Revolutionizing Cataract Surgery from Innovation to Commercialization

PODCAST EPISODE 298

Click here to watch the video version of this podcast.

You’ve got an idea. Now what?

It takes years of trial and error to move an ophthalmology product from concept to commercialization. But when you believe your technology could “change the future of cataract surgery,” you’ve got the motivation you need to keep moving forward.

After nearly a dozen prototypes, Lexington, Kentucky-based Gary Wörtz, MD, chief medical officer of Omega Ophthalmics, has a product that’s producing strong data in early research.

The Gemini Refractive Capsule reduces variables in the predictive effect of intraocular lens implants. The technology fits inside the natural capsular bag once the surgeon removes the cortex. The lens capsule, Dr. Wörtz says, is the safest place to implant a medical device because the area has no nerve endings or blood vessels. The technology helps reduce posterior capsular opacification and stunts fibrosis.

To date, Dr. Wörtz says Omega Ophthalmics has about 100 devices implanted that have been well tolerated. The company is evaluating next steps.

Tune in now to listen to the conversation between colleague and friend, and OIS Podcast host, Paul Karpecki, OD, and Dr. Wörtz. You’ll discover:

• The implementation process for the Gemini Refractive Capsule and the advantages of using “the most important real estate in the body.”
• How Dr. Wörtz balances his medical practice, entrepreneurial endeavors, family life, and personal time. Hint: learn the art of “no.”
• What he learned through nurturing a product to fruition—from the idea, through the “messy middle,” to commercialization.
• How Omega Ophthalmics raised funds without venture capital.

Click “play” to listen.

Transcript:

Paul Karpecki: Hello and welcome to the OIS podcast. I’m Dr. Paul Karpecki practice in Lexington, Kentucky and today I’m extremely excited to interview a true close friend. In fact, someone I worked with for three years. And if I look back over my career, those might have been my three most enjoyable years. I mean, I really think of some great memories of learning a lot from Gary have just always been kind of almost pushed as we kept pushing ourselves further and along in different ideas. And in actuality, what we’re going to talk about today was something even introduced to me at that time, and I was just fascinated about the potential. But you know, the ability to take an idea through fruition is a whole other level, but Gary has been able to do that. And so today I’m honored to have Dr. Gary Wortz. He is board certified ophthalmologist specializes in all forms of laser refractive surgery, including femtosecond laser assisted cataract surgery, all laser LASIK, he works with optometry ophthalmology. He’s one of the most respected surgeons in our community provides a teamwork approach die care. He’s currently a practicing physician with Commonwealth eye surgery here in Lexington, Kentucky and founder and chief medical officer of Omega Ophthalmics. Gary, thanks for joining us today on the OIS podcast.

Gary Wortz: Oh, Paul, it’s always good to talk to you. You know, I just want to echo what you said, you know, it’s so nice to talk to a friend of a colleague and you know, those three years, you know, there’s some hilarious memories and patients that we got to take care of together. And I also just want to echo, You know, I think I learned as much or more from those three years, and I have from any anyone I’ve worked with. And so I just want to say, it was always a real pleasure working with you and I counted as a real blessing.

Paul Karpecki: Thank you. I do too. I mean, even getting through some of the times in those years, and then things we did to get through just a great memories I’ll cherish for a lifetime. But it’s exciting to get to interview you now. And I’m not from that clinical standpoint, we’ll bring a little bit of that up, but actually from an innovative and innovator standpoint, just in terms of what you’ve been able to achieve. And I think you can share a lot of insights with our listeners, help them in this, we might be in similar situations who have come up with a great idea and just don’t know what the next steps are? Or how do you balance that with everything, family life, clinical practice being a surgeon coming up with this great idea, but then creating the business plan around it and then where it is today, I truly think what you’ve developed is going to change all of surgery for the future. And eye care and I’m not being exaggerating, I just I know even as an optometrist to see some of these patients after cataract surgery the ability to eliminate issues that could come with tiltable lens or in refractive error that we don’t expect or fibrosis of the capsule, it changes some of the results and just making it so easy, you know i and just having that ability to adjust in the future. Some new technology comes in I’m not exaggerating, I think this could really change the future of cataract surgery and eye care, but I want to start with I want you to walk me through kind of just getting everybody to know you. I’ve been lucky to get to know you but through your personal background, where did you grow up? Were there any early influences that inspired you to become an ophthalmologist and then an entrepreneur?

