Sonal Pendharkar Kulkarni, Co-founder & CSO at Uvisa Health

In this episode, we’re joined by Sonal Pendharkar Kulkarni, Ph.D., Co-founder and Chief Science Officer at Uvisa Health. With a background that bridges women’s health, the microbiome, digital health innovation, and medical device development, Sonal is at the forefront of creating smarter, science-driven solutions for vaginal health management.

Sonal shares her journey from research scientist to entrepreneur, the insights that shaped Uvisa Health’s mission, and the importance of designing products that truly respond to women’s real needs. We explore her multidisciplinary approach—combining clinical research, product design, and technology—to rethink how women’s health challenges are understood and addressed.

Transcript

Julio Martinez-Clark (00:01.385)
Welcome back to another episode of the Global Trial Accelerators Podcast. Today, my guest is Sonal Pendarkar Kulkarni, PhD. She is a medical scientist turned entrepreneur focused on women's health, microbiome science, digital health, and medical devices with a particular emphasis on vaginal health management and product design.

She's also the co-founder and chief scientific officer of Uvisa Health, a Copenhagen-based medtech startup developing a drug-free vaginal light therapy device to treat common intimate health issues. So now, thank you for joining the show today. I'm really, really excited about our conversation.

Sonal Pendharkar Kulkarni (00:48.622)
Thank you, Julio, for inviting me. It's a pleasure to be on your show, on your podcast, and having this conversation today.

Julio Martinez-Clark (00:55.26)
Excellent, excellent. So let's get started with your personal professional journey. How is it that you got to where you are? I'm sure there's a fascinating personal story. You coming from India, right? And Copenhagen.

Sonal Pendharkar Kulkarni (01:08.366)
Yes, yes. There is an interesting story of a girl coming from India. I grew up in a small city called Pillai. It's more known for the steel plant in central India. And ever since I was in my high school days when I started studying biology, I had sense of genuine interest in biology. I'm also a singer, and I was pursuing that equally in yes, and more to Indian classical singing during those days.

Julio Martinez-Clark (01:32.723)
Wow, really?

Julio Martinez-Clark (01:38.079)
Fascinating.

Sonal Pendharkar Kulkarni (01:39.042)
But I ended up then choosing biology and life sciences to actually go into enter the university education. And with the idea and thought that I would become a research scholar because I wanted to become a scientist. That was one of the dreams apart from being a performer. So I decided to pursue that dream of becoming the scientist and probably doing something meaningful. At that time, that was the only idea behind what I wanted to do, something meaningful.

And that brought me to Stockholm, to Karelinska Institute, where I did my PhD and doctoral research within the space of vaginal microbiome. And those five years, I was studying vaginal microbiome, the dynamics, how very highly recurrent cases, women experiencing these vaginal dysplastic conditions several times a year for several years, how they respond to different treatment interventions.

and also looking into how probiotics improve the results of the treatment. So that was what gave me the entry in women's health space, and I learned a lot about vaginal microbiome and its impact on overall well-being of a woman. And while doing the thesis and writing the thesis, going through several references, literature published around the world, I realized that there was a gap, and the gap was that

We at that time as well knew quite a lot about vaginal microbiome. It wasn't defined in categories like as it is today, but there was no service actually available, no test or product available for women in real world that would help them manage their vaginal health better. So that was what ignited this passion in me that I do want to pursue work within women's health space.

And that sort of that created the path moving forward from that time. And this is like 10 years ago. And of course, life changes. Life throws you different situations. So I went through with that, moving to Switzerland to join my husband over the next eight years. And that was from 2014 and onwards until 2020. So that was a time when I actually worked on how I could contribute.

Julio Martinez-Clark (03:47.975)
Mm-hmm.

Sonal Pendharkar Kulkarni (04:03.51)
and how I could up my skills within the space of clinical trials, regulatory within Europe. And five years back, I came to Copenhagen with the idea that the startup network and culture is so strong that it would give me a good chance on working on this solution. And during that process, I met my partner who was also the founder at that time.

