Innovations in Overactive Bladder Solutions with Isaac Oppenheim

In this episode, I welcome Isaac Oppenheim, CEO of Zida, to discuss revolutionary solutions for overactive bladder (OAB). Isaac shares his personal motivation behind developing the Zida control sock, a device utilizing percutaneous tibial nerve stimulation designed to provide an accessible and effective treatment. We delve into the challenges of existing OAB treatments, patient-centered care, and the impactful results of clinical trials showing an 80% success rate in symptom relief. The conversation also explores the integration of neuromodulation, lifestyle changes, and pelvic floor therapy as comprehensive approaches to managing OAB. Emphasizing the importance of accessibility, we discuss the device's design, ease of use, and affordability through various purchasing options, including Medicare. Join us as we explore these innovative solutions aiming for 100% symptom improvement and the future of personalized medicine in treating overactive bladder.
Zida website https://livezida.com/

TimeLine:

00:28 Introduction to Overactive Bladder 

00:59 Isaac Oppenheim's Background and Inspiration 

02:21 Developing the Zida Control Sock 

09:12 Clinical Trials and Success Rates 

11:43 User Experience and Practicality 

13:46 Innovative Technology in Textiles 

16:10 Understanding the Fit and Sizing 

16:57 Overactive Bladder: Prescription vs. Over-the-Counter 

17:19 The Importance of Doctor-Patient Communication 

18:17 Challenges with Overactive Bladder Treatments 

20:46 Insurance Coverage and Costs 

25:06 How the Zida Control Device Works 

27:09 Future Goals and Research 

29:04 Conclusion and Final Thoughts

Transcript

Hi there. I'm here today with Isaac Oppenheim, who is the CEO of Zaida, and they make a product to help with overactive bladder. So, as you know, overactive bladder urgency incontinence is going to the bathroom frequently, feeling a sense of urge, maybe not being able to get there before you leak. And this is.

A problem that is super bothersome to women, I think possibly the most bothersome form of incontinence. So let's go ahead and let's get started. Do you want to tell me a little bit about yourself?  

So my name is Isaac Oppenheim. I grew up in Washington DC and I come from a family that's innovative, that's been involved in, um, in textile for, for a long time.

Um, Okay. I came into the world of Overactive Bladder kind of by accident, literally. It was on a family roots trip with my 93 year old grandfather, who escaped Nazi Germany at age 13,  and he took us on a family roots trip with the, you know, the extended family. He was 93, back to Frankfurt. And standing there in front of, you know, a historic building that had family significance, I discovered the problem of overactive ladder.

And, you know, in my world of textile,  our factory had made a lot of products as a prime vendor for the biggest brands in the malls in America, Victoria's Secret, Gap, Nike, Calvin Klein. But we all know where textile is made today. It's made in the Far East. And so we put a lot of effort into developing medical devices for outside startups.

Cardiovascular stents that were made for startups that later were acquired by companies like Edwards Medical and, you know, also, you know, catheter products in the world of urology and I came back and I told my father, I said, Dad, you know, we got to do something to help grandpa like it's not, you know, he's lived 93 years old.

He's a dignified guy. He took his himself from nothing and  literally nothing, you know, when he arrived in America and he built a beautiful family with dignity, how can we help him? And so, you know, everybody went with him to his appointments with the urologist, with the GP. And basically the answer was there's nothing to do.

Yeah. He's got a bunch of comorbidities. He's not so mobile. He's certainly not so young  and, you know, because of the other medications he's taking, he's not a candidate for X, Y, or Z drugs. And so, um, you know, stock up on diapers. And that was not an acceptable answer to me. I came back to my team at work and I said, I don't know what we're going to do, but I need a solution for, you know, people like my grandfather.

And over the course of. You know, kind of taking a textile factory that knows how to make tights and understands anatomy, you know, as well as Lululemon, you know, kind of Lululemon understands anatomy because we understand anatomy.  And, you know, let's take that. Let's figure out how we can help people like my grandfather.

