Episode Transcript
[00:00:00] Speaker A: Hey, everyone, this is Tom Salemi of Device Talks. Welcome back to the Device Talks weekly podcast. We have a fantastic episode for you today. A little later in the podcast, I will speak with Helen Reeve stouffer. She's the COO of ReCore Medical.
We love renal renovation here at Device Talks. And I talked to Helen about her time at Recore Medical, which of course is one of the two companies that stuck with renal renovation during the dark days. And we'll talk about that time, but we'll also talk about the brighter times ahead for the sector and for Recore Medical. Before that, I'm going to give a snippet of a conversation I had with the legendary Mandy Vilafana at Device Talks Minnesota.
I'll get into the details as to why a little later in the podcast. But recent events have reminded me of the story that Manny told at Device Talks Minnesota when we gave him the Device Talks MedTech Trailblazer Award for all he's done for the industry and for the Minnesota region.
And we'll, we'll share the the end of my conversation with Manny and what was really a great Q and A session as well. So that'll be our FOMO of the day. And to kick things off, I'm happy to welcome Skyla Rivera. She's the associate editor of Mass Device. She joined us a little earlier this year, and she's been an absolutely great addition to the Mass Device team. We'll talk about a project she's working on at Medical Design and Outsourcing.
No Device Talks Tuesdays to pitch. We've got one coming up next month, and we've got a series at the end of next month that I'll mention in the episode.
We're working on a Device talks west for Nov. 30 and Dec. 1 in San Jose. More details coming. But now let's just get this podcast started.
All right, you ready for this?
[00:01:50] Speaker B: Ready.
[00:02:09] Speaker A: Skyler Rivera, welcome to the Newsmakers.
[00:02:13] Speaker C: Hi, Tom. It's nice to be here. I've never been. Well, I've actually been on the podcast in Boston, but never, never here on Never in Newsmakers. So I'm excited.
[00:02:21] Speaker A: No, never in the Newsmaker studio. It's pretty lavish. I know you're, you're enjoying. I know you enjoyed the green room and the free coffee and the espresso machine and all that. Quite fancy.
[00:02:31] Speaker D: Oh,
[00:02:34] Speaker C: yeah. The work from home. Green room.
[00:02:37] Speaker A: Exactly. Exactly. So the moment we hired you, I was looking forward to the day we could have you on the podcast. Just so I could say your cool Name, Skylar Rivera. Which is the best broadcast podcast news name you could have. So congratulations on having just a great tag to carry around.
[00:02:58] Speaker C: Thank you. I know my background is in broadcast journalism, so I've actually heard that before.
I have the.
So you're watching Channel 5 News at 6. I'm Skylar Rivera.
[00:03:09] Speaker A: There you go.
That's the end of the. That's all I needed from you. Thanks so much for joining us today, Scott.
[00:03:17] Speaker C: I've got it down, Tom. You know, I was born to be
[00:03:20] Speaker A: on this podcast, so I know it, I know it. And that day finally came. Thank you, Chris Newmark, for taking some time off. So let's. We're going to get into a bit of a different newsmakers again. Last week Sean was on and we focused on the ADA meeting. The. This week we'll focus on a different topic, but just take a moment and introduce yourself to our listeners. How did you find your way to mass device?
[00:03:44] Speaker C: Yeah, so I used to be a sports writer. I worked at the Athletic and Major League Baseball and I really loved sports. But, you know, I guess I tried it out. Working in sports really wasn't for me. I love sleeping and sports happen at night. So I didn't really like working at night.
I guess I never put the two together until it happened. But then I went back to school. I got a master's in science writing. I started working at Edwards Life Sciences as a technical writer, and I really, really enjoyed it. You know, I got into journalism wanting to, you know, make a difference in the world, whether that be keeping people accountable, writing about entertainment, making people happy. But after Covid, it really hit me that health care, I mean, it should have hit me before, but healthcare is such a big part about, about the United States, about the world and everything. Um, and there's different nuances to it, whether it be payers or, you know, in innovation engineering. Um, and I really found a niche in medtech at Edwards, you know, writing, talking to engineers, writing technical stuff about things that are barely coming to market. I wrote about them a couple years ago.
So, yeah, I found my way here. You know, I still have that journalism background in me, so this was the perfect opportunity to mesh the two. And I've been having a good time so far. It's been a few months, and I'm writing some good stuff, learning a lot.
[00:05:02] Speaker A: That's great. No, I'm thinking now. I know Sean had started off in sports writing as well. And early on when I was in college at journalism school, I had considered sports as well. And I actually had as for an assignment, I had to interview someone famous. So I interviewed, I don't know if you know, Dan Shaughnessy from the Boston Globe, but famous sports columnist.
And he bought me a beer, even though I was probably only 19, at a hotel in Boston and spent the next hour just complaining about athletes and how. And he was honest about it. They're just very difficult to cover, young people who are entitled. And after that hour with him, I was like, you know what?
I don't think I want to be a sportswriter anymore.
So it's interesting that you ultimately found that decision as well and found your way to Medtech. Accidentally or not, that's how I found my way to Medtech also.
So what just matters is that we're both here. So. Well, that's a great story and I'm glad you found your way here.
I know you're working with Jim Amarand at Metal Design and Outsourcing on some articles for the next issue of Medical Design and Outsourcing. So we were going to review sort of just the big picture or the theme that you're pursuing for that article. What are you looking at? What's the topic?
[00:06:18] Speaker C: Yeah, so our July issue is about surgical robotics. So we're covering a ton of different topics, but the COVID story is going to be about telesurgical stroke technology.
And so stroke is such a big area for opportunity in Medtech. You know, even now we've, we've had so much innovation, but somebody has a stroke every 40 seconds and you know, they always say time is brain, but it is true. It if you're not close to that level one stroke center or stroke specialist, like you're losing valuable time and quality of life. And so we decided to talk to developers working on technology that can do thrombectomy, any type of stroke care remotely.
