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-01TM 2 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.
Press Contact
seed@ellecomm.com
1 Based on a survey conducted in
partnership with YouGov of n=3000 women who are 18-55 and
interested in vaginal health.
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