Kim (00:01.843)
Welcome to this week's episode of Between Two Lips. I am joined today by Derek Sham, who is doing some really incredible things with regards to pessaries and support for prolapse. So welcome Derek, I'm really excited for our conversation.
Derek Sham (00:17.942)
Thank you, Kim. Great to be here.
Kim (00:19.659)
Yeah. So if you can start out by just kind of, I guess, introducing yourself, but tell us what led you to work in the field of pelvic health, but also very specifically with regards to pelvic organ prolapse and looking to innovate in the realm of pessaries.
Derek Sham (00:37.494)
Yeah, so my background is I'm a medical device engineer, went to university for it, worked in cardiology, gastroenterology, ended up spending a decade in urology and gynecology.
I became the general manager of a company called Laboree, a Canadian company that developed Eurodynamic systems. And I was essentially in charge of the R&D and commercialization of the most utilized Eurodynamic system in the world. So it's a gold standard diagnostic, measuring and quantifying lower urinary tract symptoms so doctors can properly plan.
PT, surgery, different components. And during my time there, I watched my grandmother go through prolapse. It was an interesting experience because I had...
I used doctors in my Rolodex, knew some of the best doctors in the world. She ended up failing multiple pest refittings, developing urosepsis, multiple surgeries later put into a home. So it was one of those things for me when Labry was successfully exited or sold. I was like, well, the world's bigger than penises, vaginas, and assholes, and I'm gonna go do something different. And I actually came up with this, you know, with this idea on a beach in Bali.
Kim (01:53.263)
Hahaha
Derek Sham (02:01.256)
training, traveling, quit my job, trying to figure out what next to do and I woke up one morning and ended up drafting a patent on a napkin. I think partially because you know deep down I was incredibly frustrated with what happened to my grandmother and you know I thought I'd come home, finished an MBA, launched Cosm on what I call our mission for personal pelvic health.
You know jump starting, you know when we when I went full-time into Cosm in 2018 until now We're now
I'm very grateful to be leading really an impact driven company with the opportunity to really modernize gynecological devices for unique bodies and needs. We're now a team of 18 and growing. We have experienced engineers, execs, four PhDs covering biomechanics, ultrasound, AI, 3D printing. And we're back by a growing village. We've got Silicon Valley and Canadian VCs, doctors, hospital networks really supporting
indent and really aiming towards improving over 1 million lives by 2030.
Kim (03:12.111)
That's amazing. That's amazing. So maybe if we can start by what is a pessary? I mean, before we get too into the weeds about the technology and everything we've done, some people may not even know what a pessary is.
Derek Sham (03:18.603)
Yeah.
Yeah.
Derek Sham (03:24.886)
Yeah, totally. So, so, pesteries are a form of conservative therapy for pelvic floor disorders, such as prolapse and stress urinary incontinence. They're actually one of the oldest known medical devices. They date back over 2,000 years of use to the Egyptians. The word pesterie comes from the Greek word pessos, which means round river rock, which is still used as a treatment for prolapse in animal husbandry.
And, you know, so how they work is their temporary prosthetics placed inside of the vagina. Kind of like how a sports bra supports breasts, it's used inside of the vagina to support pelvic organs to alleviate symptoms associated with incontinence and prolapse. They really have not changed in the last 50 years since the advent of medical grade silicone.
Derek Sham (04:24.72)
100 different shapes and sizes, and they're fit by trial and error. So the current gold standard is a doctor goes like this with their fingers and they're like, hmm, I think you're a ring size three, puts one in, patient walks around for 10 minutes, if it's uncomfortable, it falls out, they try another one over and over again. From published research, a third of women fail pest refittings, half stop using them within a year or two, and over half develop complications with long-term use.
Now, even noting all those problems, right? Over 10 million pessaries are sold globally per year. So, you know, most people have met somebody wearing a pessary, but don't know about it. And, you know, what we're doing is we're modernizing that. We are essentially bringing, you know, digitization or the modernization of.
3D printing and other technologies to this field.
Kim (05:26.091)
Yeah, and the one of the words that you, I think I believe you've trademarked is gynothotics. Is that correct? Is that the pronunciation? So you're essentially like orthotics for the shoe that are supporting the foot. This is like an orthotic for the vagina that's helping support the anatomy there. Is that a fair way to describe it?
Derek Sham (05:32.15)
Yeah, yeah, yup, yeah.
Derek Sham (05:39.135)
Yeah.