And so they have the system in it's a SCS hospitals around the country, but a stroke specialist could be ten hundred maybe across the ocean away, and they're the one performing the procedure. And so the surgeon isn't actually in the room with the person. And so we thought that was super innovative. As of right now, to our knowledge, there is no available product on the market in the US that does this, that has this capabilities. And so we kind of have this concept of a race, like who is going to get this technology to patients first? And so we asked these developers a are you in the race and do you have what it takes to win and why?
And yeah, it's a really interesting story. We Highlight six developers and we can dive into that if you'd like.
[00:07:45] Speaker A: Yeah, we can in a moment. And I agree with you 100% about stroke and telesurgery capabilities. I mean it seems to be. Well, number one, stroke is just a horribly random event that can completely upend and change your life.
Like a car accident. Like you could start your day on the top of the world and find yourself in a completely different place very soon. And if we can give surgeons the tools and the access to help people who have no chance of getting to them in time, it's certainly an important market. And you're right for telesurgery as well. And for robotic surgery, this would seem to be the perfect fit. I mean, obviously we're seeing telesurgery procedures in the heart and elsewhere and those are all obviously important. But for me, if we could, I think calling it the Low hanging Fruit is a bit dismissive, but for me, I think the market we need to get to the soonest is stroke, because I think you can do immediate good there. So this is exciting that you're focusing on that we'll actually have one of the companies. I don't know if we're going to talk about them today or not, but I'm sure you will at some point. Xcath we'll have them on Device talks Tuesdays interventional series that'll be coming up. That's a virtual conversation we'll be having with the CEO Eduardo Fonseca, that'll be at the end of July and he'll be on the podcast as well next month. So we'll be exploring that. But so I love that you sort of have developed this race narrative and the storyline.
I'm curious, how have the companies that you've reached out to, I don't know if you've shared that narrative with them or the basis of the article. I wonder how they're responding to the notion that they're in some sort of race.
[00:09:36] Speaker C: Oh yeah. So when we brought up this idea to these developers, yeah, we told them that this story is about this race and I had to kind of describe this race.
I said, as you know, there's other people working on similar technologies. And why do you think you have what it takes to win? Well, first obviously I asked them, do you have what it takes to win? Do you think? And they all said yes.
And so then I asked why. And so that story will detail in their own words, whether it be the CEO or the founder of these companies in their own words. We asked them to write 200 word response on why they think they would win. And yeah, they outline it. Some of the companies keeping their cards close.
Some of them are keeping their cards close. We talked to Navigantis, who is still in stealth mode. So we didn't get too much info out of them.
And then, you know, other companies like you said, xcath, who are actually doing these procedures already outside of the U.S.
that's excellent.
[00:10:35] Speaker A: No, I love that you're sort of introducing almost a sports sort of theme to medtech. I mean, we spend our time talking about the technology in a gwow and anytime you can sort of, I think, bring a new focus and a new angle to these important stories, I think that's great. And I love the fact that they're all sort of making their own pitches. So what are some of the companies that people will see in the magazine next month? Who have you talked to and are you.
I'll ask you at the end if you're prepared to pick a winner. But who are some of the companies you're talking to?
[00:11:10] Speaker C: So I had spoken to, to xcat, like you said, who is already doing those procedures. We spoke to Microbot Medical, which I know you've already spoke to their CEO Harrell Godot, and he spoke at Device Docs, Boston.
We also spoke to Remedy Robotics and they're doing something super cool with their N1 system. They're also testing their system outside of the U.S. they did a procedure and from one end of Toronto to the other end of Toronto. So they're, they're testing out some interesting stuff.
We also spoke to Nanoflex Robotics. So they're a little bit different than the other ones we spoke to. Most of them are doing some type of, you know, mechanical thrombectomy. Remote mechanical thrombectomy. Nanoflex is using electromagnetic fields to maneuver wires through this person's vasculature.
And so it's very investigational. Right now it's still in development.
Nothing's being tested. But yeah, some super, super interesting stuff. A nanoflex.
They also have super cool pictures of their stuff going through a, you know, a tabletop vasculature.
You also spoke to Santante. I don't think you've had them on.
[00:12:21] Speaker A: I haven't seen that name before. I saw when you sent over your draft. That's a name I didn't recognize. So tell me about Sentente.
[00:12:27] Speaker C: Yeah, so I had spoke to the CEO of Sentante a couple months ago in a Q and A on mdo. So there's a few stories up at MDO right now, But Sentente is interesting. They have a whole workstation and then a whole remote control room. And so similar to the other ones, there's two parts of the system, one where the. Where the patient's at and the other one where the physician's at.
And they have, like a joystick that's kind of. It's haptic. So the surgeon is feeling exactly what's going on in the. In the. In the room with the patient. They're testing stuff in internationally. So outside of the US I know they had just done a mechanical thrombectomy on a cadaver, and they're in the FDA's TAP program, so they're looking to get that clearance with the fda. They're working really closely with them, but, yeah, we speak to them, too.
[00:13:16] Speaker A: That's fantastic. So do you have a sense of how many companies you'll ultimately be highlighting? Is that all of them, or you still have some more that you're emailing with and trying to get them included?
[00:13:27] Speaker C: That is all of them. So we did speak with six. We reached out to about 10, 15 companies. A couple of them we didn't hear back. Yeah, a couple of them we didn't hear back. A couple of them, you know, they're not publicly telesurgical. They're not working on that technology yet. Not that we know of. Not that I know of. We did ask, though, so I know. Last year, Siemens healthineers and Stryker announced a partnership working on neurovascular intervention technology.
Robotic. Like I said, they're not remote. They didn't say they're working on stroke. But I went ahead and asked them. They said they didn't have any updates to share about that partnership. So I know, who knows? But we did ask a ton of people, and these are the six that we wanted to highlight.