Gary Wortz: Sure. Well, I actually grew up in Michigan. I grew up in you know, rural very, very rural Michigan Barre county actually went to a place called Delton Kellogg, high schools where I went, I grew up actually on a dirt road, we had 120 acres on a sort of a hobby farm. We had llamas and other animals. So I was always, you know, out, either mending a fence or you know, tending to the animals or I was, you know, trying to brush hog trails through the woods, etc. I was really just an outdoors kid, I was always hunting fishing or, you know, taking care of the animals. So I really, you know, I will say that, you know, my father’s an internist. And so I really enjoyed the conversations around the dinner table about interesting patients, sort of the detective works my dad would do about, you know, trying to diagnose something, I thought that was really interesting. And he was a hero, a real hero of mine. And then on the other side, my grandfather was a Chief Master Sergeant in the Air National Guard, and a real kind of fix anything kind of guy and I was always by his side. And so we would take apart diesel engines, or we would drop plans up to build a new barn or, you know, it would rebuild a boat motor, like just anything that needed to be fixed. He would fix it, but he would bring me along and I always was interested to watch him take things apart and put them back together and fix things. So I would say that early on, I really enjoyed like the scientific aspect of, of medical diagnosis, but also really the practical aspect of figuring out how to things work, taking things apart and rebuilding and fixing things and I think those two sides Watson in ophthalmology for me,

Paul Karpecki: That’s a great combination. I love that, you know when we work together, it was actually in 2013. And you had introduced or started Omega Ophthalmics, you remember you having all these drawings and this concept, and you know, and I kept thinking, wow, this is brilliant. I wonder if anybody’s ever thought of that. And really, if you look at patents and IP, no one had and you’re well on your way to, you know, disrupting that industry with that concept. least that’s what I felt like, when you when you first were showing me this renditions and these ideas, what drove you to make the leap from, you know, being a surgeon and a physician to an entrepreneur and starting up an innovative business and something that could change, you know, millions of lives and cataract surgeries? We know it.

Gary Wortz: Well, I mean, it’s probably a couple of things. The naivete of youth would be one. not really knowing my weaknesses, they have probably, you know, being bold. But I’ll also I’ll just say that, you know, I look at the inventions and the technology that we have, with a heart of gratitude. You know, I think about Charlie Kalman and you know, what he means to me, every day when I go to do phaco? You know, I just sort of think about what if he had stopped? What if he just would have this great idea just died with him? On the back of a napkin? What if he, you know, what, if other ophthalmologists or, you know, engineers did not invent the foldable IOL or the tori, IOL or LASIK? You know, think about Marguerite McDonald and all the folks down at LSU, that, you know, brought that technology forward. So, I’ve worked with technology that I recognize that there was a lot of hard work that went into giving me those tools. And, you know, it would be very, I guess, bold, or maybe even arrogant to say, I know that this is going to work, and it’s going to change the industry. But I have a very strong feeling. And I have since I thought of this from the very first moment, that this could disrupt and change the way we pursue cataract surgery forever. And even thinking about technology inside the eye. When we talk about that sometimes people think all that sort of pie in the sky. But you know, it starts with an enabling technology, once you have a new platform, it makes the possibilities of what else can now exist inside the eye, almost limitless. So we do have some pretty practical ideas for how the Gemini refractive capsule can help cataract surgery today and make it better. But we really have, we really think about this as, as this sort of phased option happens, hopefully, in the future, we feel like this could be you know, sort of enabling a whole new pipeline a technology that is really never been thought of before.

Paul Karpecki: It’s great time to go into that. You know, and then we’ll look at other aspects of, you know, young other colleagues, surgeons, optometrist ophthalmologist, who have ideas, how do they balance their surgical practice and all that, but right now is good time to kind of take us through a little bit more of, of really the Omega Gemini refractive capsule, how does it work? How is it the implantation process? How does it work with the current IOLs that are available? And what is the real benefit for now and in the future?

