors. I think one of the things that I take away from here, my last 20 years in this field with you guys, is the the ability to build trust between the board and management. And the way you do that is management, do everything it can to manage the business plan ahead, respond, communicate, be transparent, that trust building, you know, gives you the resiliency to overcome problems, even when you're in the trenches saying, Okay, we're ReCor, we don't have any money left, who in the world would give us money after the HTN, three, Medtronic failure, and you all put your heads together, you're, you're in the trenches, and you do it together. I've also been on a number of boards where they end up to be circular firing squads. And so as investors and as, as CEOs, you know, the thing to do is just build the trust through communication, planning, commitment. And then when you encounter problems, because you guys know, there's a problem every week, right? So that that the trust level gives you the resiliency to overcome those. And, you know, running Coaxial, we ran trials, Mr. Endpoint got turned down by the FDA, the management team worked for six months at half pay to try to get whatever chance we could to get a positive outcome, because the commitment level was there. And it ReCor the same thing. When the HTN, three results came out negative mono called me from Europe, it was 530 in the morning. And we immediately said, Okay, what does that mean for our business, because you got to face reality. And you've got to be able to have that trust level with the board. If there's one thing I take away from this group of the five of us is we've worked together over the years, and we built that kind of trust. And my advice for investors and CEOs is, get there get to that trust level.
Maria Sainz 33:44
It's interesting, there's one thing that nobody has said here over the last 35 minutes or so, which is give up. Or even or even thinking of giving up or even thinking of contingency planning. I mean, it's, it's it's about believing in keep going, I guess keep going until the bitter end.
Andrew Weiss 34:06
We had the we had the it doesn't work close the business scenarios, both at coax in our record, we had the whole Gantt, the branch tree and the odds and what we would do and
Maria Sainz 34:17
was that behind closed doors, or was that open to everyone?
Andrew Weiss 34:20
Management Team and the board and end the company. We had weekly meetings with a company, here's where we are, how much money we have, what the odds are. And we would say to people, if this is too much risk for you and your families, we get it. We'd love you to stay. But it's got to be a volunteer organization every day.
Todd Powell 34:38
Absolutely. We and we say that all the time. I mean, I think we really try to be as transparent as we possibly can not just with management, obviously with our board, but with the whole company. I mean, people want to know, and if you're if you're not filling in those details, the details that they will assume might actually be worse. And I suppose by definition, they're worse because they're not grounded in plans and activities and data.
Antoine Papiernik 35:00
from an investor's standpoint, you know, our own investors, the you know, the limited partners have the benefit of hindsight. And sometimes giving up is should have been the best option we need to know about this. And there are many sometimes because of who we are, we tend not to give up. But sometimes you should have given up $10 million before. It's called hindsight. The beauty is when you have experiences like this, where you build companies that are new categories. Yeah, I mean, it's you will lose some by not giving up. But But all you gain from building companies that can be huge companies, huge new categories, I think, suddenly pay so that you need to have a few of those in order to convince your LPS that you're not completely crazy. By just not knowing when to stop.
Jay Watkins 35:51
I can can remember, I worked. I worked for Joe Mendota who some of you may know, and Joe used to say, hey, we can fail quickly. And we can do that in a bar. So if you think about these contingency plans, usually they look pretty, pretty much like we expect they would look, first we you know, lay everybody off, and then we shut the doors. And then pretty soon we're, you know, we're nowhere. That's those things are quick. And so. So they exist, and they're out there. And I think they're in the management consciousness of great leaders. Like these two folks we have on the stage, but but it's not what you focus on, because you your focus, okay, has to be on things that take that are harder to do take a little bit more time. And so what I've noticed in these crises is that if you can get that little pocket of time to move the real, the real issues forward, which are usually not that leg of the of the decision tree that says shut it down, because we can do that in a bar. Okay. They're the leg of the decision tree that says find the proofs and the path to go from here to some kind of success. And that's where the work gets focused. And I think in both these cases, that's exactly what happened.
Maria Sainz 37:18
I've taken away a couple of things here. I've heard you, Jay say a couple of times, we all talk about proof of concept, but I hadn't heard before the proof of potential. And I think potential can be a big number on a slide. But that's not proof of potential. So I think that's a great way of thinking about being building any business plan, not even in a near death experience. The other one is, is I know this team has worked together in a variety of roles, and you guys have each other's back. But at the end of the day, a conference like this, and the networking that happens, and the the networking that you keep through Your career is gonna be helpful through the tougher times more so than through the good times, right. So, cherish, build, invest, they are given takes, but those are really, really important. I myself have gone in that slow roll to no capital and close the company. But I have also gone into that slow roll to $10,000 in the bank and transacted in the middle of COVID and sold a company so believe until the bitter end. I love the fact that the notes are quick they can happen in the bar. They are in the subconscious of all of us, because it's the is the obvious thing to feel like you need to know or have ready, but that's not that's the easy one. The tough one is that they keep it going. So I appreciate you sharing candidly all of your experiences. And hopefully this has been helpful for everyone here and I'm sure the panelists will hang around for the rest of the day and be open to everyone. So thank you.
