FDA-cleared devices for the parts of women's health medicine kept skipping - from painful sex to the delivery room.
The plate reads "Materna Medical." Behind it: two devices, sixteen years, one CEO who keeps raising money in a market that funds almost no one who looks like her. She is not making a statement. She is filling a gap.
There is a version of the women's health market that gets the attention: fertility apps, period trackers, glossy consumer brands with lowercase logos. And then there is the other part - vaginismus, painful intercourse, the pelvic floor muscles that tear during childbirth. It is a large market. It is also a market that, for reasons that are more cultural than clinical, medicine mostly declined to build devices for. Materna Medical, a company in Mountain View, California, decided to build them anyway.
The pitch is unusually clean for a health company. Materna sizes the opportunity in women's pelvic health at roughly $6 billion, and it is not obviously wrong, because the need was never small - it was ignored. The company's answer is a portfolio of two devices sitting at opposite ends of a woman's life. One is already FDA-cleared and sold to consumers. The other is in clinical trials and aimed at the delivery room. Both are the kind of unglamorous, physical, regulated products that take a long time and don't trend on social media.
That is worth sitting with, because the interesting thing about Materna is not that it found a big market. Lots of companies find big markets. The interesting thing is that it chose the version of the market that requires FDA clearances, pivotal trials, and the patience to spend sixteen years building two products. In an industry that prizes speed, Materna is a slow company on purpose. When the product goes inside a patient during labor, slow is the responsible answer.
"Empowering women to protect and restore their pelvic health at every stage of life."
— Materna Medical, company missionThe first and only vaginal dilator that expands incrementally, one millimeter at a time, with optional vibration. It's cleared to treat vaginismus and dyspareunia - painful intercourse - and since 2023 it's available over-the-counter, no prescription required. Where the old approach handed patients a bag of rigid plastic cones and a shrug, Milli lets the user set the exact size. The name is the mechanism: one milli-meter at a time.
Formerly known as Materna Prep, Ellora is an expanding obstetrical dilator placed in the vagina during the first stage of labor. It gradually pre-stretches the pelvic floor muscles over a longer, gentler window than the baby's passage allows - the goal being to make vaginal delivery easier, faster and safer. In a pilot study, the device reduced pelvic floor injury by 60%. It is now being evaluated in the EASE pivotal trial in first-time mothers.
Selected disclosed rounds. Cumulative funding to date ~$82.6M.
| Round | Amount | Year | Lead |
|---|---|---|---|
| Series A2 | $10M | 2021 | InnovaHealth |
| Series B | $22M | 2022 | InnovaHealth |
| Series B2 | $5.7M | 2024 | InnovaHealth |
| Series B3 | $5M | 2026 | InnovaHealth |
Repeat backers: InnovaHealth Partners (lead), Wavemaker360 Health, Band of Angels.
"We are thrilled to be entering this next phase as we prepare for the Ellora launch, bringing an important innovation to women's health."
— Tracy MacNeal, CEO, on the 2026 Series B3Launched in the Bay Area to address unmet needs in women's pelvic health.
The incremental-expansion dilator is cleared to treat vaginismus and dyspareunia.
Brought to market as the first dilator that expands one millimeter at a time.
InnovaHealth Partners leads a round to advance the pelvic health portfolio.
FDA clears Milli for OTC sale, removing the prescription requirement.
Enrollment finishes for the Ellora pivotal trial in first-time mothers; Series B2 first close.
New funding to complete the EASE trial and prepare for the Ellora launch.
FDA-cleared medical devices for women's pelvic health: Milli, a vaginal dilator for vaginismus and painful intercourse, and Ellora, a clinical-stage obstetrical device designed to reduce childbirth-related pelvic injury.
Milli is the first and only vaginal dilator that expands incrementally, one millimeter at a time, with optional vibration. It's FDA-cleared, sold over-the-counter, and priced at $395.
Tracy MacNeal is President and CEO. The company was founded in 2010 by Mark Juravic and Michael Stewart.
Roughly $82.6M to date across multiple rounds, with InnovaHealth Partners as lead investor, including a $22M Series B in 2022 and a $5M Series B3 in July 2026.
Formerly called Materna Prep, Ellora is a clinical-stage device placed during the first stage of labor to gradually pre-stretch pelvic floor muscles, aiming to make delivery safer and reduce injury. It reduced pelvic floor injury by 60% in a pilot study and is being evaluated in the EASE pivotal trial.