What Materna Medical does

Materna Medical is a privately held medical device company founded in 2010 and headquartered in Mountain View, California, that develops hardware devices for women's pelvic health. The company's core technology is a proprietary incremental-expansion mechanism applied to vaginal dilators, with two products on this platform. Milli is an FDA-cleared expanding vaginal dilator with optional vibration launched in 2019 as a consumer wellness device; it received 510(k) clearance in December 2021 for vaginismus and dyspareunia and over-the-counter clearance in 2023, enabling direct-to-consumer e-commerce sales at hellomilli.com and clinician-driven referrals through a network of 200+ OB/GYN practitioners. Ellora (formerly Materna Prep) is a clinical-stage expanding obstetrical dilator designed to reduce pelvic floor muscle injury during vaginal childbirth, currently in the EASE pivotal trial that enrolled 420 first-time mothers across 20 leading US hospitals (enrollment completed July 2025); FDA De Novo submission is planned and CMS has established ICD-10-PCS procedure code XU7 effective April 1, 2026, to enable hospital billing.

Materna monetizes Milli through direct hardware sales to consumers and via healthcare professional referrals, with pricing not publicly disclosed. Ellora revenue, contingent on FDA authorization, will flow through standard hospital procurement supported by the new CMS reimbursement code. The company is venture-backed with $30M+ in equity raised (Series A2 of $10M led by Wavemaker Three-Sixty Health in 2021; Series B2 of $20M led by InnovaHealth Partners in 2025) plus a $2.2M NIH grant. Materna originates from Stanford University's Biodesign program and is a Company-In-Residence at Fogarty Innovation.

The company targets a stated $25 billion women's pelvic health opportunity, addressing both treatment of vaginismus/dyspareunia (Milli) and prevention of childbirth-related pelvic floor injuries (Ellora), with clinical validation from the EASE trial showing 0.0% full LAM avulsion in the device group versus 10.9% in control, and the POMPOM post-market study demonstrating 90% progress toward intercourse goals and 70% improvement in vaginal pain and sexual function. Materna also benefits from clinical advisor relationships with leading urogynecologists at Columbia, University of Michigan, and Baylor College of Medicine.

Name

Materna Medical

Legal name

Materna Medical, Inc.

Website

https://maternamedical.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Materna Medical is a Mountain View-based medical device company developing FDA-cleared expanding vaginal dilators for women's pelvic health, including the Milli direct-to-consumer device for vaginismus and the clinical-stage Ellora obstetrical system to reduce pelvic floor injury during childbirth.

Ownership category

akta.pro rank

Product category

Women's Pelvic Health Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Urogynecology & Pelvic Reconstructive Surgery (Female Pelvic Medicine) (HLAKAJAE)

Keywords

• Vaginal dilator devices
• Women's pelvic health
• Obstetrical medical devices
• FDA-cleared women's health
• OBGYN medical devices

Headquarters

HQ city

Mountain View

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Milli Direct-to-Consumer Sales: Milli vaginal dilator sold direct-to-consumer through e-commerce at hellomilli.com. FDA-cleared for over-the-counter sale since 2023, enabling streamlined consumer access without prescription. Also available by referral from healthcare professionals.
2. Ellora Hospital Billing: Upon FDA marketing authorization, hospitals will use ICD-10-PCS code XU7 to bill for procedures using the Ellora Obstetrical System during childbirth, creating a reimbursement pathway for the clinical-stage product.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Materna Medical develops and sells medical devices for women's pelvic health. Its first product, the Milli Expanding Vaginal Dilator with Vibration, is an FDA-cleared, over-the-counter device that incrementally expands one millimeter at a time to treat vaginismus and dyspareunia. Its second product, the Ellora Obstetrical System (formerly Materna Prep), is a clinical-stage expanding dilator designed to reduce pelvic floor muscle injury during vaginal childbirth, currently under investigation in the EASE pivotal trial.

Product overview

Materna Medical is a women's pelvic health company offering two distinct medical devices. The first product, Milli™ Vaginal Dilator, is an FDA-cleared expanding vaginal dilator with vibration launched in 2019 for treating vaginismus and painful sex. The second product, Ellora™ Obstetrical System (formerly Materna Prep), is an investigational device used during labor and delivery designed to reduce pelvic floor muscle injury during vaginal childbirth in first-time mothers, currently under study in the pivotal EASE trial. The company operates as an OBGYN platform defining a $25 billion market addressing unmet needs in women's pelvic health.