Antoine Papiernik is Chairman and Managing Partner at Sofinnova Partners, which he joined in 1997.
“Life Sciences investing is not just about recognizing good science,” Papiernik says, “it’s about people — learning how to interact with co-investors, limited partners, and entrepreneurs. Listening, discerning, negotiating, and finding common interests.”
When you find the right people to invest in, he adds, “you can bank on them more often than you can predict how the science is going to turn out.” He looks for entrepreneurs with the nimbleness to adapt, “even if that means a making a major shift from where one starts out on the journey.”
Antoine actively invests for our Capital Funds. He has been an initial investor and active board member in a number of public companies, including Actelion, ProQR, Shockwave Medical, NovusPharma (sold to CTI), Movetis (sold to Shire), and Pixium Vision. Trade sale success stories include CoreValve (sold to Medtronic), Fovea (sold to Sanofi Aventis), Ethical Oncology Science (EOS, sold to Clovis Oncology) and Recor Medical (sold to Otsuka).
He has also invested in and is a board member of private companies Reflexion Medical, Tissium, Pi-Cardia, SafeHeal, Noema Therapeutics, Ablacare, Highlife and Inspirna (formerly Rgenix).
Antoine has an MBA from the Wharton School of Business, University of Pennsylvania. He has been selected twice for the Forbes Midas List, an annual ranking recognizing the world’s top venture capital investors. Antoine is one of the few European and life science investors to have appeared on the prestigious list.
Antoine Papiernik is Chairman and Managing Partner at Sofinnova Partners, which he joined in 1997.
“Life Sciences investing is not just about recognizing good science,” Papiernik says, “it’s about people — learning how to interact with co-investors, limited partners, and entrepreneurs. Listening, discerning, negotiating, and finding common interests.”
When you find the right people to invest in, he adds, “you can bank on them more often than you can predict how the science is going to turn out.” He looks for entrepreneurs with the nimbleness to adapt, “even if that means a making a major shift from where one starts out on the journey.”
Antoine actively invests for our Capital Funds. He has been an initial investor and active board member in a number of public companies, including Actelion, ProQR, Shockwave Medical, NovusPharma (sold to CTI), Movetis (sold to Shire), and Pixium Vision. Trade sale success stories include CoreValve (sold to Medtronic), Fovea (sold to Sanofi Aventis), Ethical Oncology Science (EOS, sold to Clovis Oncology) and Recor Medical (sold to Otsuka).
He has also invested in and is a board member of private companies Reflexion Medical, Tissium, Pi-Cardia, SafeHeal, Noema Therapeutics, Ablacare, Highlife and Inspirna (formerly Rgenix).
Antoine has an MBA from the Wharton School of Business, University of Pennsylvania. He has been selected twice for the Forbes Midas List, an annual ranking recognizing the world’s top venture capital investors. Antoine is one of the few European and life science investors to have appeared on the prestigious list.
Jay Watkins has over 30 years experience founding and funding healthcare companies. Jay’s career in healthcare began when he co-founded Origin Medsystems, a venture funded medical technology start-up that was acquired by Eli Lilly & Company and later spun out as part of Guidant Corporation (NYSE: GDT).
He served as president of several Guidant divisions, led its global business development activities, and later served as a managing director at DeNovo Ventures. Jay lectures at the Stanford Graduate School of Business and at the Stanford Byers Center for Biodesign.
He is widely sought after for his strategic insight and knowledge of structuring M&A transactions and currently serves on the boards of several healthcare companies, including Shockwave Medical (NASDAQ: SWAV), Avail Medsystems, RefleXion Medical, Tissium and Neptune Medical.
Jay Watkins has over 30 years experience founding and funding healthcare companies. Jay’s career in healthcare began when he co-founded Origin Medsystems, a venture funded medical technology start-up that was acquired by Eli Lilly & Company and later spun out as part of Guidant Corporation (NYSE: GDT).
He served as president of several Guidant divisions, led its global business development activities, and later served as a managing director at DeNovo Ventures. Jay lectures at the Stanford Graduate School of Business and at the Stanford Byers Center for Biodesign.
He is widely sought after for his strategic insight and knowledge of structuring M&A transactions and currently serves on the boards of several healthcare companies, including Shockwave Medical (NASDAQ: SWAV), Avail Medsystems, RefleXion Medical, Tissium and Neptune Medical.
Todd Powell joined RefleXion in May 2017 as president, chief executive officer and a member of its board of directors, bringing with him 29 years of experience in leading global organizations and developing innovative products in cancer care. Before joining RefleXion, Powell spent 11 years at Elekta AB, a world leader in radiation oncology solutions where he held senior executive roles of increasing responsibility, most recently as executive vice president of Comprehensive Oncology Solutions where he led a business unit with more than $1 billion in revenue and 1,200 employees across North America, Europe and Asia. Prior to this, Powell served as president and CEO for IMPAC Medical Systems, Inc. His career also includes senior executive and management positions at IMPAC and Varian Medical Systems. Powell received a Bachelor of Applied Science, Physics and Mathematics from California State University, Chico, and he completed the Executive Innovation and Leadership Programs at Stanford University Graduate School of Business.