And we were blessed and discovered this thing called percutaneous tibial nerve stimulation, which is a great treatment out there. It's not so accessible. It's hard to get to. A lot of providers don't want to give it because it takes a lot of time and real estate. Uh, from staff and their office, basically you go into the office once a week for 30 minutes and that's a lot for, for offices.

And so basically what I said is, Hey, can we do that for patients at home? Because we know how to put, you know, call it that whole, uh, infrastructure into a sock. And, you know, we said, yeah, is there a regulatory path to do that? Yes, there is. Can we do a clinical trial for that? Yes, we can. Was it successful?

Yes, it was. Are we a bunch of scrappy people from the textile industry inventing a medical device? Yes, we are. But kind of our, our fundamental of who we are as a business, unlike, you know, I know that you've interviewed. Um, kind of the laundry list of people in the neuromodulation space and the difference between us and them is that, you know, our 100 percent focus is helping patients and understanding patients are devices super simple because, you know, I've got parents, I've got grandparents, and I know how complicated things can get for them and taking something that's really complicated and making it really simple.

Is kind of the, the miracle of Zyta. Now, if you can put on your sock in the morning and open up your car, using your key fob, then you are, you are able to use the Zyta control sock. And I'm not one to get up. I'm not a medical device sales guy. I'm not the CEO of, uh, you know, a multinational company. Our device is just as good as everybody else.

You can go get an implant. If your insurer wants to pay for that. Um, it'll do the same thing as using our soft. You want a fancy thing that has an app. There's a product, you know, there's a company out there that's got that for you, but our product is simple and it's inexpensive because, you know, we come from, we make the product, you know, kind of vertically integrated.

I am there to say, Hey, let's not make this something that's going to be expensive for the patients. It's an expensive product. Let's not be, you know, let's not. Let me not dilute anybody, but that's how I got to this product. That's, I think what kind of differentiates us and why I am so passionate about helping people, you know, in the course of running our clinical trials, particularly in, you know, women were so affected.

I would say one of the things about overactive bladder is nobody's ever died of overactive bladder. Let's, you know, it's not cancer. But 

I think one of the things that's so important in your story is, you know, you use the word dignify so many times and, and I think overactive bladder does rob you of your dignity, right?

I mean, it's so embarrassing for, you know, mature, uh, established people to have, have this problem. And so the fact that you have, you know, the face of your product is someone that you,  Respect and you're looking to restore dignity. I, you know, I think that's such a, an amazing thing. And it, it also highlights that this is a big problem for men and women, right?

I mean, women are more affected, but it is definitely a big problem for men as well.  

For sure. Yeah. And yeah, kind of in the world of partners. You know, I know when I get out of bed, I'm a young guy. I get out of bed at night because I'm thirsty because whatever it is, it bothers my wife's sleep. When I get out of bed, when, you know, a husband gets out of bed five times, six times a night to go to the bathroom because they've got nocturia,  you know, it's not just impacting them.

It's impacting their spouse. And the same is true. You know, if a woman's getting out of bed five, six times a night, her husband's, you know, body of sleep, their relationship is impacted. The impacts of overactive bladder are not but medical death is,  you know, the death of a lifestyle. I can't, you know, I met a woman who was  literally suicidal over the fact that her, her, her overactive bladder had is preventing her grandkids from coming to visit her because they say that she smells. 

That breaks my heart. Like, I can't. I can't, you know, express how, how, you know, how we have to help, you know, everybody out of this situation.  And unfortunately, as you know, you and a lot of people know, the solutions that are out there today aren't good, you know, the medicines that are available, they're not particularly great.

And everybody out there will tell you, I have the golden ticket. And there is no golden ticket, unfortunately. I believe that there, you know, there is a combination solution that Zyta can really help to provide because we're not, because we're honest. Yeah, we're not going to tell you, Oh, just put this sock on and you'll be cured.

Take X drug, Y drug, Neuropetric or whatever it is, Gemtessa, and your, your, your OEP symptoms will be go away. Let's talk about the, you know, what is called the clinical success rate to be, you know, for success for a drug or device to say, this works, it's a 50 percent reduction in symptoms. So that's already setting patients up for, you know, kind of expectations of failure because have you met the patient that says, Oh, I have four incontinent episodes a day and you brought me down to two.

