At the Forefront of Innovation
THE UNMET NEED
Women Are Underserved
73% of women in the US want a birth control method that is highly effective and has few or no side effects, but this combination of features does not exist today.
OUR SOLUTION
We are developing an innovative long-acting cervical barrier device with the high effectiveness of the IUDs without their side effects.
WHAT WE WANT TO OFFER ALL WOMEN
Low-To-No Side Effects
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Hormone-Free
Does not contain any synthetic hormones and does not cause hormonal side effects
Copper-Free
Not associated with the side effects common with the copper IUD and is not toxic
No Menstrual Changes
Not expected to change bleeding patterns nor cause spotting because it does not have hormones or copper and is not in the uterus
Set-It-And-Forget-It
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Long-Acting
Expected to last several years
Reversible
Fertility will return to normal immediately after the device is removed
Forgettable
Discreetly worn in the cervix without interfering with intercourse and does not need regular maintenance
Accessible & Acceptable
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Fitted to User
Inserted by any trained medical professional without triggering IUD pain points in the uterus
Affordable Option
Designed to be low-cost and accessible for patients who do not have insurance coverage
Self-Removable Option
Designing a 2nd generation device with user-controlled removal to give people more autonomy over their birth control
MARKET SIZE
Large & Growing Market Opportunity
$2B
US IUD Market
13M IUD users in the US
$10B
US Contraceptive Market
80M birth control users in the US
$36B
Global Contraceptive Market
1B birth control users worldwide
Global Market Insights Report 2023-2032 (2030)OUR ROADMAP
Completing Our Preclinical Development Toward Clinical Studies
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Concept & Design
An unmet need is identified. Concepts are generated and researched in the laboratory for proof-of-concept.
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Preclinical Research
Prototypes are tested in non-clinical settings, such as in animals and excised human tissues.
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Clinical Trials
Devices are tested in humans, first in a small trial and then a larger trial, for safety and efficacy.
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Regulatory Approval
Clinical data is thoroughly examined by regulatory bodies to determine if the device will be approved.
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Product Launch
The approved device becomes available to providers and patients. Safety will continue to be monitored.
PRECLINICAL RESEARCH OVERVIEW
De-Risking Our Technology
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Product Market Fit
We have spoken with 50+ medical professionals and 50+ women and people who have used birth control, and we validated the unmet need for more non-hormonal and copper-free options.
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Functional Testing
We tested the performance of our device with hyper-realistic anatomical models and with simulated fluids, including artificial menstrual fluid, simulated mucus, and simulated seminal fluid.
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In Vitro Efficacy Study
We have shown complete blockage of human sperm from 10 donors and of rat sperm with our device.
Note: Rat sperm are smaller than human sperm!
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Hysterectomy Study
We have tested our device in 25+ excised human tissues after they are removed from patients undergoing hysterectomies. We have demonstrated fit, retention and ease of insertion and retrieval.
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Pilot Baboon Study
In a 2-week pilot study in baboons, our device was safely and tolerably worn through menses. We did not observe any changes in animal behavior, microbiome, inflammation, or tissue pathology.
FUNDING SOURCES
Primarily Grant-Funded
OUR VISION
Women Deserve Better
As an impact-driven team, we not only want to deliver a solution directly designed for 73% of women in the US, we want to ensure equitable access so all women and girls can achieve their reproductive goals.