Todd Powell joined RefleXion in May 2017 as president, chief executive officer and a member of its board of directors, bringing with him 29 years of experience in leading global organizations and developing innovative products in cancer care. Before joining RefleXion, Powell spent 11 years at Elekta AB, a world leader in radiation oncology solutions where he held senior executive roles of increasing responsibility, most recently as executive vice president of Comprehensive Oncology Solutions where he led a business unit with more than $1 billion in revenue and 1,200 employees across North America, Europe and Asia. Prior to this, Powell served as president and CEO for IMPAC Medical Systems, Inc. His career also includes senior executive and management positions at IMPAC and Varian Medical Systems. Powell received a Bachelor of Applied Science, Physics and Mathematics from California State University, Chico, and he completed the Executive Innovation and Leadership Programs at Stanford University Graduate School of Business.
Mr. Weiss brings over 20 years experience in the Medical Device Industry, starting with global management responsibilities at GE Medical Systems. Mr. Weiss left GE to become Vice President of Sales & Marketing at Marquette Medical Systems. Following Marquette, Mr. Weiss became President & CEO of Vital Images, a company he took public in 1996. Mr. Weiss then joined Medtronic as VP & General Manager of its Surgical Navigation Systems business, following which he became VP & General Manager of the Medtronic Neurological business. Prior to joining ReCor Medical, Mr. Weiss served as President & CEO of CoAxia, Inc. Mr. Weiss is a graduate of the Massachusetts Institute of Technology with a degree in mechanical and electrical engineering and has an MBA from the Columbia University Graduate School of Business.
Mr. Weiss brings over 20 years experience in the Medical Device Industry, starting with global management responsibilities at GE Medical Systems. Mr. Weiss left GE to become Vice President of Sales & Marketing at Marquette Medical Systems. Following Marquette, Mr. Weiss became President & CEO of Vital Images, a company he took public in 1996. Mr. Weiss then joined Medtronic as VP & General Manager of its Surgical Navigation Systems business, following which he became VP & General Manager of the Medtronic Neurological business. Prior to joining ReCor Medical, Mr. Weiss served as President & CEO of CoAxia, Inc. Mr. Weiss is a graduate of the Massachusetts Institute of Technology with a degree in mechanical and electrical engineering and has an MBA from the Columbia University Graduate School of Business.
Transcription
Maria Sainz 0:09
Well, thank you for the opportunity, we're going to be talking about near death experiences, which as we were kind of prepping last night for our discussion here, we talked about how, how much collective mistakes we have made over the course of careers that span 30 plus years for all of these distinguished panelists. So I'm actually very excited to be talking about this, we are going to take it into what I believe is the most constructive way, which is trying to share the lessons learned, what we wish we hadn't done. And what we would do all over again, if we had to face the same challenges. It is obvious that we learn a lot more from when we fail, and when we face challenges that were from when we succeed. So we hope this is going to be helpful for all of you. As we share, as I say, many, many years of collective experience here, we also have two sets of really interesting perspectives to put forward here. We do have two people that were down in the trenches, frontline sweating it and going home thinking this is maybe the last day of the rest of my life. Or maybe tomorrow is the first day of the rest of my life. And then we had two people. And those are, of course toward an end. And then we had two people that sat a little bit on the sidelines behind them on the one hand coaching them and mentoring them as board members and investors but also needing to make really tough decisions as to when to give up when to keep going, how to really sell the keep going if you kept going, which I know in some cases you did. So I'm very quickly going to turn it over to them to just say like two or three words on their background and their experience, and then I'll kick off the conversation. So Antoine, do you want to start?
Antoine Papiernik 1:53
Sure. Thank you, Maria. So Antoine Papiernik managing partner and chairman of sofinnova, which is a venture capital firm specialist of investing in medical technologies and life science in general. So I've had the real pleasure of working with three gentlemen over several companies, for most of them. So yeah, I look forward to the discussion.
Maria Sainz 2:18
Right, Jake.
Jay Watkins 2:19
I'm Jay Watkins. I am a partner at Sonder capital, which is a venture firm focused on very early stage. And I mean, sometimes before there's a name for the company, investment opportunities have I have had the pleasure to work truly with everyone here on the stage. I think some of some of the appeal of this session it sort of reminds me a little bit of car racing, where people watch it for the crashes. And this is this is a little bit about sort of the crashes, what they look like and how they unfold real time. I'm very happy to be here and participate in. Hey, Todd.
Todd Powell 3:06
Great. Thank you. I'm Todd Powell and CEO of Reflexion, I think, along with Andy representing the crashes today. But surviving those crashes as well excited to be here, spent most of my career in med tech over the last 30 or so years, early on as an engineer and then more recently, various levels of leadership, big companies and small alike. Good to be here.
