Episode: 205 - Greg Lambrecht on How a Spinal Implant Prevents Repeat Back Surgery

1 - > Geoff Pardo: Welcome to the MedTech Talk Podcast. 2 - > This is your host, Geoff Bardo, and it's my distinct pleasure 3 - > to welcome Greg Lambrecht, the founder and executive director 4 - > of Intrinsic Therapeutics, a company which is changing the 5 - > way we do discussing therapy tour. 6 - > And in addition, the founder and chairman of Coravin, which 7 - > is one of the most innovative wine accessible inventors over 8 - > the past 20 years. 9 - > Greg is one of the brightest minds in our place and someone 10 - > I've learned a lot from over the years, and I look forward to 11 - > more people discussing not only on his in his journey, but also 12 - > what he's learned from his entrepreneurial experiences and 13 - > some of the lessons which could be particularly impactful for 14 - > our medtech industry.

15 - > Greg, welcome to the podcast. 16 - > Greg Lambrecht: Thank you, Geoff. 17 - > Thank you for the kind words. 18 - > And sorry about the city noises of London, which you'll hear in 19 - > the background.

20 - > Geoff Pardo: Yeah, here a global traveler. 21 - > And I miss the days when we were interacting a lot more, 22 - > actually. 23 - > We were used to see each other in the halls of the spinal 24 - > conventions, and it's been a long journey for you, but one 25 - > which is, I think, really gaining momentum. 26 - > But before we get to that, you know, I always love to hear 27 - > about people's backgrounds, what kind of sparked their interest 28 - > from an early age, even in entrepreneurship and medicine, 29 - > science, innovation.

30 - > So maybe we start there. 31 - > What what what's your background? 32 - > How did you grow up? 33 - > What what triggered some of your interests?

34 - > Greg Lambrecht: Yeah, it's so I have two wonderful parents, 35 - > one still still with us. 36 - > My father and mother met in New York City, so I was born in 37 - > Manhattan. 38 - > I was raised there until I was 11 years old. 39 - > So I couldn't tell you all the best bars to go to because it 40 - > was but it was an extraordinary experience being a young person 41 - > in Manhattan.

42 - > You know, my we would instead of playing soccer and and other 43 - > things outside, you would go to museums. 44 - > So my my youth was filled with trips to the Met and the Museum 45 - > of Natural History and really a wonderful educational experience 46 - > as a kid. 47 - > My parents divorced and and we moved out to Southern 48 - > California, my mother and my brother and I. 49 - > So I went to Newport Beach, California, just about the exact 50 - > opposite of downtown Manhattan in the early 1980s and had a 51 - > wonderful high school career out there, learning to surf and 52 - > drive and and spend time on the beach.

53 - > So it was a completely different experience. 54 - > years. 55 - > Geoff Pardo: Yeah, that's a that's amazing. 56 - > And I and I love these conversations because I actually 57 - > hadn't I didn't know that about you.

58 - > The one that you could surf, that's pretty good. 59 - > Yeah, yeah, not not so much anymore. 60 - > It's not a big thing in Boston. 61 - > Yeah, right, exactly.

62 - > So so then so to take us through sort of your early 63 - > experiences, maybe after college, and how you really 64 - > started to channel, you know, some of these interests into you 65 - > know more, you know, the tangible work experiences and 66 - > ultimately the inventions. 67 - > Greg Lambrecht: Yeah, I was I was always a creator of things. 68 - > I loved being in a machine shop, I loved shopping in high 69 - > school, I loved the machine shops at MIT. 70 - > So I went went to MIT for undergraduate and graduate 71 - > school.

72 - > My undergraduate work was in plasma physics, and I took my 73 - > grandfather's first set of advice, energy. 74 - > And so I was fascinated by fusion power and the potential 75 - > that it held. 76 - > And we'd just been through the sort of the first Iran struggles 77 - > and and the oil scare of the 70s, and so I thought, you know, 78 - > there has to be a better source of power, and and I was 79 - > intrigued by the beauty of recreating the sun on the 80 - > planet. 81 - > And so I went to work in Japan, had a brief career in Japan in 82 - > plasma physics, working on an experimental fusion reactor 83 - > design, and realized that it was never going to be financially 84 - > viable.

85 - > It might actually technically work, but it'll never be cheaper 86 - > than pulling black stuff out of the ground or sun from the sky. 87 - > And so I was like, okay, well, this is not the career I thought 88 - > it was going to be. 89 - > And I went back to Hyde in graduate school at MIT again and 90 - > and went after the second piece of advice he gave, which was 91 - > medicine. 92 - > And I was in grad school and was interested in business 93 - > because fusion power was one of its fundamental flaws, but it 94 - > wasn't economically viable.

95 - > They didn't teach much business to physicists when I was an 96 - > undergrad. 97 - > So I wound up in the in the business school for an important 98 - > series of classes, and I worked on a product for Johnson ⁇ 99 - > Johnson and the protective peripheral IV catheter way back 100 - > when. 101 - > And was fascinated by the fact that you could create something 102 - > out of a couple of pieces of metal and plastic and and it 103 - > could be such a success. 104 - > M y luckiest day was when I wandered into the MIT career 105 - > office and there was a job advertisement from Pfizer and 106 - > one Josh MacAuer looking to hire somebody to invent new medical 107 - > devices for Pfizer back in the day when it had a hospital 108 - > technology group.

109 - > And I was lucky enough to interview with Josh and get 110 - > hired into Pfizer. 111 - > And we were, you know, he won, he believed that that invention 112 - > could be scheduled and that we could create a program where we 113 - > would target a market and in three months we would have 114 - > developed six to ten new important medical devices for 115 - > whatever that market was. 116 - > And I was lucky both to be hired by him and that he was 117 - > right. 118 - > And and so he started me on my invention career in medicine and 119 - > has been part of my career in life ever since.

120 - > He's a close friend and and on the board at Coravan and was 121 - > part of intrinsic for quite a while, my spine company. 122 - > So yeah, it's that I'd always made things, but he taught me 123 - > how to identify important unmet needs that represented not only 124 - > significant clinical problems that affected a lot of people's 125 - > lives with real severity, where if you could solve it, it would 126 - > be not only important medically, but also important financially.

127 - > And so that that process has sort of governed my life ever 128 - > since. 129 - > Geoff Pardo: And yeah, and I bet a lot of listeners forget 130 - > that Pfizer was in the device industry in back then. 131 - > And what what were some of the early products you you 132 - > worked on? 133 - > Greg Lambrecht: Yeah, well, Josh and I went after big swings 134 - > when we were at Pfizer.

135 - > So they had Valilab, the electrosurgical surgical company 136 - > at Schneider, which is cardiology, and they had AMS 137 - > Urology Company that we worked with, and then Hamedica, 138 - > importantly, orthopedics, hips, knees, trauma. 139 - > Josh and I developed a lot of different technologies, 140 - > including a you know, vascular access device for high flow 141 - > applications like hemodialysis. 142 - > That's another place where I got very good at needles, which 143 - > was important for the Corbin story.

