PE: The FDA first approved Femaseed last September. Can you briefly explain to our viewers how the technology works and what improvements you think could be made in the future?
Lee Sepsick: Femaceed was specifically designed to enhance the normal transport of sperm needed for fertilization. We put the sperm directly into the fallopian tube where fertilization occurs. Our technology is a much safer way of delivering sperm to the fallopian tube because we intentionally place a balloon technology at the opening of the fallopian tube. The goal is to enhance what happens naturally. So there is no embryo generation or egg retrieval required. With our technology, none of that happens. We simply put the sperm directly into the fallopian tube. In terms of enhancement, we have been developing this product for a long time and have been carefully enhancing it along the development process.
We believe it is very important to deliver the entire specimen, which is why during the development process we redesigned our product to allow the device to be loaded at the tip of the catheter. This allows us to deliver nearly all of the specimen to the patient. With other technologies, this is not the case; once loaded, sample is lost within the structure of the catheter. We wanted to ensure that everything goes where it should be delivered as intended.
PE: Can you identify some of the major areas of unmet need in the field of reproductive medicine, and how are current research efforts working to fill those gaps?
Lee Sepsick: When I started the company, I didn’t want to be a single-product company. So we’ve taken the initiative to look at key areas where there are gaps. One of them is permanent contraception. We’ve seen a lot of development and innovation in temporary contraception, reversible contraception, but ultimately when women have to make a choice, or families have to make a choice about what to do to control that risk, that choice is often over a very long period of time. Most women only want a certain number of children. We felt that permanent contraception was a really important focus and an area that was lacking innovation. That’s one of the reasons we’ve been developing a product called Femblock to address that need. On the other hand, we saw that there was also a huge need in infertility. We’ve made a lot of progress over the past few decades, but the biggest focus has been innovation around IVF, which is the most expensive type of infertility treatment. Most women can’t afford the costs that IVF treatment requires or are not willing to do it mentally. We felt that there was a big gap in the early stages of infertility treatment that we could make accessible and affordable for patients. We also saw that from a diagnostic standpoint, there was a huge lack of cancer detection tools, so we chose to advance the technology here as well.