Maria Sainz 3:28
Andy.
Andrew Weiss 3:29
Hi, I'm Andy Weiss, until January of this year, I was President CEO of ReCor Medical, the company that has been winning in the renal denervation space to treat hypertension. I spent about 10 years at GE medical, most of that at GE Healthcare. I was at Medtronic for five years and then saw the light and went to startups. So I've spent about half my career in startups, half in large cap. Antoine was an investor in my last two startups, ReCor, which is on the green side of the ledger and CO Axia. Before that, we failed and lost some money there. But we we've made it up at ReCor so far.
Maria Sainz 4:11
Oh, thank you guys. So as you see a lot of great experience. We were reflecting on near death. And it's interesting because the panel is here can talk about two levels of near death. We're very familiar with challenges that any of the companies that we all represent face, but it is a little more rare to talk about a category undergoing a near death experience. And there were two that came to mind when I was reflecting on it. And very recently there was one of those with scaffolds when the late thrombosis clinical data came and most programs shut down. But Andy was there firsthand and experience word, the HTN three data from Ardian slash Medtronic created a an A before And after for the highly promising initial run at renal denervation with an interventional procedures, and can you walk us through that?
Andrew Weiss 5:10
Yep. For those of you in the audience who haven't followed the renal denervation space, the concept is by killing the nerves that are surrounding the renal arteries, you can interrupt the signals from the brain to the kidneys, which can cause high blood pressure. And we at ReCore felt very strongly that that mechanism of action could manage blood pressure by cutting those nerves or bleeding those nerves. And thanks to mono, who helps in the audience might my partner and the founder along with with Antoine and Jack, the founder of ReCore, they felt they had a unique technology that could uniquely and safely ablate the nerves and treat blood pressure. For those of you don't know there are about 150 million Americans with high blood pressure about 200 million Europeans. So it's a big indication, you may know that Ardian was one of the first companies in the field, Medtronic acquired them for about a billion dollars, they were in a very, very large trial, under an IDE for pivotal over 300 patients. And when the trial results were announced in January of 2014, their trial was negative. So there was basically no treatment effect. And there were many other firms that tried to get into this space alongside Medtronic and Ardian and ReCor. And within 30 days, everyone left the field, because the general sense was is Medtronic couldn't do this, then obviously, it didn't work, or it was undoable. And I'll say that that was sort of the inflection moment that we as a Board had to face. Antoine and his team had put a lot of money into ReCore. And was facing really a pivotal moment, which is, what do we do? Do we add more money do we try again. And so all of the lessons learned came from that. I don't know how far you want me to go. But the long story short, that was a little that was nine years ago. And what we had put together in there are a few lessons learned here. And then I'll stop. So first of all, face reality, the whole field was reset. The moment Medtronic was negative. It was basically the whole field was set ground back to zero. So we had to basically reprove all of the science, all of the clinical evidence from scratch. And so then we had to make sure we had the right team that was scaled, costed and ready to go reprove the science. So we had to create the best clinical trials with the best team and focus 100% of our efforts to do that. That was the value creation effort for the investors and for patients.
Maria Sainz 7:51
Andy, just because I know the story a little bit, how important was it to connect with thought leaders that were true believers?
Andrew Weiss 7:58
Yeah. So we believed in the science and in order to really reprove the fundamental science and efficacy, mono Helen, Lesley Neil and I went to the most critical thought leaders in the field, the physicians, and we spent a lot of time listening to them. How can you does this work? How can you design a trial? How can you implement it, and then we we follow the I hate to say one of the Jack Welch, you know, truisms from my years there, which was control your destiny or someone else will. So we worked with our board and investors to say, if we're going to run these trials, and make this actually valuable for patients and investors, we got to control every single aspect of them. So we ran the trials with our own team, no, CRO, we controlled every single site, we control the recruitment, the procedure, data collection, every single thing to make sure that if we're going to spend the time to run these trials, we were going to do it 100%, right. And I think that's what paid off. The other part along the way, is navigating everything else, like raising money, communicating with the team, you know, keeping the board informed and communicating transparently every single step of the way, for every high and low. And then it takes unbelievable resiliency for you and your team. And if there's one lesson I learned, get people that you can talk to truthfully, be 100% Transparent every day. Because if there's people on your team that can't handle the truth, they shouldn't be on your team. People that can deal with that. They're the people that will stick with you, and they will make you successful. So, you know, this was clearly a face reality. It was a sector reset, go back to the basics, realize what that is and go do it. And Jay and Antoine you lived through this whole time. You know, you guys have insights from the board and investor perspective, right.
Maria Sainz 9:54
And I was going to turn it over to Antoine because you are an investor the cat Gauri is is clearly publicly slaughtered it felt and and you take a chance on this crazy guy out there this crazy guy on stage and and you sell that to your LP's you look like, like you're on top of the world?
