Uresta CEO Lauren Barker on the Transition to Over-the-Counter Availability

In this episode, I spoke with Lauren Barker, CEO of Uresta, about the transition of Uresta's pessary from prescription-only to over-the-counter status. Uresta treats stress incontinence, commonly caused by physical activities like coughing and exercising. Lauren discusses the rigorous FDA approval process, safety studies, and the extensive user data gathered from Canada, reinforcing the product's safety and effectiveness. She explains the broad target audience, including women in their 20s to 80s, and details the purchasing process, including the starter kit and pricing. Additionally, Lauren teases upcoming complementary products, such as a natural cleaning gel and hyaluronic acid vaginal moisturizer, aiming to enhance user experience and accessibility.

You can find more information on the Uresta:
Website:  www.uresta.com
Instagram @myuresta
Facebook: Uresta
Pinterest: My Uresta
TikTok: myuresta

Timeline:

00:28 Introduction to Uresta and Guest Lauren Barker

00:57 Transition to Over-the-Counter Availability

01:46 Safety and Clinical Studies

04:12 Target Audience and Usage

07:32 Purchasing and Fitting Uresta

10:10 Customer Feedback and Effectiveness

13:45 Future Developments and Conclusion

Transcript

Hi there. I'm here today with Lauren Barker, who is the CEO of Euresta. So Euresta is a pessary that is used to treat stress incontinence. So leaking with coughing, sneezing exercise. Euresta has been available for a while now, but by prescription only and things have changed. So, can you tell me how things have changed?

Well, first I should say it's good to see you today. 

Thank you for having me today. Excited to be here. Yeah,  but yes  a big change. So we've had the opportunity to talk with you before about your data, but very exciting news. So, we previously were only available in the U. S. via prescription. But over the last few years, we've been working with the FDA to be cleared as an over-the-counter product.

Which means you no longer require prescription for your stuff,  which is great for us because 1 of the reasons we actually your address was actually founded was to have a self managed self fitted solution for women that. They didn't have to go to their physicians to get fitted for.  

So, when I've talked to other companies who have pessaries  they have talked about really wanting their pessary to be available by prescription only because of safety issues.  

 So can you talk about the studies and, and why we think that's safe, that it can be over the counter? 

Yeah. So, Uresta  has   Gone through 4 independent clinical studies. None of the data suggests that it's unsafe. There's no increased risk of UTIs or other types of infections. The 1 thing we do recommend is that your resta is taken out daily.

So if you, you know, women used to rest in different ways, like, they might use it all day. They might just use it for exercise. Some women just use it at night. But it's just important that in that 24-hour period, you're taking it out and having a rest. For most women, that means taking it out at night and leaving it out overnight.

And that's really more to make, let the vaginal tissues rest    and, and take a breather. But  there's no data to suggest that it would be unsafe. 

And Uresta last for? When do you have to replace it?  

So it won't break down or anything like that, but we do recommend replacing on an annual basis   or for hygienic reasons, kind of like when you replace your toothbrush, that sort of thing.

Yeah, on an annual basis. Yeah. 

And, and I would assume, I mean, it's been available for so long by prescription in the United States that I would assume that you have a lot of. You know, anecdotal data from that. 

Well, not not only that, but we're actually a Canadian based company. And we've been over the counter in Canada for several years.

 So just in the last, you know, couple of years, we've sold over 20, 000 drustas in Canada. And we have no  no adverse effects, nothing to suggest. Any concern, which was great. We were able to actually use a lot of that user data when we were going for FDA clearance in the US. So, yeah, so it is. It is definitely been a trusted product already in Canada is the opportunity now bring it to the US as it over the counter product.

Yeah, which is amazing. I mean, I really think that there's such a need for this, right? So many women want to manage this on their own, and I think if you're healthy and up to date on all of your annual screenings, it's a totally reasonable thing to do. So I, I think this is definitely something that's needed and, and women want.

 Who is your target audience?  

So it's funny because I've had, you know, some women will look at your rest and go that's for, you know, that's for my mom or that's for my grandma, right? We've had women or I have specifically personally had with women in their 20s using your resta and women in their 80s.