Gary Wortz: Yeah, so it’s, it’s sort of like an inner tube or a doughnut that goes inside of the natural capsular bag at the end of cataract surgery once you’ve removed cortex. So basically, you’ve got this it’s made of medical grade silicone, the same type of silicone that IOLs are made out of, and it goes in through the same type of the same size incision through the same type of shooter, and in itself expands. So once you inject it into the capsular bag, it opens up, and you basically have the capsular space now stented open in a three-dimensional fashion. And at that point, because the that real estate, is really important, because it is, you know, the safest place to implant, you know, a medical device, really in the human body because there’s no nerve endings, and there’s no blood vessels. So the the lens capsule is the thickest basal membrane in the human body. It safely holds millions of implants per year, every year safely for decades. And it’s actually in the, you know, central axis of our visual system. So, this, I really think that the capsule is sort of the most disrespected real estate, and maybe some of the most important real estate to protect in the human body. And so if we can keep that space that capsular space open if we prevent capsular, collapse and fibrosis, it really allows us to think differently about what is cataract surgery, you know, the lens we implant in the year 2021 In a 50 year old or 40 year old, for example, you know, they’re stuck with that technology for the rest of their life, they live another 40 or 50 years, you know, we know that the design cycle in IOLs is accelerating, and I don’t do, I don’t implant any lenses, any premium IOLs today that were available 10 years ago. And I know the lenses that I plant today, as good as they are, I’m so pleased with the technology we have right now. But I just know it’s going to continue to get better. And so this idea of keeping the space that holds a lens open, it really enables us to, you know, if a patient wants a better lens in the future, or, for example, that one and 100 or two and 100 patients who are not satisfied with their multifocal lens for the reasons that we can discuss, you know, it’s just really hard to predict who those people are going to be. But if that’s the case, we have a backup plan. If we need to remove the IOL, we’re removing it from this protected environment, we’re not trying to tease, you know, haptics away from a fibrous capsule. We’re also showing that we’re reducing PCO, so by keeping the anterior and posterior capsule leaflets from fusing, were actually preventing the mesenchymal epithelial transformation that occurs here, that tissue becomes more fibrous and contractile. And if we keep that capsule open, it really just looks like a natural lens capsule, it doesn’t become fine modic. And, and fibrosis really seems to be stunted. And it’s just amazing to see it just looks beautiful in the eyes. So we look at this as a technology, it’s going to help us with lens position. So we can really predict where the lens is going to sit inside the eye preoperatively to a hopefully a greater degree, it’s going to hopefully prevent PCO, so if we need to secondary interventions like lens exchanges or upgrades, that’s going to be very easy. And also, we’ve got additional space that we’re holding open. And so if we need to put a, you know, a long-term glaucoma drug implant, for example, or even something as crazy as a wireless pressure sensor, we have the space inside of this and next capsule to do that, and really in, you know, continue to protect and enhance patient’s vision throughout their lifetime.

Paul Karpecki: It’s extremely exciting, exciting to know when this will be available. So how far along are we now with this technology, in terms of the process, development, patients implanted and even an FDA process, Gary?

Gary Wortz: Yeah, So we have taken that, you know, the past, you know, number of years to prototype. And we’ve really been in in an r&d phase, where we’re making little changes, we’re testing them outside of the US on small groups of patients. And then if we see something, an opportunity to improve that device, we’ll make another incremental change, or maybe we’ll make a couple of incremental changes and retest the device. So far, we have almost 100 implants, in various designs throughout the world that have been very, very well tolerated, we’re so happy with that. But we’ve really kind of come to a design lock, where we’re really happy with the size, the shape, just the performance of the device is really where it needs to be. So we really are at this point, we’re pivoting from a research and development, prototyping phase more into, you know, deciding where we go from here, which the next steps would probably be either a early feasibility study, or a true feasibility study, hopefully, you know, leading to a pivotal trial with the FDA, you know, we’re sort of evaluating our options right now, because we do have a pretty good number of got about 30 patients at this point, some are at six months, others are at three months, where we’re really looking at the data, the data is looking so strong, that we’re really just sort of evaluating our options of next steps, because we have, you know, there’s some interest, of course, you know, I mean, and we’re just kind of evaluating where we go from here. But the next steps really would be to take this, I think, into the US and enter the FDA process, and that’s a multiyear phase, you know, process and, but those steps are pretty well developed, and with the results that we’ve achieved outside the US, we feel like, repeating that inside of US would really not be problematic. We feel like we know what we would get based on our numbers and how safe and effective the device is.