Differentiator

Problem solved

Functional benefit

Brands

• Milli: Milli Expanding Vaginal Dilator with Vibration - an FDA-cleared device to treat vaginal muscle tightness (vaginismus) and painful sex. Launched in 2019 as a wellness trainer and received OTC FDA clearance in 2023.
• Ellora

Products and services

• Milli Expanding Vaginal Dilator with Vibration FDA-cleared expanding vaginal dilator with vibration for treating vaginismus and dyspareunia (painful sex). First and only dilator that expands incrementally one millimeter at a time with optional vibration for muscle relaxation. Sold direct-to-consumer through e-commerce at hellomilli.com and by referral from healthcare professionals.
• Ellora Obstetrical System

Quantifiable outcome

• 90% of participants made progress towards or met goal of returning to intercourse (POMPOM study)
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eight partnerships are on record, tiered core partner, strategic partner and minor partner.

• Fogarty Innovationcore partnerStrategic or Co-development PartnerMaterna is a Company-In-Residence at Fogarty Innovation in Silicon Valley, providing access to MedTech ecosystem, mentorship, and innovation infrastructure.
• Centers for Medicare & Medicaid Services (CMS)core partnerStrategic or Co-development PartnerEstablished new ICD-10-PCS procedure code XU7 for the Ellora Obstetrical System, fundamental to market access and reimbursement pathway.
• Columbia University Irving Medical Centercore partnerStrategic or Co-development PartnerDr. Ronald Wapner serves as overall study co-leader for Materna's pivotal EASE trial. Dr. Helai Hesham leads the EASE study as urogynecology investigator. Site for clinical research.
• Baylor College of Medicinecore partnerStrategic or Co-development PartnerDr. Francisco Orejuela, urogynecologist at Texas Children's Pavilion for Women and primary investigator for Materna Prep study. Leading institution for EASE clinical trial.
• University of Michigan Pelvic Floor Research Groupstrategic partnerStrategic or Co-development PartnerDr. John DeLancey and Dr. James Ashton-Miller provide biomechanical analyses research for the EASE trial. World-renowned pelvic floor research experts.
• Stanford University Biodesign Programcore partnerStrategic or Co-development PartnerMaterna's technologies were developed through Stanford University's Biodesign program. Company maintains connection through Stanford Center for Biodesign as investor.
• Kickminor partnerImplementation/ SI/ Consulting PartnerMinneapolis-based branding and design agency that partnered with Materna to redesign the Milli brand and packaging.
• University of Sydneystrategic partnerStrategic or Co-development PartnerDr. Hans Peter Dietz provides ultrasound imaging research support for EASE trial.

Scale indicators9 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• CooperSurgical: Women's healthcare and fertility device company offering surgical, OB/GYN, and reproductive health products. Overlaps with Materna in OB/GYN surgical instruments and pelvic floor procedures relevant to Ellora's hospital customer base.
• Hologic: Large women's health medtech company with franchises in diagnostics, surgical, and skeletal health. Materna's Chief Medical Advisor is a former Hologic Medical Director. Comparable as a broad incumbent serving OB/GYN channels that Materna targets with Ellora.
• Boston Scientific: Large diversified medtech with a women's health and pelvic floor portfolio including mid-urethral slings and surgical solutions. Operates an extensive hospital sales channel relevant to Ellora's go-to-market model.
• Coloplast: Global medtech company with a major ostomy, continence, and pelvic floor franchise. Comparable as an incumbent offering devices for incontinence and pelvic organ prolapse repair, addressing the same end patients Materna targets for postpartum complications.

Emerging players

• Joylux: Women's intimate wellness technology company selling devices for pelvic floor strengthening and menopause-related concerns. Comparable as a DTC women's pelvic health brand competing for similar consumer mindshare as Milli.
• Viveve Medical: Women's health medtech focused on vaginal tissue and sexual health treatments using energy-based devices. Comparable as a niche emerging player addressing vaginal health indications adjacent to Milli's vaginismus/dyspareunia positioning.
• Intimina: Consumer intimate wellness brand offering Kegel exercisers and personal care devices for women. Comparable as a direct-to-consumer intimate wellness brand overlapping with Milli's e-commerce channel and target demographic.

Direct peers

• Caldera Medical: Medical device company specializing in pelvic floor disorders, including surgical mesh and sling products for stress urinary incontinence and pelvic organ prolapse. Direct competitor in the female pelvic medicine space Materna targets with both Milli and Ellora.
• Laborie Medical Technologies: Specialist in pelvic floor and urogynecology diagnostics and therapeutics, offering urodynamic systems and related disposables. Directly comparable as a pelvic-floor-focused device company selling into the same OB/GYN and urogynecology channels as Materna.

Regional players

• Materna Health (UK femtech): European femtech company focused on perineal and pelvic floor health products for postpartum recovery. Comparable as a regional peer operating in the same postpartum/pelvic health category but serving UK and European markets rather than Materna Medical's US focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks1 record

Key highlights7 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds8 records

Investors16 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Materna Medical