Seeking Participants to Advance Research on Vaginismus and Related Painful Sex

Materna Medical, Inc., a leading innovator in women's pelvic health solutions, is proud to announce the launch of a new clinical study, Prospective On Market Patient-reported Outcomes for Milli™ Vaginal Dilator (POMPOM). This groundbreaking clinical investigation aims to gather valuable data on the effectiveness of the Milli Vaginal Dilator to help relieve the symptoms of vaginismus and related painful intercourse.

Millions of People Are Affected by Vaginismus

Vaginismus is a common yet underreported condition affecting between 5-17% of people assigned female at birth. The condition is characterized by involuntary muscle contractions of the vaginal wall, making sexual penetration difficult or impossible. Many suffer in silence because they are not aware that vaginismus is a treatable medical condition and don’t realize that help is available.

"Treatments for male sexual dysfunction are well-funded and well-researched, but there is a critical lack of research on medical interventions for vaginismus and related painful sex," says Tracy MacNeal, CEO of Materna Medical. "The POMPOM study will generate essential data on the Milli Vaginal Dilator, a discrete, convenient, at-home solution for managing this common condition."

Materna’s Solution for Vaginismus

The Milli Vaginal Dilator, our first product, addresses this condition 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.

Seeking Participants to Drive Research Forward

Materna Medical invites people experiencing vaginismus symptoms to participate in the POMPOM study (ClinicalTrials.gov NCT06397885). The virtual, secure, confidential format allows convenient participation and makes research accessible to a broader population.

“By participating in this study, Milli users will help clinicians learn more about how to help women with vaginismus and associated painful intercourse,” said Sheryl Kingsberg, Ph.D., Professor, Departments of Reproductive Biology, Psychiatry, and Urology, Case Western Reserve University School of Medicine and POMPOM’s Principal Investigator. “Treatment for this debilitating problem remains underutilized though technological advances in pharmacology and devices, like the Milli Vaginal Dilator, may help in alleviating the painful symptoms associated with vaginismus.”

The POMPOM study builds on the initial Milli Vaginal Dilator data previously published in the April 2021 issue of Sexual Medicine Reviews, Vaginal Dilators: Issues and Answers.¹

For more information on POMPOM Study selection criteria and compensation, please visit info.hellomilli.com/pompom.

About Materna Medical

Materna Medical is a novel OBGYN platform company defining a $6B 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.

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

*Indication Statement: The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

¹Liu M, Juravic M, Mazza G, Krychman ML. Vaginal Dilators: Issues and Answers. Sex Med Rev. 2021 Apr;9(2):212-220. doi: 10.1016/j.sxmr.2019.11.005. Epub 2020 Jan 31. PMID: 32014450.

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