Paul Karpecki: That’s really exciting, you know, and at same time it I can see why there would be a lot of interest and this is a truly a platform change, which we’ve not had since perhaps when I was you know phaco first came out and the ability to implant them and I could see so many of the advantages of this for the long term I’d even as a thing in from a patient perspective, the ability to wander what’s going to come out next, Should I wait? Well, I don’t have to worry about that. If something does come out and we know is gonna only improve over time that gives you some option ability, so to speak, as a word to allow for that. That’s exciting! From your experience as far as you know. What’s been the biggest challenges in development of any new technology for those who have got an idea and starting to think about it, and bringing new product to market, because you’re well, on your way to that, what have you found to be something that maybe others haven’t thought of as you go along, that you’ve learned through this experience?

Gary Wortz: I think early on, it’s probably just having the confidence in yourself to really decide that your idea is good enough to pursue. I think that, you know, sometimes it’s easy to think, Well, you know, my idea probably isn’t good enough, or maybe you know, someone else is probably thought of this, or, you know, maybe I shouldn’t be, I should just stick to my day job. So I think early on, it’s just being confident enough that this is, you know, if you’ve got a good idea, if you, you know, this is something John Berdahl has said, so I want to give him credit, but he said, you know, it’s got to pass the sleep test, you got to have an idea that, you know, you sleep on a couple of nights, and you can’t poke holes in it, and it’s like, you almost can’t not do it. And that’s really how this was, I just really felt like, you know, this could be something that’s really important. And for whatever reason, this idea was, you know, given to me, and maybe it’s maybe it’s my job, maybe that’s what I’m supposed to do. So I, I think part of it is just going for it just understanding, you know, being confident yourself. But you know, then it’s there’s just a lot of good ideas really distilled down into a lot of hard work. You know, the problem is, you see how good it could be at the end, from the very beginning. There, the blurry part is that middle, that messy, middle, or the long middle. And so I think the challenge is always, you know, making sure you’re well capitalized, making sure that the people that you’re talking to that you’re under a nondisclosure agreement, that you have good patent attorneys who are protecting your idea, these are all things I’m telling any, you know, anyone could kind of figure out that those would be the hard things. But I think, particular to developing class three medical devices, which the FDA parlance, that means devices that go inside the body and stay there, okay, so IOLs, any medical implant that’s designed to stay inside the body, you know, finding the engineers finding the manufacturing facilities, and then a real challenges in any sort of developmental process, there’s going to be some trial and error that occurs where you have to prototype, you have to test you have to learn some things, and then you have to redesign and retest. And so you know, the design cycle, it takes some time, it takes some time to make these devices, you know, to do the engineering, to get the molds to do the manufacturing. And then to get a trial set up, actually go do the get approval, do the implants, and then analyze the data and make a smart decision on how you should change your device. So you only get about one or two turns per year to change your device. And so it just takes a while. And you think that you know, you should get it right away. But you know that just not that’s not how it works. I listen to a podcast from Dyson, the guy who made the vacuum cleaner, and he did something like over 5000 different vacuum cleaners before he got it right. You know, so doing about, you know, 10 or so of these, I felt a little better about myself that we got it in about 10 tries, versus Dyson, who had to go over 5000 different vacuum cleaners before he got it right. So…

Paul Karpecki: That’s incredible. Yeah, that number of filaments. I think Edison went through some astronomical numbered, persistent and they kept that positive attitude of saying, well, I just eliminated one more potential design that won’t work and then do your right in 10 in relative to it. Now, that’s still a lot of work. You know, and a lot goes into that you’re constantly kind of thinking how do you balance all that you’ve had a very successful surgical practice and phenomenally good surgeon but you also very well respected community here is a great family man, and active in many ways, church and other things, plus now entrepreneurial, how do you balance all of that? So well?

