WEBVTT - Advancing Medical Technology for Women

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<v Speaker 1>Bloomberg Audio Studios, Podcasts, radio news.

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<v Speaker 2>This is Bloomberg Business Week with Carol Messer and Tim

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<v Speaker 2>Steneveek on Bloomberg Radio. Well, according to the CDC, about

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<v Speaker 2>one in five married women in their child bearing years

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<v Speaker 2>experience infertality. That's defined as being unable to conceive after

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<v Speaker 2>one year of frost.

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<v Speaker 3>A lot, it's a lot of the time. I hear

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<v Speaker 3>that from statistic is substantial.

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<v Speaker 2>Yeah, A host of things can lead to infertility. Often

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<v Speaker 2>people who are looking to get pregnant consider IVF as

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<v Speaker 2>a way to conceive. But before going the route of

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<v Speaker 2>IVF or other assisted at reproductive technologies, some people consider

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<v Speaker 2>intra uterine insemination, also known as IUI and sometimes called

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<v Speaker 2>artificial insemination. It's less expensive and less invasive than IVF,

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<v Speaker 2>but the success race rate is not so great.

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<v Speaker 3>All right, Enter Femesist, a publicly traded biomedical company working

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<v Speaker 3>on a more effective method of IUI. Femsist, by the way,

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<v Speaker 3>a micro camp with a market cap of about thirty

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<v Speaker 3>six million dollars. Kathy Lee Sepsik is founder, president and

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<v Speaker 3>CEO of Femesists and joining us from AE. We work

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<v Speaker 3>in California. We like to say it because it's just

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<v Speaker 3>kind of interesting. We've been talking about rework a little

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<v Speaker 3>bit in our world. Kathy, great to have you here

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<v Speaker 3>with us, just you know again, tell us a little

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<v Speaker 3>bit more about your company. It is a very small

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<v Speaker 3>micro cap company. Tell us little bit more about all

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<v Speaker 3>the work you guys are up to.

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<v Speaker 1>So, femicist mission from day one has been to advance

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<v Speaker 1>medical technologies for specifically for women, and we've looked at

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<v Speaker 1>those underserved areas where there just has been a dearth

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<v Speaker 1>of innovation and we've been battling this and bringing things

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<v Speaker 1>forward for about twenty years now.

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<v Speaker 2>So late last month, Femsist announced data from a trial

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<v Speaker 2>that showed how effective your method of IUI is. We're

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<v Speaker 2>talking about fema seed. Tell us what exactly femaseed is

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<v Speaker 2>and how it's, in your opinion, revolutionizing, revolutionizing the way

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<v Speaker 2>IUI is done.

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<v Speaker 1>So, femasy was designed to augment what naturally occurs for fertilization.

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<v Speaker 1>So the travel that sperm needs to make, the journey

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<v Speaker 1>is to get to the egg, and the egg is

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<v Speaker 1>located in the Floppian tube. So for femasy, what we

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<v Speaker 1>do is we place sperm aliquatted into the Filoppian tube,

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<v Speaker 1>and we design this product so that every reproductive endocrinologist,

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<v Speaker 1>even their mid level practitioners or ABE guides at large,

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<v Speaker 1>could perform it. And that's the premise of the product

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<v Speaker 1>is to look at the front end of care where

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<v Speaker 1>we're not requiring egg extraction or multiple injections, but we're

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<v Speaker 1>able to augment that fertilization process and to bring hope

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<v Speaker 1>to women.

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<v Speaker 2>Is it an actual medical device or is it a

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<v Speaker 2>procedure a process.

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<v Speaker 1>It's a medical device that allows for the artificial insemination procedure.

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<v Speaker 2>And what's the data that you have at this point?

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<v Speaker 2>As I mentioned this trial last month, the data that

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<v Speaker 2>you have at this point that shows that at least

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<v Speaker 2>in your trials, it is more effective when it comes

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<v Speaker 2>to conception than traditional IUI.

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<v Speaker 1>So we looked at actually a pretty challenging segment to

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<v Speaker 1>establish efficacy. We looked at low male sperm count and so,

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<v Speaker 1>as I mentioned, the journey, the natural biological processes for

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<v Speaker 1>sperm to enter into the fallopian tube. So when you

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<v Speaker 1>have less sperm to work with, which unfortunately is a

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<v Speaker 1>worldwide dilemma. It's been established at less than fifty percent

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<v Speaker 1>sperm counts exist in all male age categories around the world.