Julio Martinez-Clark (04:27.218)
Mm.

Sonal Pendharkar Kulkarni (04:33.11)
of very newly registered company called URESA Health, and who was also looking for someone to work with, but coming from science and vaginal microbiome space. And so that instantly clicked between us, and we identified that we have the complementary skills to form a strong team and actually build this idea into a real product that women can use to tackle their vaginal health.

Julio Martinez-Clark (04:43.005)
Sure.

Sonal Pendharkar Kulkarni (05:02.602)
So that is, in short, my journey, how I ended up with UISA and my partner Ella Harris here. And since then, we have been building UISA.

Julio Martinez-Clark (05:06.375)
Yeah.

Julio Martinez-Clark (05:12.816)
Okay, excellent.

Yeah, you guys are building the world's first drug-free vaginal light therapy device aimed at conditions like recurrent infections and intimate discomfort that are poorly served by current options. We're gonna talk about that later, but let's talk about trends. So now, what do you see happening in your space, in the industry in general, in clinical trials, in...

Sonal Pendharkar Kulkarni (05:23.008)
Yes.

Sonal Pendharkar Kulkarni (05:33.923)
Yes.

Julio Martinez-Clark (05:40.343)
in investment of startups. So what can you tell us about that, please?

Sonal Pendharkar Kulkarni (05:47.79)
So I mean, clinical trials and the trends, of course, they have been changing with times. We can see now more home-based trials, decentralized trials happening a lot. And we are actually now relying on data a lot, including more women say or patients say in the trial design, how we can improve their overall experience with the product itself, but also

participation in the clinical trials. So that's something I have noticed personally that has changed and has improved a lot. It's the new focus, think, including women and their demands or their situation into consideration.

Julio Martinez-Clark (06:34.748)
Okay. What can you tell us about funding, getting funding for companies like yours? Is the funding sentiment getting better, worse, the same? What do you see coming up in 2026? Because 2025 was challenging, right?

Sonal Pendharkar Kulkarni (06:40.183)
Yes.

Sonal Pendharkar Kulkarni (06:50.654)
Yes, 20-25 is challenging. for not all women's health companies, but especially those who are within medical devices or hardware sector, they have a longer route. And if that hardware is a medical device, you have the regulatory process ahead of you when you start. And so getting funding is also difficult.

It helps or it helped us as well in our journey to find those very specific angel investors who are on board because of us, our skills, the idea and the vision. And that helped us grow to the stage that we are in today. But moving from here and looking for VC landscape, it is difficult. It's a difficult time to also fundraise today. There is lot of genuine interest.

Julio Martinez-Clark (07:41.105)
Yeah.

Sonal Pendharkar Kulkarni (07:43.574)
also from VCs, but the longer return on investment or longer market entry is definitely a hurdle that makes them uncomfortable taking that risk. Yeah.

Julio Martinez-Clark (07:53.744)
Yes, yes, I hear that they are investing in later stage companies. They are asking for more proof, more traction before they invest.

Sonal Pendharkar Kulkarni (07:58.484)
Exactly. Exactly. Exactly. Speaking of traction, you can show that traction, if you can show that interaction with your consumers, if they are on board, that gives them that additional confidence. And then they see that they can be on board investing in the company. Yeah. Yeah.

Julio Martinez-Clark (08:18.47)
Yeah, yeah. Before they were investing in the preclinical stage, they are investing now after they see clinical data, I human data, that's what I hear.

Sonal Pendharkar Kulkarni (08:28.746)
Absolutely. Human data and tied with how quickly can you enter the market. Yes. And we see,

Julio Martinez-Clark (08:36.374)
Yes. no, no, go ahead, go ahead, please.

Sonal Pendharkar Kulkarni (08:42.446)
There are big investments also happening within this space, but then you can see that they are happening more in deep tech. So lot of platform technologies are being invested in.