144 - > But it was really after Josh left to start his own companies 145 - > when I was given control of the of the whole fresh tech process, 146 - > this invention process, that I was able to sort of dumb it down 147 - > for the large company. 148 - > I mean, they we kept going after, you know, new indications 149 - > with new devices, so PMA products. 150 - > And I realized that Pfizer, despite its resources, was 151 - > interested in quick hits. 152 - > And so it's when I had the opportunity to run an invention 153 - > program for Pfizer for Hal Medica that we really started to 154 - > create products that that had a meaningful impact.

155 - > So we developed new artificial hips for the Japanese market, 156 - > artificial knees, new fracture fixation devices, some of which 157 - > I'm very, very proud of that still affect, you know, well 158 - > over 100,000 people every year. 159 - > So we've we launched, I think, six orthopedic and 160 - > trauma-related devices in the last two years of my of my work 161 - > at Pfizer. 162 - > Geoff Pardo: Wow. 163 - > And so so then take us through, did did you go from there to 164 - > really conceiving of of the, and we'll get into the exact 165 - > technology and intrinsic, but is is that how you started 166 - > thinking about spine and discectomy?

167 - > Greg Lambrecht: Yeah, you know, I was my last my last year at 168 - > Pfizer, I was, you know, involved in selling off the 169 - > medical device division. 170 - > So I knew I didn't want to stay in pharmaceuticals. 171 - > I like, I love devices. 172 - > And and so I think we we sold off the the Homedica business to 173 - > Stryker, and they were great and and sort of gave me a lot of 174 - > control of the of the Asia Pacific markets and Japan in 175 - > particular.

176 - > But I always had this desire to start my own businesses, and so 177 - > I took the fresh tech process, this invention process, and 178 - > applied it to fields I hadn't worked in. 179 - > And my mother had just been through her third spine surgery, 180 - > and she'd had a discectomy in her lower back and for 181 - > discarniation. 182 - > She then had another dyscectomy at another level, both wound up 183 - > failing by recurrence, and so she had two more operations, 184 - > then degenerative collapse and curvature, severe low back pain, 185 - > opiate dependency, disability.

186 - > Uh, it really changed the trajectory of her life. 187 - > And so that that screamed unmet need. 188 - > And so in 1999 and 2000, I left looking to see if I could solve 189 - > that problem. 190 - > I think that's when we met.

191 - > Way back when. 192 - > Geoff Pardo: Way back when, yeah. 193 - > The founding investor was Spray, right? 194 - > Which joined.

195 - > So got to be a part of at least some of those ear early ish 196 - > board meetings. 197 - > But yeah, so maybe this is a good chance to talk more about 198 - > intrinsic because it has been, you know, a labor of love for 199 - > you a long, a long journey, lots of challenges. 200 - > But you're coming out the other side of it. 201 - > So may maybe give some more background to the intrinsic 202 - > technology, a bit of the journey and kind of where things stand 203 - > today.

204 - > And of course, I have lots of questions after that. 205 - > Greg Lambrecht: Yeah, sure. 206 - > I summarizing 20 some odd years in in a couple of minutes. 207 - > You know, I one thing about entrepreneurship is that it's 208 - > something my father said, you never win if you give up.

209 - > And and so I, you know, I really it's a testament to the 210 - > team that nobody ever gave up. 211 - > The clinical need was still there. 212 - > There are people suffering, hundreds of thousands of people 213 - > in the United States suffering every year. 214 - > So the solution needs to exist.

215 - > And so that really drove us. 216 - > The barricade technology, that's the name of our system, 217 - > barricade is a technology that essentially closes the hole 218 - > definitively at the end of a lumbar discectomy. 219 - > The fundamental flaw with lumbar disquectomy is that you 220 - > know the problem ultimately originates from a hole in the 221 - > outer structure of the disc, the annulus fibrosis. 222 - > So when the disc ruptures, this outer structure tears, and the 223 - > nucleus on the inside comes out and compresses the dura, the 224 - > nerve roots behind the disc, causing severe radiating pain, 225 - > loss of motor function, sciatica.

226 - > It's like I've had it. 227 - > It's like lightning going down your leg. 228 - > It certainly grabs your attention, can even stop you 229 - > from breathing. 230 - > It can hurt so badly.

231 - > And so the most people get better without surgery, but 232 - > about 450,000 people every year get surgery every year. 233 - > And they, so they they go down, they make a small incision in 234 - > your back, a little bit under an inch, and they they remove the 235 - > offending fragment of nucleus that came out. 236 - > The problem has been that that the hole is still there and that 237 - > the disc is under such enormous pressure, , up to 10 times your 238 - > tire pressure, that it has no innate real healing capacity.

239 - > It doesn't have a blood supply directly to it. 240 - > It's an avascular structure. 241 - > And so healing is disorganized and it certainly can't hold back 242 - > the 23 atmospheres the disc can make. 243 - > And so barricade is a is a tire patch, essentially.

244 - > It's a bone-anchored barrier, flexible barrier that's tacked 245 - > into either one of the neighboring vertebral bodies 246 - > with a titanium bone anchor that holds this barrier in place to 247 - > resist the pressures of the disc and block the hole to stop the 248 - > nucleus from coming out that same hole again. 249 - > And so that that's the simple concept of it. 250 - > It was this is it was not an easy problem to solve. 251 - > And there are many reasons why that's true.

252 - > And you know, our company went through all the phases. 253 - > We we tried three different device designs over the course 254 - > of eight years trying to block this hole in all of its various 255 - > forms, and and the the extent of the pathology mattered, and the 256 - > size of the hole mattered, and you know, the disk height and 257 - > the flexibility mattered, all these factors destroyed our 258 - > first two devices that we tried that were not anchored to bone.

259 - > And then in 2008, so it was three years until our first 260 - > inhuman, two years of struggle with that first inhuman device 261 - > to in clinical trials to try to get it to work, giving up, going 262 - > to another device design, another two years in clinical 263 - > trials, struggling to get that to work, and then finally coming 264 - > up with the current design, which really hasn't changed much 265 - > since its first implantation. 266 - > So that was the first phase.

267 - > The second phase is clinical proof. 268 - > And so first in human studies, 2008, two of them, 75 patients, 269 - > and we took a a one in four rate of reherniation and reoperation 270 - > and and dropped it down to about three percent. 271 - > So it was a big improvement and big enough to make a gamble on 272 - > a randomized clinical trial. 273 - > And so we needed a randomized prospective study, not only for 274 - > regulatory but for insurance.

275 - > And so we initiated our RCT in December of 2010. 276 - > Four years to enroll 554 patients, randomized equally 277 - > intraoperatively after the discectomy was done to either 278 - > receive the device or not. 279 - > Three years of follow-up for the FDA, two years of 280 - > negotiation with the FDA. 281 - > So final approval in 2019, real launch in 2020.

282 - > We got approval of the commercial device three days 283 - > before the pandemic hit. 284 - > So another, then there's the commercial phase. 285 - > So there's the there's the regulatory approval phase, then 286 - > the commercial phase, and so we are at the end of our our sort 287 - > of reimbursement struggles. 288 - > The light is finally shining upon us, which is great.