Derek Sham (05:44.85)
Yeah, that's a fair way to describe it. I think, you know, I came up with that name actually after talking to...
both a patient and a clinician one day, and they're like, look, like, the doctor was like, look, pessaries, they're so pessimistic. And the patient was like, I just don't, I just don't love the name of it. And I think it exemplifies our approach to bringing science into a field that's essentially clinical trial and error. It's, you know, arguably archaic in certain ways.
and doesn't serve the patients and their unique bodies and needs. So if you look at what a pessary is, it's essentially a gynecological prosthetic based upon the dictionary definition of the term. And we've now trademarked the term gynothotic in our approach to bring science and replace clinical art.
Kim (06:44.795)
And you are using, like, as you say, there's really been no innovation or evolution in this space for so long. And now leveraging what we have from 3D printing and AI, you're marrying those two together. So what will the final, you're in clinical trials, final stages right now, which is really exciting, but what will the final product be like, and sort of what's the procedure that somebody will, like not necessarily the procedure,
process that somebody would go through to actually be able to use one of your products.
Derek Sham (07:19.082)
Yeah, we actually finished our first clinical trial last year. We published the science in the American Eurogynecology Journal, a small ennemy comparing quality of life of women with a standard pessary. So they're all pessary wearers versus a gynothotic. And what was super interesting is that we were able to demonstrate improved patient satisfaction and improved symptoms on all eight patients.
Kim (07:22.604)
Oh, you did? Oh, good.
Derek Sham (07:48.976)
Basically for the 70% of women that try pessaries and it works, the definition of it works is that it doesn't fall out. It doesn't mean that they don't have incontinence. It doesn't mean that they still don't feel a bit of the bulge. They still have symptoms. And we're in the process of essentially optimizing that so more women can get back to their lives. So the process as we go forward is essentially a, we have two methods of generating gynothorax. One from clinical assessment.
So, leveraging the current gold standard, what's called a POBQ, to quantify prolapse and a set of other clinical assessments, we can generate gynothotics kits or a kit of semi-customized devices for patients. So think of that as kind of like getting a custom orthotic at a physical therapist, chiropractor, or podiatrist. So same kind of business and push forward.
Thanks for watching!
partially because I come from the diagnostic realm, is we're building a imaging-based diagnostic to mold and scan the female pelvic floor to develop uber-custom optimized gynophotics. We've actually completed a clinical study for that also, and it was actually just accepted for publication, so that'll be coming out later on this fall. And what I found interesting,
about, you know, last year we won the...
Derek Sham (09:23.938)
did a top five poster presentation at the Canadian Society of Pelvic Medicine. And it was interesting because the feedback was, okay, if you can personalize pessaries with this, what else can we do? Can we look at obstetric prediction of perineal tear? Could we do surgical planning? Where does this go? And I'm not the scientist of the group.
of my team and you know my core what grinds my gears about it is the fact that the vagina is the only muscular tube of the body orifice of the body that doesn't have a reimbursed high quality functional diagnostic test. In your urethra there's your dynamics and down your throat there's high resolution
in the butt to look at incontinence or fecal incontinence and constipation is anorectal monometry. The vagina is the only tube that doesn't have it and arguably it's the one that needs it the most because it's the most complex. It has multiple functions, sexual function, it affects urinary function, rectal function, it affects so many things but there's no gold standard diagnostic. So you know as part of our platform you know we're swinging for the fences and
also the diagnostic front, i.e. how to measure. Because the better, if you can't measure it, you can't improve it. So we're working on both ends, not just the 3D printing, but also the measurement, and then the AI and cloud software are the bridge that manages the process throughout. So for a patient, you can envision either getting measurements or a scan two weeks later, going back to your doctor, and getting fitted by a customized device.
And for the patient, there will be a patient app accompanying the device that provides them education before they go in, what to expect during the fitting, asks quality of life questionnaires, what are your priorities, are you sexually active, how physically active are you, because those come into factor on the customization of design.
Derek Sham (11:55.4)
really drive improvements going forward.
Kim (11:59.711)
That's amazing. And, and, and I, I didn't know that you were going to be having two, like sort of one that's similar to a, you know, it's partially customized, but then one that would be like almost a step up. So as I understood from what you said, there will be a, if it's sort of a fairly typical or standard cysticel or rectocele or something, there'll be a less customized, but it, for others with more complex, there would be more detailed imaging and then more customization. Is that?
