Seed Health Launches VS-01, A First-of-its Kind Vaginal Microbiome Innovation to Redefine Vaginal Care

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May 21, 2024, 06:07 ET

An optimal vaginal microbiome is a key driver of gynecological, urogenital, and reproductive health

VS-01™ is a multi-strain probiotic and prebiotic clinically validated to establish an optimal vaginal microbiome and sustain regulated vaginal pH

Built on the research of renowned vaginal microbiome scientist Dr. Jacques Ravel, VS-01™ is the first to pioneer a microbial genomics approach powered by the most comprehensive host-microbiome vaginal data set

LOS ANGELES, May 21, 2024 /PRNewswire/ -- Seed Health, a microbiome science company, today launched VS-01™ Vaginal Synbiotic, the first vaginal synbiotic clinically validated to rapidly establish an optimal vaginal microbiome dominated by Lactobacillus crispatus, the vagina's most protective bacteria. Dr. Jacques Ravel's pioneering research has elucidated the crucial role of the vaginal microbiome in gynecological, urogenital, and reproductive health, though everyday factors like stress, sex, menstruation, and diet can disrupt its equilibrium and deplete the abundance of L. crispatus. Dr. Ravel's extensive clinical data set indicates that 90% of women lack a stable microbiome dominated by L. crispatus, a key driver of vaginal health. Developed from Dr. Ravel's discovery that not all strains of L. crispatus are equally protective, VS-01™ is formulated with an ecology of three proprietary strains of L. crispatus, which were identified from over 600 candidate probiotic strains for their superior efficacy in maintaining regulated pH and promoting stability in vaginal health.

The launch builds on Seed's award-winning portfolio of microbiome-directed innovations and expands the company's pipeline beyond the gut.

"This launch represents the very essence of why we founded Seed: to translate pioneering microbiome discoveries into life-changing health innovations," stated Ara Katz, Seed Health co-founder and co-CEO. "As a woman and a mother, it is especially meaningful to accelerate advancements in an area that has been so deprioritized and systemically overlooked. The vaginal microbiome is the next frontier in women's health, and VS-01™ embodies its vast potential—an entirely new paradigm of care that empowers greater agency over our bodies."

The Next Frontier in Vaginal Health
Discoveries from Dr. Ravel over the last two decades have been pivotal to the understanding of the vaginal microbiome. His landmark 2012 study demonstrated that the most stable and optimal vaginal microbiome is dominated by one bacterium: L. crispatus. However, everyday factors such as menstruation, sexual activity, exercise, stress, as well as contraceptives, and cleaners, disrupt the vaginal microbiome and deplete the abundance of L. crispatus. Dr. Ravel's extensive clinical data set indicates that nine out of 10 women have an unstable vaginal microbiome, making them more prone to complications like infections, malodor, discharge, and inflammation. Even though more than two-thirds of women report experiencing vaginal discomfort in the past year,^¹ available products often target only the symptoms and can further disrupt the vaginal microbiome.

VS-01™ • Seeding the Future of Vaginal Health
Dr. Ravel's research not only helped elucidate the critical role of L. crispatus in maintaining a protective and stable vaginal microbiome but also revealed that specific strains of L. crispatus are markedly more protective and proficient at promoting vaginal health.

Leveraging these discoveries, VS-01™ is formulated with an ecology of three proprietary L. crispatus strains (LUCA103™, LUCA011™, LUCA009™), each identified for key genomic features that confer stability in the vaginal environment.

"During my more than two decades of research in this field, I've seen countless consumer products that fail to address the unique needs of the vaginal microbiome. Many probiotics aimed at vaginal health utilize gut strains or are administered as oral supplements, ignoring that these methods do not direct the microbes from the GI tract to the vagina," said Dr. Ravel. "I am inspired to see Seed pioneer a new frontier in vaginal health, translating my research from the lab into innovations that make a real difference in women's lives."

Beyond consumer applications, Seed Health is working with Dr. Ravel under LUCA Biologics to develop live biotherapeutics targeting the vaginal microbiome for unmet needs in urogenital and reproductive health.

Clinically Validated to Restore an Optimal Vaginal Microbiome
In a double-blind, randomized, placebo-controlled clinical trial, VS-01™ established an optimal vaginal microbiome dominated by L. crispatus in 90% of participants with a non-optimal vaginal microbiome within one menstrual cycle. The full clinical results will be presented at the 2024 annual conference of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG):

Established an Optimal Vaginal Microbiome: 90% of participants established an optimal vaginal microbiome dominated by L. crispatus within 21 days of use.
Non-Efficacy of Oral Probiotic for Vaginal Health: The VS-01™ suppository tablet rapidly increased abundance of L. crispatus in the vaginal environment. In contrast, no strains from a leading oral probiotic for vaginal health were detected in the vagina by the end of the study.
Advanced Delivery Technology: Seed's proprietary SMART Tablet™ provides an extended-release profile that is superior to both placebo and a fast-release vaginal capsule with the same strains.
Safety: Demonstrated to be well-tolerated and non-disruptive to the vaginal pH.