289 - > So CMS issued a new payment code for our device very early 290 - > on due to some smart advice that I received before we started 291 - > the RCT. 292 - > So we we had we had CMS payment, but the vast majority 293 - > of our patients are under the age of 65, so private insurance. 294 - > And and so CMS payment in 2020, and you know, we had to get a 295 - > new CPT code, , which we achieved last year, got rucked 296 - > over the course of last year, and became live in January of 297 - > 2026 this year.

298 - > And Cygna has moved to positive coverage, Anthem is neutral and 299 - > paying everything, and Blue Cross Blue Shield seems to be 300 - > next in line. 301 - > So yes, the the winds have changed in our favor, which has 302 - > been great, but it's a haul. 303 - > Geoff Pardo: It makes such intuitive sense. 304 - > I mean, if you you know, for anyone who's about to go through 305 - > a discectomy, I mean, it's there's very little downside and 306 - > all the upside you mentioned in terms of pre preventing that 307 - > whole degenerative cascade that can follow and and all the 308 - > things that means.

309 - > As you look back though, on on the history of it, I'm sure 310 - > there's a ton of lessons, a ton of things that you would, you 311 - > know, you know, you might consider differently or do 312 - > differently, and not to mention, you know, just thoughts on our 313 - > regulatory process and how we pay for things in this country. 314 - > But I'm curious as you think about it from, you know, if you 315 - > talk to other entrepreneurs and you you talk about this whole 316 - > journey you've been on, what what are there a handful of 317 - > things that you would advise, like other entrepreneurs on how 318 - > to do things and how to, you know, make it happen, maybe in a 319 - > you know quicker way?

320 - > Greg Lambrecht: Absolutely. 321 - > So I'll go on the on the clinical technical side because 322 - > we went through eight years of doing the wrong thing before we 323 - > got to the right thing. 324 - > If you have a brand new idea for brand new field of medicine 325 - > or opening up a new opportunity, start with the simplest, most 326 - > rugged possible solution, not this sort of idealized optimal 327 - > solution. 328 - > The thing that that is the simplest, most rugged expression 329 - > of your solution.

330 - > The body is a violent place that is extraordinarily varied 331 - > in anatomy and in pathology. 332 - > And so I've seen certainly intrinsic, our company, and 333 - > others that had brilliant ideas go after the optimal, this sort 334 - > of theoretical optimal. 335 - > That is call that your second generation device. 336 - > If Gen 1 works, if the rugged simple works, then start 337 - > experimenting with with the this theoretical optimal.

338 - > Because there are so many surprises along the way. 339 - > If you've got a great core idea, close the hole in the 340 - > annulus fibrosis, do it in the most secure way possible. 341 - > That the the safest, simplest way that has the has a decent 342 - > chance of working. 343 - > Because you might be surprised by how effective it actually is.

344 - > Here we had this up this idea of optimal, like we were gonna 345 - > have a self-expanding stent that covered the entire posterior 346 - > part of the annulus, and it was gonna be, you know, nitinol and 347 - > covered in Gore-Tex. 348 - > And you know, it it it was optimal, sure. 349 - > It absolutely eliminated the risk of recurrent disc, but it 350 - > was also nearly impossible to implant and really dependent 351 - > upon the anatomy and the pathology. 352 - > So just going for simple early is the best way to go when 353 - > you're working on something brand new.

354 - > That's the clinical advice I have. 355 - > The the thing that I would do differently from a trial 356 - > perspective, you know, we in the United States and actually 357 - > around the world, because we've been commercial in Europe as 358 - > well as in Korea and Australia, the regulatory approval body and 359 - > the reimbursement bodies not only don't talk to each other, 360 - > they don't respect each other. 361 - > And so many people design their clinical trials with the 362 - > regulatory agencies without considering designing them with 363 - > the payment agencies.

364 - > And I've I've learned the hard lesson that an FDA approval or a 365 - > CE mark or an Australian approval is the approval to sell 366 - > your device for nothing. 367 - > Yeah. 368 - > Right. 369 - > And so it is, I was very lucky early on.

370 - > There was a really smart guy who said who said to me, you 371 - > know, in the end you're gonna need CMS to issue a payment code 372 - > for this thing. 373 - > Why don't you take this protocol you're negotiating with 374 - > the FDA and negotiate it with CMS first? 375 - > And then whenever they tell you, if it's different from what 376 - > the FDA wants, fight like hell for what they what CMS wants. 377 - > That was spectacular advice.

378 - > And in our in our case, the one change that it led to was you 379 - > know, the CMS was saying, why does the FDA always cut off 380 - > enrollment at the age of 65 and then for spine studies? 381 - > And then the companies come to us asking for reimbursement, and 382 - > you haven't studied our patient population. 383 - > Why would we pay you? 384 - > So, you know, we made a very simple change.

385 - > We we had 18 to 65 for our age group, and and we went 18 to 75 386 - > and and let CMS know we were doing it for them, and then 387 - > fought with FDA tooth and nail over that change. 388 - > But we enrolled, you know, 10% of our population, 15% of our 389 - > population over the age of 65 as a result. 390 - > And that led to CMS's approval. 391 - > They also really appreciated the fact that we gave them our 392 - > protocol to edit, and and when our device was found superior, 393 - > they were like, okay, here you go.

394 - > That was great. 395 - > The mistake I made was I should have done the same thing with 396 - > private insurance. 397 - > There is an opportunity to interface with the medical 398 - > directors of private insurance companies, because we do it now 399 - > to talk to them about our data. 400 - > And I don't know that they would have changed our clinical 401 - > trial protocol in any meaningful way, but involving them in the 402 - > process early, , even though the people are likely to change 403 - > over the course of the, you know, six, seven years you do a 404 - > PMA or eight, at least their input was there and their stamp 405 - > is on the on the protocol.

406 - > It's it's easy as a as an entrepreneur in medicine to get 407 - > lost in the arguments and negotiations with the FDA. 408 - > It's important to remember that at the end the goal is to make 409 - > sure the device is paid for. 410 - > So I think if you're doing something new, that's the advice 411 - > I'd give. 412 - > My my strong advice would be find a 510K with an existing 413 - > paying code.

414 - > Geoff Pardo: Yeah. 415 - > Right. 416 - > Yeah, for sure. 417 - > That is, I think, where a lot of investors certainly gravitate 418 - > to.

419 - > Yeah. 420 - > Because it's hard. 421 - > It is hard. 422 - > You took on one of the biggest challenges spying and and 423 - > getting something both approved for, given the length of the 424 - > follow up, and then paid for that's truly novel and spying.

425 - > I mean, there's not been a lot of really rigorous studies in 426 - > spine. 427 - > You probably have among the most evidence and rigor of any 428 - > spinal implant, I would wager. 429 - > Greg Lambrecht: Yeah, I think we do. 430 - > I credit Pfizer for that.

431 - > There's one thing that you did come out of Pfizer with, which 432 - > is a a healthy respect for good science from a from a randomized 433 - > trials perspective perspective. 434 - > And, you know, they also had Schneider Cardiology Company 435 - > that I just work with. 436 - > You know, you in cardiology, you do you do clinical trials at 437 - > the drop of a hat. 438 - > Right.