Antoine Papiernik 10:20
Well, there was some lonely moments because you'd go into a conference like this one it says, This is my investment in renal innovation and people would say I'm sorry. I'm so sorry. So this is I mean renal innovation became really a joke where it would Yeah, I mean, there were dozens of companies because everyone understood the the power of of finding a solution to hypertension. So, but then okay, we were there and you know, no choice is a choice. He's like, Okay, what do we do? Do we stop and pull the plug? Which is, you know, something you can do? Or do we believe that there is indeed something there. And, I mean, some of the we talked about some of the key guys, one of them was Michelle Azizi, actually, all the way from from Paris, and he was a hypertension clinician, most of a big part of the issue with the HCN three trial was that we were talking to the the interventional cardiologist and not to the hypertension specialist, if you ask him. What do you think? Do you think that works? And yeah, actually, I know, it works, because I've actually run my own study. And I know it works. Okay. So if if the clinicians are convinced to have conviction that this could work, we did exactly what, what Andy and Manu said to do, it's like, okay, let's just run that study, with the same sort of, you know, dedication that this clinician, this public hospital clinician in France had done proving that it worked. And that's, you know, the results were outstanding. I mean, I've rarely seen p values in the medtech space that were of the, of the, the 0.001, that that the,
Andrew Weiss 12:04
for those that don't know, we ran and completed three blinded randomized, Sham controlled trials, each one's positive, over 600 patients were enrolled, we recruited millions to get there. And we're now at the final stages in the FDA process. Hopefully, we'll have FDA approval on this this summer. So it's still that when it's not done,
Jay Watkins 12:27
yeah, I yeah, I I lived through this one, as chair of the board, trying to keep the investors and the management team from jumping over the cliff. You know, I sort of lead off with an analogy about car racing and crashes. But my my real view of startups is that they generally don't fail in a catastrophic, traumatic, you know, cloud of dust, they actually roll to a stop. And that process is the process, I think, that we experienced at ReCore. And when they roll to a stop, they usually roll to a stop because they're missing fuel of two kinds. One is capital, just pure capital. Okay. And in some senses, oddly, weirdly, that's the easiest thing to tap. The other piece is the hard piece of the fuel. And I think what, what happened at ReCor, in part was they kept the focus on the proof of potential. And it was those proofs like Michelle Azizi who came forward at a really fundamental level and addressed potential. And so that, that never really waned. And we were able to, to architect interest in continuing, which was a hard thing. I mean, you know, you look at the investors and in those circumstances are hard to imagine, okay, now I'm going to, I'm going to put some more money in here and, and, and expect great things following Medtronic. So I think those those elements of fuel that are commitment, because you have proof of potential, that's currency, that's real currency. It's like money in the bank. And so I believe that mono and Anandi did just an exceptional job of keeping that and elevating that to the front.
Maria Sainz 14:52
So thank you. There's something you guys have mentioned, which I had experienced as well. This idea of going to the clinician that understands the disease the best and champions did for their patients, is it's incredibly fundamental AF and we have developed tools that other clinicians can use, but they don't understand the disease, they don't understand some of that happens in the heart failure space. But it was phenomenal that there was someone that was so convincing and such an expert and, and was part of that, that potential sort of currency that you've you've mentioned. So I'm gonna, I'm gonna switch gears to the company. And I think at some point in time, Antoine, I want to make sure that you tell the audience what you call the near death experience, because I'm not going to use your words, but you can. But Todd, there, there's a little bit of an FDA induced near death experience that you have gone through and gone through during COVID years, as well, and through what is a very challenging healthcare access and financing time. So walk us a little bit through that, and then I'll have Jay partner with you on some of that as well. That sounds
Todd Powell 16:07
great. Thanks, Maria. And you're right, it was during COVID, which is amazingly, we almost forget, because it somehow made COVID seem a little less severe. And we were definitely in our own little storm, just a real quick bit of background might be useful about how our machine works. So we're a radiation therapy company. But we target the radiation to the cancer in a new way that no one has ever done before. The concept is actually really straightforward, even though there are a bunch of electromechanical miracles to make it happen. And what we do is we inject a pet tracer, that pet tracer, as I'm sure you all appreciate, collects in the cancer, and then begins to emit signals. And we've made a machine that is sensitive to that not too dissimilar from a PET scanner, which obviously, we collect multiple signals over time to form an image. That's not what we do. We collect those signals in real time, and then immediately send therapeutic radiation back to the source of those signals, which is the cancer. And of course, because we're locking on in a homing beacon like fashion to the cancer itself, and we light up all the cancer in the body starts to create opportunities to not only do a better job of targeting the cancer itself, but getting that same therapeutic benefit to metastatic disease in patients that are presently beyond the reach of existing radiation therapy. So as we started to go into this process, we had had multiple queue subs with