Julio Martinez-Clark (08:55.938)
Okay, okay. And your investors are mostly local in your area or you're also getting investors from overseas from the United States or elsewhere in the world?

Sonal Pendharkar Kulkarni (09:07.544)
So currently, the investors we have on board, are local from Denmark, and who are very strategic investors, very active, coming from medical device industry or medical health space, women's health space. But now, as we are fundraising for the seed round, we are going global. So we have nice and good interactions with investors from all across. Some are based in Europe. Some are based in the US and other parts of the world.

Julio Martinez-Clark (09:36.215)
Okay, are you doing the direct approach or are you using a third party like an investment bank or some sort of direct approach?

Sonal Pendharkar Kulkarni (09:42.092)
Now we're doing the direct approach. So we have been lucky, receiving a lot of good response when we go to the events, go to the conferences. So last year, we really focused on that, also building connections throughout the last three years. And that is now resulting into these direct conversations. Or at least we have been able to get that introductory call from most of the investors. And that is when we can convert their interest.

into taking the next more deeper conversation.

Julio Martinez-Clark (10:15.469)
Excellent, excellent. All right. So let's talk about what exciting.

projects or the technology that you guys are developing. So the broader thesis from what I understand is that women's intimate health is under engineered, under researched and is still stigmatized and that targeted light plus microbeam informed design can offer safer at home scalable solutions. So let's talk about your technology about where you guys are going with this.

Sonal Pendharkar Kulkarni (10:34.275)
Yes.

Sonal Pendharkar Kulkarni (10:49.19)
Yes. So what we are tackling in HAYULU is vaginal dyspiasis. And we are starting this journey, addressing the two conditions which are most commonly known and experienced, bacterial vaginosis, which is the disbalance in bacteria in the microbiome, and yeast infection, also medically known as vulvavaginal candidiasis. And these are...

very commonly experienced by all women, almost every woman in the world, experience it at least once in their lifetimes. And the more we research and look into published data, also looking into our own survey and data, now we can see that 11 % of all of these women, they experience it three or more times a year. So these are the chronic sufferers. And 11 % of all women worldwide is a huge population.

Not only that it brings discomfort and impacts their daily life, when these conditions are untreated or mistreated, or when they have had repeat antimicrobial treatments, they start to develop resistance against medications. And not only antibiotics, but also antifungals. We are seeing that in other disease conditions, parasitic infections as well. So overall, antimicrobial resistance is becoming a huge problem.

And not only patients, clinicians, they are also desperate to find solutions. So what we are doing at Uvisa Health is we are bringing this very known technology, the antimicrobial property of light, into a device. We packing that in the device that can be inserted in the vagina. And in a controlled 30-minute treatment time, it delivers the treatment. So we are using different wavelengths.

tested them clinically, pre-clinically, and we have good confidence in our product.

Julio Martinez-Clark (12:52.327)
Very good. Alright, so let's talk about your clinical plans. Are you planning to do a first in human anytime soon or are you still in the pre-clinical stage? What can you tell us about your clinical plans in general?

Sonal Pendharkar Kulkarni (13:02.702)
Yes. So for now, we have wrapped up our pre-clinical research because we had sufficient data, sufficient enough that the ethics committee and medicines agency found it safe to be tested in human trial. So we are actually conducting our first in human studies, and we see good progress and good indications in the study. Yeah.

Julio Martinez-Clark (13:29.601)
Where are you doing your first human?

Sonal Pendharkar Kulkarni (13:31.758)
We're doing it here in Denmark, in Odense. So it's a local single center study that we are doing. And we are close to finishing it soon.

Julio Martinez-Clark (13:43.083)
Okay, and I infer that you didn't have much of a challenge getting the trial approved because of the safety data that you had in the preclinical testing, right?

