Speaker 1: Bloomberg Audio Studios, Podcasts, radio news.
Speaker 2: This is Bloomberg Business Week with Carol Messer and Tim
Speaker 2: Steneveek on Bloomberg Radio. Well, according to the CDC, about
Speaker 2: one in five married women in their child bearing years
Speaker 2: experience infertality. That's defined as being unable to conceive after
Speaker 2: one year of frost.
Speaker 3: A lot, it's a lot of the time. I hear
Speaker 3: that from statistic is substantial.
Speaker 2: Yeah, A host of things can lead to infertility. Often
Speaker 2: people who are looking to get pregnant consider IVF as
Speaker 2: a way to conceive. But before going the route of
Speaker 2: IVF or other assisted at reproductive technologies, some people consider
Speaker 2: intra uterine insemination, also known as IUI and sometimes called
Speaker 2: artificial insemination. It's less expensive and less invasive than IVF,
Speaker 2: but the success race rate is not so great.
Speaker 3: All right, Enter Femesist, a publicly traded biomedical company working
Speaker 3: on a more effective method of IUI. Femsist, by the way,
Speaker 3: a micro camp with a market cap of about thirty
Speaker 3: six million dollars. Kathy Lee Sepsik is founder, president and
Speaker 3: CEO of Femesists and joining us from AE. We work
Speaker 3: in California. We like to say it because it's just
Speaker 3: kind of interesting. We've been talking about rework a little
Speaker 3: bit in our world. Kathy, great to have you here
Speaker 3: with us, just you know again, tell us a little
Speaker 3: bit more about your company. It is a very small
Speaker 3: micro cap company. Tell us little bit more about all
Speaker 3: the work you guys are up to.
Speaker 1: So, femicist mission from day one has been to advance
Speaker 1: medical technologies for specifically for women, and we've looked at
Speaker 1: those underserved areas where there just has been a dearth
Speaker 1: of innovation and we've been battling this and bringing things
Speaker 1: forward for about twenty years now.
Speaker 2: So late last month, Femsist announced data from a trial
Speaker 2: that showed how effective your method of IUI is. We're
Speaker 2: talking about fema seed. Tell us what exactly femaseed is
Speaker 2: and how it's, in your opinion, revolutionizing, revolutionizing the way
Speaker 2: IUI is done.
Speaker 1: So, femasy was designed to augment what naturally occurs for fertilization.
Speaker 1: So the travel that sperm needs to make, the journey
Speaker 1: is to get to the egg, and the egg is
Speaker 1: located in the Floppian tube. So for femasy, what we
Speaker 1: do is we place sperm aliquatted into the Filoppian tube,
Speaker 1: and we design this product so that every reproductive endocrinologist,
Speaker 1: even their mid level practitioners or ABE guides at large,
Speaker 1: could perform it. And that's the premise of the product
Speaker 1: is to look at the front end of care where
Speaker 1: we're not requiring egg extraction or multiple injections, but we're
Speaker 1: able to augment that fertilization process and to bring hope
Speaker 1: to women.
Speaker 2: Is it an actual medical device or is it a
Speaker 2: procedure a process.
Speaker 1: It's a medical device that allows for the artificial insemination procedure.
Speaker 2: And what's the data that you have at this point?
Speaker 2: As I mentioned this trial last month, the data that
Speaker 2: you have at this point that shows that at least
Speaker 2: in your trials, it is more effective when it comes
Speaker 2: to conception than traditional IUI.
Speaker 1: So we looked at actually a pretty challenging segment to
Speaker 1: establish efficacy. We looked at low male sperm count and so,
Speaker 1: as I mentioned, the journey, the natural biological processes for
Speaker 1: sperm to enter into the fallopian tube. So when you
Speaker 1: have less sperm to work with, which unfortunately is a
Speaker 1: worldwide dilemma. It's been established at less than fifty percent
Speaker 1: sperm counts exist in all male age categories around the world.
Speaker 1: This is a problem that's going to continue, and so
Speaker 1: we looked at that particular segment and we were able
Speaker 1: to establish that twenty four percent of women that fell
Speaker 1: into that category where there wasn't actually a known fertility
Speaker 1: factor for her, it was the male factor that was contributing,
Speaker 1: and we showed that, you know, twenty four percent of
Speaker 1: women actually were able to benefit from the procedure and
Speaker 1: get pregnant.
Speaker 3: So, Kathy, is this something that you think could replace IVF?
Speaker 3: Essentially give me some more information in terms of you
Speaker 3: know who who you guys would be targeting with this,
Speaker 3: or is this kind of a first round, first step
Speaker 3: before maybe somebody considered IVF.
Speaker 1: So we definitely see it as a first step in
Speaker 1: the process. There are certain categories of women that are
Speaker 1: definitely appropriate for IVF. She has a genetic disorder, she
Speaker 1: clearly should have her eggs screened. But for the majority,
Speaker 1: we feel like this is an ideal option for people
Speaker 1: because it's cost effective, it's convenient, and we'll be able
Speaker 1: to be at that front end when those are major
Speaker 1: issues that people are contending with.
Speaker 3: What does it cost? What would it cost for someone
Speaker 3: to do this?
Speaker 1: So it'll be incremental to just a standard EUIs we're
Speaker 1: talking in a few thousands as supposed to a couple
Speaker 1: thousand as opposed to thirty thousand for an IBF on average.
Speaker 2: That's pretty standard for IUI though, right Yeah, it's pretty standard.
Speaker 1: So the only difference will be the cost of the device.
Speaker 1: The overall procedure costs are as they are.