the FDA. And we explained our rationale for the type of evidence we were going to produce, which was all going to be benchtop evidence, a lot of people are surprised to learn that that's how radiation therapy machines are cleared, they all have about 510K process pointing back to a prior machine. So we did a similar thing where we pointed back to a prior machine that was similar. And we also pointed to a PET CT. And we figured that the two those two devices coming together with novel software and capability in between them is what really what unlocks the potential of our device had FDA agreement on that submitted a 510 K that was sort of late 19. And then in sort of December of 19, we learned that they had changed their mind, they didn't believe that was the right approach any longer. And they actually wanted us to take two different approaches, the second of which was undetermined to address questions that weren't asked with evidence that was not defined. And other than that, the 510K was going great. So we wound up getting cleared in in q1 of 2020 for conventional radiation therapy, because our machine can support that to think of it kind of as the backward compatible mode. That puts us on a level playing field. But of course, none of us were there to be another conventional machine that that you know, it was, in some sense, comforting. But it was clearly not the value proposition of the company or the clinical indications that it would represent. So then we had to spend, and really just take a total reset, and go back and and unlearn everything that the FDA believed they understood about our machine because we learned through the process where they brought in the drug branch, which participated in our review time that the drug branch had no idea what we were really trying to do. And they were brought into the review team late in the process, and completely reset the opinions. And so we had to sort of unlearn 40 or 50 years of radiation therapy and how that was managed through the FDA is mines. Because we again, do things completely differently. No one does anything like we do. And we had to unlearn all that and then re educate them on that process. We had to invent a new clinical trial approach. We had to produce clinical data, we had to define endpoints that didn't exist in the industry. We wanted to finally an IP on that which which was maybe another little silver lining about the approach, defined all of that study through 2020. Ran the clinical study through 21 submitted a De Novo application after getting breakthrough device designation in 22. And then we're just cleared about a month ago and so now we're fighting for biology guided radiation therapy. Thank you. So that's sort of the story and in
Maria Sainz 19:56
How was the capital available through That time, how was the management of the team through that time?
Todd Powell 20:03
I mean, it was just an amazing journey, honestly. I mean, I'm so you know, and I think you said it as well. I mean, I think we're all saying it here. And I think this panel represents the notion that you've got to be transparent, you got to keep everybody close. It's it is all about the management team and the board relationships, making sure that you don't run out of the fuel along the ways you get what was effectively $150 million reset for the company, right to two and a half years, a lot of capital, we didn't lose a single member of the management team through that process. And every blow that we would have with the FDA to kind of realize just how much they didn't know or misunderstood, where we we got kind of comforting, yeses early on, turned into very uncomfortable no's very quickly. That was tough, it was really tough. But it was that transparency was bringing in the KOL, as you mentioned yourself, Maria and others, to backstop the story and to talk about the patience and the opportunity. It was an incredible journey. And we did raise a lot of capital during that time. And it was all about keeping our eye on the ball, right? It wasn't about all of this is just the noise in the way. And if you believe you have something new that no one else can do. And it's different, it's clinically valuable. You've just got to keep the faith and keep chugging along, provided you can have people that also believe and will pay for that journey.
Maria Sainz 21:26
So So Jay was there before you. And he was there when the promise was huge. But it had to be proven. And I know that you needed to raise not an insignificant amount of money for that time on a very binary outcome. Do you want to tell a little bit about how that went? financing
Jay Watkins 21:48
Yeah, I mean, the the first, finance, first financing. So Reflexion, in some ways has been a long series of impossible financings, starting with the first one, which was which was summed up as we need to raise $13 million to build a prototype. And it'll take us a year and a half. And if we build this prototype on one day, we're going to learn one of two things. It looks pretty good and promising or you lost $13 million. Okay. And so it was a completely binary $13 million bet. And you can imagine walking into venture capitalists in 2009. With that value proposition was a little tough. So we we failed spectacularly. It took us two years of conversations to accumulate 50 turndowns. From investors. So we had we kept like we all do, right, we kept a spreadsheet. And we color coded it. And so sharing shades of red. Yeah, share it. Well, it was read. I mean, every block on this spreadsheet was read because we had been turned down by pick your venture people. Okay. And so, accidentally, we ended up in a conversation with Pfizer trying to learn more about Pet tracers, because we didn't know a lot about pet tracers, at the time. And they called up a couple of weeks later and said, we'll fund the whole thing. And, and we were kinda like our phones broken or something. And so we were, we were we were not actually expecting capital from them. And yet they stepped up in this is Bill birkoff. And offered to fund $13 million, and send us a term sheet. So
Maria Sainz 23:46
what did you realize had happened?