Did I hear that correctly?
Derek Sham (12:30.306)
That is correct and that's gonna be the evolution, right? And I think that's the difficulty with women's health. I think if you look at like the history of women's health, how women weren't allowed to participate in clinical studies and whatnot.
you know, this space lacks data. And within Pest refittings, it's essentially clinical art and trial and error, which doesn't generate data, which you can't really build an AI on. And what we're doing is we're, you know.
better quantifying the measurements of the diagnostic so we have better inputs, while also collecting the data to be able to train the AI and go forward, noting that as we go forward, we wanna optimize, okay, minimizing obviously the prolapse symptoms, minimizing urinary function symptoms because of if the pessary doesn't fit right, or it could cause urinary retention.
you know, some pesteries, I'll leave.
demonstrate occult stress urinary incontinence. You put a pessary in, correct the urethra, then the patient is incontinent. There's also a lot of pessaries cause constipation. So we're really optimizing the system for both functions. And as we go forward, we're developing a device that's both personalized and easy to self-manage, kind of like modern diva cups are and whatnot, as they evolve.
Kim (14:03.791)
Sorry, so that sort of like threads into another question I have. I know with certain pessaries and with certain populations, the insertion and removal is a little bit challenging. I would say more so the removal. People have a hard time going in and kind of capturing it, and it can create some erosion sometimes with tissues. So how, what will the...
Derek Sham (14:18.806)
Yeah.
Kim (14:26.803)
insertion and removal process be if it differs from the current sort of fold the taco, insert it, and hopefully it expands in the same way.
Derek Sham (14:34.342)
That's a great question. Yeah, fold the taco, I love it. That's actually in our training as part of our cloud portal is fold the taco. I'm like, is there a better way to say that? But there really isn't. We landed on fold the taco also. You know, our SOAR version one gynothotic based upon regulatory requirements is essentially current designs of pessaries. So rings, gale horns, cubes.
Kim (14:39.319)
Hahahaha
Derek Sham (15:04.056)
allowing the doctor not just to customize the diameter, but also length, width, thickness, and the material. So we're able to generate materials that are softer than current pessaries, which theoretically could alleviate abrasions, discomfort, pain, and other things as we go. We do have also eight new designs that we're working through different clinical studies
insertion removal. Some operate like a stent, some operate like a tampon with a deployment system. We're working, you know, with world-leading researchers to really pick which makes the most sense as we go forward, but we do have, you know, essentially eight novel designs that are, you know, version two and going into clinical studies right now.
Kim (15:57.647)
Very cool. And the length of, so different, different pessaries or different manufacturers have guidelines with regards to how long the pessary can be left in. Will your, will your designs be any different or will there be, do you have a guideline with, is it a daily insertion removal? Is it something that can be left in for a period of time? And could somebody have intercourse?
Derek Sham (16:08.782)
Yes.
Derek Sham (16:23.362)
That's a great question. I think it depends on, we are not validating the clinical studies on intercourse. It's a very interesting one. I think with a standard ring pestery, it's doable. The Q and the Galehorn are much more difficult. And as we evolve,
I am confident that it will be possible with the Pessarion, but that is an evolution of the technology as we expand forward. With regards to indications, I'm gonna have to refer to my team within regulatory on the details of that, but our version one will follow this current standard of recommending daily insertion and removal.
Kim (17:12.655)
Okay. And will it still, you mentioned potentially being softer, is it still going to be silicone in terms of the actual? Yeah, it is. Okay. Awesome.
Derek Sham (17:19.191)
Yeah.
We're using high quality medical grade silicone, and we've passed most, pretty much the entire biocompatibility spread of tests. It's been really actually interesting working with the regulatory bodies as I believe this group is highly sensitive with regards to biocompatibility, which they should be, because the vaginal environment is unique in its own right. And it's been interesting,
clearly sensitive as a result of what happened with mesh and the implants there.
Kim (17:58.531)
Um, from an imaging perspective, so we've talked about the pop cue and the, you know, the finger measurement. So that, that for somebody using say the more, I don't know, I don't want to say necessarily off the shelf, but the less customized piece, will that be the, still be the standard. And then when you go up a level to make it more customizable, that's where we're using imaging, you mentioned ultrasound. Is it, is it parent transparent Neil? Is it.
through the vagina? Is it like, how are you getting the imaging?