439 - > That's just the way that that business rolls. 440 - > And it was one of the things that I recognized when I worked 441 - > in orthopedics how little data there was to support anything. 442 - > And how most decisions are made on, you know, gestalt. 443 - > Right.

444 - > Geoff Pardo: Yeah. 445 - > Greg Lambrecht: And most indications are off label one 446 - > way or the other. 447 - > And so I made a concerted effort, and maybe that's sort of 448 - > pigheaded on my part, but made a concerted effort to be 449 - > counterculture from a data perspective. 450 - > I wanted to make sure that that, you know, I it was my 451 - > mother that I saw I found the company for.

452 - > You know, I wanted, I wanted to make sure that when Barricaid 453 - > was launched and was used broadly, that it was going to be 454 - > safer than discectomy alone. 455 - > You know, that we were gonna not just reduce reherniation, 456 - > but all cause reop and make people's lives better, get them 457 - > back to work faster. 458 - > Geoff Pardo: You know, I wanted it to work. 459 - > You you bring up a an important point here, which is kind of 460 - > the patient experience and then the surgeon experience.

461 - > Because from a patient experience, they're the ones 462 - > that experience the reherniation and everything that follows 463 - > from that. 464 - > The surgeons, at least in my experience, they do the 465 - > procedure. 466 - > It looks great, you know, procedurally. 467 - > They maybe do a follow-up with the patient, but they often 468 - > don't see that patient again.

469 - > If they reherniate, maybe that patient may go to another 470 - > surgeon. 471 - > So they don't really appreciate kind of the downstream effects 472 - > of the procedure that they did. 473 - > I mean, I'm sure they do, and to some degree, so I'm over 474 - > probably overemphasizing that. 475 - > But but in in many cases, I don't think they feel like, oh, 476 - > I did a, you know, a poor discectomy, or I could have done 477 - > it better with this device.

478 - > How hard it has it been to change the surgical mindset 479 - > given that backdrop? 480 - > Greg Lambrecht: It it yeah, there's the only person in this 481 - > whole process that doesn't have a conflict of interest is the 482 - > patient. 483 - > Right? 484 - > There's, you know, it's actually fine, not that this is 485 - > a a big driver, but it's actually financially more 486 - > lucrative to reoperate a patient.

487 - > Geoff Pardo: Right? 488 - > Greg Lambrecht: The surgeons paid for the primary operation 489 - > and then they're paid for the reoperation. 490 - > And you know, as long as global payments don't extend a window 491 - > out too far. 492 - > So, you know, there's that.

493 - > There is the fact that that patients go elsewhere. 494 - > You know, if they if you do the dyscectomy and then they felt 495 - > better and then all of a sudden they felt worse, even worse than 496 - > they did before their dyscectomy, they the patient 497 - > tends to blame you as a surgeon and and go find somebody else. 498 - > And it, you know, I've had some funny conversations with 499 - > surgeons. 500 - > I was like, you know, do you do you do you appreciate a 501 - > recurrence rate or a recurrence risk in your in your hands?

502 - > And it really comes down to how you have this discussion. 503 - > I'll get to the right way of having it. 504 - > This is this is the wrong way of having it. 505 - > You know, I would say, do you appreciate the the recurrence 506 - > risk that that your patients undergo and or at risk of?

507 - > And and they'll always say, no, no, no, in my hands, I mean, 508 - > wow, I can't think of the last reherniation I had. 509 - > Maybe, maybe one a year. 510 - > I just had this conversation with a surgeon, maybe one a 511 - > year, you know. 512 - > I probably do 150 discectomies, so I would say, oh, it's a 513 - > fraction of a percent.

514 - > And then I always say, Do you operate on your neighbor 515 - > surgeons' recurrent disc herniations? 516 - > Oh, yeah, all the time. 517 - > Right? 518 - > Uh I don't have reherniations, but my oh, the guy down the 519 - > street, he has them all the time.

520 - > And like, you know, you you you hope that they come to 521 - > recognize some surgeons are great, right? 522 - > Some surgeons are like, yeah, of course, we have r ecurrence. 523 - > And I've learned to have the question ask the question a 524 - > different way. 525 - > When I when my team goes into the operating or goes into a the 526 - > office with a surgeon, they'll say, you know, who is it that 527 - > walks in your door that you know is gonna be a high recurrence 528 - > risk?

529 - > And there are those people, there must be those people. 530 - > Who is it that when they when they come in your door, you're 531 - > like, oh no, I'm gonna do this discussion. 532 - > This is, but this is a this is a high recurrence risk. 533 - > And they all have some sort of preconceived notion of who that 534 - > patient is.

535 - > And you start from there. 536 - > There's some great research that shows that not everybody is 537 - > at the same risk. 538 - > And people that are at the highest risk are the people with 539 - > the biggest hole, right? 540 - > The larger the hole in the tire, the higher the risk that 541 - > air is going to come out in the disk sense.

542 - > And it sort of logically makes sense. 543 - > And if they have a preserved disk height, if they still have 544 - > nucleus left, you know, they and they have a big hole, they're 545 - > at a really high risk. 546 - > And so, you know, what I'll normally do in with surgeons to 547 - > walk them there is to say, whatever group they've said, 548 - > normally it's young women, obese women, obese somebody, football 549 - > player, sports, heavy labor, whatever it is, I'll say yes.

550 - > And there's great research that shows that patients with a 551 - > large hole in their disc, no matter their age, no matter 552 - > their profession, are just at a higher risk. 553 - > And nine times out of ten, you get somebody nodding. 554 - > Geoff Pardo: Yeah. 555 - > Greg Lambrecht: You also want to just put it in their head so 556 - > that when they have their next recurrence, they're like, hmm, 557 - > there was that barricade thing.

558 - > Geoff Pardo: Yeah. 559 - > Yeah. 560 - > And I mean, this is where data and data in spine is so 561 - > important. 562 - > The fact that you ran a randomized trial.

563 - > You certainly didn't go after, you know, sort of fly-by-night 564 - > spine surgeons. 565 - > You went after, you know, really high quality spine 566 - > surgeons, and and the data, you know, is pretty 567 - > incontrovertible. 568 - > Announcement: Are you enjoying the conversation? 569 - > We'd love to hear from you.

570 - > Please subscribe to the podcast and give us a rating. 571 - > It helps other people find and join the conversation. 572 - > If you've got speaker or topic ideas, we'd love to hear those 573 - > too. 574 - > You can send them in a podcast review.

575 - > Geoff Pardo: I'm curious, you know, as you reflect more as a 576 - > from an industry perspective on your regulatory experience and 577 - > now the reimbursement experience. 578 - > And let's start with the regulatory. 579 - > I mean, three-year follow-up sounds really long. 580 - > I mean, , there's few devices that have to undergo that length 581 - > of follow-up, but I'm curious if there are things from a 582 - > regulatory standpoint that you feel like could really we should 583 - > be thinking about in in terms of expediting the pathway to you 584 - > without compromising safety or efficacy to market for patients.

