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This is Bloomberg Business Week with Carol Messer and Tim Steneveek on Bloomberg Radio. Well, according to the CDC, about one in five married women in their child bearing years experience infertality. That's defined as being unable to conceive after one year of frost.
A lot, it's a lot of the time. I hear that from statistic is substantial.
Yeah, A host of things can lead to infertility. Often people who are looking to get pregnant consider IVF as a way to conceive. But before going the route of IVF or other assisted at reproductive technologies, some people consider intra uterine insemination, also known as IUI and sometimes called artificial insemination. It's less expensive and less invasive than IVF, but the success race rate is not so great.
All right, Enter Femesist, a publicly traded biomedical company working on a more effective method of IUI. Femsist, by the way, a micro camp with a market cap of about thirty six million dollars. Kathy Lee Sepsik is founder, president and CEO of Femesists and joining us from AE. We work in California. We like to say it because it's just kind of interesting. We've been talking about rework a little bit in our world. Kathy, great to have you here with us, just you know again, tell us a little
bit more about your company. It is a very small micro cap company. Tell us little bit more about all the work you guys are up to.
So, femicist mission from day one has been to advance medical technologies for specifically for women, and we've looked at those underserved areas where there just has been a dearth of innovation and we've been battling this and bringing things forward for about twenty years now.
So late last month, Femsist announced data from a trial that showed how effective your method of IUI is. We're talking about fema seed. Tell us what exactly femaseed is and how it's, in your opinion, revolutionizing, revolutionizing the way IUI is done.
So, femasy was designed to augment what naturally occurs for fertilization. So the travel that sperm needs to make, the journey is to get to the egg, and the egg is located in the Floppian tube. So for femasy, what we do is we place sperm aliquatted into the Filoppian tube, and we design this product so that every reproductive endocrinologist, even their mid level practitioners or ABE guides at large,
could perform it. And that's the premise of the product is to look at the front end of care where we're not requiring egg extraction or multiple injections, but we're able to augment that fertilization process and to bring hope to women.
Is it an actual medical device or is it a procedure a process.
It's a medical device that allows for the artificial insemination procedure.
And what's the data that you have at this point? As I mentioned this trial last month, the data that you have at this point that shows that at least in your trials, it is more effective when it comes to conception than traditional IUI.
So we looked at actually a pretty challenging segment to establish efficacy. We looked at low male sperm count and so, as I mentioned, the journey, the natural biological processes for sperm to enter into the fallopian tube. So when you have less sperm to work with, which unfortunately is a worldwide dilemma. It's been established at less than fifty percent sperm counts exist in all male age categories around the world.
This is a problem that's going to continue, and so we looked at that particular segment and we were able to establish that twenty four percent of women that fell into that category where there wasn't actually a known fertility factor for her, it was the male factor that was contributing, and we showed that, you know, twenty four percent of women actually were able to benefit from the procedure and get pregnant.
So, Kathy, is this something that you think could replace IVF? Essentially give me some more information in terms of you know who who you guys would be targeting with this, or is this kind of a first round, first step before maybe somebody considered IVF.
So we definitely see it as a first step in the process. There are certain categories of women that are definitely appropriate for IVF. She has a genetic disorder, she clearly should have her eggs screened. But for the majority, we feel like this is an ideal option for people because it's cost effective, it's convenient, and we'll be able to be at that front end when those are major issues that people are contending with.
What does it cost? What would it cost for someone to do this?
So it'll be incremental to just a standard EUIs we're talking in a few thousands as supposed to a couple thousand as opposed to thirty thousand for an IBF on average.
That's pretty standard for IUI though, right Yeah, it's pretty standard.
So the only difference will be the cost of the device. The overall procedure costs are as they are.
I talk to us a little bit, yeah, talk to us a little bit about the regulatory process right now, because when you're talking medical devices here, I mean now, this is a long road when it comes to the past.
It's been twenty years for me, so it's been pretty long.
But for FEMASED, we were actually able to work with the FDA and get the device approved or cleared technically back at the end of September of last year.
That was a bit of a road that we traveled with them.
It also is why we have all of this data where we were able to run a prospective study and have data available upon a commercial launch. So we are making this product available to women and couples right now, and we're amassing support, as you mentioned, on a small
microcap company. So we're taking our dollars and pennies and allocating it to this commercial effort so that we're not just building these amazing products and designing them so thoughtfully that we're actually going to get them in the hands of practitioners so they can attend to their patients need.
Hey, Katy, I want to go back to and I know you and Tim touched on this earlier, but I'm thinking about people who are watching or listening right now who may be interested in trying to figure out kind of their own course forward, if you will, How is what you guys, specifically, how is it different from other IUI methods.
It is entirely different because other IUI methods deposit the sperm into the uterine cavity, which is a very hostile environment, lots of white blood cells that attack the sperm. We actually deliver the sperm directly into the Filippian tube, which is the ultimate location that the.
Sperm needs to arrive to in order to create conception and pregnancy. So that's how we.
Work, Okay, So it's a different location ultimately where the sperm get deposited, if you will. Having said that, I know when you guys put out this press release and talking about twenty four percent of women pregnant after using FEMASD, No new safety concerns are reported. What are the safety concerns though, that do get reported most when doing it?
Most for and we're inter uterine because we deliver into the uterine cavity. As far as where the device is placed, what makes us very different is where the sperm actually is delivered to. So the common possible side effects are a little bit of cramping, a little bit of spotting. Because the device is actually delivered into the uterine, it's more invasive.
If you will right, you're going in deeper.
Essentially, it's definitely minimally invasive. We go to the exact same location. We just have a catheter that directs the sperm to the tube. So we put a balloon technology like a balloon cather like a fully catheters that people are aware of. We just put that balloon in a very specific location within the uterine cavity that allows the sperm to travel from the device into the tube.
If delivering the sperm to this location is so much more effective, then why is why has it taken so long to develop a way to do this? So if this is the effective way to do it, So there.
Was one other product that was actually approved in nineteen eighty nine, excuse me, nineteen ninety eight, and that product required that the tube, which is about the size of spaghetti, that a wire be placed into that tube and then a cathere to follow. So it's a much more technically difficult procedure, and it has inherent safety risks because you could damage.
The filopian tube. No one thought to do it. So that's what all of my ip is around.
You know, sometimes the simplest of things are definitely the most valuable. But all of my technologies revolve around putting this type of balloon technology within the unine cavity, right outside the fallopian tube.
Hey real quickly, just got a minute left. The political firestorm, if you will, around fertility treatments. What are your concerns about how this product might get caught up in that, certainly when it comes to certain states or municipalities, if you will.
So we kind of come outside of the storm that's happening.
Around IVF so far so far, but we don't do any egg extraction and we have no embryo maintenance. We are augmenting the natural process. So this is true a frontline therapy where someone can engage in this before all of the other requirements of an IBF. All right, So we're outside of that storm, but it certainly affects the practitioners, all right.
And the patient saved you twenty seconds. When does this come to market real quickly?
It's coming to market right now, all right.
So you've gotten all the approvals and you guys can move ahead.
We can move ahead now. We're just hiring the appropriate people.
And you know, obviously we're a publicly traded company, so people can follow the progress. But we're trying it very hard to get this available to women right now, all right.
Couldn't leave it on that note, Hey, Kathy, thank you so much. Kathy Lee Sepsik, founder, president, and chief executive officer of Femicist. As she said, it is publicly held. It is a small microcap company, if you will, and the stock right now is actually up about seventy eight percent.