So that's a success. No, nobody, that's not what people want. They want not to be incontinent at all. Are there ways to get there? Yeah, absolutely. Neuromodulation is an excellent tool. The Zydecontrol sock is a wonderful tool, but yeah, there's also behavioral lifestyle, lifestyle changes that you need to do.

Maybe you also need to do your pelvic floor therapy, right? 

Yeah. No, it usually is multifactorial.  So in your randomized control trial, how successful was it? 

Sure. So, I mean, we had an 80 percent success rate, um, which is, you know, I would say, Just as successful as everything out there on the market.

Everybody's kind of in that same spectrum. Now it's, it's more effective for incontinence and urge. Yeah. When you look at frequency, nobody wants to get to zero, right? Time's going to go in the bathroom a day. So yeah, the, the improvement there is typically about 30%. And that's where  the success threshold is there.

I can say. You know, we did not have this in our study, but when I talk to patients, the most impactful thing for them is nocturia. Nocturia, you know, getting up at night, going to the bathroom is something that, you know, really makes people's lives hard. They're tired in the morning. It disturbs their spouses or partners sleep.

And being able to get up and, uh, you know, go to the bath, you know, if they were getting up six times a night to get up twice a night,  that's an incredible benefit to them. And that's really, you know, aside from called the improvement in urgent improvement of incontinence.  That's really where. People get excited when I speak with them. 

It is a huge problem, right? And it affects your days as well, because being tired just impacts so many health conditions, right? And just the way that you feel. How often do you have to wear it?  

Sure. So our device is designed to be used once a week, uh, for, for 12 weeks as kind of that initial course of therapy.

Then patients typically go into maintenance therapy. It's something that maintenance means for the rest of your life, but it's half an hour a week. You can do it while watching the news at night. You can do it while sitting on the couch, having a cup of coffee. It's, you know, like I said, as easy as sitting in wearing a sock.

It doesn't require any attention. Turns off after that half hour, you know, you can keep wearing that sock till, uh, till you're ready to take it off, but it's easy to do. It's something that fits into a, you know, everybody's lifestyle. And that was something that was really important to us.  

Does it, is there a dose effect?

If you did it more frequently, would it be more efficacious? 

So I would say that the FDA would not allow me to comment on that statement, but you're a medical provider, and I'm sure that you could comment on that, uh, within, uh, your experience. 

You know, I mean, one of the reasons that we always did PTNS once a week was because, you know, people have to come into the office, right?

That is really difficult. And so you do wonder if you use it more frequently, if it would make it better. Can, can patients feel it? I mean, when it's stimulating that nerve, what do they feel?  

Sure. So, I mean, I, I think that the, you know, what patients can feel is a range of things, kind of a, of, you know, we have patients that don't feel anything and call it a sensory perception is not called a marker of clinical success.

But, you know, kind of a funny story is when we were setting up training, the, the primary investigator for our clinical trial, like the first patient that came in was this lady. She sat down. She told her how to use the sock. We're training the physician and this team and she says, I don't feel anything and call it in the lab.

I'm 40 something today. At the time, maybe I was 35. You know, we had all tried it on. You know, if we just turned, you know, turned up the device a little bit. Yeah, we felt it. And this lady was like, I don't feel anything. And we're like, maybe it's broken. I don't know what. So I did kind of, uh, but the very basic, uh, you know, electron electrical engineering mistake of licking both of my fingers and putting them near the electrodes and I got the zap of a lifetime, but he was sitting there saying, I don't feel any.

So there are, you know, as, as a practitioner, you know, that there are sensory perception and physiological responses. And we do see those, whether that's, uh, the curling of toes, whether that's people saying that. They're getting involuntary motion of, of their toes, uh, heel flexing, uh, or sorry, arch flexing.

And so those are definitely kind of the, the typical things, the guidance that we give to people is, you know, turn up the device. Until you feel it and then turn it down below that sensory threshold. I can't say that everybody does that. Some people seem to be masochists and like to cause themselves pain.

And yeah, there's, there's a placebo benefit to that. 

We always think more is better, right? 