[00:14:11] Speaker A: That's great. And I know earlier I asked if you would have a winner. Do you have any favorites at this time? It's fine if you don't want to pick anybody. I understand.
[00:14:19] Speaker C: Ooh, favorites. I'm not sure.
They're all, you know, unique in their own ways. I think the closest. I mean, the leader in this race based on procedures, inhuman procedures. And I. I'm going to throw distance.
Maybe xcat. Xcat did do the.
[00:14:38] Speaker D: The.
[00:14:39] Speaker C: The remote thrombectomy in Panama, in Panama City or within the country of Panama. And it was over 100 miles distance between the patient and the surgeon. Super, super impressive. And then I would think Remedy Robotics are really, really close. Second, they were doing some neuro interventional procedures. Not quite sure if that was remote thrombectomy. It could have been, but they were doing them in Canada. And so still they're doing it in human and it's working. So really successful stuff.
[00:15:08] Speaker A: Awesome. All right. And this will come out in the next issue of Medical Design and Outsourcing. Do we know when that's going to hit the quote unquote newsstands? And when might your article hit the less quote unquote Internet? When do you think you'll post?
[00:15:23] Speaker C: Yeah, so we are actually rolling out each response along with a description of the company and their technology starting yesterday. So what's live on the website right now is a story about Remedy Robotics, a little bit about what they're doing on their technology and then why they think they could win. And and so we're going to be rolling them out as we lead up to the July publication. In July is when the magazine hits the newsstands. And the magazine story will be a little bit different than the online features. So they're all different. Exclusive Watch mdo. Stay tuned for all these stories, but the big one comes out in July.
[00:16:02] Speaker A: Fantastic. All right, Scott, well, you, as I said at the top, I had high expectations when you first joined us and you absolutely surpassed them. Thanks so much for joining us on the podcast.
[00:16:13] Speaker C: Oh, thanks, Tom. It was a pleasure. And yeah, it's going to be a great magazine. I have a few stories in there. Sean, Jim, Chris, everybody's been working really hard, so we're excited for it to come out hit the newsstands.
[00:16:26] Speaker A: Take care, Skylar.
[00:16:28] Speaker C: Bye.
[00:16:31] Speaker A: All right, thanks again to Skylar Rivera for joining us on this version of the Newsmakers. Great to have Skyler on the team. We're going to move into the FOMO part of our show and this week is a little different as well. We're going to pull the final 10 minutes of a conversation I had with Manny Vilafana.
He's a Medtech legend.
He's founder or co founder of companies like cardiac pacemakers, which CPI St. Jude Medical, ATS, GV Medical. He's currently working on a new company, Medical21, and each of them have tackled huge and aspirational dreams for medtech.
If you want to start off at pacemakers, move into heart valves.
It's just been an extraordinary career. And it was my honor to talk to him at Device Talks Minnesota. And I was reminded of the conversation not only by its excellence and by Manny's influence on the sector, but Also by the attention being given to SpaceX, deserved attention being given to SpaceX and Elon Musk. And I just wanted, I drew from this article I just read in Forbes starts off. Before SpaceX became one of the most valuable companies in the world, it suffered three consecutive rocket failures. By 2008, Elon Musk had invested nearly everything he had.
The fourth launch wasn't merely important, it was a matter of survival.
And that's an amazing story. It's an entrepreneurial story. It's a story I'm sure many of you may have personal connection with, if not directly. You know, people who have.
And Manny Vilafana told one of those stories at Device Talks, Minnesota. So this FOMO episode is going to draw from that. It actually was a response to a question during a Q and A.
So we're going to play those 10 minutes and just shine some attention on amazing medtech stories like these that are just as aspirational, just as far reaching and I would argue, at least immediately more impactful on people's lives and people's health. So we're going to hear this conversation again that I had with Manny Villafana AT Device Talks, Minnesota. It's only the last 10 minutes of it. So we kind of start off just as I'm concluding, which is an interesting place to start. Let's listen just in conclusion. I mean, you're, you're, you're, you've started and succeeded many times. You're, you're, you're, you've started this company. What lessons have you taken away from the past? And tell us, if you will, how is this experience compared with past experiences in starting companies? You're taking on perhaps your biggest, your biggest opportunity yet.
Is it easier over time? Is every challenge its own, its own challenge?
[00:19:31] Speaker B: No, no, no, no, no. I would hate to ask you, how many of you guys here, men and women, work for a little area in a regulatory area? Okay. All right. I'm sure a lot of you do and you all know how much more difficult it is in the regulatory environment.
I'm afraid at times I feel that the regulatory environment is much more difficult than even that the technology that you might be inventing and developing. Okay, yes, it's much harder. I kid around.
I was talking to someone today, I forget, could have been Mac, where I opened the doors on CPI on February 4th and we implanted the first lithium powered facemaker in a human body on November 29th of that same year.
In other words, nine and a half months from concept to an implantable device. Okay.
And it's interesting that some of those early devices are still working. 55, 50 years later, if you come to my home, I still have the first pacemaker I made with my own hands, still working. 52 years later, 50, 54 years later is still working.
[00:20:58] Speaker A: That's amazing. Well, your success has bred all of this. Success has created opportunities for me, for Chris, for others in the industry, and Kayleen to cover these great stories. So I couldn't be more grateful for all you've done for the industry for this time, and for you sharing your experiences and your story here today. Manny, thank you so much.
[00:21:24] Speaker B: Let me say one thing. Thank you very much, and thank you to all of you for your careers, because you have no idea how many people benefit from your work. Think about it. You could be doing something else.
But you are touching the lives, individual lives of a lot, a lot of people. They start from a couple of months old to 99 years old, you know, and things like that.
Is there any questions?
Did we miss anything here? Any questions?
[00:21:54] Speaker A: Anyone have a question for Manny?
[00:21:58] Speaker D: Oh.
[00:21:58] Speaker B: Oh, my God. It had to be at the other end.