585 - > Greg Lambrecht: Yeah, it's I think about this a lot because 586 - > I, you know, we we got we had regulatory approval in the 587 - > European Union in Korea and in Australia long before we had it 588 - > in the United States. 589 - > And the Koreans and Australians and the Europeans benefited 590 - > from barricade earlier as a result. 591 - > In the end, I'd probably need a randomized clinical trial of 592 - > the size that it was just to battle with the private 593 - > insurance companies.

594 - > In the end, that study needed to get done. 595 - > The the follow-up length was was ridiculous. 596 - > That, you know, we had to extend an additional year was 597 - > ridiculous. 598 - > There's always here's my thought.

599 - > The FDA is not celebrated for approving something great. 600 - > They are only derided for approving something they 601 - > shouldn't have. 602 - > They're there there's no upside to benefit and there's enormous 603 - > downside to new risk. 604 - > There they have this risk-benefit ratio that they pay 605 - > lip service to, right?

606 - > They are required by law and statute to evaluate risk versus 607 - > benefit. 608 - > And if the benefit outweighs the risk, then they should 609 - > approve. 610 - > And if the evidence shows, and while that is written into law, 611 - > their risk aversion is so enormous that they they struggle 612 - > mightily with approving rational studies and and and 613 - > even agreeing with themselves when that study is shown. 614 - > I mean, Barricaid was shown to be superior to discectomy alone 615 - > from three months now out through five years, ten-year 616 - > data is about to be published.

617 - > And you know, they they should have had a mechanism of 618 - > approving us earlier and faster. 619 - > I think there's all sorts of fixes that are possible. 620 - > But you know, I for the US defining safety in a clear way, 621 - > right? 622 - > Because the because paranoia wins otherwise.

623 - > I remember one of the people on our FDA panel saying, Well, you 624 - > need 10-year data to prove that this is still safe. 625 - > Right. 626 - > Like you know, if if 10-year data were required for anything, 627 - > we would have nothing on the market. 628 - > Right.

629 - > Right. 630 - > And yet, you know, that's that sounds rational in certain 631 - > circumstances, but it has nothing to do with actually 632 - > advancing therapy. 633 - > So, you know, I think for a for a field of medicine to be able 634 - > to define data from a safety perspective, you know, if you're 635 - > gonna be doing surgery in the lumbar spine, you need to 636 - > demonstrate X, right, from a safety perspective, X number of 637 - > years at a minimum or a maximum.

638 - > That would be wonderful. 639 - > Efficacy is going to be dependent upon the indication, 640 - > but the safety part needs a line in the sand. 641 - > So because you know, the the the the it's interesting, the 642 - > assumption is that the current procedure is perfect, yeah. 643 - > Yeah, and that anything new just generates new risk.

644 - > And here we had data that showed that the barricade had an 645 - > overall dramatically reduced rate of reoperation, all cost 646 - > relative to the existing procedure. 647 - > And even that was not considered enough to overwhelm 648 - > their risk, their fear of theoretical concerns that had 649 - > not raised their head, you know, that that have never been a 650 - > reality. 651 - > That that seems like a flaw. 652 - > And then there are all sorts of things.

653 - > The appeals process goes through the FDA. 654 - > So if you're to appeal, you're appealing to the organization 655 - > that's rejecting you. 656 - > That doesn't make any sense. 657 - > I think defining a safety line is one thing that would help 658 - > them.

659 - > Defining what safety is rigidly, so at least it's 660 - > predictable, would be great. 661 - > Having an approval issuance with an ability to withdraw 662 - > approval might give them the sense that they have the power 663 - > to control safety if there's something untoward that's 664 - > discovered once you've launched. 665 - > I'd be comfortable with that. 666 - > You know, one of the things that I love about the the US 667 - > system is that there is a forced mechanism of reporting adverse 668 - > events post-approval through the mod database.

669 - > I mean, if I think if you've got continued reporting 670 - > requirements to the FDA, that should be allowed for approval, 671 - > you know, measuring your safety once you're actually out in the 672 - > field. 673 - > It's a little bit like the European used European Union 674 - > used to used to do. 675 - > They would audit you every year. 676 - > Geoff Pardo: Yeah.

677 - > And they had the right to pull. 678 - > This is really interesting because it's indexing more 679 - > towards safety. 680 - > I mean, the the tragedy of what we have to go through right now 681 - > is you you go through safety efficacy studies, , you get 682 - > approval, and then you if you're novel and you don't fit under 683 - > the existing reimbursement, you know, coding coverage and 684 - > payment, then you have to go through another set of studies 685 - > or, you know, another many, many years to so you in effect have 686 - > two different approval processes that you have to go through.

687 - > And I think what I hear you saying is index more on the 688 - > safety side, so we're not putting stuff out there that's 689 - > it's gonna harm patients, and allow companies to build the 690 - > efficacy data post in a post-market situation, which 691 - > they're gonna have to do anyhow to convince the payers to pay 692 - > for it. 693 - > Greg Lambrecht: Is that that is absolutely true? 694 - > And so thank you for summarizing my meandering. 695 - > I but it's because it's that is what the EU did ultimately.

696 - > The regulatory body was responsible to f for defining 697 - > safety, the payers are responsible for defining 698 - > efficacy. 699 - > The EU has now changed, unfortunately. 700 - > But you know, the the FDA should make sure that whatever 701 - > is out there is safe. 702 - > It would still require two years in a in a spinal implant 703 - > for safety to be well defined.

704 - > I think that's a a good endpoint. 705 - > Everything that's almost everything that's gonna happen 706 - > is gonna happen in two years. 707 - > But the efficacy side of it, when the FDA defines efficacy, 708 - > it frequently does not align with what the insurers define 709 - > efficacy as. 710 - > It's interesting.

711 - > The the FDA, you know, we had an eight-point composite 712 - > endpoint involving all sorts of factors, some of them, you know, 713 - > asymptomatic radiographic outcomes were were almost 714 - > equally as important as whether or not somebody was reoperated, 715 - > right? 716 - > In the FDA's endpoint. 717 - > And from an insurance standpoint, all they care about 718 - > is reoperation rate. 719 - > That's it.

720 - > How early does it happen? 721 - > How often does it happen? 722 - > And how is how expensive is reoperation? 723 - > Yeah, you know, all cause.

724 - > And and that's rational from their perspective, but it wasn't 725 - > the FDA's point of view. 726 - > And so, you know, I think if I had negotiated with the 727 - > insurance companies, maybe I would have been able to sell a 728 - > reopt endpoint to the FDA, but maybe not, right? 729 - > So I'd I'd very I like in the end, the constraint on the broad 730 - > application of a new medical device is the payer. 731 - > Yeah, that they are the ones.

732 - > The FDA is always worried they'll give FDA approval and 733 - > all of a sudden this thing's gonna be everywhere. 734 - > No, not if it needs a new code. 735 - > Yeah, , it's gonna take a while, and you're gonna have to 736 - > prove to societies and insurance companies that you are worth 737 - > paying for. 738 - > And so it is a risk of multiple new clinical trials.