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<v Speaker 1>This is a problem that's going to continue, and so

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<v Speaker 1>we looked at that particular segment and we were able

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<v Speaker 1>to establish that twenty four percent of women that fell

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<v Speaker 1>into that category where there wasn't actually a known fertility

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<v Speaker 1>factor for her, it was the male factor that was contributing,

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<v Speaker 1>and we showed that, you know, twenty four percent of

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<v Speaker 1>women actually were able to benefit from the procedure and

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<v Speaker 1>get pregnant.

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<v Speaker 3>So, Kathy, is this something that you think could replace IVF?

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<v Speaker 3>Essentially give me some more information in terms of you

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<v Speaker 3>know who who you guys would be targeting with this,

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<v Speaker 3>or is this kind of a first round, first step

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<v Speaker 3>before maybe somebody considered IVF.

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<v Speaker 1>So we definitely see it as a first step in

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<v Speaker 1>the process. There are certain categories of women that are

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<v Speaker 1>definitely appropriate for IVF. She has a genetic disorder, she

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<v Speaker 1>clearly should have her eggs screened. But for the majority,

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<v Speaker 1>we feel like this is an ideal option for people

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<v Speaker 1>because it's cost effective, it's convenient, and we'll be able

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<v Speaker 1>to be at that front end when those are major

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<v Speaker 1>issues that people are contending with.

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<v Speaker 3>What does it cost? What would it cost for someone

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<v Speaker 3>to do this?

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<v Speaker 1>So it'll be incremental to just a standard EUIs we're

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<v Speaker 1>talking in a few thousands as supposed to a couple

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<v Speaker 1>thousand as opposed to thirty thousand for an IBF on average.

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<v Speaker 2>That's pretty standard for IUI though, right Yeah, it's pretty standard.

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<v Speaker 1>So the only difference will be the cost of the device.

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<v Speaker 1>The overall procedure costs are as they are.

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<v Speaker 2>I talk to us a little bit, yeah, talk to

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<v Speaker 2>us a little bit about the regulatory process right now,

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<v Speaker 2>because when you're talking medical devices here, I mean now,

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<v Speaker 2>this is a long road when it comes to the past.

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<v Speaker 4>It's been twenty years for me, so it's been pretty long.

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<v Speaker 1>But for FEMASED, we were actually able to work with

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<v Speaker 1>the FDA and get the device approved or cleared technically

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<v Speaker 1>back at the end of September of last year.

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<v Speaker 4>That was a bit of a road that we traveled

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<v Speaker 4>with them.

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<v Speaker 1>It also is why we have all of this data

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<v Speaker 1>where we were able to run a prospective study and

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<v Speaker 1>have data available upon a commercial launch. So we are

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<v Speaker 1>making this product available to women and couples right now,

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<v Speaker 1>and we're amassing support, as you mentioned, on a small

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<v Speaker 1>microcap company. So we're taking our dollars and pennies and

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<v Speaker 1>allocating it to this commercial effort so that we're not

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<v Speaker 1>just building these amazing products and designing them so thoughtfully

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<v Speaker 1>that we're actually going to get them in the hands

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<v Speaker 1>of practitioners so they can attend to their patients need.

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<v Speaker 3>Hey, Katy, I want to go back to and I

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<v Speaker 3>know you and Tim touched on this earlier, but I'm

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<v Speaker 3>thinking about people who are watching or listening right now

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<v Speaker 3>who may be interested in trying to figure out kind

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<v Speaker 3>of their own course forward, if you will, How is

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<v Speaker 3>what you guys, specifically, how is it different from other

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<v Speaker 3>IUI methods.

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<v Speaker 1>It is entirely different because other IUI methods deposit the

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<v Speaker 1>sperm into the uterine cavity, which is a very hostile environment,

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<v Speaker 1>lots of white blood cells that attack the sperm. We

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<v Speaker 1>actually deliver the sperm directly into the Filippian tube, which

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<v Speaker 1>is the ultimate location that the.

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<v Speaker 4>Sperm needs to arrive to in order to create conception

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<v Speaker 4>and pregnancy. So that's how we.

