Materna Medical Announces Oral Presentation Comparing Outcomes of Dilator-Experienced vs. Naïve Patients from an At-Home Study

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MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Oct 10, 2025--

Materna Medical announced today that an interim sub-analysis comparing dilator user types from the Prospective On Market Patient-reported Outcomes for Milli (POMPOM) clinical study will be presented orally at the Sexual Medicine Society of North America (SMSNA) Annual Meeting; the sub-analysis suggests a dramatic difference in effectiveness between the two user types.

The abstract, titled “POMPOM 3-Month Comparative Analysis of Static Dilator-Experienced vs. Naive Participants Using the Milli Expanding Vaginal Dilator,” evaluates outcomes in women with prior static dilator experience versus those new to dilation therapy with an at-home solution.

When experienced dilator users were asked why they purchased Milli, one POMPOM participant said, “[I] want to have more intermediate options than my static dilators, and [I] also want the vibration option.”

When asked to describe any impact that Milli has had on their sex life, one POMPOM participant reported, "Wonderful to have a gradual diameter change rather than a bunch of individual dilators that all need to be stored and cleaned.”

This comparative data is a crucial step forward for sexual medicine. It confirms the efficacy of an expanding vaginal dilator and provides valuable guidance for clinicians on managing patients with varying treatment histories. This research presents a novel, evidence-based approach to a frequently challenging condition.

Key findings from the interim comparative analysis include:

• Both groups showed statistically significant improvements from baseline in pain during intercourse, sexual function (FSFI), and anxiety.
• Naive participants demonstrated a greater reduction from their baseline pain with intercourse on the visual analog scale (VAS) (27.8% reduction, p<0.0001) compared to experienced users (22.5%, p=0.0028).
• Naive participants demonstrated a greater reduction from their baseline in VAS anxiety (24.2%, p=0.0021) compared to experienced users (15.8%, p=0.0291).
• At 6 months, 81.8% of naive participants and 65.0% of experienced participants who attempted intercourse were successful.

“It’s an honor to be selected for an oral presentation at SMSNA, which highlights the scientific rigor and clinical importance of this specific sub-analysis,” said Dr. Sheryl Kingsberg, Chief of Behavioral Medicine in the Department of Ob/Gyn at University Hospitals Cleveland Medical Center and principal investigator in the POMPOM study. “The ability to demonstrate positive outcomes in dilator-naïve and dilator-experienced patients is a powerful finding that validates this therapy as a viable option for a broad range of individuals. This data can inform clinical practice and offer hope to patients who are new to or have exhausted previous therapy options.”

The SMSNA oral presentation will be during Abstract Session 4—Innovation on Friday, October 10, 2025, from 1:30 PM to 3:30 PM Central Time.

For more information about the POMPOM study and the Milli expanding vaginal dilator, visit www.hellomilli.com or www.maternamedical.com.

About Us Materna Medical

Materna Medical is a novel OBGYN platform company defining a $25B market with core technologies addressing unmet needs in women's pelvic health. With headquarters in Mountain View, California, Materna pulls from the top minds in MedTech to truly transform the standard of care in OBGYN. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical’s mission is to empower women to protect their pelvic health.

Our first product, Milli™, is a vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device launched as a wellness trainer and, in 2023, received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes have been studied in a post-market prospective virtual study named POMPOM.

Materna’s second product, Ellora™, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery in first-time moms. This product is being studied in the EASE trial, a large, randomized controlled trial in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic floor health for moms.

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CONTACT: Media Contact:

Debbie Donovan

Head of Commercial Operations

Materna Medical, Inc.

[email protected]

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES CONSUMER OTHER HEALTH BABY/MATERNITY GENERAL HEALTH CLINICAL TRIALS

SOURCE: Materna Medical

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PUB: 10/10/2025 02:30 PM/DISC: 10/10/2025 02:29 PM

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