So I think as long as you are comfortable with the idea of it   there is like, you know, a little bit of like hand dexterity and flexibility to take it in and out.   If someone's ever used a menstrual cup, it's a similar   it's a similar   process for taking it in and out. But the biggest thing I would say is   You know, generally, anyone who is experienced, like, leaves when they cough, laugh, sneeze, or jump  if they've had a recent vaginal surgery, I would definitely recommend chatting with their physician prior  if they have a more advanced prolapse, the rest of the likely wouldn't be successful for them.

So, typically, you know, grade 1, grade 2,  Would still be successful with your resta. And then we do  it's not for women who are pregnant and women under the age of 18. Okay. Yeah. So pretty broad. Yeah.  But I will say like from just chatting with a lot of our customers, I mean, there's a lot of women in their thirties and forties who use it maybe just for exercise that are super active. 

And then you have women who are starting to go through perimenopause, maybe they've had a little bit of leakage. Maybe this is something that's new to them. Then they go through menopause and becomes even more prevalent post menopause. It's an issue. So, I mean, it is really quite. It is quite broad. 

Yeah. I think it always helps people to hear kind of who uses it, right.

To see if they kind of identify with that, with that person.   And I, I think it's, you know, important to say that, you know, there are a lot of young women who use this. There are a lot of women who use it just during exercise. There are a lot of women who use it during really intense exercise. Right. So.

Crossfit distance running.   So if you know you have leaking and those activities, I, I think, you know, it's, it's a great thing to try. It's also great for people who don't want surgery or aren't ready for surgery and, and don't have time for surgery. And, you know, from my perspective as a surgeon, if someone comes to me and they've tried your rest  and it works for them  then I think surgery is also going to work, right?

Because the mechanism is the same, it's supporting the urethra. And so I always take that as, you know, kind of a positive test. So I, I think even someone who's interested in surgery, if they kind of want to know. how effective it might be for them. It's a, it's a reasonable, you know, kind of trial. And I always think you should try the nonsurgical things first.

Yeah, for sure. And I definitely think we see that, like, I mean, we see some women who maybe they won't have more kids. So, surgery is not an option yet. Maybe it's not that big of a nuisance. Maybe they don't want to go for surgery, right? Or it just happens, you know, twice a week during a long run or something, right?

There's one specific activity. Yeah, I agree with that. So if I, let's say I'm  I don't know, a 40 year old runner and I leak with running and I really want to try the rest of what do I do?  

Yeah. So now what's really exciting is you can go to our website, which is just urresta. com. And you can purchase your directly 1 thing that is interesting about your is that it comes as a starter kit.

There's a fitting kit associated with it. And that's because. You know, you might try, you want to probably try different sizes. And kind of do your activities, for example, like, we've had women. You know, use 1 size, maybe during the day, or use a larger size  when they're exercising, or maybe after a couple of weeks of using your on a regular basis.

Sometimes women need a larger size, and sometimes they actually need a smaller size. And so you can go directly to our website. You'd want to purchase the starter kit, which looks like this for those 2 who can see us on video today. But basically, this includes 3 sizes. And  in the, when you open it up.

We recommend trying the smallest size or to the middle size first and then sizing up or down based on on what you're experiencing. That's kind of 1 of the things that was important to us as an over the counter product to make sure women could kind of find the side that works for them. Without a physician,  

yeah, and so if I get the starter kit, I try those 3 sizes and I don't think those sizes work for me.

What are my next options?  

So as you can see, there's only three in this box, but we actually have five  from our  all of our sales in Canada and all our clinical studies. What's in here will actually work for 90 percent of women  but there's actually a very small size and a very large size that's not included in here.

If you   email us within 30 days of receiving your starter kit and you want to try that smaller one or the largest one, we will send that to you for free to try. But definitely recommend starting with this.  

How expensive is the starter kit? 

So this is US   179. Okay.   For the starter kit. And then once you are at the one year mark to replace, it's 129.

Okay. So usually at that point, you know what size you're using on a regular basis. So you'll just buy that single size. And we are offering a 30 day refund window on the starter kit. Once you buy a single size at that point  it's final sale. Okay. 

Yeah.  And, and what kind of feedback do you get from women when they get the starter kit? 