Yeah. I mean, and I think that gets to one of the things that really is better about our stock. So. How did I get to this world of embedded electronics in, in textiles  back, call it 15 years ago. I don't know whether you remember all the men were running around wearing halters. 

You know, like there was this company polar and then all the men were out running with their polar halters, checking their, you know, checking their pulse and, you know, aspiration rates, whatever it is, and, you know, women couldn't wear that product, right. Because they were wearing a sports bra. So Adidas came to us and wanted to make a sports bra with, uh, you know, called it an embedded altar in the bra.

And so we got, we helped them make that product. And so effectively our product is able to deliver. 40 percent more stimulation to the body than anything else on the market. And that's because of our understanding both of anatomy, but also our understanding of how to deliver more electricity, electricity safely, because when you have to monitor signal signals in the body, well, the less conductive the material you have, the more artifacts and the more.

call it garbage that's going into that signal that makes it harder to to read. So we got really good, you know, to be the world's experts on reading signals from the body. And so we were able to use that to deliver a whopping amount of electricity safely into the body, which is, which is amazing, particularly because, like I said, there are patients who don't feel anything.

And when you look at our device, Call it the innovation of our devices that it's elastic, right? When you go into a shoe store or you go into the department store to pick up a pair of socks, you know, you know, what size sock to buy you. There's not like a question in your mind. Oh, am I medium, large, small, whatever it is, extra large.

You just pick up the socks and you know, 90 percent of the time they fit. And if they don't fit, it's probably because they were mismanufactured rather than the sizing is, uh, Is, is actually wrong. And so what we know is, you know, how to find the tibial nerve across a population size group, because when we had to make products for Victoria's Secret for a little loan for Nike, that was critical, you know, the product had to fit everybody.

And so that knowledge and understanding of how elasticity works across body shapes and sizes means that when we, you know, ran a study to check, well, how well does this fit across, different body shapes and sizes, 90 some odd, 96 percent of patients, it fit. And the people that didn't fit were people who had lymphedema and diabetic, you know, swelling of limbs, all sorts of  crazy or extreme medical conditions.

But your average person, it fits pretty well. Are there sizes?  

Yes. Small, medium, large, extra large.  

And you would just get whatever you get for a sock or do you have to be fitted for it? 

You do not have to be fitted for it. This is something that, you know, if you, if you know your shoe size, this will fit you and it will work for you.

And then that's, what's amazing, like making it so simple as buying a pair of socks, kind of in that description, like I go out with my wife, right? If I need to buy my wife socks, it's really easy, right? But if I have to go buy my wife abroad, that's a nightmare. 

That's 

like a multi day affair.  

Is it over the counter or is it prescription only?

So I think that that's a really important question. I think that the concept and like we've been discussing about overactive bladder, it's not something that over the counter is right. Overactive bladder is a condition that if you've got it, you're probably going to suffer from it from the rest of your life.

Why? Because the mileage on your bladder and your body is just going up. Being in contact with your doctor is critical to your longterm success.  And we don't see ourselves as caught the golden ticket. We believe that if you use this device. And we can work with you, our team of continence experts to get you forward.

We can get you results that other people can't, not because our device is better than anybody else. Take, take our pills, take, you know, take this pill. Take everybody's going to give you plus minus that same kind of result. Our caring team, our caring education, and  we'll help you get to better results. And those results will last you longer because we understand you.

We understand patients. We care about you. We've got a listening ear. 

Does that mean if you were to go ahead and get the Zyta control sock that there's coaching involved with it? Tell me what you're talking about.  Okay. Yeah, 

absolutely. Yeah. One of the, call it as a doctor and you are a caring doctor, right?

But most urologists, most urogynecologists, to be honest, don't want to deal with overactive bladder patients. The average overactive bladder patient is like, Oh, I hope he doesn't ask for something because when a doctor prescribes a pharmaceutical,  the average person comes back and says, it didn't work for me, or I had a, uh, a side effect. 

And the doctor doesn't want that.  The doctor, you know, most urologists, most urogynecologists have got bigger fish to fry. They like cancer. They like kidney stones. They like, 

yeah. I mean, there's always so many lifestyle factors that go in to overactive bladder, right? So there is a lot of education and coaching and, and handholding because it is such a miserable journey for so many people.

