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Q&A: Using sound science to advance women’s healthcare needs

What makes FemaSeed different and truly revolutionary, is that it directs the sperm right to the fallopian tube on the side that the patient is ovulating.

Palestinian baby Sabreen al-Ruh al-Sheikh, delivered preterm by caesarian section minutes before her mother died of injuries after an Israeli strike, receives care at the Emirati hospital in Rafah, southern Gaza
Palestinian baby Sabreen al-Ruh al-Sheikh, delivered preterm by caesarian section minutes before her mother died of injuries after an Israeli strike, receives care at the Emirati hospital in Rafah, southern Gaza - Copyright AFP MARCO BERTORELLO
Palestinian baby Sabreen al-Ruh al-Sheikh, delivered preterm by caesarian section minutes before her mother died of injuries after an Israeli strike, receives care at the Emirati hospital in Rafah, southern Gaza - Copyright AFP MARCO BERTORELLO

In the medical field women have many significant unmet healthcare needs, often as the result of drug development containing gender biases. Seeking to address this is Kathy Lee-Sepsick, Founder, President, and CEO of Femasys, a biomedical company with a broad portfolio of in-office, accessible, and cost-effective therapeutic and diagnostic products.

Digital Journal caught up with Kathy Lee-Sepsick to discover more about her company’s work and objectives.

Digital Journal: What does Femasys do and why did you launch the company 20 years ago?

Kathy Lee-Sepsick: Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products.

I founded Femasys 20 years ago to make a difference in women’s health as I deemed the options available to me to be suboptimal. I believed I could advance solutions to replace antiquated options for basic healthcare needs, like permanent birth control, and expand and improve options so women could have more choices. As the lead inventor of all of Femasys’ technologies, only those products that could potentially become standard of care were advanced through our rigorous development process.

DJ: Can you discuss the infertility landscape and what makes FemaSeed different?

Lee-Sepsick: Infertility has become a significant global problem with a considerable physical, psychological, and social impact. There are several socioeconomic factors, reproductive choices, and trends impacting the fertility landscape. We’ve seen a decline in the nation’s birth rate, as women are giving birth to fewer and fewer children. Delayed childbearing, a prominent trend in recent decades, has given rise to both a decline in fertility rates and a decline in birth rates. The state of childlessness and efforts to restore fertility often cause substantial financial, emotional, and social stress on couples. With more and more women and men seeking pregnancy later in life and male sperm counts sharply declining (over 50% decline around the world), help in the form of fertility treatment is becoming a growing need.

FemaSeed is an FDA-cleared innovative infertility treatment designed to deliver sperm to the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a first-line treatment option for those seeking pregnancy. What makes FemaSeed different and truly revolutionary, is that it directs the sperm right to the fallopian tube on the side that the patient is ovulating, which significantly reduces the distance the sperm must travel. When compared to other reproductive technologies such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), it’s a highly cost-effective and affordable procedure. FemaSeed is very safe and well-tolerated by patients and is a great option for women looking to avoid invasive procedures required for both IVF and ICSI (egg retrieval and injections).

DJ: Can you discuss the permanent birth control landscape? What makes FemBloc different and what are the next steps for the product candidate?

Lee-Sepsick: There are a number of factors that we see impacting the permanent birth control landscape. Women’s health is an overlooked and notoriously underfunded sector in the biomedical industry. This has led to a significant global unmet need for new contraceptive options for women desperately seeking alternatives, particularly that are permanent, due to side effects, medical concerns, and the inconvenience of available options. A clear need exists for innovative new methods without the use of hormones, implants, unwanted side effects, or surgery.

Our lead product candidate, FemBloc, is a permanent birth control in late-stage clinical development. FemBloc is an office-based approach that eliminates surgical risks and does not utilize implants, hormones, or anesthesia. Femasys is conducting a multi-center pivotal trial and believes FemBloc will be revolutionary for women seeking a non-surgical method for permanent contraception that is accessible, cost-effective, and substantially less risky than the surgical alternative. The Company is working to make this much-needed option available to women worldwide.

DJ: Embryos, IVF, abortion rights, and the President Biden’s executive order calling for $200 million in research for women’s health have all been in the news in the last few months. What are your thoughts on everything that is happening in the legislative space?

Lee-Sepsick: There is a lot of controversy over women’s health issues in the legislative space. However, the executive order, prioritizing women’s health across various federal agencies, as well as the legislative discussions have brought long-standing issues surrounding women’s health, including the lack of funding and innovation, to the forefront. This is an unprecedented time and the opportunity to be awarded funding for our late-stage technological advancements to support quicker access for women to much needed options are highly welcomed.

Femasys’ products are designed to be lower cost, safer, and more accessible options in the categories that we are advancing. With limitations on abortion rights, FemBloc is intended to aid in reducing the risk of unintended pregnancy to avoid the contemplation of an abortion. With controversy over embryos and IVF, FemaSeed is intended to be a first-line treatment, avoiding the creation of embryos, circumventing the issues as well as the exorbitant cost.

DJ: You recently met with seven members of the US Congress. What interested them most about Femasys and what are your key takeaways from those meetings?

Lee-Sepsick: Femasys met with an overwhelming positive sentiment to our mission to bring a broad portfolio of revolutionary products to women that are safe, cost-effective, and accessible. Specifically, our FemBloc and FemaSeed products were discussed and the urgency to bring these approaches to women to alleviate the lack of innovation and the uncertainty in the marketplace was expressed. We are excited to continue discussions as we explore how Femasys’ initiatives align with those in congress and the administration.

DJ: What is next for Femasys?

Lee-Sepsick: Femasys has committed to commercialize our infertility portfolio and advance our pivotal trial for FemBloc. We plan on continuing to expand our product portfolio and fully support our presence in the U.S. market and then globally, as we work to bring breakthrough technologies to improve the lives of women around the world. Femasys intends to be a major player in women’s health by providing revolutionary product solutions in areas that have seen limited to no innovation for many decades.

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Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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