[00:22:01] Speaker A: Bill Batten from S3 Connected Health. Manny, earlier today I was going to ask you a question, but you mentioned a story about an almost failure. And for all the aspiring folks here who are trying to do startups, could you tell that story to the broader audience about yourself?
[00:22:17] Speaker B: St. Jude. Okay.
You know, there will be times when you want to hang it up. And I was laying in bed and it was March of 1978 and a snowstorm outside.
And it turns out that we had implanted the first St Jude Balm on the 3rd of October of 1977.
So now we are now a full five months after the first implant, and we're trying to make the valve.
And they would break.
If you know how a St. Jude valve looks like. It's a ring of pyrolytic carbon, which is basically glass.
And you're trying to put in a couple of leaflets in there, basically glass. And if you handle them improperly, they don't just go crick and break. No, they. They explode. Literally. Literally explode in your hands. Okay.
And in the month of February of 1978, we broke 97 out of a hundred valves that we had tried to make.
And then all of a sudden, it's March, it's snowing, I'm trying to sleep. And at three o' clock in the morning, one of my employees, one of my engineers calls me up, manny, Manny, Manny, Manny, I got it. You got What, Peter? It's three o'clock in the morning.
I had a dream. Oh God, you had a dream?
Yeah, I had a dream. Manny, Manny, I gotta have a dream. I'll see you at the office at 5 o'. Clock. I said, no, you won't. It's snowing. You'd be lucky if I'm there at 9 o'. Clock. Well, anyway, I got there at 9 o'. Clock. He grabs the coat off of me energetically, just grabbed it and hangs it up and say, come on, come on, come on, let's go into the, let's go into the lab.
And there in the lab he had laid out very carefully 13 valves. 13, just the, the rings.
And said, now sit down, I want you to make the valves.
Peter, why don't we invite one of the, the ladies on the assembly line?
You know, they had the goggles. We had to wear goggles because if it exploded, you want to make sure no one got hurt.
No, no, it's just one of the gals. Because I said, I remember that. I said, I'm the president of the company. I don't think I'll be making valves for the rest of my life here.
Okay? And we proceeded, we proceeded and I made 13 valves. None of them broke.
He had dreamt of a new change in the process and it worked. And we never patented that process change and we kept it as a corporate secret.
That was close. We were almost closing the doors on St. Jude.
[00:25:10] Speaker A: That's amazing. Anything else back there, Chris?
[00:25:14] Speaker B: There's another one down there. Yep.
Speak loudly.
[00:25:21] Speaker E: Hello.
[00:25:22] Speaker B: Hello.
[00:25:25] Speaker E: Thanks so much for sharing your journey.
I've probably known you almost half my life and very proud to say I do. There are many times and I get questioned about the sensibilities of starting a medical device company about six years ago now. And I, I point to Manny Vilafana as the person who inspired me to say, oh, I don't just need to be a health policy person and a health economist. There's a problem needs solved and lots of people could say someone else should solve it. And Manny always said, no honor, Marie, someone like you should try to solve it. So thank you for that. And I wanted to say, I don't even know if you know this, but my grandmother was the third patient on Dr. Walt Lillehei's heart lung machine in 1950s. And I bought her five extra years of life at that stage. And then all those years later when my daughter was diagnosed with critical heart defects as a newborn, Manny Vilafana was the second phone call I made.
And he Came to her surgical consult when she weighed 8 pounds, stood in the surgeon's room with my husband and myself with the smallest valve that St. Jude made at the time and asked the surgeon straight out if he could repair my daughter's heart using that valve. Yes or no.
And I swear to God she's alive today because he took the time to come to that consult with us and show us what he had. He's a good man.
[00:27:04] Speaker B: Thank you.
Thank you, Anna Marie.
[00:27:09] Speaker A: Good?
[00:27:10] Speaker B: I think so.
[00:27:10] Speaker A: Wow. Thank you so much for sharing that.
I was going to ask you about. I asked you open this up by just asking about your impact, the companies you help start, the job you help create. But you must also think about the patients that have going through life, have gone through life because of all your work.
What does that feel like, having all of that love behind you?
[00:27:33] Speaker B: He keeps asking me about the feelings of this and that and everything.
[00:27:36] Speaker A: I'm going like that.
[00:27:37] Speaker B: I know I'm going to end the presentation today with one comment. And people who know me have heard this.
Okay. I openly say to people that I don't know of anybody in the world that has had a better life than me.
God has blessed me with a wonderful family and God has blessed me with work that allows me to help other people. And that is the best part of working in the medical technology area.
You are not just making something, you are helping someone.
Thank you very much.
[00:28:18] Speaker A: All right. Well, I hope you enjoyed that conversation. Once again, it was an honor to talk to Manny Belafana. And I do want to note that I cut out a loud, long and heartfelt standing ovation.
It was an honor to be up on stage with Manny as he was duly and deservedly honored by the folks in the McNamara Alumni Center. So thanks to everyone who was part of that and very grateful to share that part of his talk and his story here on Device Talks Weekly. Now we're going to move into our keynote conversation. And it's a very similar story in that Recore Medical was one of two companies, Medtronic and actually I was reminded there was a third. And we'll talk about that in the interview that were left sort of holding the renal renovation bag after the simplicity. Three trials came out in 2000, 14 Medtronics trials came out in 2014 with disappointing results that essentially flattened the renal renovation sector.
But Recore stuck with it. Medtronic, of course, stuck with it. And today they have FDA approval on one of the hotter growing sectors in medtech.
Not only is renal derineration being used for Hypertension, but it's being applied to derinervation, is being applied to other parts of the body as well for other conditions. And we'll talk about what Recore is doing in that space with Helen Reeve Stouffer. She's the chief operating officer of Recore Medical.
At the time, though, she was head of the clinical program, the clinical trials. And we'll talk about her experiences there and how Recor responded to the disappointing Medtronic clinical trials and how they took a different tact and found success. So, really happy to have the opportunity to speak with Helen Reeves Stouffer, and I know you'll enjoy this conversation.
