Innovating Pelvic Health: Personalized Pessaries and AI Solutions with Dr. Goli Ameri

In this episode, we welcome Dr. Goli Ameri from COSM, a leading Toronto-based medical device company dedicated to revolutionizing pelvic health. Dr. Goli, Head of Research at COSM, holds a PhD in Biomedical Engineering specializing in image-guided therapy and surgery from the Robarts Research Institute at Western University. She has played a crucial role in COSM's growth, contributing to 4 peer-reviewed publications and 11 conference presentations. We explore the limitations of traditional pessaries and delve into COSM’s advanced technologies, such as 3D printing and AI-powered tools, which create personalized pessaries for conditions like pelvic organ prolapse and incontinence. The discussion also highlights the potential of non-invasive ultrasound imaging and accurate measurement tools. But what truly sets COSM apart is its data-driven platforms, which offer comprehensive digital support to physicians and patients. We examine the integration of educational apps, peer support, and remote monitoring to enhance overall care. Discover how COSM transforms pelvic health with precision-based solutions for unique bodies and needs, all underpinned by its robust data-driven platforms. For more information, be sure to check out their:

Website: https://www.cosm.care

Instagram: @cosm.medical

Facebook: Cosm.medical

Timeline:

00:00 Introduction to Golia Ameri and Cosm 

00:04 The Problem with Traditional Pessaries 

01:03 COSM's Innovative Solution 

02:05 Custom Pessary Fitting Process

04:21 Challenges and Measurements 

09:27 Provider and Patient Support 

13:27 Future Developments and Products 

13:36 Future Innovations in Personalized Pastries 

13:58 Postpartum and Post-Surgery Recovery Solutions 

14:41 Clinical Trials and Studies 

15:09 Personalized Devices for Different Needs 

16:06 Stabilizing Tissue for Better Healing 

17:37 Collaborations and Innovations 

19:19 AI and Machine Learning in Women's Health 

20:15 Advanced Measurement Tools 

22:41 Challenges and Future Directions 

23:32 Connecting with Cosm 

24:57 Conclusion and Gratitude

Transcript

Hi there. I'm here today with Golia Mary who works for Cosm. Cosm is a company from Canada that makes an individualized, customized pessary and you know, it's interesting because I have fit patients with pessaries for a very long time and never really thought about what a very. old technology it is, um, and how nothing has really been updated or changed for decades.

And they work for some patients, not for other patients. And we just kind of accept that they don't work for other patients. So pester ease are a device that fit in the vagina that help with pelvic organ prolapse. They help with stress incontinence.  And so can you just tell me How you guys saw that problem and what you did about it.

Hi there. Thank you for having me. Very excited to share with you what we are doing at COSM and why we believe we are changing the future of women's pelvic health. How did we see this problem? Well, it all started with our vision that every woman is different. And as you mentioned, pastries are used for pelvic floor disorders, such as pelvic organ prolapse and incontinence, and these issues affect half of all women in their lifetime, and are met with shame, silence, and limited treatment options.

Existing non surgical treatment options like therapy or outdated pastries fall short, and surgery has been banned. Burdened by complications and lawsuits.  And frankly, for too long, innovation in women's health space has been stagnant, particularly with products like pessaries, which haven't changed since the 1970s at cause.

And we saw this gap and knew that something needed to happen. We are pioneering the world's 1st personalized gynecological devices, just like how invisalign revolutionized the dental industry. Uh, with custom solutions. We are doing the same in women's health.  

So when you say custom solutions, what does that, what does that mean?

Right. So right now someone comes to my office, they need a pessary. I have a pessary fitting kit. They're all made out of the same material. There's slightly different materials depending on the brand, but it's essentially the same material. There are custom sizes, right? So it's kind of like buying choose when we fit you for the size.

Some different shapes, but there are pretty standard ones that we use all the time. Um, so I fit you with one, my off the shelf options either work for you or don't work for you. And so what does that, what does that mean that it's a customized pessary? 

So that'd be a good question. As you mentioned, these devices come in fixed size and shapes, and more than that, they're fit by, they're fitted by trial and error, which could be a very tedious process for both patient and provider. 

We use advanced technologies to create passivities that are personalized to each patient's unique anatomy. And what that means is that. The physician can take certain measurements from the patient. They can assess how the past three that the patient's currently using has issues and based on a shared decision model, the provider can determine what needs to be changed with the patient.

The current pessary in order for the patient to have a better treatment outcomes. And then the provider can design a personalized device, a personalized pessary, which we call gynecotics pessaries. And we use advanced technologies such as 3D printing to develop personalized devices for each patient.

That's all. 

So, so you're right. Pastry fittings are pretty tedious. So someone comes to the office, we fit you with it. And then once we find one that we think works, you have to get up, move around, make sure that it, it stays in place, that it's not uncomfortable. Sometimes it's hard to know if it really fits until you go home.