Derek Sham (18:27.71)
Yeah, yeah, yeah. So from a clinical assessment standpoint.
developed a hand tool to support increasing the reproducibility and quality of that. From a POPQ standpoint, from a science perspective, it's about a plus or minus one centimeter incher in intraoperative reproducibility. And we're essentially opening a hand tool to improve that. There are a set of additional measurements that we're taking as part of actually the largest clinical study in the world in this space. We call it the POP AI study.
Derek Sham (19:05.78)
size. Right now our AI at this point can essentially predict pest resuccess type and size to a certain quality interval where we're confident that we'll be able to at the very least remove the trial and error of pest refitting. Now as we extend forward towards personalization you know our
Our imaging system is based upon transparent ultrasound and is essentially somewhere between, for people that know this space, somewhere between a bladder scanner and a video aerodynamic system for the vagina or a souped up paratron slash perino.
Kim (19:48.695)
Okay.
Derek Sham (19:51.938)
that allows us to actually quantify both the shape and the biomechanical properties of the tissue. How rigid is this compartment? Which part is distending? What does the anorectal angle look like? How strong is the levator hiatus? Different components that are critical for really understanding both the physiology, biomechanics, and the function of the muscles, tissues, and ligaments.
Kim (20:18.607)
That's really cool. And if somebody had multiple compartments, so I know that can be a challenge with pessaries as well, that it might be helpful for the bladder, but then if you have the uterus and the rectum at the same time, it might pose other complications. So is there, I would assume it would kind of be the next level up, the most customizable that would be able to help this population. Is that correct?
Derek Sham (20:40.106)
Yeah, and I think for multiple compartments, the first, our first approval, looking at it, the level of customization, if you look at multiple compartments.
The first one I would point to is our cube. So instead of a standard cube, you can customize length, width, and height, noting that the anterior and posterior walls are different lengths and different things. So we're working with the regulators to get that through, to drive towards the first level of customization. I think if you look at multiple compartments, I mentioned earlier about 30% of women can't get fit by pessaries, right?
A fair amount of that is women post-hysterectomy, so short vagina, combined with a large general hiatus or posterior compartment prolapse. And we have, again, novel designs in clinical study specifically designed to correct the compartments that can't get fixed with standard pessaries.
Kim (21:47.225)
Mm, that's awesome.
Derek Sham (21:51.312)
multiple compartment factor because, okay, like you can fix prolapse, but if that causes constipation or incontinence, that doesn't really get a woman back to her life, right? So we're looking at it as a multifactorial process within customization.
Kim (22:11.535)
That'll be huge, especially I know having lived with erectocele and not been able to use pesteries and that's a big challenge with people specific to posterior compartments. That'd be amazing. So in the, just kind of reflecting back on the study you did, you said N of eight and they were all people with prolapse. Did they all have the same type or were there multiple presentations, different types of prolapse?
Derek Sham (22:18.167)
Yeah.
Derek Sham (22:35.194)
multiple types of prolapse, anterior, like they wore ring, gale horns, different types. They were of ages, I think from 45 to 75. Don't quote me on that. I'd have to look up the study specifically. And I think what was interesting about the first study is we...
Kim (22:51.885)
Yeah, yeah.
Derek Sham (22:59.986)
And as we train the AI, we engage both the clinical and patient community to what...
patient wears their pessary, what is their problem with it? And the clinician does an assessment with the pessary in and they partner to design the customized device. And I think what the platform that we're building allows is for really cool research within both the PT and the urogynecology community and everybody in between, let's say OBGYN, general gynecology and whatnot, to really bring science and data to it.
excited as in the next three to six months we'll be announcing some really awesome partnerships to really leveling up the research that we're doing you know bringing data into a space that's just understudied underserved you know
Kim (23:54.572)
Mm-hmm. I want to ask about the data, but first, before I forget, people with levator avulsion or other severe sort of birth injuries, is this something that population also has been one that historically hasn't had a lot of success with pessaries? Is this something that you could potentially address as well?
Derek Sham (24:15.894)
Success with pessaries, the surgery is fairly complicated. There's a whole lot there. I think there are, you know, having talked to a fair amount of patients, we get a fair amount of patients reach out to us on our website. And that's part of my like staying grounded is communicating with a lot of them through email. I have team members that, you know, run interviews with patients. So if you do have patients and you'd like to get involved, you know, within your community, feel free to reach out to us. We're happy to engage and kind of learn
story and see if we can help as we go. I think with the levator evulsion population, there are, I know...