739 - > Luckily, we have the one that proves both. 740 - > Geoff Pardo: Yes. 741 - > Which leads us to another interesting topic, and 742 - > particular you have particular insight here because of how 743 - > global you you've been for, you know, really throughout your 744 - > career, and you've seen how things are paid for in different 745 - > countries and and now wrestling with the US system. 746 - > And I know you're a capitalist at heart as well, so but but 747 - > how would you you know the problems in our system are so 748 - > many?

749 - > I mean, there's so many, you know, conflict of interest, as 750 - > you pointed out, and so much cost that is you're probably not 751 - > well directed. 752 - > So I'm curious as you reflect upon selling in different 753 - > countries and and and now the experience in the US, are what 754 - > are the things we should be thinking about or or maybe 755 - > considering to help streamline this so that patients are 756 - > getting access to the best care? 757 - > And you know, we spend 18, 19% of our GDP on healthcare.

758 - > I mean 50%, maybe even 100% more than other well-developed 759 - > countries. 760 - > So there's a clear problem here. 761 - > Uh so it can't be just, you know, I think there's concerns 762 - > on both sides, but how would you think about addressing this? 763 - > Because I think it's the biggest, one of the biggest 764 - > issues we face as a medical device industry.

765 - > Greg Lambrecht: It absolutely is. 766 - > It's not only that we spend one and a half to two times as much 767 - > as other countries, our efficacy is worse, right? 768 - > Life expectancy, , general health and well-being, you know, 769 - > the level of disability, there's almost no excuse at this 770 - > point. 771 - > We can't say we're leaders in medicine and then have the life 772 - > expectancy that we have, no matter what the fentanyl crisis 773 - > did.

774 - > I mean, just overall, we don't deliver as well as other 775 - > countries. 776 - > So, you know, the the the striking difference between my 777 - > commercial experience in Europe and Asia Pacific and the United 778 - > States is the extent of single payer coverage or national 779 - > coverage, government-related healthcare. 780 - > You know, the the best systems that I've seen across the world, 781 - > Australia, Germany, Singapore. 782 - > Germany's big.

783 - > It's right, 85 million people. 784 - > You know, it's it's not a small country. 785 - > So we can't use the excuse that it's a small European country. 786 - > It's not nothing.

787 - > And their healthcare system works with a government payer 788 - > that everybody has access to and private insurance on top. 789 - > So, you know, you can opt out of the government insurance and 790 - > go into private insurance coverage, but if you do that, 791 - > you can never go back. 792 - > So nobody chooses, or very few people choose, the fully private 793 - > side because it means that they've cut themselves out of 794 - > the government side forever. 795 - > Uh, so you know, a government system based on a percentage of 796 - > the tax collections and it being available to everybody equally 797 - > across state lines.

798 - > They have 15 states, not 51 like us, 51, 52, is an extremely 799 - > efficient way of delivering basic health care. 800 - > And the private insurance on top is a choice by the employed 801 - > or by the retired. 802 - > You can pay for additional coverage to be able to select a 803 - > particular doctor, go to a particular hospital, have a 804 - > certain type of room, things that are in addition to your 805 - > basic healthcare. 806 - > Now, why is that a better system?

807 - > Right now in the United States, we have 51 different healthcare 808 - > systems across our country, each state regulated. 809 - > And that means essentially 51 different health insurance 810 - > markets and multiple insurance players in most markets. 811 - > So a physician's office needs to gain prior authorization for 812 - > a given procedure from, you know, three to four different 813 - > major insurers that are in their market. 814 - > And each one of them has a different reject rate, a 815 - > different requirement rate for each of these prior 816 - > authorizations.

817 - > And so they employ staff to fight the prior authorization 818 - > battle. 819 - > And then they employ staff to bill appropriately from the 820 - > physician side. 821 - > The facility does the same thing. 822 - > The facility is also fighting for billing on the back end.

823 - > And as a result, and with the varying insurance policies that 824 - > are out there, plus the different negotiations between 825 - > the facility and the physician's offices and the various 826 - > insurers in each of these markets, we have a lot of 827 - > headcount that are not delivering health care. 828 - > They are fighting for prior authorizations and payment. 829 - > A lot of headcount. 830 - > When I'm in Germany, I'm in a procedure, they do the 831 - > procedure, they enter the codes in the operating room of what 832 - > was done, and the government pays them within a week.

833 - > There's nobody there. 834 - > There's somebody handling facility finances, but that's 835 - > about it. 836 - > It it eliminates a whole category of overhead in the 837 - > facility and the in the physician side when you have a 838 - > national pair that works equally across state lines or largely 839 - > equally across state lines. 840 - > I would love it if this, you know, it sounds socialist of me 841 - > because I am a capitalist, but having sort of health insurance 842 - > provided by Medicare across the country with the ability to add 843 - > private insurance on top for people that want to pay for it.

844 - > I really do believe in that. 845 - > Just to eliminate the bureaucracy. 846 - > The one thing you talk to physicians about, you know, what 847 - > they hate about their jobs, it's dealing with insurance 848 - > companies. 849 - > Geoff Pardo: Yes.

850 - > I would say that's a huge cause of burnout. 851 - > And yeah, I mean, patient dissatisfaction. 852 - > So it is pervasive. 853 - > And, you know, I too am, you know, have always sort of 854 - > hesitated to think about a single payer or single payer 855 - > with this sort of private insurance layer.

856 - > But I agree. 857 - > You see the you see the armies of people in the cost that is 858 - > dedicated, and you think about how that cost is really not, you 859 - > know, it's not really improving anything. 860 - > It's sort of just wasted dollars that could go in so many 861 - > different more productive directions. 862 - > Greg Lambrecht: Yeah, that's it's not decreasing our 863 - > healthcare expenditures, right?

864 - > It's not increasing our efficiency of of healthcare 865 - > delivery. 866 - > Geoff Pardo: Yeah. 867 - > Greg Lambrecht: And then when you think about it, the the you 868 - > know, you go all the way to the Swiss direction, which is 869 - > eliminate eliminate for-profit health insurance. 870 - > Uh, you know, their their basic argument was who who does who 871 - > is benefited by the profit margins of a private health 872 - > insurance company, right?

873 - > You know, that that's just if you think about a 15% margin for 874 - > private insurance on a whatever it is, 18% of GDP. 875 - > Yeah, you know, you you can understand why United 876 - > Healthcare's stock price is up high, right? 877 - > But who's that helping? 878 - > Geoff Pardo: Yeah.

879 - > Yeah. 880 - > And , you know, unfortunately, the way they make money is to 881 - > create that spread between the insurance premiums they come in 882 - > and what they pay out. 883 - > And so there's a there is that conflict of interest we talked 884 - > about. 885 - > And and you know, on top of that, most people are staying 886 - > with their private insurer for three or four years.

887 - > So there's not a real incentive to think long term about the 888 - > long-term health of these, their member population. 889 - > Greg Lambrecht: It was remarkable the negotiation with 890 - > Barricaid and the Australian government payment system. 891 - > They asked us for our clinical data. 892 - > And we gave them our clinical data, and they gave us a 893 - > reimbursement price that almost rivals the US price.