"Seed's VS-01™ Vaginal Synbiotic is a scientific breakthrough that restores the vagina's super defender, Lactobacillus crispatus, protecting against everyday pH disruptors," said Diane M. Harper, M.D., Professor, Departments of Family Medicine and Obstetrics & Gynecology at the University of Michigan, and internationally recognized expert in vaginal health. "This breakthrough can empower women to protect their vaginal health."

A New Standard of Safety
VS-01™ redefines safety standards in vaginal health products prioritizing the vaginal microbiome and important biomarkers other products do not test for. Using a cruelty-free tissue model recognized for preclinical validation by the Food and Drug Administration (FDA), VS-01™ is tested for vaginal biocompatibility to ensure non-disruption to the vaginal mucosal barrier. Seed's comprehensive safety protocol also includes testing for over 500 contaminants, including chemical residues and heavy metals, and 14 classes of allergens. VS-01™ is formulated without artificial fragrances, preservatives, or dyes and is free from dairy and other animal-derived materials. It is also vegan, cruelty-free, and excludes common endocrine disruptors such as PFAS, parabens, BPA, and phthalates.

A Protocol to Address the Source, Not Just the Symptoms
VS-01™ is designed to establish a vaginal microbiome dominated by L. crispatus and to sustain regulated pH and a healthy vaginal environment for ongoing protection against everyday disruptors. VS-01™ begins with an intensive first-month Reset to rapidly establish an optimal vaginal microbiome and continues with monthly Sustain—a simple, two-tablet monthly protocol to maintain a regulated vaginal pH and stable vaginal microbiome.

VS-01^TM2 Month Starter Kit is now available for $99, with Sustain refills for $39.99 per month at seed.com/vaginal-synbiotic. VS-01™ is HSA/FSA eligible, and available at a discounted cost for nurses, doctors, students, teachers, first responders, and military veterans.

About Seed Health
Seed Health is a microbiome science company pioneering innovations in probiotics and living medicines to impact human and planetary health. Founded to realize the potential of the microbiome, our platform enables the translation of breakthrough science across a portfolio targeting health outcomes from infancy to aging. Our consumer innovations are commercialized under Seed®—an award-winning, science-first brand known for clinically validated innovations in probiotics, including DS-01® and PDS-08®. Our pipeline encompasses both indication-specific and preventive applications for gastrointestinal and digestive health, women's health, skin, pediatrics, brain health, metabolic function, and healthy aging. Our environmental research is conducted under SeedLabs, which was founded to advance novel bacterial interventions to enhance biodiversity and restore ecosystems impacted by human activity.

About Dr. Jacques Ravel
Dr. Jacques Ravel is the Director at the Institute for Genome Sciences (IGS) and Professor of Microbiology and Immunology at the University of Maryland School of Medicine, where he is applying modern -omics technologies and ecological principles to characterize the role of the vaginal microbiome in women's health. His research is dedicated to deciphering the mechanisms by which the vaginal microbiome is protecting against infections and obstetric conditions. His work seeks to better define the interactions between hosts, microbial communities in the human body, and the environments that drive these ecological systems, and leverage these findings to develop efficacious interventions to modulate the composition and functions of the microbiome.

Dr. Ravel is also co-founder and Chief Scientist of LUCA Biologics, a biotechnology company developing a new class of living medicines targeting the vaginal microbiome to impact reproductive and urogenital health.

Dr. Ravel is currently the Co-Director of a NIH-funded Collaborative Research Center on Human 3D Biomimetics Cervicovaginal Models for Sexually Transmitted Infections which aims to develop an innovative biomimetic model of the lower reproductive tract to study aspects of the sexually transmitted infections, chlamydia and gonorrhea, that are not achievable in humans or with current animal or cell models. He has published over 330 peer-reviewed publications (62,595 citations) and has attracted over $50 million in grants with continuous Federal funding since 2004. His laboratory is currently supported by grants from the U.S. National Institutes of Health, the Bill and Melinda Gates Foundation, as well as the U.S. Department of Agriculture.

He received his Ph.D. from the University of Maryland in Environmental Molecular Microbiology and Ecology and performed his postdoctoral training at Johns Hopkins University, working on microbial natural product chemistry. In 2012, he was elected to the Fellowship of the American Academy of Microbiology (AAM) and in 2015, he was awarded the Blaise Pascal International Research Chair, a prestigious European science honor. Dr. Ravel is the founding Editor-in-Chief of the journal Microbiome and an Associate Editor at the journal mBio.

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^¹ Based on a survey conducted in partnership with YouGov of n=3000 women who are 18-55 and interested in vaginal health.

SOURCE Seed Health