I know at least four levator evulsion patients, some very close to postpartum, still looking to have a family, some for the long, and four of them that I know wear a cube pessary, but it obviously isn't optimal and has its issues. So I think there will be a subset of patients with the levator evulsion that we can serve
served. But I, as a realist and a bit of an engineer and science dork, I simply don't have the data to say that it will work for everybody. But we're gonna, we're gonna effing try, you know? Like, and I think it's gonna be a combination of novel designs plus personalization plus feedback from both the clinician and the patient as to what are their core priorities. For instance, if it does work...
Kim (25:40.044)
Mm-hmm, mm-hmm, mm-hmm.
Derek Sham (25:57.627)
it might not be as easy to insert and remove. So how do you think through those balances and really engaging in people really managing their care?
Kim (26:08.503)
Mm-hmm, mm-hmm. I was just hosting a retreat. It was called the Pelvic Love Retreat, and there was a gal on there who, when I was talking about your company and sort of innovation in the pessary space, and she came up to me after and she said, I'm on their list, and I really hope that I get selected. So she was, yeah. So yeah, I think it's amazing that you have that available for people to reach out.
Derek Sham (26:18.326)
Knuckle.
Derek Sham (26:24.926)
Ahaha! That's awesome! That's great! Yeah! Yeah, well, we're, uh...
We're expecting Health Canada approval by end of this year. So we're actually reaching out in the next month or two to all our Canadian patients that have reached out. So thank you. I really do appreciate those messages because it keeps us on track. And then probably November, December, we'll be reaching out to the American patient population that have reached out.
Kim (26:37.795)
Very cool.
Derek Sham (26:57.006)
as we hope to begin serving North America near end of this year and the majority of the world by end of 2024, early 2025.
Kim (27:11.727)
That's awesome. And just going back to the beginning to confirm in terms of the process. So this will be something that, as you said, you're aligning with practitioners who will be able to, will potentially have the technology or the capacity to refer on and will they then with the patient or the consumer purchase this through the website or is it a practitioner who is placing an order with you? Okay.
Derek Sham (27:39.214)
Practitioner, practitioner. I think because of, you know the standard risk with pessaries, if it's not maintained, well, there is a slew of issues that can occur. You know, we are, we're a prescription only device, working with doctors to better service patients, just like custom orthotics, custom dental, custom hearing, now.
As we kind of drive the platform forward, there are opportunities to engage patients. For instance, in our digital gynecology software, we have baseline physical therapy exercises that patients could do. We obviously state that you should go see a pelvic floor PT because I believe in the community.
Derek Sham (28:33.412)
world, right? Like, you know, when my grandmother was going through this, she got fit with pessaries by three different providers. A journal gynecologist, two different urogynes. They all had different types of pessaries. They all tried different ones. Nothing worked, right? So I think helping the levator avulsion population is, you know, something near and dear to me. And, you know, it's crazy in Canada.
and even in the US to think that, my best guess is that somewhere between 60 to 80% of estuaries are fit by urogynecologists. Cause it would be like, it would be like, so I used to play a lot of sports, so I've got chronic ankle knee pain, so I wear a customized orthotic. It'd be like me having to go see an orthopedic surgeon to get a customized orthotic. It just doesn't, like the healthcare system.
Kim (29:30.439)
and have a potential 12 to 18 month wait list to be able to even get in for that first appointment.
Derek Sham (29:33.91)
Boom. Exactly. And the craziest part is that beyond that, urogynecology as part of COVID, I was here in wait times of three years. That's crazy for surgery. That's even crazier to fit a low risk.
you know, or thought conservative self removable device. It's it's you know, and, and I think, you know, our goal is not just to improve quality, but it's also to improve access as we as we go forward. I you know, one of my team members next week is actually going to Pelvicon Conference, the PT pelvic conference next week. Are you going to that camera? Okay. Oh, cool.
Kim (29:56.463)
conservative management.
Kim (30:19.147)
not but the gal who I just hosted the retreat with she will be she's there and she's speaking at it as well. Yeah, yep.
Derek Sham (30:24.378)
Ah cool, maybe Shilpa and my team can team up with your partner. It would be great to meet. Yeah, yeah, yeah. Cool. Yeah, yeah, yeah.