Sonal Pendharkar Kulkarni (13:54.376)
Yes, yes, yes, yes, yes. We got approval in record time as expected. We had confidence, but of course, it was the first time. It's the first kind of a trial, first kind of a treatment and product. So we had to have that buffer time or buffer thoughts, actually. And when it went through, it went through in record time. So that really boosted our confidence that

Julio Martinez-Clark (14:09.163)
Yeah.

Sonal Pendharkar Kulkarni (14:23.17)
what we have done so far, that is actually in the right direction. And that's a testament in itself. Yeah.

Julio Martinez-Clark (14:29.502)
Excellent. So what's the next step after that first inhuman ends?

Sonal Pendharkar Kulkarni (14:35.958)
So the next steps, typically we would be, mean, a company should judge whether this first trial is sufficient or not, how we have designed it. So based on that, we'll do an assessment. What makes sense? Do we need more studies? Of course, authorities would be also in assessing the study and trial once we reach them for the first assessment. And so we will wait and see if more studies are required or that

is a sufficient evidence as we have today or when we finish the study. So if all goes well, we could possibly speed up our regulatory process and get ahead. Otherwise, doing a follow-up study and testing more conditions and treatment conditions, treatment regime, and so on, is this a possibility, like in any drug trial? Yeah. Yeah.

Julio Martinez-Clark (15:30.392)
So, are you planning to get approval in the European Union first before you go to the United States or what's your commercial plan for approval?

Sonal Pendharkar Kulkarni (15:42.03)
So currently we are focusing in Europe, because we are based here. It's a market we understand we can immediately launch and we can test this kind of a very new product. Scandinavia has been known to be a very good test market. So it always helps in testing something very new. People are more open to using new products. So we plan to launch here once we have...

Julio Martinez-Clark (15:51.543)
Yes, that's true.

Julio Martinez-Clark (16:04.811)
Yes.

Yes.

Sonal Pendharkar Kulkarni (16:10.914)
been through the regulatory approval process. That's the focus. Of course, we are assessing how and when we can enter the US market. It's also very attractive. Investors love to see it. So we are assessing what are our chances and our ways of entering the US market. Yeah.

Julio Martinez-Clark (16:22.112)
Yes.

Julio Martinez-Clark (16:28.181)
Yes, yes, yeah, yeah, it's challenging to enter the US market from what I've seen from other clients. I think it's really key that you get a local person to help you, yeah, who understands the market and everything and can lead the...

Sonal Pendharkar Kulkarni (16:32.371)
Exactly. Exactly. Exactly.

Sonal Pendharkar Kulkarni (16:40.832)
Absolutely. Yeah, yeah, exactly. Of course, doing the clinical, because the current study is based in Denmark, we're also aware that entering the US market would require the US-based study, or at least having a good representation of US population. So it is going to be longer, but of course,

Julio Martinez-Clark (17:02.793)
Yes.

Sonal Pendharkar Kulkarni (17:07.874)
people do expand and so we're also assessing how we can expand to enter the US market.

Julio Martinez-Clark (17:14.083)
Excellent. So let's talk about potential acquirers, strategic acquirers for the company against you're looking for an exit, right, down the road.

Sonal Pendharkar Kulkarni (17:24.974)
We don't know. I think we have been very open to different routes. When we started building UISA, the vision was to actually serve women. So the long-term vision is to be in the market. But of course, if an opportunity comes in as for exit, then we were also open to it. But that is not one way that we are planning for. So we still keep our options open.

Julio Martinez-Clark (17:43.638)
tour.

Julio Martinez-Clark (17:47.67)
Yes, yeah.

Sonal Pendharkar Kulkarni (17:55.042)
Yeah. Yeah.

Julio Martinez-Clark (17:55.446)
Sure. No, happens is that it takes different skills to develop a product and bring it to regulatory approval than the skills required to commercialize.

Sonal Pendharkar Kulkarni (18:03.136)
Yes. Yes. Yes.