And so, you know, we're trying multiple ones. It's it's multiple offices. So having one that's customized based on measurements sounds better. For everybody, but I'm sure the question that both providers and patients would ask is, you know, how, how hard is it to get those measurements? And how much time does it take to get that information to design the perfect pessary?

Because that's something I've never done before. So is that hard?  

For sure. Um, for sure. And that's a good question. It's, is it hard? Okay. No, for I think fitting, fitting pastries through a trial and error process is harder  than taking measurements. There are certain standardized measurement tools available that your gynecologist, for example, use to assess the prolapse stage  and you know, 

Yeah, I mean, you're right.

We, we do a measurement called the pop Q, where we're measuring different  parts of the vagina to see what's coming down to see how big the opening is all of those things. Those are measurements we standardly take. Is it all based on the pop Q, or are there other measurements that you have to take? 

Yes, there are some additional measurements that based on our research, we realized are important for passivity.

A good fit and also when a patient presents with issues with their off the shelf pastries, the process in the office, this is 1 of the options that the provider could assess the pastry in situ to  figure out. What the issue with the past three fitted is, like, for example, they could assess and be like, oh, the past three sits to know it's too wide.

It's too too big in 1 dimension while it's, you know, 

so inside just meaning examining the patient with the pestering place and looking at the fit. And yeah, okay. 

Yeah, and there's also a patient in information as well. Look at the patient feedback about their own past story. If they feel there is discomfort in specific area, that's taken into account to figure out what needs to be changed and is it a hard process?

Back to that question.  As anything that is new, there is a learning curve. However, we provide a lot of support to providers to set them up and make sure that they, um, they have all the right rules and techniques to be able to design kind of audience  and so far, our experience has been that. Um, with the workshops or training that we provide, which doesn't, you know, take long and maybe half an hour to an hour, um, the most providers, they feel ready to design novel gynecotics, but still, our support does not stop there.

We have clinical experts on the team who. Physicians and providers can directly contact to talk about cases  or ask specific questions about a patient's, um, and issues and, you know, how to personalize and, you know, we, we provide support as much as possible. 

Yeah, 

that person. 

How often, I want to ask you about the support that you provide, but I just have one more question about the pessary and, and that is this, how often do you get it right the first time?

I mean, how often do we say, okay, you know, we think this is the perfect pessary, but then that patient lives with it for a little bit and it's not, it's not quite right. Right. Because as you know, prolapse looks very different when someone, depending on your position, right? And so someone, when some, sometimes when someone is up and active and doing things, the prolapse can look much different and provide, you know, impact to pessary in different ways.

Yes, yes, for sure. Based on the data that we have seen so far, based on our real world evidence, basically the success rate is close to 90%. That being said, as part of our platform currently, we allow physicians, uh, providers to design a couple of devices, not just one, you know, to so that they can try a couple of different de designs. 

For the patient. And yeah, so far, the success rate has been pretty high. 

Which is really amazing that it is that high. I mean, I think this is just such a great idea because there are, I mean, it is not uncommon to have someone who really wants a pessary and we can't quite get the right Fit it's either a little bit too uncomfortable or it just doesn't stay in place.

So being able to design something that's a little bit different, I think is pretty amazing technology. And, you know, it's definitely patient centered and allows the women who want to, to avoid surgery, which is always a good thing. Exactly. Okay. So this product right now is,  FDA approved in the United States, but not available in the United States.

I just want to say that although, you know, stay tuned because hopefully it will be available soon.  Tell me about the support that your company provides for patients. I mean, you provide a lot of support for physicians in terms of fitting and as, you know, behavior change is hard, right? So, anytime we do something.

Different and we're worried about it taking more time in clinic. It's always hard to get people to do that. So it sounds like you provide a lot of support. So the, the fittings go well, or the sizing goes well, but what support do you provide for patients? 

Yes. Thank you for asking this question. It's very near to our heart here at QASM.

We, yes, our support doesn't stop at just providing the device for patients. We have developed a clinic app for providers and also an app for. Patients for patients are app provides reliable and educational content, including articles and hands on  videos to go to help them go through this difficult journey as you know, they're like, there are a lot of information online, but not everything you read online is  necessarily reliable.

So we want to make sure that patients have the right information. So we want You know, going through this journey, this app also provides patients with a way to track their symptoms and their progress with kind of products or their pastories.  And this enable this kind of bridges the gap. Currently, I can.

I always think of it as like the  feedback loop is broken for patients don't necessarily have an easy way to let their providers know how how they're doing with their with their symptoms, how they're progressing. So this app provides a seamless method for patients to track their progress and makes it easy for them to report it to their provider.