Kim (30:31.275)
Yeah, yeah, that'd be amazing. Yeah, very cool. So then, um, yeah, like everything you're saying is just, it is, it is crazy. It is crazy. The wait times, the challenges. And then if you finally, or when you finally get in and you have to go through multiple visits and the cost of those multiple visits, plus the cost of the pestery each time, I just, that's a big reason why people just say, forget it. And.
it's not gonna work for me. And then either they're in the situation of just putting up with it and suffering, or then they may go down the surgical path, which surgery can be a fantastic option, but there's wait lists for that. And then it's also, again, just the whole conversation around the bigger picture of pelvic health and all of the things that we need to address as part of the challenge that person is facing. So your app and the education and the alliance with pelvic PTs is that should be standard of care.
Derek Sham (31:00.044)
Yeah.
Derek Sham (31:18.132)
Yeah.
Kim (31:29.208)
Really.
Derek Sham (31:29.386)
Yeah, well, you know.
Derek Sham (31:34.35)
I was born in Hong Kong. I love being Canadian. I think and dream in English, so I am Canadian through and through. You know, pelvic PT, postpartum is covered in France.
Derek Sham (31:48.39)
OHIP, so on health quality Ontario, has generated a report demonstrating and suggesting that OHIP cover pestries here in Ontario. This was two and a half years ago, they haven't done anything.
there was a recent publication on sexism in reimbursement. Basically, if you decide to service women versus men, i.e. if you're doing the same procedure as a urologist versus a gynecologist, you make less money. There are systemic...
issues that even though I worked in industry wasn't aware of until I kind of worked, you know, until I started kind of going down the rabbit hole as one would say. But there are people trying to make a difference.
You know, I'm very fortunate to be leading a team that both challenges me, but also aligns on the fact that we're here to make a difference, you know? And it's pretty exciting times as we, you know, actually five years later from, you know, from kind of, you know, writing this on a napkin, from the napkin to really actually beginning to serve patients so that they can keep the devices. I know, you know,
Kim (33:02.399)
the napkin.
Derek Sham (33:12.772)
that we had in our clinical study, Innovate, they kind of disappeared on us, because they wanted to keep the device. But we're really excited to actually start serving patients, gather feedback, and improve. Because if you don't measure it, you can't improve it. And without trying, you can't get to that next level. So it's one step at a time with this. So, yeah.
Kim (33:20.467)
Oh, interesting.
Kim (33:40.327)
Yeah. And will this, do you have any plans for this to eventually be covered by insurance or is that in place now? So with all the different providers who will refer is the goal that this could be covered by insurance?
Derek Sham (33:50.285)
Yeah.
Derek Sham (33:55.31)
We have been in discussions with insurers, providers, employers in both Canada and the U.S. In Canada, 80% of...
they'll have private health insurance coverage. And if you have a health spending account, this will be covered. So I've had chats with associations and the larger insurers in Canada, and basically I just have to let them know once we get the approval to, you know, and we're obviously within certain pricing things. So, you know, that's one of the first things that I'm excited to test out, is Health Canada, you know,
coverage in Canada. The situation in the U.S. is significantly more complex. And, you know, either way, it will get coverage starting with health spending account coverage. And, you know, we're hopeful for some really large research organization support, you know, NIH in the U.S. and also CIHR in Canada, to support some of our large clinical studies to validate
not just not how this will not just improve patient's quality of life but it will save our health care money because it
Kim (35:16.543)
1000%.
Derek Sham (35:19.134)
Right now it doesn't make sense. Like why, if you can manage it, potentially reverse it at a younger age, i.e. postpartum, as you've experienced, and why not invest money there instead of waiting till the issue is at a point where you need surgery, which has its own costs and issues. And I'm not saying surgery isn't great. Surgery is great for a lot of things. But there are...
you know, our healthcare system is designed to...
help people with major issues, but isn't designed to support people trying to manage and prevent issues from occurring. But I think the world is changing, the reimbursement models are changing, and our goal is to evolve with that. And we're basically following the same path as custom orthotics, custom dental, custom hearing with the intent that, you know, with the backing of awesome VCs in Canada and US and whatnot and doing the right research.
and whatnot and the research community to really you know driving reimbursement and getting these things covered you know because does it does it make sense that we cover Viagra but not pastries? Probably not you know as a society like I don't like you know like I don't you know and that's the thing is like I come from like I come from the prostate device side right like we used I used to do both men
Kim (36:34.232)
Yeah, yeah.
Kim (36:39.247)
Oh my God, don't get me started. Don't get me started.