Well, Helen Reeves Stouffer, welcome to the podcast.
[00:30:20] Speaker D: Hey. Thank you, Tom. It's good to connect with you again.
[00:30:23] Speaker A: Yeah, it's been a few years. As we were talking before, we pushed record.
We last spoke when Recore Medical was still hoping to get FDA approval for.
For its renal renovation device. You've had it now for a bit of time. You've been able to build a market, you've got approval and reimbursement in multiple countries. So we have a lot to catch up on.
But I do want to just. I can't assume that everyone listens to every single episode of the Device Talks week with podcasts, although they should.
[00:30:50] Speaker D: They should.
[00:30:50] Speaker A: Yeah, absolutely. Should and should go back four years and listen to those as well.
I think folks would love to learn a little bit about you and your path into medtech. So how did you find your way here?
[00:31:01] Speaker D: Yeah, sure. So my path is a little unusual, I think. I started off in academic research.
I was working at the VA Medical center in Minneapolis, and I got to the point where I felt I wanted to move into something that was actually touching patients.
And I was taken on by a company called Guidant, which of course everyone in the medtech space knows. But at that time, sadly, I'd never heard of, if you can imagine that.
So they took me on as a project manager, clinical project manager in their CRM side, and it was almost like a coming home for me.
I loved it ever since I stepped into the doors of the device world. And I think my journey's probably a little bit different to what a lot of sort of the clinical focused people do through their device world careers.
I could tell from the beginning that to be successful in clinical, you had to really understand the business from the beginning to the end.
And so I sort of shaped my career by trying to understand not only from kind of the R and D side of things. So as a clinical project Manager. I work very closely with R and D at Guidant, but also from the customer's perspective, how it works at the hospital, what's it like to be in the cath lab, the pressures of being in that environment.
So I took myself from the comfort of the office and I actually was in the field for a couple of years. Hated it, was terrible at it, but learned a lot.
And then subsequent to that I have kind of worked through business development, clinical business development, worked with commercial partners, went through the Boston Scientific acquisition of Guidant and then decided to start up my very first startup pathway. I was working with a company called Cameron Health, also in the CRM space.
And that was where I kind of understood the importance of being able to be sort of nimble and sort of drive your own journey. I remember sitting in my office for the first couple of days, waiting to be told what to do, realizing that wasn't going to happen and then just kind of moving on. Cameron was bought by Boston Scientific. I went there for a year and then I joined Recall. So I've actually been with recall for 13 years. It's my anniversary next week.
I started off in Europe and commuting back and forth to the Palo Alto office. I moved here in September of 2019.
Started off as VP of Clinical.
When we got FDA approval, I became Chief Clinical Officer, so responsible for clinical, medical and scientific affairs. And now I'm Chief Operating Officer. So I'm leading the company on a day to day basis with very strong support from our Japanese partners on Otsuka.
So it's a different little bit different journey for most clinical people. This is not usually where they end up. So.
[00:33:59] Speaker A: So I, I love that you committed yourself to learning every part of the industry is that advice you would give to a young person today it seems like a big bite to chew to commit yourself to, to spending time and in jobs that as you indicated, sometimes you don't like them, but you know, it's part of a bigger formula.
[00:34:17] Speaker D: I do think it's important, I think, you know, whichever part of a company you're in, understanding the business and why you're doing what you're doing is ultimately the key. And I mean we're all here because of treating patients, right? And so you have to understand from the beginning of the development side of any kind of device or drug or whatever industry you're in through the commercial piece because ultimately you have to be able to sell to be able to get therapies to patients. And I think it helps as you do your day to day job, having that full picture, whether you're in clinical, whether you're in R and D, you know, whichever side of the pond you're on. And we do try actually here at Recall to bring that back to each of the groups. We have a patient day where we bring patients in so that everybody from those that are in the manufacturing, through R and D, clinical, et cetera, can see the impact of what they do every day. And I think, you know, I would definitely advise that to people who want to understand the device industry and be part of it, to learn more than just your own space.
[00:35:20] Speaker A: That's fantastic. So when you joined in 2013, if I'm remembering my timing correctly, renal derineration was still very hot space. There were a lot of different programs going on. I think every corporate had its own program.
Was that the. Were you sort of part of. Did you see the excitement of the entire field? Were you joining? What was the. I guess what I was trying to get to is what drew you to recore medical? Were you drawn by the excitement around the space?
What did you find appealing about the opportunity?
[00:35:51] Speaker D: Yeah, so, yeah, in 2013. So June 2013 was prior to the Simplicity HTM3, as you said. I mean, every corporate had a renal Lena vice division. There were probably 60 or 70 startups, if you can imagine at that time.
And for me, I think it was twofold. It was moving to a therapy that was very different from where I'd come from. So my background was CRM and neurovascular. So an implantable device that, you know, you treat someone and you understand kind of immediately what happens. This was such a different play in terms of looking at the hypertension space, which has been so much more traditionally pharma driven.
And looking at it from a device perspective, the physiology was very strong.
You know, the early data seemed like it was showing that there was a huge potential.
And so I think from those two side of things, learning something new, going into a play which was not necessarily device driven and having a strong scientific background to support it, those were the things that drew me to it.
Now, when we heard about the Medtronic
[00:37:03] Speaker A: trial, we'll go there next. Yes.
[00:37:05] Speaker D: I wasn't sure it was the right career decision.
[00:37:08] Speaker A: I was going to ask that. So, yeah, six months later, the third simplicity trial I think cleared and we. I've talked about this enough that if anyone listens to any of our podcasts, I probably mentioned this a few times. I've heard it a few times, I should say.
But yeah, 2000, January 2014, the Medtronic Simplicity trial produced some disappointing results.
It seems like the industry, the renal renovation space, disappeared almost overnight. Folks folded up their tents and closed programs.