Yeah. I mean, I'll give you, you know,  every one of our patients is a intelligent, smart  person. But I can, yeah, I can't tell you. We started our clinical trial. One morning I get a get a call from the practice that was running the trial. They said, Oh my gosh, this lady called. She said that her symptoms have been so improved.

But this, you know, as of last night, Everything's gone wacky. She's gone running to the bathroom all the time. You know, she's, she's worried that the devices is, you know, causing her harm. I said, that that's interesting. Can we get the doctor on the phone? Let's talk about what could be the issues here. You know, what could be the issues and doctors like, does she know, did she check whether she has a UTI?

Yeah, I, that would have been my first guess, right? That there's something else going on. 

So, you know, again, you know, the practice got back to the secretary, whatever the, the administrator handling the clinical trial got on to it. Phone to this lady. It was during Covid, so getting her A-A-U-T-I test was a little bit more complicated, but guess what?

She had a UTI. And you know, it's not that this lady didn't know about U uti. I, she's probably had a dozen UTIs in her life. But that handholding is critical because if you are a patient and you're like, oh my gosh, this medicine, this device. Maybe causing any harm. What do you do? You stop using it. But if there's somebody to say, Hey, did you check whether you have a UTI?

Yeah. 

Yeah. They're back on track with them, you know, what, three, four days. And they're back to where they were. 

Well, and it's, it's so important to put it in the context of your overall health, right? Because I mean, it's not like these patients just have overactive bladder. There are so many other things that can be going on and new medications.

And yeah, it is often multifactorial. How expensive is it? Yeah.  

So, you know, I think that the thing that's important to start with is that the device is covered by Medicare thus far. Private insurers are coming on board. We do very well with Blue Crosses, Humana's, other providers we're working with, um, trying to get coverage.

I think that 1 of the challenge with coverage for neuromodulation  in general. is that in order to be eligible for what today is a third line therapy, you have to have failed behavioral modification and two classes of drugs for three months. That's, that's the general rule. There are exceptions to that, but most people in the market today haven't failed two drugs.

Call it most patients in the world haven't failed two drugs. And that that's a real challenge because how do you fail two drugs, particularly when the two classes of drugs that specifically Medicare wants you to try. Are associated with dementia. Do you really want to taking their drugs? I've talked to physicians that have said, I've literally walked into, I've had patients who I've walked into a, you know, managed care facility who are suffering from dementia and I've taken them off of their OEB drugs because why is this person on OEB drugs when they're wearing a diaper and all of a sudden they're back to being coherent and living back at home.

So, you know, You know, a lot of people don't want to take that. So what we are working with and what we're trying to make available is an option to try out the device for the least amount of money that we can as a trial. You know, rent a device, it's 549 to try it for those three months. If it works for you, great.

If it doesn't, there's an 80 percent success rate with this, with this product. So 20 percent of people aren't going to have success. Don't, you know, don't keep paying us. We want people to experience. We want people to get the benefit. In many cases, like I said, there is insurance coverage, but, you know, the broad swath of  the sufferers of overactive bladder won't qualify for insurance coverage because they haven't failed all the things that insurers today want you to.

That's really important, particularly when you look at, uh, both the American Urological Association, the AUA,  and AUGS, the American  Urogynecological Society, which have both said to, call it, practitioners, stop following this step, you know, step therapy protocol that we had previously recommended because it's not going to work.

It's probably not right. 

Yeah, 

for most patients,  unfortunately, insurers and particularly Medicare haven't caught up with. 

I mean, it's really true the side effects and the complications from medicines, especially as you get older. I mean, it can create a lot of havoc on the system right and having a treatment that is local.

Right. And just, you know, impacting, you know, that nerve or directly impacting the bladder is just so much easier for most people, right? I mean, you're not getting constipation, dry eyes, dry mouth. There's no risk of memory loss, right? Which is so very important. So you said you rent it. Can you buy it as well?

Or is it always renting? So, 

I mean, we do, we do offer to buy it. It is an expensive purchase. The MSRP, I believe on the price is 3600, which is like 2000 less almost than our competitors, but it's still an expensive device. And my goal, my goal as a human being is to make this as accessible as economically possible for patients because.