Derek Sham (36:51.282)
So the diagnostic neurodynamics is men prostate issues affects half of men, right? Pelvic floor disorders affect half of women. They're equivalent in prevalence. And I would argue equivalent in the devastation that it can cause with regards to quality of life. One has really nice reimbursement models and really advanced and cool technology that already exists.
and one is coming. It does not yet, but it's coming. There's actually really cool, there's really cool surgeries, there's like new surgeries coming out, there's some really cool companies, both out of US and Israel coming out with new surgeries. There is a slew of researchers beyond us trying to develop personalized devices in different groups, Europe, US, Canada, you know, like it's exciting to be in a,
Kim (37:25.298)
Yes, thank you for the yet.
Derek Sham (37:51.504)
macro lens in a space where the world sees the inequality. The world is projecting that women's femtech is growing at over 16% year-over-year because it's underserved and women control health care dollars in all households anyways. So the world is saying, oh like we're gonna start serving this. We're projecting it to grow double digits year-over-year for a while.
Kim (38:19.959)
Yeah, yeah.
Derek Sham (38:20.77)
We're also in a space where we're also in elderly care space in age tech. And age tech is projected to grow at 17% per year, both, you know, baby boomers and also the fact that, you know, we also, you know, COVID taught us anything. We do not take care of it elderly well. And we're, you know, so the world I would argue is like,
beginning to divert resources to it. There are obviously entrenched interests that would like to keep it the same, business as usual, but there are people like me, my team, our collaborators, our supporters, that are really, you know, you could say the saving grace of capitalism is entrepreneurship, and we're really trying to drive that forward.
Kim (39:10.135)
Yeah, yeah, it's been interesting to watch the menopause explosion that's happening as well because that's also contributed to a whole other conversation around pelvic health because GSM, a big component of menopause is it can't be ignored in that space. So it's it has opened up, you know, it's taken a long time for pelvic health to really be talked about or really to be considered. And you know, even in the last...
Derek Sham (39:14.271)
Oh yeah.
Kim (39:37.091)
five years, which kind of was around the same time that you were starting, we were finally making a little bit of headway. And now Menopause, that conversation has exploded and has a lot of dollars behind it and has celebrity behind it. So the pelvic health has kind of expanded even more because of that, which is really cool, exciting to see.
Derek Sham (39:47.823)
Oh yeah.
Derek Sham (39:55.466)
Yeah, it's interesting, like where it's all going. I related to where men's pelvic health was when I started in this industry, urology, about 20 years ago. This was a time when, I think it was like...
Green Mile and Tom Hanks in the Green Mile has prostate issues and the guy like put his hand in, healed him, he could pee normally, you know, wasn't suffering. It was also the time when Viagra came out and they spent a billion dollars in marketing to normalize it.
November, prostate awareness month, all these things started to change and drive the social conversation that led to the Capitol, that led to the new technologies, that led to the, you know, all the things. And I feel that happening, you know, in the women's pelvic health space. And I'm just kind of, you know, kind of grateful, arguably, to my grandmother for giving me like a purpose as part of her last, you know, years of life. And, you know,
It's been a fun journey. It's a bit of a rabbit hole. And yeah, and you know, yeah. So, yeah.
Kim (41:12.579)
Before I let you go, I just kind of want to wrap up with the data piece. I had mentioned I wanted to come back to that. So you've talked about you're creating a digital health portal. You've got the app and it will be collecting data. So what is it collecting and what will that data be used for?
Derek Sham (41:26.902)
Yeah, so one of the asinine things around this is understanding that every pessary fitter, every clinician fitting pessaries has a different level of experience, a different inventory. So your likelihood of going through the arduous journey of trial and error or clinical assessment and clinical trial and error versus the likelihood of success is different throughout, right?
And as we go forward, our AI or machine learning requires reinforcement, i.e. take measurements, predict an output, does it work, does it not. So it requires that data set to validate.
We obviously have trained our AI not just on that, but also biomechanics and the science of it. But you have to combine the two for this to work because it is a uber, this is an uber complex issue because it affects multiple organs, multiple functions, right? So our cloud software collects clinical assessments, does the prediction, and also how patients are doing in a way that
us to really train AI because if a woman has the same symptoms, the same clinical assessments, let's say in England, and she gets an optimized device for her care, gets her quality of life back to where it was before, a clinician doing in their first year of fitting gynothotics in the, let's say the, I don't know, like...
Nashville in the US.
