Reference

Formulation

• Prepare: Wash your hands and gently press a VS-01™ vaginal tablet out of the aluminum pack.

• Load: Place the tablet into the applicator. The tablet is in the correct place when it’s protruding halfway out of the applicator.

• Insert: Insert the applicator into your vagina and push the inner tube towards you to release (just like a tampon). 

• Dispose: Dispose of the applicator in the trash. Note that each applicator is a Class I Medical Device and cannot be recycled. 

VS-01™ requires your body’s natural lubrication for proper dissolution, and therefore may not be as effective among women experiencing significant vaginal dryness.

For Optimal Seeding-Reset

Begin VS-01™ Reset––a clinically-validated protocol to seed an optimal vaginal microbiome and maintain vaginal pH within one month. 

If you menstruate regularly, start Day 1 immediately after your period when bleeding stops (spotting is okay). If you do not menstruate regularly, you may start at any time. 

Continue on Days 4, 7, 14, 21, and 28.

If you miss a day, simply resume as soon as possible. 

For Ongoing Protection-Sustain

Continue VS-01™ monthly to support maintenance of a stable vaginal microbiome and protect against pH disruptors from lifestyle and the environment.  

If you menstruate regularly, start Day 1 immediately after your period when bleeding stops (spotting is okay), and the second vaginal tablet on Day 14. If you do not menstruate regularly, you may start Day 1 at any time. 

If you miss a day, simply resume as soon as possible.

Acclimation

When first starting VS-01™, acclimation can be a common and anticipated experience. Symptoms such as vaginal discharge, mild-to-moderate irritation, or minor cramping may occur shortly after inserting the first vaginal tablet. These effects will normalize as your body adjusts to the protocol. If you are concerned about any potentially unwanted or negative effects, consult with your physician. 

Menses

It is recommended that you do not use VS-01™ while experiencing moderate to heavy bleeding, in order to allow the VS-01™ vaginal tablet to fully dissolve in the vagina and maximize absorption. Generally, Day 1 of each protocol starts as soon as bleeding stops.

Note that it is completely fine to insert VS-01™ while spotting or experiencing light bleeding.

If you experience breakthrough bleeding, <28 day cycles, or irregular periods that may disrupt the VS-01™ protocol, do not worry.  If you are unable to follow the recommended dosing schedule, please take each tablet as close to the dosing schedule as possible.

A vaginal microbiome dominated by L. crispatus is associated with favorable health outcomes. Synbiotics designed to support or shift vaginal microbiomes into this beneficial ecology from multiple starting ecologies have the potential to deliver health benefits. 

A randomized, double-blind placebo-controlled clinical trial (n=70) in healthy premenopausal women was conducted to compare multiple candidate L. crispatus vaginal synbiotic formulations, versus a leading oral probiotic for vaginal health, and placebo. Participants were randomized to each arm, and received a 30-day dosing regimen with 21-day follow-up. The primary outcome was safety, and the key secondary outcome was vaginal microbiome profiling by high-depth metagenomic sequencing. 

Results revealed a vaginal tablet formulation of VS-01™ demonstrated a significant increase in L. crispatus relative abundance, and the highest rates of conversion to an optimal vaginal microbiome. Participants with a baseline non-optimal vaginal microbiome experienced up to 90% conversion to an  L. crispatus dominant vaginal microbiome during the dosing period, compared to 11% in the placebo arm. VS-01™ significantly outperformed other candidate formulations and a leading oral probiotic for vaginal health. Colonization of VS-01™ strains,  (LUCA103™, LUCA011™, LUCA009™,) was associated with conversion to an optimal vaginal microbiome and a significant increase in strain relative abundance in the vaginal tablet arm. Overall, all formulations were well-tolerated with a favorable safety profile.

This study is the first to demonstrate that a multi-strain vaginal synbiotic (VS-01™) can drive persistent conversion to an optimal vaginal microbiome, coupled with colonization of product strains in different vaginal microbiome ecologies. Oral formulations were not effective in modulating the vaginal microbiome.

(RCT-X) VS-01™ Perception Study + QOL assessment

This randomized (2:1) placebo-controlled trial will assess the overall user experience of VS-01™ compared to placebo among 200 premenopausal women (18-55 years) with self-reported vaginal discomforts. Over the course of the study, following the standard VS-01™ protocol, participants will complete questionnaires to evaluate health-related quality of life and self-perceived changes in vaginal discomforts.  

Vaginal health has long been overlooked as an important health outcome. Significant disparities exist among gender in the health and medical community. Specifically, women of color often experience lower-quality health care and have worse health outcomes (Gillispie-Bell, 2021). This study ensures a broad representation of identities and experiences are represented in the sample population. 

This study is part of a broader aim to enrich the biological, ethnocultural, and linguistic diversity of medically studied populations, the applicability of the research findings, and to foster inclusiveness in clinical research and equity in health within the United States. 

