Skip to page content

This Bay Area startup just got FDA clearance for a device designed to prevent pelvic pain


Materna Medical CEO Tracy MacNeal
Materna Medical, headed by CE Tracy MacNeal, just won regulatory clearance for a device designed to prevent pelvic pain.
Martino Mingione

See Correction/Clarification at end of article

Women and people with vaginas could soon have new ways to prevent pelvic pain.

Materna Medical Inc., a women's health startup based in Mountain View, is developing two devices that could address the malady. It's targeting one of them — which just received regulatory clearance earlier this month — at women who experience pain while having vaginal intercourse. It designed the other to help pregnant people reduce their chances of getting a pelvic injury while giving birth.

"We seek to transform the standard of care in (obstetrics and gynecology)," company CEO Tracy MacNeal told the Business Journal. "We empower women to protect and restore their pelvic health."

Of its two devices, the one that is farther along is called Milli. Materna already sells a version of the gadget as a personal wellness product. The intravaginal device, for which Materna charges $300 through a dedicated website, is designed to train vaginal and pelvic floor muscles by expanding and vibrating.

On Dec. 1, the Food and Drug Administration gave Materna its thumbs up to market another version of the gadget, called the Milli Vaginal Dilator, as a medical device for the treatment of vaginismus. A condition in which the vagina tightens in response to penetration, vaginismus can result in chronic pelvic pain or dyspareunia, an ailment in which pain is felt just before, during or after vaginal intercourse.

Materna plans to offer the Milli Vaginal Dilator as a prescription-only device. It hasn't yet determined how much it will charge for that version of the gadget, MacNeal said.


  • Company: Materna Medical Inc.
  • Headquarters: Mountain View
  • CEO: Tracy MacNeal
  • Year founded: 2010
  • Employees: 8
  • Website: maternamedical.com

In addition to the Milli devices, Materna is also developing Materna Prep, a vaginal trainer gadget for pregnant people. Many such people experience pelvic floor injuries while giving birth; those injuries can lead to incontinence and prolapse, which is when organs drop from their normal positions because the pelvic muscles can no longer support them.

Materna Prep is designed for pregnant people

The startup designed Materna Prep to prevent pelvic floor injuries and is currently undertaking a clinical study of the device to confirm its safety. An initial feasibility trial indicated Materna Prep could reduce rates of pelvic floor injury from childbirth by 60%, MacNeal said.

Materna is seeking FDA approval for Materna Prep. As such, it's limited in what it can say about the device.

Assuming it gets regulatory clearance, Materna plans to sell Materna Prep to hospitals for use in labor and delivery.

Founded in 2007 by Mark Juravic as part of his classwork at Stanford University's Byers Center for Biodesign, Materna has had a long road to commercialization of its products. Juravic was a "man ahead of his time," MacNeal said. When he went out to raise funds for his new startup, he faced skepticism and repeated rejection from investors, she said.

"So many women's health companies in that era went to raise money and were told by investors something like, 'Women's health? Come back when you have a real market,'" MacNeal said.

Still, Juravic, who stepped down as Materna's CEO in 2018 but remains involved with the company, was able to raise numerous rounds of funding for it, including a $4.6 million A round in 2016, according to PitchBook Data.

More investors have started to come around now that women's health is a hot market, MacNeal said. Materna raised $10 million in a Series A2 round in July, according to a press release. Investors in the round included Wavemaker Three-Sixty Health, Kimera Limited, Women's Venture Capital Fund, Golden Seeds, Black Capital, Shatter Fund and Astia Angels.

The company is out fundraising again and will be accepting term sheets for its Series B round in January, MacNeal said.

"Venture investment into women's health has trailed for too long," Jay Goss, a general partner at Wavemaker Three-Sixty, said in the July press release. "Materna's platform is the most extraordinary innovation in labor and delivery since the epidural was introduced as commonplace over 50 years ago."

Correction/Clarification
A previous version of this story reported that Materna Medical had gotten "approval" from the Food and Drug Administration for the Milli Vaginal Dilator. In fact, the startup received clearance from the FDA for the device. We regret the error.

Keep Digging

Fundings
Profiles
News
Fundings


SpotlightMore

Raghu Ravinutala, CEO and co-founder, Yellow Messenger
See More
Image via Getty
See More
SPOTLIGHT Awards
See More
Image via Getty Images
See More

Upcoming Events More

Aug
01
TBJ
Aug
22
TBJ
Aug
29
TBJ

Want to stay ahead of who & what is next? Sent twice-a-week, the Beat is your definitive look at the Bay Area’s innovation economy, offering news, analysis & more on the people, companies & ideas driving your city forward. Follow the Beat

Sign Up