894 - > They said, This is how much money you save us over five 895 - > years. 896 - > Right. 897 - > And and I was like, Well, that was rational. 898 - > Did you pull yourself off the floor?

899 - > I'm sorry, what did you say? 900 - > Yeah, it it's it was shocking how clear-headed that was. 901 - > Now they they've had their struggles too. 902 - > I don't want to make it sound like it's it's super easy 903 - > everywhere.

904 - > And I know that cervical discs, which are a great technology, 905 - > cervical artificial discs, really struggled in Australia 906 - > for years to get the appropriate reimbursement for them, but but 907 - > but ultimately did. 908 - > So it's, you know, I mean the current process in the United 909 - > States is you know, get the CMS to pay you a a to develop a 910 - > code for your procedure, get the societies to back a CPT code, 911 - > get that CPT code valued. 912 - > These are all very similar in Germany and Australia, right?

913 - > You need societal support to issue , in their case, an OPS 914 - > code, and you need they have a very interesting way of pricing 915 - > a procedure in Germany that I thought was sort of beautiful. 916 - > You they have a they have a cost collect they have a group 917 - > of cost collection hospitals, 300 or so across their country, 918 - > and your procedure needs to be done in those cost collection 919 - > hospitals, and the facility needs to essentially pay you 920 - > without any reimbursement.

921 - > So the facility has to believe in the value of the procedure so 922 - > much that they're willing to lose money for two years. 923 - > And you're essentially that gives enough data to the 924 - > government for them to be able to calculate the value of this 925 - > new CPT code or OPS code. 926 - > And and so it's really a partnership between the 927 - > procedure technology provider and the facility to absorb this 928 - > burden of paying for a device without being reimbursed for it, 929 - > with the knowledge that if they do that for two years, then 930 - > there will be an appropriate payment code for that device.

931 - > Talk about a constraint on broad broad use of a new 932 - > technology, right? 933 - > They have to lose money for two years to adopt a new technology 934 - > so that it has a payment code. 935 - > And trust me, the the physicians won't do that unless 936 - > they believe it works, right? 937 - > They it that it's delivering benefit to the patient.

938 - > It is a it is a fundamental flaw of our private insurance 939 - > company as well, that that that they, you know, you said three 940 - > years. 941 - > I've been hearing a year and a half to two years. 942 - > Wow. 943 - > They don't care about adverse events that occur after their 944 - > coverage window.

945 - > And and you know, when you say it's one and a half to two 946 - > years, the patient has a discectomy, let's say at month 947 - > 14 of their health insurance coverage with this company. 948 - > So, you know, even if there's a six-month high reherniation 949 - > rate and your benefit is, let's say six months out, with us 950 - > we're lucky, it's three months. 951 - > Uh, so it's not a very strong argument from the insurance 952 - > company to say that somebody else would be paying for it.

953 - > But if it's if it goes beyond their window, they're like, I 954 - > don't care, that's somebody else's problem. 955 - > Geoff Pardo: Yeah. 956 - > Yeah. 957 - > Greg Lambrecht: That is a broken system.

958 - > Geoff Pardo: Right. 959 - > Exactly. 960 - > Exactly. 961 - > I mean, so there's so much in there, you know, the how we 962 - > think about primary care, diagnostics, you know, all the 963 - > things that can help prev you know prevent longer-term 964 - > disease.

965 - > Yeah. 966 - > But, you know, the and there's so many th this could be an an 967 - > episode unto itself. 968 - > There's a couple other things I wanted to ask you about. 969 - > One, you know, you've you've you are in the unique position 970 - > where as founder of intrinsic, you have stayed with the company 971 - > even when you're you stepped down as a CEO.

972 - > Yeah. 973 - > And you know, I think that's remarkable because you're you're 974 - > you're a very charismatic leader. 975 - > You're someone who obviously have built a company where 976 - > people have been extremely loyal to you know over the last 20 977 - > years. 978 - > And I'm curious how how chall you know, how how would you give 979 - > advice to a founder who with a new CEO coming on board where 980 - > you're staying with the company?

981 - > I mean, how do companies sort of adapt to that? 982 - > Because as a as a director of you know, these companies, you 983 - > know, the traditional adage is, well, it's a root that's gonna 984 - > be super difficult because people will look to Greg, not to 985 - > the new leader. 986 - > And how do you kind of manage that situation so the new leader 987 - > is actually in place and able to lead effectively? 988 - > How have you been able to do that so well?

989 - > Greg Lambrecht: Oh well, I appreciate that the assumption 990 - > that it was so well. 991 - > I hope it was or has been. 992 - > Look, I think it comes from number one, recognizing what I'm 993 - > good at and what I love to do versus what I felt I had to do. 994 - > So I realized when I stepped back from being CEO that there 995 - > were parts of the CEO job I didn't like, and there were 996 - > parts of it that I loved.

997 - > And so what I did when Kerry Hagan joined and now Keith 998 - > Valentine, two really great leaders, was be able to take 999 - > them aside and say, here are the parts of being a CEO that I 1000 - > loved, here are the parts that I absolutely hated. 1001 - > If you want help with anything, I'm there to help you. 1002 - > My goal is to get this company to be successful. 1003 - > That's the most important thing to me.

1004 - > That's why they are here leading this company is to make 1005 - > this company successful. 1006 - > That's why I want to be here. 1007 - > That's why my BP of RD or RBP of RD wants to be there. 1008 - > The goal is success of the company and treatment of the 1009 - > patient.

1010 - > Our whole goal is to get through the government, the 1011 - > insurance companies, through the hospitals, through the 1012 - > physicians to the patient. 1013 - > And if that's your goal, this is the right place. 1014 - > I am here. 1015 - > These are those, these are the parts of being a CEO I love.

1016 - > If you would like help with those in particular, I'm really 1017 - > happy to help you in any of those. 1018 - > And, you know, and make myself available to them and then say 1019 - > to them, what is it that you want me to do as founder to help 1020 - > this company be successful? 1021 - > I think it's just being open, honest, and and honestly, as 1022 - > founder, inventor, having the slow self-awareness of what it 1023 - > is. 1024 - > CEO sounds like a great title, right?

1025 - > You're you're in control. 1026 - > Finally, you can drive this thing forward and you're gonna 1027 - > get it to the end. 1028 - > And this is the only position from whence I can drive this 1029 - > forward. 1030 - > And that's simply not true.

1031 - > CEO is a role, like CFO, like chief operating officer, like 1032 - > CTO, like it's it is a role that has specific responsibilities. 1033 - > And and I've come to realize that I like and don't like some 1034 - > of those. 1035 - > And if I can find somebody who's who loves the things I 1036 - > don't like and is really good at them, we make a great team and 1037 - > partnership. 1038 - > Uh and so Carrie was that way, and and Keith Valentine now is 1039 - > spectacular at the things that I didn't like to do, and he loves 1040 - > them.