Just what was your. Where. Where was your state of mind at that point? And I'd love to sort of unpack Recor's response because you folks did not pack up your tent. You, you, you, you stayed true, and you, and you pushed forward. What was that experience like?
[00:37:55] Speaker D: Yeah, you know, I think, you know, some people remember where they were when Elvis died. I remember where I was working when Medtronic put the press.
[00:38:02] Speaker A: I do, too.
[00:38:02] Speaker D: I was actually in London at a conference with Manoaya, the founder of Recall.
So, you know, joking aside, I actually think the reset was the right thing. I think it was the right thing for the industry.
I think it allowed us to go back to kind of the drawing board and understand what was necessary to really prove whether these therapies work or not.
There was a huge exuberance because of the early data and the blood pressure changes that they were seeing in the early data. So in a way, the Simplicity trial failing was a good reset for the industry.
It meant that there were three of us left. So at that time, Medtronic US and Boston Scientific, I think people forget that Boston continued in the space as well for a while too.
You know, it was all we were doing, so we didn't have the ability to decide to do something else. And luckily, we had very strong partnerships and funding, both from the Sofinova BC side, but also from Otsuka. At that point, they had come in to fund us.
And I think Andy Weiss, as leader of the team then, he has just got a tenacity which basically said, we're just gonna have to work this out and make it happen.
And so it was a perfect opportunity to go back to the drawing board and determine what we needed to do to evaluate the therapy properly.
I mean, we talked with a lot of hypertension specialists. Michel Azzisi is one of those, and he's actually the only person at that point that had run a randomized trial which was successful, and talked to him about what he'd expect to see from these types of trials. And he was very clear that when you're trying to look at blood pressure as an outcome, it's a very difficult endpoint because you've got patients involved. And we know, you know, if you take blood pressure medications, it will impact your blood pressure. If you don't take medications, it will. Won't impact your blood pressure. So when you're designing trials, you have to take the patient into consideration and you have to standardize everything across the board.
And we took that on board. I think the other thing which was unique at that time with the industry was the FDA came out and they said, we don't believe that simplicity. HTN3 proves that the therapy does not work. It shows that in this trial you weren't able to demonstrate a difference between, between sham and treatment.
But we wanted to go back to the drawing board and actually kind of design trials in the way that a pharmaceutical industry would. And there was a meeting of FDA and some of the societies at the time which industry was asked to participate in as observers. And FDA and the societies basically told us what they wanted us to do. They told us we had to go back, look at what pharma did, take low risk patients off their medications, allow their blood pressure to safely go up, and then you have a population without confounders and that's your proof of concept. So if your therapy works in that population and it's better than sham, you've got proof of concept.
And at that time, of course, all of the data that existed was from the resistant hypertension population. A lot of data that had come from the European market post CE Mark.
And as a single company with only one product, we're a little concerned that if we only did that of meds trial, as it became known, we called it the solo trial, we might be missing something. Maybe there was something about renal denervation and medication that was synergistic. And so we designed the trio trial, which was our resistant hypertension trial as well, so that we had two arms. And we went back to FDA and we said, absolutely, we understand your proof of concept trial, but we also would like to do an on med trial in the resistant hypertension space. And that's how our original program came about. And Medtronic of course, did a similar thing.
Boston Scientific, they did an off med trial. They weren't able to demonstrate the difference between the two groups. And so I think that was kind of the end of their program until till now, where they entered the market again.
[00:42:13] Speaker A: That's a great point. I often forget, I forget that Boston Scientific push forward with their program as well. The acquisition, I think it was.
[00:42:22] Speaker D: That's right, it was basics.
[00:42:23] Speaker B: Yeah,
[00:42:26] Speaker A: I love.
Failed trials are rarely seen as a good thing, but it does seem to present, it did seem to present a great reset opportunity for recore and for the space. But Recore specifically, since we're talking about the company in that you had the Time and sort of a reset of the clock really allowed you to kind of look in and fix things that needed to be fixed. And I'm wondering, as you were talking, did this.
Does this have. Has this had broader impact on medtech as a whole? Because I don't think we've seen the same sort of Me too following since that time. And they may be because of a dearth of venture capital, but I feel like that was kind of a reset for the industry as well. And I think perhaps more attention are being paid to the patients, to the trial design, as opposed to having things be a technology question. They're being more of a patient question. Do you feel that it's had a broader impact on the industry or am I reaching?
[00:43:26] Speaker D: I think in some ways it has.
You know, device companies are not really good at doing trials in therapeutic areas, which is traditionally pharma.
When heart failure, crt, et cetera came on board, some of those trials were not the strongest either. And it's for the same reasons that that's evolved. I think what has definitely had an impact is how we go about running those trials.
So again, when we were starting the solo trial and the trio trial, we would go to the cardiologists and explain to them the patient population and they'd say to us, oh, yeah, we've got lots of these patients.
And of course they don't have these patients because if you've got a patient that's on a couple of antihypertensive medications and they're low risk, they're not in the cardiology office.
I used to call them the Walmart population because they're just normal people walking around and they're generally seen by primary care.
And we actually had a couple of points in time where we were struggling with enrollment in the trials and we had to be nimble and pivot and work out how we did things differently.
So back in 2014, 2015, we actually did direct to patient marketing through Facebook.
And now that's just accepted that that's the way you do it. But right back then, that was completely novel. And honestly, it saved us because it did a couple of things. It, firstly, it proved that there are patients with hypertension that are interested in another option other than medications. But also it got us the patients that weren't being seen in the interventional cardiologist offices so that we could complete the trials. So that was incredibly important. And I think if anything, from a smaller company's perspective, that's what you have to do.
You have a finite amount of money, you have a finite amount of time. And you have to be able to demonstrate whether you can prove your therapy or not. And so you have to be nimble and you have to pivot. And I think that's something that I've taken into the commercial world as well as I sort of lead from this side, just understanding that if things aren't working, then look at them and pivot and learn from them. I think it's absolutely key.