Julio Martinez-Clark (18:10.377)
the product, as I'm sure you know. And that's why usually companies like yours are looking for an exit, meaning that that exit is gonna bring the product to a larger company like Medtronic, Bustle Scientific, J &J, because they have the distribution network and the mechanism to get into hospitals and to really make an impact, because the impact that a small company can make is usually small.

Sonal Pendharkar Kulkarni (18:10.422)
Yes, absolutely.

Sonal Pendharkar Kulkarni (18:22.184)
Yes. Yes. Yes.

Sonal Pendharkar Kulkarni (18:28.384)
Exactly, Yes.

Sonal Pendharkar Kulkarni (18:38.186)
Exactly, and very rightly said, Yulu, this has been our experience as well. But of course, for a device like ours, which is very new in the market, it is application of technology in a very new way. Getting the regulatory approval remains still as a milestone that we need to achieve before we would be at a stage where someone would take us, acquire us. So we still have that journey to take.

Julio Martinez-Clark (18:58.602)
Yeah.

Julio Martinez-Clark (19:04.522)
Yeah.

Sonal Pendharkar Kulkarni (19:07.254)
succeed in before we probably have a good exit offers.

Julio Martinez-Clark (19:12.49)
Yeah, and the other issue that we haven't discussed that is also important is reimbursement. Is there reimbursement for this type of technologies, especially being so innovative? What can you say about that?

Sonal Pendharkar Kulkarni (19:17.016)
Yes.

Sonal Pendharkar Kulkarni (19:24.33)
Yes, so reimbursement models, they are course difficult to establish to begin with. But once you have a product which is approved, where you have clinical data to support its effectiveness, it can be launched or in our case, we plan to launch it direct to consumer because then we can directly relate with our consumers who are women, who are desperately looking for new solutions that works.

And that's in the pharmacies, right? So once the product is out in the market, you start to collect data. The data that helps in filling the gap for your health economics, how that would look like. And once you have built up that data on health economic, you have that piece ready is when the reimbursement model, the route becomes easier. It becomes easier to get the insurance companies.

Looking at the trend, especially now, more than ever before, we're seeing more of these women's health products or services, health management services being reimbursed or being brought into those plants because infertility has been a big challenge and it is a growing challenge worldwide. And all of these conditions that sort of contribute

directly or indirectly towards fertility issues. They are of very high interest for generally in general the population. Women's health products otherwise as well. All those solutions looking into menstrual blood or looking into data that can actually answer those unanswered questions on endometriosis or PCOS or these conditions which have not been studied so much before.

they are gaining lot of traction. So any solution coming with a very effective plan, effective product, I think is gaining interest going the reimbursement road. Of course, that will also depend on which market we are talking about. In some markets, it's easier. In some markets, it's more difficult. But there is definitely more increase in traction in that way.

Julio Martinez-Clark (21:21.173)
Mm.

Julio Martinez-Clark (21:39.071)
Where?

Julio Martinez-Clark (21:42.855)
Of course.

Julio Martinez-Clark (21:49.21)
Okay, so it just occurred to me, now that you mentioned markets, where do you see in the world that the problem that you guys are trying to solve in women's health is more prevalent? Latin America, Europe, Africa, where? Or is it a general female problem, regardless of the country?

Sonal Pendharkar Kulkarni (21:54.434)
Yes.

Sonal Pendharkar Kulkarni (21:59.34)
Yes.

Sonal Pendharkar Kulkarni (22:07.883)
Yes.

It is prevalent all over. But of course, we have difference in prevalence. If we have to look at the countries or even the regions, continents, which have highest prevalence, then that's African countries. South Africa has been having highest prevalence of vaginal dyspiasis conditions, especially bacterial vaginosis. We see comparable prevalence rates.

Julio Martinez-Clark (22:16.721)
I love it.

Julio Martinez-Clark (22:36.723)
Hmm.