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<v Speaker 3>Work, Okay, So it's a different location ultimately where the

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<v Speaker 3>sperm get deposited, if you will. Having said that, I

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<v Speaker 3>know when you guys put out this press release and

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<v Speaker 3>talking about twenty four percent of women pregnant after using FEMASD,

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<v Speaker 3>No new safety concerns are reported. What are the safety

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<v Speaker 3>concerns though, that do get reported most when doing it?

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<v Speaker 1>Most for and we're inter uterine because we deliver into

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<v Speaker 1>the uterine cavity. As far as where the device is placed,

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<v Speaker 1>what makes us very different is where the sperm actually

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<v Speaker 1>is delivered to. So the common possible side effects are

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<v Speaker 1>a little bit of cramping, a little bit of spotting.

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<v Speaker 1>Because the device is actually delivered into the uterine, it's

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<v Speaker 1>more invasive.

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<v Speaker 3>If you will right, you're going in deeper.

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<v Speaker 1>Essentially, it's definitely minimally invasive. We go to the exact

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<v Speaker 1>same location. We just have a catheter that directs the

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<v Speaker 1>sperm to the tube. So we put a balloon technology

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<v Speaker 1>like a balloon cather like a fully catheters that people

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<v Speaker 1>are aware of. We just put that balloon in a

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<v Speaker 1>very specific location within the uterine cavity that allows the

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<v Speaker 1>sperm to travel from the device into the tube.

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<v Speaker 2>If delivering the sperm to this location is so much

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<v Speaker 2>more effective, then why is why has it taken so

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<v Speaker 2>long to develop a way to do this? So if

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<v Speaker 2>this is the effective way to do it, So there.

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<v Speaker 1>Was one other product that was actually approved in nineteen

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<v Speaker 1>eighty nine, excuse me, nineteen ninety eight, and that product

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<v Speaker 1>required that the tube, which is about the size of spaghetti,

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<v Speaker 1>that a wire be placed into that tube and then

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<v Speaker 1>a cathere to follow. So it's a much more technically

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<v Speaker 1>difficult procedure, and it has inherent safety risks because you

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<v Speaker 1>could damage.

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<v Speaker 4>The filopian tube. No one thought to do it. So

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<v Speaker 4>that's what all of my ip is around.

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<v Speaker 1>You know, sometimes the simplest of things are definitely the

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<v Speaker 1>most valuable. But all of my technologies revolve around putting

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<v Speaker 1>this type of balloon technology within the unine cavity, right

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<v Speaker 1>outside the fallopian tube.

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<v Speaker 3>Hey real quickly, just got a minute left. The political firestorm,

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<v Speaker 3>if you will, around fertility treatments. What are your concerns

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<v Speaker 3>about how this product might get caught up in that,

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<v Speaker 3>certainly when it comes to certain states or municipalities, if

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<v Speaker 3>you will.

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<v Speaker 4>So we kind of come outside of the storm that's happening.

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<v Speaker 1>Around IVF so far so far, but we don't do

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<v Speaker 1>any egg extraction and we have no embryo maintenance. We

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<v Speaker 1>are augmenting the natural process. So this is true a

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<v Speaker 1>frontline therapy where someone can engage in this before all

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<v Speaker 1>of the other requirements of an IBF. All right, So

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<v Speaker 1>we're outside of that storm, but it certainly affects the practitioners,

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<v Speaker 1>all right.

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<v Speaker 3>And the patient saved you twenty seconds. When does this

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<v Speaker 3>come to market real quickly?

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<v Speaker 4>It's coming to market right now, all right.

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<v Speaker 3>So you've gotten all the approvals and you guys can

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<v Speaker 3>move ahead.

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<v Speaker 4>We can move ahead now. We're just hiring the appropriate people.

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<v Speaker 1>And you know, obviously we're a publicly traded company, so

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<v Speaker 1>people can follow the progress. But we're trying it very

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<v Speaker 1>hard to get this available to women right now, all right.

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<v Speaker 3>Couldn't leave it on that note, Hey, Kathy, thank you

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<v Speaker 3>so much. Kathy Lee Sepsik, founder, president, and chief executive

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<v Speaker 3>officer of Femicist. As she said, it is publicly held.

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<v Speaker 3>It is a small microcap company, if you will, and

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<v Speaker 3>the stock right now is actually up about seventy eight percent.