[00:45:38] Speaker A: That's fantastic. You remember where you were when you heard the Simplicity 3 results? Where were you when you heard the FDA gave you approval for your device?
[00:45:48] Speaker D: So I was actually. We were in a hotel room.
I presented to the panel. So it was my job to actually be the interface with the panel, which I have to say was probably the most terrifying day of my life.
[00:46:02] Speaker A: I can only imagine.
[00:46:05] Speaker D: And I don't know if, you know, the way they do it, but it's sort of cloak and dagger. So you do the presentation, you take all the questions, etc. And then they go basically off camera, off mike, and they vote in the background.
And so we're all sitting around in the hotel, you know, waiting to hear. And of course there's all this sudden concern about, you know, well, labeling is a concern. Are they going to say no?
And then when the vote came out, it was, yeah, it was incredible, exhausting. You know, we went for an after party. I think I was gone in about five minutes because I was so, yeah, huge, huge moment for us. Really was.
[00:46:46] Speaker A: That's fantastic. I'm sure all the adrenaline that had been holding you up for those years, it just washed away.
So let's talk then about the shift from a clinical trial focused organization to a commercial organization. What has, what has it been like? What has it. What has that been like for Recor Medical?
[00:47:06] Speaker D: Well, I think, you know, the first thing I'd say that everything we learned from those last 13 years rolls into the commercial. Building a commercial therapy in a world where there is no, you know, existing platform or process is not easy.
You know, we rolled into a commercial world without reimbursement.
So, you know, an issue.
The things that we learned from the clinical program are very much true in the commercial world. So, for example, you know, you have to establish programs at the hospitals so that those patients that are potentially able to be treated can come into the system, because that hasn't changed. It's not that they're all sat there at the cardiologist's office waiting.
It's education, it's educating physicians it's educating patients, it's educating societies, all those people that do the guidelines, because again, we do this every single day. So to us, this is our bread and butter and we know about it, but still, renal denervation at the time that we got commercial approval was not that well known, especially amongst the community that is much more farmer driven. So there's a huge education piece that goes with it.
And probably the most important thing, as you alluded to, is just establishing reimbursement. The pathway to full reimbursement is long, it involves many steps and that has to happen. So while I would say it hasn't been an easy journey over the last couple of years, it certainly has been an amazing learning journey.
And all the things that we've learned and applied are now starting to actually give us some traction in the market. So I think one of the things that we have done, and maybe it's because this is our focus entirely, is that we sort of individualize the way that we support our sites. So everything from trying to help them build the programs, from dealing with some of the reimbursement challenges, which are huge, and then also being there for the clinical and the commercial support, we do that on a very focused basis for each site.
And, you know, that's a lot of time and effort, but this is the only thing we do. So that's what we do.
[00:49:31] Speaker A: Is your therapy seen as taking away from someone else, either from the farm industries prescribing drugs, not from another device, obviously, or have you created a whole new patient customer class?
[00:49:47] Speaker D: I think the market in the hypertension world is potentially so huge that we're not taking away from anything.
What it does is it provides another option for patients who may not want to take drugs, or it provides an option for patients that can't take drugs. So I think it's actually very clearly synergistic with the pharma world. I don't think we take anything away from them at all. It's just providing, you know, new options for patients. And, you know, there's quite a lot of patient preference work that was done by both us and Medtronic, which went and asked patients if you had the option of a device based therapy for your blood pressure reduction, would you do it?
And there's definitely a proportion of patients that said, sure, I would prefer that over something else. So, yeah, I think it's synergistic with the pharma world.
[00:50:40] Speaker A: Do you see that population growing of patients who would prefer, who would prefer not to take a drug for the rest of their lives from everything from blood pressure medicine to cholesterol medicine. I know you're not focused on that, but there seems to be an openness for folks to find other ways as opposed to just taking a pill every morning or evening.
[00:51:02] Speaker D: Yeah, the only one I think that they do seem to like taking is the GLP one.
You know, I think there's always going to be a population that prefer not to take drugs, especially as you get to multiple drugs. Right. We're talking about patients that likely do have cholesterol medication and do have something else and are taking, you know, multiple other, maybe diabetes medications and then their hypertension medications. And on top of that, so while they may be three, four hypertensive medications in total, they could be six, seven, eight, nine, ten. And you know, when you get to that point, firstly you're pretty sure that most of the patients probably are not 100% compliant because many drugs are they. But also you start getting confounding side effects. So as more patients become aware of the clinical evidence supporting renal denervation and there's absolutely no question about the safety of renal denervation, that's been clear from the start.
I think then we'll start to see more patients that are willing to consider device based therapies. We'll also see more physicians that are willing to refer for device based therapies because that still is a barrier certainly in some physician groups.
And ultimately, Tom, it's the same as it was at the beginning. All of this is driven by clinical evidence. And so now we're in that post market world. It's really collecting real world evidence to support that so that patients can make choices and have options.
[00:52:28] Speaker A: You mentioned with the trials that you would engage patients via Facebook. Are you doing direct to consumer marketing now and how are you engaging patient populations?
[00:52:37] Speaker D: Yeah, so we've actually just started a little bit of direct to patient marketing. It's actually a balance because as the, the market is kind of growing, as the reimbursement is improving, you have to balance the amount of patients that you get into a hospital with things like the pre authorization process.
So as you go through the payers, of course there's a pre authorization process where they approve a patient to go forward to the procedure.
You can have a balance between having so many patients go to a site and then having so many negative approvals that it actually can become almost a negative thing. In that, you know, hospitals are trying to build programs, they get patients in the door and then they get a number of, of denials and that dampens the whole program. So it's a balance of improving the pre authorization process, improving the reimbursement and growing the programs at the right speed so that everybody is happy with the whole process. So it's that balance.
[00:53:42] Speaker A: And how are you engaging the physicians? I know you mentioned data. I think you released some data at TCT last year. Talk about your engagement of, of the physicians and how you're using that clinical data.