I care about patients. You know, we are a business. We, we can't not make money, but we, we have to do it in the most, in the most accessible way possible. And that's, you know, that's why we came up with that rental model, which I is designed to, to, to give access to that vast majority of people who don't qualify for insurance coverage.

Yeah. Um, if you bought it, how long does it last?  

Excellent. So, you know people who buy this, so, you know, they're, they're buying called a a three year package. A three year package includes.  But the device and all the socks that you need in order to get through your treatment protocol, we typically recommend that people replace their socks.

After every 12 treatments, so call it after that first round of 12 treatments, you need a second sock, depending on how often you use the maintenance therapy, you know, in consultation with your doctor, whether that's weekly, whether it's by monthly or monthly, that'll determine how often you have to replace the sock if you've purchased the device, you know, but socks are on us.

Okay. So once you put the sock on, what do you do? How do you turn it on? 

So, you know, the Zydecontrol device is made to be extremely simple. We have videos and illustrations on our website, but the device itself has three buttons. It's like an old radio. If you know how to, there's a power button, you turn on the device.

It immediately gives you a little bit of information using a single LED light saying I'm good. I'm working a green light turns on after that. It'll flash battery status. I'm full, I'm on half empty, or I'm not going to work because battery's dead.  You put on the sock and then you attach the device. It's uses magnetic snaps, which is, which is really important because you just get the device close to the snaps. 

They're, um, unidirectional. You can't mess it up. It won't snap on because one side is the magnet on each, and then when it's attached to your sock, uh, to, to your foot,  you turn up on the plus button, the power, you know, you add some power, if you depress the button, it, uh, ramps up the, the output faster. And you know, when you feel it, you turn it down one level.

It's that simple. If you don't, if you don't feel anything, you hold down the power button for five seconds, set max power, and you sit there for half an hour. Um, we typically recommend that people view  the, you know, the weekly information that we send. We do send guidance and we send training about behavioral, uh, options that can help people.

And we, we recommend that people do that during the. during that half hour while they're doing their weekly treatment.  

So, I mean, this is a pretty amazing product. I think anything that women and men can do at home for overactive bladder. I mean, I think that's what people really want, especially for the maintenance piece, right?

Since this is such a chronic condition, what's next for you?  

Sure. So, you know, I think that one of the things that we are looking to do is to try and work with providers and universities to come up with what the ultimate combination therapy is, because my goal is to get people to 100 percent symptom improvement.

That's what everybody wants.  Unfortunately, I'm the only one who's kind of talking about that. I want to work with. A university, a professor, a doctor to say, Hey,  you know, what works best for women? Is that a combination of Jim Tessa and does that a control sock? Is that, you know, for men, Mirabetric and, you know, there's a control sock,  you know, is that Botox and, you know, let's, let's work this out.

Maybe it depends on whether you're obese, not obese. Maybe it depends on, uh, ethnic groups. 

Yeah,  it's an interesting question. And you're right. All of the research is about a 50 percent improvement and nobody ever wanted to be 50 percent better. Right? And if you're 50 percent better, the incontinence that you have  are left with becomes, you know, even more irritating than what you had at the beginning.

Right? I think the closer you get to 100 percent if the remaining symptoms are just so frustrating for patients. And it's funny how sometimes we just kind of accept the status quo, and it takes someone who's, you know, not, not in the industry, so to speak, to come along and say, Hey, this doesn't make any sense.

Why aren't you guys? Working for a hundred percent.  

That that is our, that is our next goal is to collect that data, to work with, um, professionals to come up with, with the right tool, with the right, uh, treatment is for, for each different type of person because they're, you know, we live in, in a world of personalized medicine today.

Uh,  

I love that goal. I love having, uh, the goal of being a hundred percent dry. And I, I think , you know, that's what most people want. You're definitely right. Well, thank you so much for your time today. I, I really, um, appreciate everything that you're doing and, you know, pushing all of this work further. 

Thank you so much. I appreciate it. 

Thanks for 

the opportunity.