Breakthrough IUD Faces Familiar Funding Barrier in Women’s Health

Mary Beth Cicero stepped onto the BIO International Convention’s Startup Stadium stage to pitch an idea that should be a no-brainer: a non-hormonal, frameless IUD that could eliminate the intense pain many women experience during insertion. Then she looked up and saw that all five judges were men.

“One came in later, right before I presented and said ‘Sorry I was late – I’m really interested in oncology,’” Cicero told Cure in an interview at the conference. “After I finished and sat down, the woman next to me, who presented after me and knocked it out of the park said, ‘you weren't going anywhere.’”

It was a jarring but familiar moment for Cicero, a longtime women’s health executive now leading 3Daughters, a startup developing a new class of intrauterine devices using a magnetic, frameless design. Despite strong preclinical data, a novel delivery system, and growing public attention to IUD pain, raising money has been an uphill battle.

Cure’s own May 2025 survey, reported in The Future of Healthcare Innovation 2025, showed a resilience for women’s health in the current market, with more than 70 percent of responding industry CEOs reporting that funding levels have either held steady or increased since last year. However, 66 percent felt that the funding for the sector is not at all or not very sufficient, having attracted $2.6 billion in VC funding during 2024.

Cicero’s experience isn’t unique. In the current challenging financial environment, many startups are struggling to secure funding.

IUD Pain That’s Long Been Ignored

The current generation of IUDs has remained virtually unchanged for more than 35 years. Most rely on a T-shaped plastic frame with copper or hormonal elements, inserted with a rigid device that requires multiple painful steps, including clamping the cervix and inserting a metal rod to measure the uterus. Patients have reported pain severe enough to cause fainting or trauma.

Cicero’s product uses three elliptical copper-encased magnets that self-assemble into a triangle once inserted through a flexible 2 mm catheter. During an interview with Cure, she demonstrated the small stature of the device by plopping it down on a same-sized circle on her business card. The company’s system avoids the need for cervical clamps or uterine sounding rods, which are major pain points in the procedure.

Clinical literature is sparse on IUD insertion pain, but a 2022 U.K. survey of 1,500 women found that 93 percent reported experiencing pain, many describing it as far worse than what physicians anticipated. That study remains the most cited data point in Cicero’s investor pitch.

“You don’t need to read the data if you’ve lived it,” she said. “But investors want peer-reviewed studies and endpoints. They ask if we can just give women pain meds. That completely misses the point.”

Regulators are increasingly showing interest in including the patient experience in submission packages. The topic was discussed at a BIO panel “Patient-Reported Outcomes are Front and Center for Drug Development AND with the FDA and the CDC,” that Cicero participated in this week.

Patients Hungry for IUD Innovation

The market for IUDs hit $4.5 billion last year, with more than 160 million women using them globally, according to a market report.

A review of clinicaltrials.gov identified 63 active or recent studies involving intrauterine devices, with only about one-third explicitly tracking pain as a primary or secondary outcome. Pain assessments, when included, typically relied on visual analog scales to quantify intensity during insertion or removal.

While some trials are exploring adjunctive pain-relief methods, such as transcutaneous electrical nerve stimulation (TENS), photobiomodulation or improved self-removal techniques, few attempted to redesign the IUD itself.

One trial is experimenting with removal of IUDs without visible strings, and another is testing self-removal instructions as a primary endpoint. Another is attempting to measure the “empathy” patients received from clinicians during the procedure.

Yet only a handful of venture firms actively invest in women’s health, and even fewer back contraception startups. Cicero said she’s heard many rejections with the same rationale: “It’s not our domain expertise.”

That’s despite signals that regulators and patients are hungry for innovation. The FDA has encouraged 3Daughters to incorporate patient-reported outcomes into early trials. The company recently received support from the National Institutes of Health to evaluate copper release and inflammatory response in a preclinical model, a step toward its upcoming IND filing and Phase 1 trial in 2025.

Still, Cicero said it’s hard to get VCs to commit unless a big-name investor signs on first.

“We’ve raised just under $10 million to get to IND, which is unheard of,” she said. “But now we need one more million to launch the trial. Everyone’s waiting for someone else to go first.”

Fighting a Legacy of Indifference

Cicero’s mission is personal, and increasingly urgent. Nearly half of unintended pregnancies in the U.S. occur in women under 25, many of whom fear IUDs precisely because of the pain. Even when IUDs are recommended as emergency contraception, use remains low due to discomfort and access.

The 3Daughters device eliminates strings, which are required to retrieve existing IUDs but are often cited as uncomfortable or unhygienic. The company also hopes to adapt its uterine delivery system to enable localized drug delivery for other gynecological conditions.

“This is my swan song,” Cicero said. “I want to leave something better behind for women. We’ve ignored their pain for too long.”

Despite her optimism, she’s pragmatic about the headwinds. “I hear from women all the time: ‘How do I get one?’ But goodwill doesn’t pay for clinical trials,” she said. “Until this market is treated as seriously as erectile dysfunction or male contraceptives, we’ll keep hitting the same walls.”