Gary Wortz: Yeah. I mean, I think you have to be pretty strategic in what you say no, to. If you say someone once said, If you say yes to one thing, be prepared to say no, do you know 100 things? So, you know, I recognize that, you know, I have limited capacity to do a whole lot of things. So I’m not going out and giving a lot of dinner talks. I’m not writing a lot of journal articles. You know, there’s a long list of things that I don’t do that a lot of my colleagues who are really at the top of their game are really heavily participating in. So you know, I’ve told a lot of people No, for a long time, actually, I’m almost a little bit worried that people are gonna stop asking me to give talks or do things but maybe when I’m done with this, I’ll be I’ll throw my hat back in the ring with some of those things. But you know, I think it’s really understanding what you’re good at what you want to do and designing your life around that. And then also there’s some good fortune You know, my partner Lance Ferguson, you know, he is just one of the best guys around, he gives me a lot of freedom to, you know, pursue some of these things, you know, a day or two a week, so I’m not in surgery or in clinic, you know, five days a week and just doing this nights and weekends. So he’s a great partner. And then also, I just have to say, my spouse, you know, my wife, Mary is just, I mean, you just thank God that you have a good spouse, and, you know, she takes care of so many things. And, you know, I just can’t I, you know, it’s, it’s easy when you look at, you know, say, Well, how do you do all this? Well, I don’t do it all, you know, it’s the people around me that take care of a lot of things. I’m just fortunate to be, you know, in their company.

Paul Karpecki: It’s really great. It’s a small world, I mean, Lance, for instance, who introduced me to my spouse? No, yeah, exactly, ironically, and all that he is a great guy, and a great surgeon as well. from your experience thus far, you’ve, you know, you’ve gotten through all of these steps, you’ve learned along the ways, what could, you know, assist other, you know, entrepreneurs that they go from, you know, this idea of development to products, such as the Gemini capsule, and all of the steps in there. So I guess your main encouragement is just to keep going at it, keep trying, you have an idea if it gives me to sleep tests, just keep moving forward?

Gary Wortz: Yeah, I do. I think that, you know, not every idea is a good one, I think it’s important that you talk to some people who will give you wise counsel, that would be the other thing is find a neutral third party, pitch the idea, find another person pitch the idea, if the consensus opinion is that this is not a great thing, you know, maybe think twice about this, but you know, if you can explain your idea, and there’s some genuine excitement around it, I think that that’s another good way to kind of, you know, test market things before you get too deep. You know, that gets to be a point where you’re kind of passing a point of no return where you really kind of need to succeed. And, you know, that’s a little stressful also. But, you know, you want to make sure that you’re vetting this with smart people that you’re not just pursuing any idea, you want to pick your spot, because you only have a few, you probably have a few turns of the wheel, you know, in these years. And so you got to make sure that you’re, that you’re picking the right thing, if you have that itch to scratch.

Paul Karpecki: It is great. There’s so many steps to this success to and, you know, besides the development, and you’ve had to do the testing and various countries, and I get success, keep the data, as I’ve been funding, how do you achieve those sort of things? Has that been a challenge I imagined? Not so because it’s such a great idea, or is that a whole different world that has its own challenges to for those who might have an idea and have to look at all those steps?

Gary Wortz: Yeah, I mean, I would just have to say, again, as I was taught, as I’ve talked about, you know, the people I’ve partnered with, you know, I I’m, I’d be remiss if I didn’t mention our CEO, Rick Ifland. He has been a serial entrepreneur for, you know, 2030 years, and just done a phenomenal job of raising money for other companies. And so I brought him in as our CEO very early on, and that was probably the best decision that I could have made. He is raised, you know, all of our money, pretty much through friends and family. So we’ve only had basically Angel rounds of investing. And we’ve been able to keep, you know, we’ve not taken any venture capital or private equity capital at this point. So it’s made it really simple. And we’ve I think, you know, just based on some good relationships that he and I both have, and a lot of those have been, you know, optometrists and ophthalmologists also. So getting some people who really understand the space to invest is also a good photo confidence. But yeah, I know, this is really almost hate to say this, because I don’t want to jinx it. But it usually is a real challenge for a lot of startups. But we have just been so incredibly lucky to be well capitalized, really, from the beginning, just through Rick’s relationships, and I think the idea has sort of, you know, stood on its own merits. So we’ve not had that huge challenge. But I don’t I don’t want to say it’s not a challenge, because every time we always, you know, hope and pray that, you know, our investors will come through and it’s been great so far.

