Materna Medical, Inc.

Seeking Participants to Advance Research on Vaginismus and Related Painful Sex MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- 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.

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- Materna Medical, Inc., a leading innovator in women's pelvic health solutions, has announced the completion of the first close of a $20 million Series B2 financing round. The round was led by InnovaHealth Partners and other key existing investors included Wavemaker Three-Sixty Health, Kimera Limited, Women's Venture Capital Fund, Golden Seeds, Band of Angels, and Houston Angel Network. "Materna is a first mover, aiming to transform the standard of care in labor and delivery. Imagine a world in which women aren’t injured while delivering vaginally," commented Tracy MacNeal, Chief Executive Officer for Materna Medical. "Our nation’s maternal health crisis is a clarion call for new obstetrical technologies, and Materna is leading the way." The company has successfully reached several key milestones, including obtaining over-the-counter FDA clearance for its first commercial product, the Milli Vaginal Dilator. Additionally, clinical data from an expanded feasibility study of Materna’s second product, Materna Prep, shows substantial promise in the potential to reduce pelvic floor injury rates for women delivering vaginally. Dr. Ariella Golomb, Materna’s Board Chair and Partner at InnovaHealth Partners added, "We are pleased with the Company’s progress, excited about the feasibility data and look forward to its publication later this year. The funds from Series B2 will be used to obtain FDA marketing authorization for Materna Prep and support the commercial launch of this transformative technology.” For more information on Materna Medical, visit MaternaMedical.com. 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. Our first product, Milli, is 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 are being studied in a post-market prospective virtual study named POMPOM. 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.

As the world navigates an unprecedented era of technological advancement and health crises, the medical device industry is at the forefront of these transformative times. It is against this backdrop that the annual DeviceTalks West conference convenes this Oct. 18-19, 2023, beckoning a diverse cohort of industry leaders, innovators, engineers, and hundreds of other medtech stakeholders. The DeviceTalks team is actively seeking a dynamic range of voices to contribute to the speaker line-up for DeviceTalks West 2023. Our call for presentations is now open and represents a rare opportunity for medical device professionals to share their expertise and insights. This isn’t merely a conference; it’s a community endeavor to drive the industry forward. If you have a compelling narrative, a groundbreaking technology or a revolutionary process, your contribution can shape these discussions and influence the future of the medtech industry. Moreover, the conference offers an unrivaled opportunity to connect with a network of like-minded professionals. Engage with industry leaders, potential collaborators, and innovative thinkers who share a passion for medical technology and a commitment to improving patient outcomes. Last year’s speakers, panelists and exhibitors included leaders from Medtronic, Johnson & Johnson Medtech, Abbott, Boston Scientific, Edwards Lifesciences, Intuitive, Zimmer Biomet, Shockwave Medical, Penumbra, Avail Medsystems and Evidation, as well as startups such as Materna Medical, plus suppliers, vendors, consultants and other medtech partners. DeviceTalks West 2022: Device developers get creative to connect with physicians As a medtech professional, you have the opportunity to contribute to this industry-wide conversation. Whether you are an engineer with a novel design, an executive navigating regulatory complexities, or an innovator with a game-changing technology, your experiences are invaluable. So join us Oct. 18-19 and contribute your voice to the evolution of the medtech industry. Submit your presentation proposal at the DeviceTalks West website. Take this opportunity to share your knowledge, inspire your peers, and influence the future of medical technology. This is your call to action. Answer it. DeviceTalks West 2022: Outset Medical CEO Leslie Trigg and the beginner’s mindset