That's really nice. You know, frequently when patients come to clinic and I say, well, how are you, you doing right? I mean, that that's a horrible question because it's not specific enough. People don't know how to answer it. They may or may not have been tracking their symptoms. They think about what happened maybe yesterday, right?

But it's very hard for the average human to track small progress over time. Time right or small changes over time. Right? And so having something that is objective and systematic is is super helpful. I think both for patients and for physicians. It's also nice for, you know, we're really good at knowing when we're 100 percent better.

Right. But if you're 70 or 80 percent better, sometimes it's nice to go back and look at that data to remind yourself how far you have come. Right. Even if things aren't aren't quite perfect. Have you considered including any peer support for patients?  

What do you mean by peer support?  

So when I first started practice, I was kind of taught and I had this theory that nobody wanted to talk about these things, right?

We were kind of taught that. And so I think as physicians, we kind of perpetuated that. But over time, I've realized that a lot of patients want to talk to other women and want to know what other women are going through and don't want to be as isolated in this journey. And so. Do you offer any mechanism at this time for women to do that  

at the moment?

This is very, this is a very important aspect of care that you brought up at the moment. We don't have the bandwidth to provide sort of one on one support for patients, but as part of the app that we are developing and expanding on, we would like to. Other concepts that we are thinking about is remote monitoring.

Remote monitoring is something that we are thinking about adding to our platform to make sure that, you know, we have that continuous feedback from patients and provide a method for patients to be able to, you know, directly contact providers for us, but it's not fully developed yet. It's in the pipeline for sure.

Okay,  

so I love the idea of the personalized pastry. What is the next product that you're working on? Because there's always a next,  

there is always the next and I'm super excited to talk about the next products as well. Beyond our first version of personalized pastries, we are already working on. Other applications of our technology to encompass the full public health continuum for prevention from prevention to diagnosis to treatment. 

Our very next product line is focused on postpartum and post surgery recovery. This product is designed to help them and recover better from childbirth or  surgery post  after, let's say, prolapse repair surgery. And the goal is to aid. With tissue healing and tissue remodeling. This is similar to using casts for rehabilitation, but currently we don't have anything like that for the public floor.

Gynecotics recovery could reduce the risk of developing future public floor disorders and improve long term health outcomes. We like to think of it as a preventative measure. So is 

it a vaginal insert? 

Yes. Okay. And this, uh, we are doing a study on it. It's already in clinical trials. Uh, this, uh, what we call kind of products recovery, and we are very excited to share the outcomes of our, the 1st phase of our study at the American urogynecology society meeting, uh, which is happening in just a few weeks.

Yeah, 

it is coming up here. I'm not gonna be there. I, but I'll have to, I'll have to look for that presentation. I'm sure I can stream it. Is it the same product for postpartum patients and post-surgical patients? Or is it slightly different? It's slightly different because 

the, each patient population has different needs, right?

Yeah. But what we definitely, yeah. Um, all, all, all these devices are designed with personalization in mind.  At the bottom line, as I mentioned, you know, our vision is that every woman is different and regardless of what health, public health issue have, you know, these devices should be personalized. So, that includes, you know, 

and with this device is it is the goal to heal more quickly.

Or to prevent negative sequelae.  Right, so like with a prolapse surgery, is it okay? Well, you're going to heal more quickly if we do this  or your surgery is more less likely to fail over time. 

These are the outcomes we are tracking in a pilot.  Randomized clinical trials that we are running now, but the hypothesis, the idea behind it is that after surgery, pelvic floor, you know, the body is an incredible system, you know, it's doing its recovery, but patients go back to their real life activities, you know, lifting heavy things, being active and all of, all of these activities may add.

Or increase interra abdominal pressure and put pressure on the pelvic floor as it is healing or, you know, um, the areas, uh, where the surgery was done. So it's again similar to how we provide a cast for a broken bone to make sure that the, you know, tissue is as stabilized as possible during the healing process.

The idea here is the same that we want, we want to stabilize tissue while it's healing and. The idea, the hypothesis that it will improve outcomes.  

Yeah. I have to tell you that when I talked to you, I realized how I have just kind of accepted the way we do things, right? We operate, we minimize, talk to patients about minimizing activity, right?

And doing all of these things to, um, hopefully minimize the impact of pressure on the pelvic floor and the post surgical patient, but not thinking about, Oh, what are the other things that, that we can do? So it's very interesting to me how you guys have thought outside our current paradigm.  

Thank you.

Thank you. Thank you very much. I think it's very important. And, um, to be honest, like, we work with key opinion leaders around the world, like, in Canada and the US and this idea was, um,  came to fruition. With close collaboration with 1 of our, um, collaborators in the U. S. so  grateful for all the knowledge that physicians bring to the table to the gap is we're happy.

Well, I mean, it's something 

that we talk about a little bit, but I don't know of anyone who's actually done any. Thing to, you know, to help provide support post operatively and I think it's so important that you study it. Right? So we figure out what what works and what what doesn't work. 

