Women’s Reproductive Healthcare Options – A Growing Need
Women’s reproductive health has long been the under supported area of the healthcare system. Historically, optionality and resources to support women in their reproductive journeys have been overlooked as more and more women struggle to get the care they need and deserve.
According to the CDC, over 10 million women struggle with infertility in the U.S. Forty-three U.S. states have recorded their lowest fertility rate in the last three decades according to the Pew Charitable Trusts and the WHO estimates 60-80 million couples worldwide currently suffer from some form of infertility. In addition, many individuals are waiting until later to start relationships and some couples are delaying beginning their families. The result is that so many women are struggling to find solutions beyond expensive and invasive in vitro fertilization (IVF).
But the lack of quality options for reproductive care doesn’t end there. On the other side of the spectrum, more women are also looking for permanent birth control options these days, having already started their family or having no interest in children at all, with online searches and phone inquiries skyrocketing in recent years. The only permanent birth control option requires surgery and general anesthesia, which is both expensive and invasive. From one end of the reproductive journey to the other, women have struggled with options that are painful, leave permanent scars, cost outrageous amounts, and so much more.
Growing Legislative Attention
A large focus of our national psyche is currently on women’s health and specifically reproductive health. From the Supreme Court’s decision to allow emergency abortions in Idaho and upholding access to mifepristone to the recent two-year anniversary of Roe v. Wade being overturned to the Alabama ruling in IVF treatment that sparked outrage resulting in narrow protection for IVF providers, women’s healthcare is in the news as are differing viewpoints on the type of healthcare they can receive.
While politicians argue about what’s right and what’s wrong, it is our job to work tirelessly to make sure women have more options for their reproductive care. It is our goal to advance solutions that are safe, accessible, effective, and affordable for both ends of the reproductive care journey, whether a woman seeks to have a child or to prevent having one.
For too long, women have had the same lackluster options when it comes to both ends of the reproductive journey. The focus must be on innovation and funding for late-stage biomedical companies with solutions that make a serious impact on women’s reproductive health. Because time and time again, we are reminded that investing in women leads to outsized results throughout the community, as those women impact the lives of their friends, children, and colleagues.
Femasys – Filling a Void in Reproductive Healthcare
Like many women, I was worried about balancing my career goals with the desire to have a family. After having my two daughters, I considered permanent birth control but realized what was available carried much more risk than I was willing take for a basic healthcare need. I did not want to undergo general anesthesia and have incisions or have a coil as a permanent implant (which is no longer available for safety reasons). My frustration with the options available to me were that they carried too much risk.
This personal journey with reproductive health inspired me to focus my product and life science background on creating and developing better, safer, more efficient, and readily accessible women’s reproductive healthcare solutions to ensure that my daughters, as well as women everywhere, have more and improved options for their basic healthcare needs.
I am grateful every day for my daughters, ages seven and four at the time of founding Femasys in 2004, who have provided endless inspiration and sparked my interest in launching a biotech to make a difference in women’s health for the many generations to come. They have been my rock and foundation through the ups and downs of running the company. I am especially thankful that my work at Femasys stimulated them both to have careers in healthcare and to be motivated to make a difference in others’ lives, as they work to achieve their goals.
Femasys is a disruptive biomedical company focused on addressing significant unmet reproductive health needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products. We are committed to providing women with revolutionary products as they seek solutions throughout their reproductive journey.
We are thrilled to bring to market our revolutionary product FemaSeed®, a next generation artificial insemination solution, where sperm is delivered directly and safely into the fallopian tube, where conception occurs. FemaSeed is a highly cost-effective, convenient approach to enhance natural fertilization. As a first-line infertility treatment, it has significant advantages, including being more affordable and having fewer risks than IVF and intracytoplasmic sperm injection (ICSI). As a therapeutic option, FemaSeed is the catalyst for Femasys to initiate commercial efforts within the U.S. and ultimately scale globally, having already received CE Mark approval in the European Union and approval in Canada.
We also have a lead product candidate, FemBloc® permanent birth control, in late-stage clinical development. We are conducting a multi-center pivotal trial and believe FemBloc will be revolutionary for women seeking a non-surgical method for permanent contraception that is accessible, cost-effective, and has substantially fewer risks than the surgical alternative. We are working diligently to make this much-needed option available to women worldwide.
Our other commercially available products are FemVue®, a contrast-generating device for ultrasound evaluation of a woman’s fallopian tubes; FemCath®, a selective delivery catheter to aid in selective fallopian tube and uterine cavity evaluation; and FemCerv® an endocervical tissue sampler for diagnosis of cervical cancer.
As an innovator in women’s healthcare, we are continuing to develop technologically advanced medical solutions while we work to improve the lives of women around the world. We hold over 100 patents for our products as well as product candidates that we hope to bring to women in the near future.
When you take on a mission that has the potential to positively impact our society, especially one that can reasonably affect the lives of so many women searching for better options, the responsibility of that decision weighs heavy. I am fueled and humbled by the support of many as we ensure women tomorrow have better options than we had for ourselves.
Editor’s Note: Kathy Lee-Sepsick founded Femasys in February 2004. Ms. Lee-Sepsick has served as a senior executive in the medical technologies industry for nearly three decades, compiling a successful track record in growing emerging companies and corporate operating divisions. She holds over 100 patents globally for Femasys’ products and product candidates. Ms. Lee-Sepsick was instrumental in the various stages of product and company life cycles with strategic, operational, and executive responsibilities, at start-ups Novoste Corporation, developer of intravascular therapy solution and SaluMedica, biomaterial developer of artificial cartilage. At the onset of her career, Ms. Lee-Sepsick served in a product management role at Terumo Medical Corporation, where she was integral in the management of strategic partner, Boston Scientific Corporation. Ms. Lee-Sepsick also serves on the Board of Directors of Georgia Bio. Ms. Lee-Sepsick holds a BS in Biochemistry and an MBA from Rutgers University.
About Femasys
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. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis.
