Meet the metro Atlanta woman who invented a new permanent birth control
In Suwanee, nestled between an electronics manufacturer and a pickleball club, sits a nondescript, one-story office building. Though unassuming, past the cubicles and conference rooms are chemistry labs and clean rooms where women’s health care innovations are being developed.
This is Femasys, the brainchild and labor of love of Kathy Lee-Sepsick. A trained biochemist with an MBA, Lee-Sepsick founded the biomedical company out of her house in 2004, even doing some of the initial manufacturing from her basement.
In the 21 years since launching her company, Lee-Sepsick has raised millions of dollars, taken her company public and invented new cervical cancer screening tools, fertility devices and one of the first nonsurgical, nonhormonal permanent birth controls in the world.
“I started this company … to help women, to bring them accessible technology that is so much safer and so much better than what they have right now,” Lee-Sepsick told The Atlanta Journal-Constitution.
“In order to do that in the best way, I had to build it from scratch.”
Nearly every aspect of Femasys is run out of its 50,000-square-foot headquarters, from analytical chemistry labs to the clean rooms where employees in head-to-toe personal protective equipment assemble the products. There are even in-house quality rooms to test the shelf life of products, sometimes for years.
Lee-Sepsick’s passion for her company radiates off her, a vigor and work ethic informed by her own frustrations trying to find a permanent birth control option after having her two daughters. She didn’t want to have to use hormones long term, but also wasn’t comfortable with the risks of an elective sterilization surgery for herself or for her husband.
In 2003 she invented FemBloc, a nonsurgical, nonhormonal permanent birth control. The next year, when her daughters were 7 and 4 years old, she incorporated Femasys, juggling motherhood and entrepreneurship side by side.
“I took my know-how in medical devices, in chemistry, biochemistry … and I said, ‘You know what, this is an approach I would personally have for myself, for my girls or anyone in our circle,’” she said.
“I made a decision when I started Femasys, I wasn’t going to do products (where) I could just have a mild improvement. I went all-in to transformative technologies where I can change what’s been around for 50 or 100 or hundreds of years.”
FemBloc aims to simulate one of the causes of natural infertility. It’s a nonsurgical alternative to current permanent female birth control options on the market, like tubal ligation or a salpingectomy. FemBloc can be done in minutes in a doctor’s office.
About 30% of infertility is because of blocked fallopian tubes from scar tissue, Lee-Sepsick said. FemBloc aims to induce the body to create scar tissue through a polymer inserted into the fallopian tubes by a catheter system.
About 12 to 15 drops of the liquid polymer is injected into the tubes, and when it comes into contact with the body’s natural fluids, the polymer becomes a solid, Lee-Sepsick explained. It then creates small injuries inside of the tube, initiating a wound healing response. The polymer dissolves after a few months but the scar tissue remains, thus blocking the fallopian tubes and preventing an egg and sperm from meeting.
“There’s no hormones, there’s no implants, there’s no surgery, no incisions, no general anesthetic,” Lee-Sepsick said.
Her target patients are anyone who doesn’t want to be at risk of pregnancy,. Lee-Sepsick also sees FemBloc as an option for women who can’t undergo surgery or can’t take hormonal birth control, like those for whom blood clots run in their family.
FemBloc has so far been approved by regulators in the European Union, United Kingdom and New Zealand. The product has started to be delivered to patients in Spain after Femasys secured a $400,000 order this summer. The company will be monitoring European patient outcomes in a new postmarket clinical study.
FemBloc is still going through the U.S. approval process, Lee-Sepsick said. The Food and Drug Administration did not respond to a request for comment on the status of the approval.
Lee-Sepsick said one of the hurdles to its approval is the long shadow of Essure, a nonsurgical permanent birth control method from the mid- to early 2000s that allegedly caused serious complications in some of the women who received it.
Essure was a metal coil sold by pharmaceutical giant Bayer that was permanently implanted in the fallopian tubes. It is no longer on the market, and Bayer agreed to pay approximately $1.6 billion to settle the majority of the U.S. cases against the device.
Essure’s issues have affected FemBloc’s approval “tremendously,” she said.
“I was working with the FDA at the same time that the (Essure) safety concerns were arising, and it just made it really challenging. It was many more hurdles,” Lee-Sepsick said.
She said not a single serious adverse event has been reported in FemBloc’s trials, but she is still working on studies in the U.S.
In recent years, there has been an increase in young adults in the U.S. seeking permanent contraception after the Supreme Court overturned Roe v. Wade with the Dobbs v. Jackson Women’s Health Organization decision in 2022, according to a George Washington University study. Lee-Sepsick said she’s felt the ramifications of that decision.
“I think given what’s happened makes this even more important. I felt even more pressure to get this done because of the Dobbs decision,” she said.
Besides FemBloc, Lee-Sepsick has also invented new products for infertility, artificial insemination and cervical cancer, which have all been FDA-approved.
Maria Thacker-Goethe, president and CEO of the nonprofit group Georgia Life Sciences, said one of Femasys’ products, a tool called FemVue that helps doctors see the fallopian tubes more clearly, was part of her own fertility journey.
“Femasys is a great example of a Georgia-born company translating scientific innovation into real-world, patient-focused products. What’s notable is how the company has tackled women’s reproductive health, a space that has long been underfunded and under-innovated,” Thacker-Goethe said in an email.
For any startup, raising money is difficult. Add in a capital-intensive industry like medical technology, which requires extensive research and expensive development, and the fact that female founders on average raise a fraction of what their male counterparts do, and Lee-Sepsick had to get creative to grow Femasys.
In Femasys’ early years, she went the traditional venture capital route, raising tens of millions that way. But in 2021, she took Femasys public, which netted the company $31.6 million from its initial public offering. It trades on the Nasdaq and has gone on to raise millions more in subsequent rounds of financing.
Now, the company is in a new era. It’s grown past the startup stage, past the research and development phase and into commercialization.
“We have been building this for this moment,” Lee-Sepsick said.
As FemBloc garners more interest from clients and Femasys’ other products gain traction, the company still has work to do to build up inventory to meet growing demand. But despite more than two difficult decades of building, Femasys is a legacy Lee-Sepsick is proud to leave.
“I know what I’m doing is going to help a lot of women. And when I’m not here, it’s going to still be here,” she said. “I know how important this is. I believe in what I’m doing. I know I did it the right way.”
AJC Her+Story is a new series in The Atlanta Journal-Constitution highlighting women founders, creators, executives and professionals. It is about building a community. Know someone the AJC should feature in AJC Her+Story? Email us at herstory@ajc.com with your suggestions. Check out all of our AJC Her+Story coverage at ajc.com/herstory.
About the Author
Mirtha Donastorg is a reporter on The Atlanta Journal-Constitution’s business team focusing on Black wealth, entrepreneurship, and minority-owned businesses as well as innovation at Atlanta’s HBCUs.