Yes. Yes. For sure.

Yes. You know, 

because sometimes we have these great ideas and, and we think they're going to work and, you know, maybe they work, but maybe there's, you know, some unintended consequence that we, that we need to know about and mitigate. Okay, so, so that is your next product. When do you have our next product of your next product?

We have several, if you'd 

like, I can talk about it. Yeah, give me, give me the quick rundown. Sure.  So, in addition to gynecotics recovery, we are working on novel gynecotics shapes and designs for pelvic organ prolapse and incontinence. These, um, the idea is to build upon what we know already and improve the designs so that we can improve sub insertion removal for patients, improve fit and comfort.

The goal is to rethink the. Pestry entirely with a focus on creating devices that are not only functional, but also empower women to take control of their health.  Another aspect of our technology platform is  leveraging and taking advantage of AI or artificial intelligence and machine learning. We are developing AI power tools that will help predict the best treatment option for each patient.

This will reduce. The trial and error process even further. We are investing heavily in AI to advance personalized care. Our AI tools  are in development, and they aim to predict the best treatment option. For each patient, reducing the need for trial and error, as I mentioned, this will save time, reduce costs, and importantly, lead to better outcomes for women everywhere.

And this will be integrated in our software platform as the next step. We also are investing in Advancing measurement tools. We are creating standardized measurement tools to ensure providers have everything they need to fit patients properly from the start. As you mentioned, you know,  you had a question about how do you know what to personalize or how do you take these measurements?

So we are working on that as well to develop a tool so that it can more. Accurately take the measurements needed. 

Can I ask you a question about that? Have you ever thought about, um, instead of having it, I mean, right now we do pessary measurements based on clinical exam. And when we do clinical exam, you're supine, right?

So you're flat on your back because that's easiest.  But that is not how you spend most of your day. And so have you ever thought about doing the measurements with x ray?  

Medical imaging in general is.  It's very interesting, and  I spent a lot of my research, uh, on imaging as well. X ray, per se, is quite intrusive because of radiation.

What we explored and are investing some of our time on is ultrasound, because ultrasound is non invasive,  very accessible. Very quick and real time, you know,  you can see the anatomy right there and then, 

but it's done in the same position, 

right? 

Right. Versus being, I mean, because when we x ray people, you are flat on your back to right versus being standing.

Yeah, yeah, I know there's research on MRI  standing MRI, but all these, there isn't anything I'm 

fitting though. Right. And you would have to use contrast to outline the organ. But, yeah, 

so, yeah,  yeah, we do have a publication on it was very interesting. We, we developed. An ultrasound system that enables looking at the extended vagina. 

Because no 1 had done that. It was the 1st digitally molded vaginal model  that's ever been developed. And we are very interested in that to taking, you know, precise measurements of what the cavity looks like. And during that study, we did play around with.  Scanning patients standing up, we develop the system for sitting,  you know, do that during sitting.

So all of that is in the pipeline. It's still quite in the research phase, but these are the big important points that you brought up that he has to take measurements in supine when patients are lying down and then, you know, they have issues with their passivities or when they go for a run, you know, definitely 2 different environments and we do have that at the back of the mind as we are developing our next devices.

so much for joining us. Um, and maximum the next measurement tools. 

I think once you start asking the questions, right, it's amazing how many other questions start. 

Oh my God. 

Yes. Start flowing. I mean, I examined my patients supine so flat, but I frequently have to examine patients standing up as well because it's just so very, very different, but that it's very difficult.

If not impossible to take measurements there, right? And so you're doing a lot of expert estimation, let's say. So, yeah,  so if someone is interested in following your company and where you're at, or interested in trying to get a customized pessary, where can they do that? Where can they find you? 

We are online.

Our website is QASM. care.  We are also on social on X  Instagram, and you can reach us directly on our website. 

Okay. So Cosm, C O S M dot care. Correct. Okay. And do you have any estimates about when you're when you'll it'll be available in the United States?  

We are working on it very hard. That's 1 of our focuses this fall.

We are hoping that. I don't want to give you an exact date because a lot of things are changing, but 

it's a hard process. 

Not only that, but also we are trying to focus on at the moment. Our focus is to make sure that we can meet the demand while ensuring quality and safety of our devices.  Today we have more customers that we can serve, which is a great problem to have as we are ramping up our production and getting ready for the U.

S. market. you But as soon as, you know, we ramp up production, we will, um, enter the U S market. 

Well, congratulations. That is a great problem to have and definitely speaks to how needed this customized solution is. I just want to thank you for spending this time with me and for all the work that you guys are doing and, and moving, you know, women's health forward. 

Thank you so much for having me and thank you for creating this platform for us to be able to talk to patients and providers. 

Yeah. 

Thank you so much. Have a great day. Thank you.