 It sounds so cliche and it sounds so cheesy, but  it's actually one of the reasons we put on the box  game changing bladder support, probably hard to see on video, but women will be like, this is such a game changer for me. Like I've, you know, been holding back at the gym. Or, I didn't realize how much I was dictating, like, part of my day to my leaks.

And I had one woman describe it as packing her own diaper bag every day.   And, you know, I was always, like, had my route planned out around where my washrooms are. So I think a lot of women, it's really freeing   gives them a lot of confidence and they feel a lot more comfortable,   right? And it's crazy, some have struggled with this for decades.

Yeah. It's interesting all the behavioral things that women will do to avoid leaking, right? That they don't really realize they're doing, but occupy a lot of space. Their brain and their time, right, as they're trying to avoid leaking in public. How effective is the Eresta?  

So, Eresta is very effective.

So, for treating stress incontinence, so we're talking about bladder leak, which is cough, laugh, sneeze, jump, run. We had a clinical study done  in May 2020. And, or 2022. And in that, it actually followed a group of active women, and that was important to us because we do have a lot of women who are using Uresta when they work out  leaks are very prevalent when you're jumping, that sort of thing.

So it followed a group of women who are CrossFit participants or marathon runners, and in that group of women, 97 percent of women saw a reduction in their leaks,  and 90 percent of them continued to use the Uresta after one year period. So  very effective.  

That is a pretty amazing result. I was going to ask you how you defined active.

I mean, I would say that's super active, right? Yeah. 

And these were women who were   you know, you sometimes you hear, and I've heard this from a lot of women like, Oh, my doctor just told me to lose weight, to address my incontinence. These were women that were a healthy VMI too. So that, that was really interesting to focus on that group as well.

Yeah, I mean, losing weight will definitely help. But I think when you're doing such an intense exercise and the pressure that you're generating is so high. I mean, your system has to be working perfectly in order to to not leak. And, and, you know, weight loss definitely is not going to impact that. 

Yeah. 

So yeah, I mean, those are pretty amazing results.   Okay. So, and it is available now over the counter 

as of, as of a week ago  or just over a week ago. Yeah. Fully available in the U S at your us to. com. 

Okay. Do you, does insurance cover it at all or is it all 

still coverage at this point? Yeah. 

Is that Next or not so much.

I think it's something we'll look into. It's a little bit more complicated. I 

know 

Yeah, if you have like if someone has like a health spending account or like a yes account They should be able to get it covered. That way ins,urance is not something that we have at this time. 

Yeah, that makes sense.

Okay, so what are your next steps? What are you guys doing next? 

Well, we have some exciting things  coming in the pipeline more to complement the use of your resta. So we will have be coming out with like a natural cleaning gel. So we wanted something that was like all natural, didn't have any toxic  toxins.

Chemicals in it. We're often asked like how to clean it. And I think a lot of women boil it, which you shouldn't. It's really just soap and water. We also are coming up with a water based lubricants or something like a lot of women like to use a little bit of lubricant with your resta, a lot of over the counter lubricants today might have silicone or other chemicals in it.

So we wanted something that was all natural, non irritating. And then we're also working on a hyaluronic acid vaginal moisturizer. So hoping that that comes out  in 2025, we're actually doing a clinical study  on that. So  we're excited because. It'll be a nonhormonal option.   Obviously definitely worth chatting with your physician, but I think keeping within the theme of, you know, maybe this is something you want to try in tandem with, you know, a little bit more accessible.

 You know, I know in Canada, for example, the wait list is really long to speak to a physician. I think it's better in the US, but that's something we're looking at as well, because   and it's probably worth noting, like, women who do have vaginal dryness, they might need to discuss with their doctor their options in treating that before they're successful with Uresta.

 But some of the early studies on hyaluronic acid  for vaginal moisturizing is really quite promising. 

Yeah, no, I agree with that. And, you know, there are definitely a lot of women who. Want to avoid vaginal estrogen. I mean, I'm a vaginal estrogen advocate, but   you know, it does not work for everybody.

 So yeah, well, that all sounds super exciting and definitely well-needed. Congratulations to you and your team. I'm, I'm so excited that this is available for women now.  

Thanks. We're excited. And like, thank you for your support over the last couple of years and excited to be here over the counter.

Yeah, 

it's great. Okay. Thank you so much. 

Yeah. Thank you.