Sonal Pendharkar Kulkarni (22:40.93)
within Southeast Asia, Latin America. And we see more prevalence also in certain population groups. So there is also genetics playing some role in it because that has an impact and influence on what are the microbes colonizing women. So we see these differences, but of course we start from one market. We build the product image.

Julio Martinez-Clark (22:52.379)
Interesting, okay.

Sonal Pendharkar Kulkarni (23:10.882)
We build a brand and that will help us gain more traction, more investment that in turn would allow us to actually serve in the lower and middle income countries.

Julio Martinez-Clark (23:20.372)
Sure, I think it's important to also mention that some companies have started looking at Latin America as a launching pad before they get into the US market. For example, they get EU approval, C-Market approval, which is gonna be your case, and you can immediately start selling in Latin America. You can get record,

Sonal Pendharkar Kulkarni (23:40.982)
Yes. Yes.

Julio Martinez-Clark (23:49.556)
timelines in countries like Colombia, like Chile, Mexico, where you can get your approval, your market approval really, really fast because you already have a CE mark approval and that will give you traction in these local markets where the prevalence of the disease may be higher while you, and you also get revenue while you work on your US strategy. So that's something to consider.

Sonal Pendharkar Kulkarni (24:02.184)
Mm-hmm. Yes.

Sonal Pendharkar Kulkarni (24:10.504)
Yes. Yes.

Sonal Pendharkar Kulkarni (24:17.406)
Right, Absolutely, absolutely. And that's part of our different phased plan on how and which markets can we enter, maximizing the EU MDR approval. Yes. Yes.

Julio Martinez-Clark (24:30.981)
Exactly. Yeah. All right. So now we are close to the end of the show. Any final words of wisdom that you want to share with newer entrepreneurs or new founders who are starting their journey like you have already started and are about to complete?

Sonal Pendharkar Kulkarni (24:50.368)
I think what I would personally advise based on my experience is self-doubt. Stay away from that. When you have an idea, give it your full shot, full chance. Reach out to as many people. See how they are working. Look for whom you can work with, spar with. And just try. Just make it. And it's OK to fail. Fail faster. Learn faster.

Yes.

Julio Martinez-Clark (25:21.722)
Before we conclude, Sonal, I'm just curious about the ecosystem, the medical device innovation ecosystem in Denmark. How active is it?

Sonal Pendharkar Kulkarni (25:23.683)
Yeah.

Yes, yes.

Sonal Pendharkar Kulkarni (25:32.21)
It is actually very active. There are a lot of world leading medical device companies as well in Denmark. And then we are seeing many small startups, mid-size companies, startups moving into mid-size stage in medical devices sector. So we are seeing good interest and good traction in them. And if you also have the element of AI and diagnostics, that also really

is a positive add-on to the medical device. So in general, we have a very active medical device space within Denmark. Fundraising is a different story.

Julio Martinez-Clark (26:11.45)
Excellent. Yes, yeah, yeah. But that helps. least there is an understanding of medical innovation in Denmark, which is difficult in some countries that do not have that medical innovation mindset yet. Yeah.

Sonal Pendharkar Kulkarni (26:17.236)
Yes. Yes. Yes.

Yes. Yeah. Yeah. Yeah. Yeah.

Julio Martinez-Clark (26:25.852)
So of course raising funds for a medical device company in San Francisco will be a lot easier than raising funds for a medical device company in Santiago, Chile. Because nobody knows in Santiago, Chile about medical innovation. And investors are more accustomed to apps and technology companies rather than women health companies.

Sonal Pendharkar Kulkarni (26:32.01)
Absolutely. Absolutely.

Julio Martinez-Clark (26:46.95)
All right, so now thank you so much for being the show. I really enjoy our conversation. I hope this episode inspires new founders and potential investors for your company.

Sonal Pendharkar Kulkarni (26:57.944)
Thank you so much for having me. It was nice speaking with you, Julio.

Julio Martinez-Clark (27:02.349)
Excellent!