Strain Selection Process

We aimed to identify and characterize specific strains of L. crispatus associated with stable, healthy vaginal microbiomes. L. crispatus displays significant diversity in optimal microbiomes, so we built a consortia of three strains that maximize coverage of naturally-occuring genomic diversity. To achieve this, we leveraged V-CLOUD, the field-leading proprietary genomic database containing the largest collection of vaginal genomes and metagenomes, combined with the most extensive gene library and longitudinal dataset on the vaginal microbiome available in the field.

Using V-CLOUD and a deeply sampled longitudinal vaginal microbiome dataset generated by Dr. Ravel, we identified specific genomic elements in some L. crispatus strains associated with vaginal microbiome stability. We screened close to 100 isolates of L. crispatus from healthy women for the presence of these elements, and identified three strains that contain the stability-associated genomic elements and capture nearly three-quarters of genomic diversity found in the human vaginal microbiome. This three strain ecology with broad genetic coverage enhances the formula’s potential to support and maintain an optimal vaginal microbiome.

Additionally, we performed extensive in vitro characterization of these strains for safety (they are free of antibiotic resistance genes and virulence factors, are susceptible to commonly used antibiotics, and are non-inflammatory) and efficacy against harmful microbes.

Most supplements, fruits, vegetables, milk-derived proteins, and natural products carry some level of heavy metals, which can be very difficult to completely eliminate from the diet due to their uptake by plants from the surrounding air, water, and soil. Food and natural products are regulated in California by CA Prop 65, or "The Safe Drinking Water and Toxic Enforcement Act of 1986", which establishes "safe harbor levels" for a list of chemicals known to the state to potentially cause cancer or reproductive toxicity. Seed abides by these stringent regulations and tests all products for the four main categories of Heavy Metals: Arsenic, Cadmium, Lead, and Mercury. As demonstrated in the table, VS-01™ falls well below the established limits.

Endocrine-disrupting chemicals (EDCs) are natural or synthetic chemicals that may mimic, block, or interfere with the body’s hormones, which are part of the endocrine system. These chemicals are associated with a wide array of health issues. VS-01™ is tested for a comprehensive panel of over 50 endocrine-disrupting substances including phthalates, per- and polyfluoroalkyl substances (PFAS), parabens, corticosteroids and estrogens.

VS-01™ is tested at third-party accredited laboratories for over 500 pesticide residues using gas chromatography with tandem mass spectrometry.  We [specifically] subject VS-01™ to testing for the ubiquitous pesticide, glyphosate, as well as its breakdown product, aminomethylphosphonic acid (AMPA), using liquid chromatography with tandem mass spectrometry.  This rigorous testing protocol ensures adherence to our strict quality standards.

The full list of pesticides tested may be viewed here.

VS-01™ is consistently tested for all 14 allergen classes, including over 20 of the most common allergens as defined by the European Food and Safety Authority (EFSA). This panel extends well beyond the minimum 9 allergens required to test by the FDA.

We conducted an extensive toxicological review of VS-01™, confirming its non-toxicity and safety for both short-term (<90 days) and long-term (>90 days) use by healthy individuals. Results also demonstrate no reproductive or developmental concerns. 

Osmolality is the number of moles of dissolved particles per kg of water (units mOsm). High osmolality indicates a high concentration of solutes in a solution. Normal vaginal fluid ranges between 300-400 mOsm.

Most vaginal lubricants are hyperosmolar (>2000 mOsm), can cause vaginal epithelial cell death, and loss of barrier integrity in 3-D tissue models. Epithelial damage can increase the risk of infection. Based on third-party laboratory testing with a GLP-compliant quality system, VS-01™ falls under the World Health Organization’s (WHO) established upper limit (1200mOsm) for osmolality.

We subjected VS-01™ to an FDA-recognized tissue culture model derived from healthy, human-derived vaginal epithelial and dendritic cells. Its highly-differentiated structure parallels in vivo vaginal tissue to better understand how products impact the vaginal epithelium. Testing revealed that VS-01™ preserves the integrity of the vaginal epithelial barrier without triggering inflammatory responses. This approach not only reflects our dedication to ethical research practices but also underscores our commitment to developing products that are safe and beneficial for vaginal health.

Interactions

VS-01™ would generally be suitable to take alongside most prescribed or over-the-counter medications as there are no known contraindications between medications and probiotics, prebiotics or postbiotics. That said, if you are currently taking medication for an existing vaginal infection or concern, follow the standard of care prescribed and introduce VS-01™ as directed by your doctor.

Ultimately, we always recommend consulting with a prescribing physician regarding incorporating VS-01™ into your routine alongside any medications or pre-existing conditions.

As with any new product contemplated during pregnancy, or pre-conception, we always recommend a conversation with a physician or obstetrician before trying VS-01™.