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Femasys CEO Talks Results of the Femaseed Pivotal Trial and the History of Fembloc Birth Control


In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, discusses results of the Femaseed pivotal trial, Fembloc birth control, and how the outcome of the 2024 United States presidential election could impact women's health.

PE: Recently, during the Femaseed pivotal trial, it demonstrated that 24% of women became pregnant after Femaseed with severe male factor. Moving forward, what does this mean for the future of treating infertility, and do you expect this to improve as time goes on?

Lee-Sepsick: There was actually a landmark study that was published in 2022 that shows very concerning trends related to male sperm count. In fact, what the publication showed was that we have a decline of over 50% in male sperm count in all age categories in every country. It’s a worldwide issue and there is no therapeutic option available to improve sperm count. No one has been able to determine the exact cause. There are a number of suspected reasons. But with that being said, when you have less sperm, just by the nature of the numbers alone, it's really critical that there be technologies that help address that, which is exactly what we did with Femaseed, bringing sperm to where it needed to go.

In our clinical trial, we showed that 24% of women have a partner with a significant male sperm count issue. The results were that those 24% of women were able to achieve pregnancy. This is very significant, because the only other option for them is truly IVF, which, for many reasons, women or couples will never make it to that particular choice. IUI has already been determined not to be effective in low sperm count, so Femaseed is going to fill a very significant void that's a growing concern and a trend that we're seeing around the world.

PE: Can you briefly discuss the history of Fembloc and what it means for the safety of birth control?

Lee-Sepsick: I’m actually the inventor of Fembloc. I developed this product very purposely for something I would agree to undergo, or something I would recommend for my daughters to undergo. From a permanent birth control standpoint, there is only one option available to women around the world, and that's surgical tubal ligation. When we come to that point in our lives, whether we're had enough children in our 20s or in our 40s, or don't want to have any more children, the options are so limited. Fembloc was designed to be non-surgical. This means that there’s no anesthesia or incisions. We also developed this product so we would not leave anything behind, so there would be no implants or hormones.

The products works by delivering a proprietary biopolymer that we've created that stays in the patient for a short period of time, and ultimately, we leave her with her own tissue and growth. From a safety standpoint, it's her own tissue. We are not introducing anything long-term that's a foreign body, and that's really critical when we look at women's health. We created this product to ultimately be the safest choice that women can make when they don't want to have a risk of pregnancy any longer.

PE: With the upcoming presidential election, how do you see the potential outcome effecting women’s healthcare, particularly in areas such as reproductive rights?

Lee-Sepsick: I've never seen this much discussion and spotlighting of women's health issues and concerns for wherever anyone stands on the issue. I think most would agree that women deserve more options, and they need to be better. I don't think on either side there will be discordance around the fact that we need more options for women, and we need to support companies that are willing to undergo that task. It is a very difficult specialty to get funding. It's very difficult from a regulatory standpoint to advance technologies. The fact that it’s such a topic of conversation for a presidential election warms my heart from a feminist standpoint, because we've been for two decades trying to advance our technologies forward. I'm encouraged by looking at kind of what positive could come about, and hopefully the discussions will continue as women's voices are now being heard.

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