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Femasys Founder Discusses Femaseed Technology Designed to Support Infertility


In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, offers a description of how Femaseed works to support women who struggle with infertility.

PE: The FDA first gave clearance to Femaseed last September. For our audience, can you briefly explain how this technology works, and any enhancements that you see being made to it as time goes on?

Lee-Sepsick: Femaseed was purposely designed to enhance the normal transport of sperm that's required in order for conception to occur. We place sperm directly into the fallopian tube that is the site of fertilization. Our technology purposely positions balloon technology at the opening of the tube, so it's a much safer way to deliver it to the tube. The goal is to enhance something that's naturally going to occur, so we eliminate the production of embryos or retrieval of eggs. None of that occurs with our technology. It's simply placement of the sperm directly in the fallopian tube. As far as enhancements, we've been developing this product for some time, and we have thoughtfully enhanced it along the development process.

We feel it's very important to deliver the entire specimen, so we redesigned the product during the development process to allow for filling of the device by the tip of the catheter, so that we would allow for almost all of the specimen to be delivered to the patient. In other technologies, that’s not the case. It gets filled and then you lose sample within the constructs of the catheter. We wanted to ensure that everything goes where it's supposed to be delivered as intended.

PE: Can you identify some of the main areas of unmet need within the reproductive health space and how current research efforts are working to fill those gaps?

Lee-Sepsick: When I founded the company, I did not want us to be a single product company. So, we've taken initiatives and we've looked at those major areas of gaps, one of which is permanent birth control. We see a lot of developments and innovations along the way, as far as temporary birth control or reversible, but at the end, when women have to make a choice, or families have to make a choice of so what they're going to do to control that risk, it’s often for a very long period of time. Most women only want a certain number of children. We felt permanent birth control was a really strong focal point, and where we've seen such a lack of innovation. That’s one of the reasons we've advanced a product called Femblock to address that need. On the other end of the spectrum, we saw great need in infertility. We've come a long way over the last few decades, but where I've seen a lot of the attention is innovation around the most expensive end of infertility care, which is in vitro fertilization. Most women can’t afford or don't want to emotionally go through what's required with IVF treatment. We felt there was a huge gap in infertility treatment on the front end that could be accessible and affordable for patients alike. We also see cancer detection tools that are very lacking from a diagnostic standpoint. So we chose to also advance technology there as well.

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