Jay Watkins 23:47
Yeah, and this, this goes a little bit to the point I was trying to make about keeping the focus on, on the proof of potential what what Bill had done was, was socialized the the visit we had made to the drug side, and the drug folks had come back to Bill and said, You mean that if we had a patient with multiple tumors, we could potentially scan that patient with radiation, have all those tumors signal where they were and get and get radiation therapy. And we could do that in a sort of traditional one tumor setting. Their reaction was, we don't know if this will work, but we need to know whether it'll work because imagine that we could default those patients, those advanced state patients, to to whom and for whom there's a whole generation of drugs coming. We can have less cancer between us and total success with the drugs and so it became a story about the the many facets of cancer therapy that have to come together to really you know, to relegate cancer to us, as Sam amazing, the founder says to a chronic condition that's treatable. That potential, I mean, it, we had sort of had a sense of it, but we really didn't have it in focus until that conversation with, with Bill Birkhoff. And then Antoine and I had had conversations over time about this opportunity, and Antoine said, you know, he was interested in taking another look, and, and that's what led to our closing a Series A round with 13 dollars led by sofinnova partners, with Pfizer, and Venrock on a binary outcome where we had to spin this thing 60 rpm and hope it stayed in the parking lot.
Antoine Papiernik 25:51
You didn't tell me was binary? I did. You told me nine. It's gonna work. Don't worry. It's gonna work. And you know what the thing that was the most convincing was because we did our diligence. And yeah, I mean, the engineer said you could turn that thing at 60 RPM here. And then the other thing was, but
Jay Watkins 26:12
We haven't done that yet. By the way. Yeah.
Antoine Papiernik 26:15
No, we had to buy two old machines at half a million each or something to undo them and check that this was going to work. And it did. So you were right. It worked. So that part was good. The other part was the FDA, the FDA was clear cut, that this was a 510 K with no clinical with a major reason to invest. Yeah, we learned the hard way, a few years later, that was not exactly the case. But today, we have an amazing machine that works. And that is approved by the FDA that many patients are now, you know, benefiting from so.
Jay Watkins 26:53
Yeah. And I think what Antoine is describing there is that the the venture community did its due diligence on the FDA, this wasn't this. This wasn't like, Oh, yeah. And gosh, golly, we got to get this thing approved. So Well, I wonder what the it was. This is a big bet. We were at the time period, when Todd's referencing there were what probably a couple 100 million in the company, I would say at that point in time. So this is not like we're, you know, three guys in a dog trying to market a business plan. I mean, this thing's running. Okay. And it's, it's it's big dollar running. And so when when that event occurred, when there was a change, in course, from the from the FDA, it was against everything the investors knew and expected. Think about that. You thought it was a five to I thought it was it wasn't a 510K, it was it was a it was a as Todd described, it was another year and a half, two years, and $150 million dollars of capital. So So one of the questions you can ask yourself as well. Okay, so why didn't the company die? Right there? Okay. Two things. One is they didn't stop turning over the cards on what the proof of the potential of the technology was. We started actually talking a lot more to drug companies, for example, other drug companies, not just Pfizer, so And ultimately, today, have some very strong relationships as a result in into the pharma community, again, kind of keeping that potential kind of data stream conch, developing and sort of convincing people that there's something out there, that was worth it. The other thing we did, which was referenced from this stage, I think, in a conversation yesterday about raising capital, and and I think it's a really important message for folks who are, who are trying to avoid near death experiences, is we didn't let the valuation get ahead of where we actually were. And I know that's, that's a controversial sort of statement in the context of entrepreneurship. And in full disclosure, you know, I started into this field as an entrepreneur raising money from venture capitalists, so I get it. That said, if you if you want to have a really traumatic experience, with your investor base, it's it's going to be around encountering a problem where there's not enough headroom left, and you've used all of it up. Okay. And so I you know, it's always hard to find that set point. But there is there is a right way to balance risk and return as you raise successive rounds and tranches of capital and so many companies and particularly true in this environment today, get in trouble because we we just Don't pay attention to the guideposts.
Antoine Papiernik 30:02
It may be a comment more on the on the people side because having going through a near death experience is almost okay. If you're with people that you think you can, you can die with. It sounds silly, but because there are many other near death experience, because you really hate the people with whom you are. And were in fact in towards a near death experience. You start arguing, and so here, okay, sometimes you you are you can see the war, you accelerating towards the war. But if you think, okay, we all going to die together, you know, sorry to be to be saying those words, but that's the truth. Because the only way to survive those type of things is if you are with people with whom, you know, you feel okay. It might be our last moments, but you know, and we did go through that with Coaxia. We died together in coaxial well, okay, we sold the company for a pitiful amount to dissolve. But in the end, when I was on the other side of this, we lost the money. And I thought management had done an amazing job. Yeah, we opened we, you know, we sort of opened the box and the study was negative. But management did an amazing job. And then when I had to pick a new CEO, to read operational ReCor from the US, I thought, Okay, this guy, you know, I went to war, he went to war for us. And he is someone I want to back. So it's, I know, it's cheesy, but it's it is all about for people, it's okay, to live through. I mean, the best way to live through a near death experience is with people, and I'm repeating myself, that you can actually die with,
Andrew Weiss 31:45
you know, for those in the audience, you know, they're their CEOs or investors. I think one of the things that I take away from here, my last 20 years in this field with you guys, is the the ability to build trust between the board and management. And the way you do that is management, do everything it can to manage the business plan ahead, respond, communicate, be transparent, that trust building, you know, gives you the resiliency to overcome problems, even when you're in the trenches saying, Okay, we're ReCor, we don't have any money left, who in the world would give us money after the HTN, three, Medtronic failure, and you all put your heads together, you're, you're in the trenches, and you do it together. I've also been on a number of boards where they end up to be circular firing squads. And so as investors and as, as CEOs, you know, the thing to do is just build the trust through communication, planning, commitment. And then when you encounter problems, because you guys know, there's a problem every week, right? So that that the trust level gives you the resiliency to overcome those. And, you know, running Coaxial, we ran trials, Mr. Endpoint got turned down by the FDA, the management team worked for six months at half pay to try to get whatever chance we could to get a positive outcome, because the commitment level was there. And it ReCor the same thing. When the HTN, three results came out negative mono called me from Europe, it was 530 in the morning. And we immediately said, Okay, what does that mean for our business, because you got to face reality. And you've got to be able to have that trust level with the board. If there's one thing I take away from this group of the five of us is we've worked together over the years, and we built that kind of trust. And my advice for investors and CEOs is, get there get to that trust level.