Speaker 2: I talk to us a little bit, yeah, talk to
Speaker 2: us a little bit about the regulatory process right now,
Speaker 2: because when you're talking medical devices here, I mean now,
Speaker 2: this is a long road when it comes to the past.
Speaker 4: It's been twenty years for me, so it's been pretty long.
Speaker 1: But for FEMASED, we were actually able to work with
Speaker 1: the FDA and get the device approved or cleared technically
Speaker 1: back at the end of September of last year.
Speaker 4: That was a bit of a road that we traveled
Speaker 4: with them.
Speaker 1: It also is why we have all of this data
Speaker 1: where we were able to run a prospective study and
Speaker 1: have data available upon a commercial launch. So we are
Speaker 1: making this product available to women and couples right now,
Speaker 1: and we're amassing support, as you mentioned, on a small
Speaker 1: microcap company. So we're taking our dollars and pennies and
Speaker 1: allocating it to this commercial effort so that we're not
Speaker 1: just building these amazing products and designing them so thoughtfully
Speaker 1: that we're actually going to get them in the hands
Speaker 1: of practitioners so they can attend to their patients need.
Speaker 3: Hey, Katy, I want to go back to and I
Speaker 3: know you and Tim touched on this earlier, but I'm
Speaker 3: thinking about people who are watching or listening right now
Speaker 3: who may be interested in trying to figure out kind
Speaker 3: of their own course forward, if you will, How is
Speaker 3: what you guys, specifically, how is it different from other
Speaker 3: IUI methods.
Speaker 1: It is entirely different because other IUI methods deposit the
Speaker 1: sperm into the uterine cavity, which is a very hostile environment,
Speaker 1: lots of white blood cells that attack the sperm. We
Speaker 1: actually deliver the sperm directly into the Filippian tube, which
Speaker 1: is the ultimate location that the.
Speaker 4: Sperm needs to arrive to in order to create conception
Speaker 4: and pregnancy. So that's how we.
Speaker 3: Work, Okay, So it's a different location ultimately where the
Speaker 3: sperm get deposited, if you will. Having said that, I
Speaker 3: know when you guys put out this press release and
Speaker 3: talking about twenty four percent of women pregnant after using FEMASD,
Speaker 3: No new safety concerns are reported. What are the safety
Speaker 3: concerns though, that do get reported most when doing it?
Speaker 1: Most for and we're inter uterine because we deliver into
Speaker 1: the uterine cavity. As far as where the device is placed,
Speaker 1: what makes us very different is where the sperm actually
Speaker 1: is delivered to. So the common possible side effects are
Speaker 1: a little bit of cramping, a little bit of spotting.
Speaker 1: Because the device is actually delivered into the uterine, it's
Speaker 1: more invasive.
Speaker 3: If you will right, you're going in deeper.
Speaker 1: Essentially, it's definitely minimally invasive. We go to the exact
Speaker 1: same location. We just have a catheter that directs the
Speaker 1: sperm to the tube. So we put a balloon technology
Speaker 1: like a balloon cather like a fully catheters that people
Speaker 1: are aware of. We just put that balloon in a
Speaker 1: very specific location within the uterine cavity that allows the
Speaker 1: sperm to travel from the device into the tube.
Speaker 2: If delivering the sperm to this location is so much
Speaker 2: more effective, then why is why has it taken so
Speaker 2: long to develop a way to do this? So if
Speaker 2: this is the effective way to do it, So there.
Speaker 1: Was one other product that was actually approved in nineteen
Speaker 1: eighty nine, excuse me, nineteen ninety eight, and that product
Speaker 1: required that the tube, which is about the size of spaghetti,
Speaker 1: that a wire be placed into that tube and then
Speaker 1: a cathere to follow. So it's a much more technically
Speaker 1: difficult procedure, and it has inherent safety risks because you
Speaker 1: could damage.
Speaker 4: The filopian tube. No one thought to do it. So
Speaker 4: that's what all of my ip is around.
Speaker 1: You know, sometimes the simplest of things are definitely the
Speaker 1: most valuable. But all of my technologies revolve around putting
Speaker 1: this type of balloon technology within the unine cavity, right
Speaker 1: outside the fallopian tube.
Speaker 3: Hey real quickly, just got a minute left. The political firestorm,
Speaker 3: if you will, around fertility treatments. What are your concerns
Speaker 3: about how this product might get caught up in that,
Speaker 3: certainly when it comes to certain states or municipalities, if
Speaker 3: you will.
Speaker 4: So we kind of come outside of the storm that's happening.
Speaker 1: Around IVF so far so far, but we don't do
Speaker 1: any egg extraction and we have no embryo maintenance. We
Speaker 1: are augmenting the natural process. So this is true a
Speaker 1: frontline therapy where someone can engage in this before all
Speaker 1: of the other requirements of an IBF. All right, So
Speaker 1: we're outside of that storm, but it certainly affects the practitioners,
Speaker 1: all right.
Speaker 3: And the patient saved you twenty seconds. When does this
Speaker 3: come to market real quickly?
Speaker 4: It's coming to market right now, all right.
Speaker 3: So you've gotten all the approvals and you guys can
Speaker 3: move ahead.
Speaker 4: We can move ahead now. We're just hiring the appropriate people.
Speaker 1: And you know, obviously we're a publicly traded company, so
Speaker 1: people can follow the progress. But we're trying it very
Speaker 1: hard to get this available to women right now, all right.
Speaker 3: Couldn't leave it on that note, Hey, Kathy, thank you
Speaker 3: so much. Kathy Lee Sepsik, founder, president, and chief executive
Speaker 3: officer of Femicist. As she said, it is publicly held.
Speaker 3: It is a small microcap company, if you will, and
Speaker 3: the stock right now is actually up about seventy eight percent.