Paul Karpecki: That’s awesome. Is there anything you think that sir, any listeners or anyone that because we do have a lot in our listeners for OIS podcast range from here, ophthalmological colleagues and surgeons, optometrist, investors strategics any there could help? Or is this kind of just kind of on its way and moving in? It’s all with his own momentum at this point?

Gary Wortz: Well, I mean, I think I would just challenge everyone, you know, to think about, you know, it’s sort of the Steve Jobs, like, think differently about cataract surgery in ophthalmology, you know, what we’re doing is not changing the optics, you know, we’re not inventing a new multifocal lens or a new accommodating lens or but what we’re really trying to do is build a platform technology that is going to enable so many other things, you know, for the future. I think it’s going to start with us, you know, getting some sort of claim around you know, just you know, preventing capsule fibrosis, perhaps, or preventing capsule collapse? Or? And we’re still working through that that piece of it. But I would just challenge everyone to sort of think what if you had a protected space inside the eye? That was the extent that kept the capsule open, prevented fibrosis, and allowed any inert secondary technology to live inside the eye? What would you put inside of that container? How would you leverage that space? So it’s a lot bigger than just, you know, we’re creating an implant that is going to help you know, with IOL exchanges, I think that sometimes people think well, why would you go through this hassle of inventing this thing that is going to, you know, maybe help 1 or 2% of people who end up with a lens exchange? And I feel like, you know, I think it’s just much bigger than that wouldn’t you know, we know that lens exchanges are a rare thing. And I’m not inventing this capsule so that we can make lens exchanges easier. Although that is one thing that can be helped by this. I look at the multi-focal market and think, why is it stuck at like 7 or 8%? You know, technology has gotten better, but there’s so many surgeons out there who are really unwilling to try it. And I think it’s because as ophthalmologists as cataract surgeons, and especially refractive surgeons, we hate disappointing people. You know, one of my deepest, you know, I’m gonna give you the peek behind the curtain here that you didn’t ask for. But one of my deepest fears as a cataract and refractive surgeon is disappointing a patient, you know, they come to me, and we’re talking about fundamentally changing the way they perceive everything in their world through their eyes. You know, when we talk about refractive surgery, people think about well, 20/20 or 20/15 vision, but we’re really talking about enhancing neurologic function. And the reality is, it doesn’t always work. And when it doesn’t work, how do you explain that to a patient? And how do you tell them, hey, you’re going to be okay, we have options. You know, right now, with cataract surgery, if some if the patient doesn’t like the lens implant, or we implant, you know, there are backup plans, but I feel like we have we need better options for patients. And I sort of think about it also like a seatbelt, you know, I’m thankful that a seatbelt is invented the rare times that I need it, but I always use it, you know, because I know there’s always a small chance that I’m going to need it. So I kind of think about what we’re doing in some regard is like an insurance policy, or a seatbelt. And if we use it, and it’s there, it will be there for us when we need it.

Paul Karpecki: I love that. It’s great way of putting it. Gary, thanks for joining us today and sharing your story, your insights, your humble in person that you are but just the potential that exists here and very exciting technology that I do believe will change how cataract surgery is done in the future. What’s the best way for people to get in touch with you?

Gary Wortz: You can probably just email me that’s the best way 2020md@gmail.com pretty easy to remember that one or you can find me on Twitter, @cataractMD pretty active on Twitter. So you might see you’ll see a lot of cataract and ophthalmology links there. And also a few of my opinions about UK basketball and football. So go big blue.

Paul Karpecki: Big Blue, that is right big game this weekend. Gary, thanks so much for your time. It’s great seeing you look forward to seeing you in person, hopefully very soon, actually, I think very busy as soon but thank you for taking the time to share these insights with the OIS podcast audience.

Gary Wortz: Absolutely. Thank you, Paul. It’s always great catching up. And yeah, I look forward to seeing you soon.

Paul Karpecki: Thank you.

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