Maria Sainz 33:44
It's interesting, there's one thing that nobody has said here over the last 35 minutes or so, which is give up. Or even or even thinking of giving up or even thinking of contingency planning. I mean, it's, it's it's about believing in keep going, I guess keep going until the bitter end.
Andrew Weiss 34:06
We had the we had the it doesn't work close the business scenarios, both at coax in our record, we had the whole Gantt, the branch tree and the odds and what we would do and
Maria Sainz 34:17
was that behind closed doors, or was that open to everyone?
Andrew Weiss 34:20
Management Team and the board and end the company. We had weekly meetings with a company, here's where we are, how much money we have, what the odds are. And we would say to people, if this is too much risk for you and your families, we get it. We'd love you to stay. But it's got to be a volunteer organization every day.
Todd Powell 34:38
Absolutely. We and we say that all the time. I mean, I think we really try to be as transparent as we possibly can not just with management, obviously with our board, but with the whole company. I mean, people want to know, and if you're if you're not filling in those details, the details that they will assume might actually be worse. And I suppose by definition, they're worse because they're not grounded in plans and activities and data.
Antoine Papiernik 35:00
from an investor's standpoint, you know, our own investors, the you know, the limited partners have the benefit of hindsight. And sometimes giving up is should have been the best option we need to know about this. And there are many sometimes because of who we are, we tend not to give up. But sometimes you should have given up $10 million before. It's called hindsight. The beauty is when you have experiences like this, where you build companies that are new categories. Yeah, I mean, it's you will lose some by not giving up. But But all you gain from building companies that can be huge companies, huge new categories, I think, suddenly pay so that you need to have a few of those in order to convince your LPS that you're not completely crazy. By just not knowing when to stop.
Jay Watkins 35:51
I can can remember, I worked. I worked for Joe Mendota who some of you may know, and Joe used to say, hey, we can fail quickly. And we can do that in a bar. So if you think about these contingency plans, usually they look pretty, pretty much like we expect they would look, first we you know, lay everybody off, and then we shut the doors. And then pretty soon we're, you know, we're nowhere. That's those things are quick. And so. So they exist, and they're out there. And I think they're in the management consciousness of great leaders. Like these two folks we have on the stage, but but it's not what you focus on, because you your focus, okay, has to be on things that take that are harder to do take a little bit more time. And so what I've noticed in these crises is that if you can get that little pocket of time to move the real, the real issues forward, which are usually not that leg of the of the decision tree that says shut it down, because we can do that in a bar. Okay. They're the leg of the decision tree that says find the proofs and the path to go from here to some kind of success. And that's where the work gets focused. And I think in both these cases, that's exactly what happened.
Maria Sainz 37:18
I've taken away a couple of things here. I've heard you, Jay say a couple of times, we all talk about proof of concept, but I hadn't heard before the proof of potential. And I think potential can be a big number on a slide. But that's not proof of potential. So I think that's a great way of thinking about being building any business plan, not even in a near death experience. The other one is, is I know this team has worked together in a variety of roles, and you guys have each other's back. But at the end of the day, a conference like this, and the networking that happens, and the the networking that you keep through Your career is gonna be helpful through the tougher times more so than through the good times, right. So, cherish, build, invest, they are given takes, but those are really, really important. I myself have gone in that slow roll to no capital and close the company. But I have also gone into that slow roll to $10,000 in the bank and transacted in the middle of COVID and sold a company so believe until the bitter end. I love the fact that the notes are quick they can happen in the bar. They are in the subconscious of all of us, because it's the is the obvious thing to feel like you need to know or have ready, but that's not that's the easy one. The tough one is that they keep it going. So I appreciate you sharing candidly all of your experiences. And hopefully this has been helpful for everyone here and I'm sure the panelists will hang around for the rest of the day and be open to everyone. So thank you.
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