[00:53:53] Speaker D: Yeah, so at TCT last year we presented our first real world evidence which came from the Global Paradise Registry, so the GPS registry out of emea and very strong data in that it demonstrated that the patients that are being treated commercially are seeing blood pressure reductions of around 20 millimeters of mercury after six months.
So that was one of the challenges that people would bring up about the clinical trials that were done in that the blood pressure changes that were being seen were 6, 7, 8 millimeters of mercury. And there was a question as to whether that was appropriate to refer a patient to. And all of that is because of the way that the studies were designed and the patients that were treated. Now we're talking about patients coming through the commercial world. Much higher risk, much higher baseline blood pressures. And so the blood pressure drops they're seeing are much larger and much more, I think, appropriate for what would be necessary for someone to refer for a device based therapy.
So we do a lot of programs with physicians.
We do internal programs where we bring key opinion leaders in and educate them on the therapy, educate them on the clinical data.
We have a peer to peer program where physicians go out and educate other physicians.
We have a large number of activities that we do to try and kind of spread that word. I spend a lot of time at the clinical sites. You know, our team is very well educated and they educate the sites as well. So it's multifactorial, I think a lot of peer to peer, but also a lot of direct to physician work that we do.
[00:55:40] Speaker A: And I know you've got approval and reimbursement here in the us you got approval and reimbursement in Japan as well. What is your view for the global market? What markets are you pursuing and are you working with? I think Adsuka is assisting with some of that. What's the relationship like with the international markets?
[00:55:58] Speaker D: Yeah, so in terms of the approval? So we're actually commercially active in the Gulf region, in EMEA just started in Japan.
Reimbursement came in early in March and they've just started their commercial activity there.
We're focusing a lot on the US and then Otsuka, our parent company, is actually driving the commercial activity in Japan.
You know, what I would say is that everything that we've seen from EMEA through the US is the same in Japan. So all the challenges and the learnings that we've had over the last many years, you can apply to every single market. So as we grow, it's actually a great base of knowledge to be able to go into a new market and not really start from scratch because everything's the same. You have to have programs, you have to ensure there's reimbursement, you have to educate. It's the same across the world.
[00:56:59] Speaker A: So let's move into sort of the what's next phase of the conversation. What's next for recor? Are you going to be primarily a commercial operation going forward? Do you have a pipeline of R and D products that are going to build off what you've done or perhaps leverage that with new technologies? What's, what's the future for the company?
[00:57:18] Speaker D: Yeah, so we're actively working on our pipeline and the next thing I think for us is very clearly gathering substantial amounts of real world evidence to not only drive the high potential market, but allow us to also look at subpopulations within that for potentially other, you know, patients that are at risk.
We do have a very active investigator sponsored research program which is looking at new indications. So just a couple of examples. We had some data that was presented by VIVEC ready at HRS which was looking at atrial fibrillation. So we looked at atrial fibrillation ablation plus renal denervation. And there's a trend there that suggests that maybe there's an incremental benefit.
We have data in chronic kidney disease and end stage renal disease that's been presented. We have data in ADPKD and actually we have a clinical trial that will probably read out sometime later in this year, which is again an investigator sponsored research study in HFPath.
So that potentially could be the first time that we see positive data in the heart failure space as well. So all of those kind of seed projects are the basis for us to decide where we'll go in the future.
I don't know if you know, Botsuka has a very, very strong platform in nephrology because for us also we are able to treat patients down to a GFR of 30 in our clinical studies, 40 per a labeling. That space, the nephrology space from the CKD is very, it's a big, it's an important space for us because of the technology, but also because of the partnership. So I think plenty of places in the future that we'll be going, both clinically and technically.
[00:59:10] Speaker A: That's amazing. And just final question more broadly about renal renovation, overall, you hit upon some of the areas where the technology is being applied.
It's remarkable to me that this, again, not to dwell on it, but 12 years ago, there was no future for this. Value not only achieves what you set out to achieve, but now this is a technology that may grow into one of the next growth sectors in medtech. How excited are you to be part of that future? And did you see this day coming 14 years ago, 12 years ago, when you were in that meeting in London after you heard the news?
[00:59:48] Speaker D: No. It's interesting because the earlier time before the reset, the potential of renal denervation was very clear. There was a lot of data suggesting that it could be important in many areas.
Now we've got to a point where we've kind of gone back to that, where we're proving that that's actually true.
And honestly, I can tell you that when we got FDA approval, I was almost in shock. I couldn't believe that what we'd done over that amount of time and just trying to understand that not only had we turned a therapy around, we'd actually got commercial approval for it. It's hugely humbling.
And so, you know, for me sitting here every day running this company, it's a privilege. It's an absolute privilege. I love it. And I think we're going to drive to be able to bring this therapy to many, many patients across multiple indications. And I'm very happy to do it. So, yeah, it's my dream job.
[01:00:43] Speaker A: That's great.
It's a truly a fantastic medtech story, one of my favorites. And I'm so grateful that you shared it on the podcast. Thank you for joining us, Alan.
[01:00:52] Speaker D: Thanks, Tom. Appreciate it.
[01:00:55] Speaker A: All right, well, that is a wrap. Thanks again for joining us on this episode of the Device Talks Weekly podcast. Real quick, I hope you'll follow us, the Device Talks podcast network and any major podcast player. You can also follow the Device Talks Weekly podcast. Please tell your friends and family about the Device Talks Weekly podcast.
Great to have more listeners. Please connect with me on LinkedIn, connect with Kayleen Brown on LinkedIn, connect with Skylar Rivera on LinkedIn, and of course, connect with Chris Newmarker on LinkedIn and follow device Talks and Mass Device. All right, with that, folks, I hope you have a great day, weekend, week, wherever you're at. We will be publishing one more episode next week, and then I'll be off the week of July 4th. Take care, everybody.