Derek Sham (43:10.41)
assessing the same patient with the same measurements should be able to get the same quality of output. So it's imperative for us to really capture both the clinical assessment, combine it with quality of life to drive that data feedback loop. Now, noting all that, data is de-identified throughout the process. And also, essentially, every woman...
deciding to try out gynothotox and use it is helping every woman afterwards, which is the beauty of our world now, right? Like it's like the ability to do a podcast and share it with the world, you know, go through your treatment.
Kim (43:48.427)
Mm-hmm.
Yeah.
Derek Sham (44:04.002)
participate in sharing what did it work? Do you still have a bit of incontinence with it? All the issues, we collect that and we use that data to help the next woman going through the issue. And that is...
Kim (44:18.863)
So it's kind of like an always evolving process in a way. Yeah.
Derek Sham (44:21.642)
an always evolving process. And that's the fun part of working with regulators and the different things as to how do we think about version control, all the stuff as we go. But our cloud platform from a data security side, because we are taking images of vaginas. So obviously we meet and exceed all the standards with regards to patient information, privacy and different components there.
Kim (44:47.499)
And just talking about cost, is this, what would the cost to the patient be, even if it was reimbursable? And is there a cost to the clinician then to purchase that, the device that you talked about and is that how it's going to work?
Derek Sham (45:00.32)
Yeah.
Yeah, and so our suggested sale price is about $500 for the device. And it's essentially the same thing as custom orthotics versus Dr. Scholl's orthotics and pessaries with a revenue share model where we incentivize provider adoption. Because I think, you know, like I mentioned before, getting patients...
to get involved in their care, to optimize their own care and their own device is important because I don't know if that patient wants to do CrossFit because if they wanna do CrossFit, it's gonna have to be a little more supportive, right? Or, you know, there's nuances in what they wanna do in their lives that will affect the design of the device. Now,
We also need the clinicians to be happy providing it. And, you know, our, we serve as doctors that service the patients.
Kim (46:11.595)
And is it, I think of, I've had orthotics in the past and you get almost like a mold of your foot and it gets sent off to the lab, your orthotic is created, it's sent back to you, you put it on, there's little tweaks that are needed that, you know, it feels like it's rubbing right here or it feels like it needs to be a little bit longer or supportive here. Can there be tweaks done to the gynothotics as well?
Derek Sham (46:36.246)
That is literally what our platform is designed for, in that our version one release is you try a pessary, you've tried one, you let us know what the problem is, clinician does an assessment, we can tweak that right away. We can service, we can improve your quality of life right away, and I know, and that's the frustrating part of the field of science.
Science right is tends to sometimes be binary. Does it work? Does it not work? But we're humans. We're a whole lot more complex than that Like like when you say it does work, okay
Does it work when you're running? Does it work to the point where you can't feel your prolapse at all at any time, even if you're lifting your kid or going for a run, or do you get incontinence when you laugh? Is it just when you laugh or when you're giggling? You know what I mean? Like there's nuance to that. And I would argue...
Kim (47:18.383)
What's working? Yeah.
Kim (47:34.2)
Yep.
Derek Sham (47:41.218)
That is also the beauty of where machine learning is, because a machine trained on a million patients is gonna have more experience than any clinician that's out there, but we do not, the machine never replaces the doctor. The doctor is the one that provides care because, you know, yeah, so.
Kim (48:03.011)
Right, right, right. I am so excited about, I've been excited since I first spoke to you probably five years ago and learned about this and becoming even more excited now about the possibility. So thank you so much for the work that you're doing. Thank you to your grandma who planted the seed and keeps you going. And I really am, I'm really, really hopeful about how this is gonna transform the landscape for pelvic health specific to prolapse and pessaries.
Derek Sham (48:09.59)
Thanks.
Derek Sham (48:21.454)
Thank you.
Derek Sham (48:31.53)
No, thank you. Thank you for the opportunity to kind of spread awareness. I'm really excited to engage you, your community of providers and patients. You know, our website's Cosm.care, C-O-S-M.care. Feel free to reach out. Would love to engage in just, not just helping patients, driving research and really, you know.
driving the next evolution of devices for unique bodies and needs. We're at the precipice of change and any support towards improving 1 million lives by 2030 is greatly appreciated. So, join us on our mission for personal pelvic health. Thank you, Kim.
Kim (49:14.763)
Yeah, thank you so much. I will have all those links in the show notes below and thank you so much.
Derek Sham (49:20.598)
Cheers.