1041 - > Yeah. 1042 - > And so, you know, that's it's finding those people to fill 1043 - > those those roles. 1044 - > CEO is a great role. 1045 - > And I have to admit, I love being a board member, right?

1046 - > But still, as founder, my responsibility is to defend the 1047 - > interests of common. 1048 - > Geoff Pardo: Yeah. 1049 - > Yeah. 1050 - > And I think you said self self-awareness.

1051 - > It's one of the biggest, one of the hardest things I think for 1052 - > us all is to really, you know, be able to reflect and sort of 1053 - > objectively think about what do we do well, what don't we do so 1054 - > well, how would the organization, you know, benefit. 1055 - > So I think that's that's super important. 1056 - > The la last topic I wanted to cover, and again, there's some 1057 - > of these topics I feel like we we need a lot more time. 1058 - > But Coravin is so interesting.

1059 - > I mean, I'd love for you to I'm sure most of the list audience 1060 - > will know about Coravin, but maybe a brief description of 1061 - > Corbin. 1062 - > But what I'm really curious about is it's such a different 1063 - > business than than what you've done on the medical side. 1064 - > Are there anything any things that you've been able to pull 1065 - > either from you know the more consumer-oriented experience of 1066 - > Coravin back to intrinsic or vice versa? 1067 - > I'm just fascinated by by how you've been able to develop two, 1068 - > you know, really important products in vastly different 1069 - > industries, and there must be some kind of cross-pollination 1070 - > that's taking place.

1071 - > Greg Lambrecht: Yeah. 1072 - > Yeah, in weird ways. 1073 - > I do spine and wine presentations for physicians to 1074 - > try to talk about the my two, my, my schizophrenic life. 1075 - > So Coravin is a way to drink any amount of wine from any 1076 - > bottle you own whenever you want, without having to think 1077 - > about when you're going to drink from the bottle again.

1078 - > We call it a by the glass system. 1079 - > And our tagline is better by the glass. 1080 - > And , you know, essentially what I came up with using one of 1081 - > the chemotherapy needles, high flow vascular access needles, 1082 - > was a way of pouring wine from a bottle without even opening 1083 - > it, way back in 1999, and then ultimately launched the product 1084 - > in 2013. 1085 - > So I was busy doing medical stuff with intrinsic, and so 1086 - > this was my nights and weekends kind of thing.

1087 - > So it's a simple handheld system that pours wine from a 1088 - > bottle, displacing the wine through the cork using a needle 1089 - > and replacing the wine with an inert gas argon. 1090 - > And then you pull the needle out, the cork reseals, you can 1091 - > put it back on your shelf and drink it again whenever. 1092 - > We've expanded from that simple handheld system to a series of 1093 - > systems who have another still wine product called Pivot. 1094 - > And it we launched Champagne, Coravin Sparkling in 2021, 2022.

1095 - > So we're we're used in over 80 countries, we're used by 1096 - > wineries, restaurants, wine bars, consumers at home, the 1097 - > trade, distributors, wine stores to sample wines to their 1098 - > customers and restaurants for buy the glass and and at home 1099 - > for buy the glass. 1100 - > And you know, we're we're we've sold over two million devices. 1101 - > We serve 1.3 seconds or one glass.

1102 - > Well, every one point 1.3 glasses per second, that's what 1103 - > it is. 1104 - > About a million glasses every 10 days are served through a 1105 - > Corbin. 1106 - > So it's it's been way more successful than I thought it was 1107 - > going to be.

1108 - > It's got a reusable and a captured disposable in the Argon 1109 - > gas capsule or CO2 gas. 1110 - > The similarities and differences, I brought clinical 1111 - > trials to Corbin. 1112 - > I Carl Sagan was my hero. 1113 - > He said extraordinary claims require extraordinary evidence.

1114 - > And so I brought that sort of clinical perspective to wine, 1115 - > and and I still do it. 1116 - > I just did another one in here in London and in Manchester and 1117 - > in Switzerland last week, where we'll Corbin a bunch of bottles 1118 - > and we'll have control bottles and we'll blind taste them at 1119 - > three months and a year or two years to prove to the to the 1120 - > professionals that it actually works. 1121 - > So that that's the medical side coming into Coravin.

1122 - > I think both products, Coravin and Barricaid, are a change in 1123 - > behavior. 1124 - > Barricaid adds an implant to a procedure that didn't have one, 1125 - > and that's a perceived risk. 1126 - > And then Coravin, you know, my my biggest competitor is people 1127 - > saying, Well, I finished the bottle. 1128 - > Why do I need this?

1129 - > I finished the bottle. 1130 - > And I'm trying to introduce them to a new lifestyle where 1131 - > I'm like, I can have a bottle too. 1132 - > I just have it from five different wines, right? 1133 - > I can have a glass of white, red, dessert wine, champagne on 1134 - > a Tuesday, right?

1135 - > And put them all back and drink them whatever, right? 1136 - > So there's a there's an implied change of behavior, and the 1137 - > reception to a change of behavior is very culturally 1138 - > dependent and very industry dependent. 1139 - > In medicine, it is that fear of risk, this new risk that you 1140 - > introduce. 1141 - > I love the benefit you're describing, but that risk scares 1142 - > me.

1143 - > I don't want to be the first surgeon on the block to use this 1144 - > new thing, and then I get blamed for failure. 1145 - > And and you overcome that by coming up with a great pitch, 1146 - > right? 1147 - > So working on, I think in consumer, I learned that your 1148 - > sales pitch needs to be short, punchy, and and get to the need 1149 - > quick. 1150 - > And the same is true.

1151 - > I brought that over into intrinsic for sure when we 1152 - > started to market in the United States in particular. 1153 - > How do you get it out in a sentence? 1154 - > Yeah, you know, ever all the benefits. 1155 - > You know, how do you say it in a sentence?

1156 - > That really helped, yeah. 1157 - > Um, on the on the medical side. 1158 - > And then surgeons love wine. 1159 - > Geoff Pardo: So, you know, I think I was gonna say spine and 1160 - > wine right there.

1161 - > You got me. 1162 - > Greg Lambrecht: Right, exactly. 1163 - > Exactly. 1164 - > Geoff Pardo: That's awesome.

1165 - > It's a good life. 1166 - > Well, Greg, I can't thank you enough. 1167 - > This has been terrific. 1168 - > You know, we I forget how much, you know, I really have enjoyed 1169 - > our conversations over the years, and this being no 1170 - > exception.

1171 - > So thank you so much for for taking the time and and best of 1172 - > luck. 1173 - > The great, great things are ahead for for both companies. 1174 - > Greg Lambrecht: Thank you, Geoff. 1175 - > I mean, it's great to talk to you as well.

1176 - > And , I will never forget our early days when you were were 1177 - > sitting on the board observing and and offering wise advice. 1178 - > And it's amazing that like the only downside with life is that 1179 - > it's too short to run to do three or four PMAs. 1180 - > Geoff Pardo: Yeah. 1181 - > Right, exactly.

1182 - > Great. 1183 - > Well, thank you so much. 1184 - > Greg Lambrecht: Thank you, Geoff.