At the Forefront of Innovation
75% of women in the US want a birth control method that is highly effective and has few or no side effects.
This combination does not exist today.
OUR SOLUTION
We are developing an innovative long acting barrier device with the high effectiveness of the IUD without side effects
WHAT WE WANT TO OFFER ALL WOMEN
Low-To-No Side Effect Profile
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 to the body
No Menstrual Changes
Not expected to affect regular menstrual cycles, change bleeding profiles, nor cause spotting in between periods
Long Acting
Expected to last several years
Set-It-And-Forget-It
Reversible
Fertility will return to normal immediately after the device is removed
Forgettable
Discreetly worn in the reproductive system and does not need regular maintenance
Acceptability & Accessibility
Fitted to User
Inserted in the female reproductive system by any trained medical professional
Future Self-Removable Design
Designing for user-controlled removal to give people more autonomy over their birth control
Affordable Option
Designed to be low-cost and accessible for patients who do not have health insurance
WHERE WE ARE
Our Roadmap
STEP 1
Concept & Design
An unmet need is identified. Concepts are generated and researched in the laboratory for proof-of-concept.
STEP 2
Preclinical Research
Prototypes are tested in non-clinical settings, such as in animals and excised human tissues.
STEP 3
Clinical Trials
Devices are tested in humans, first in a small trial and then a larger trial, for safety and efficacy.
STEP 4
Regulatory Approval
Clinical data is thoroughly examined by regulatory bodies to determine if the device will be approved.
STEP 5
Product Launch
The approved device becomes available to providers and patients. Safety will continue to be monitored.
PRECLINICAL RESEARCH OVERVIEW
De-Risking Our Technology
CUSTOMER DISCOVERY
Initial Market Validation
During the National Science Foundation I-Corps Program, we conducted customer discovery interviews with women who use or have used birth control and medical professionals (such as obstetrician-gynecologists (OB/GYNs), physician assistants, nurse practitioners, nurses, and practice managers) from across the US and from a range of small private clinics to large academic hospital institutions. Through our conversations, we (1) identified key user personas, (2) learned that patients and providers are not completely satisfied with the current options, and (3) validated the unmet need for more nonhormonal and reliable options.
PROOF-OF-CONCEPT
In Vitro Testing
We tested the performance of our device with (1) hyper-realistic anatomical models to simulate the human female reproductive system and (2) with simulated fluids, such as artificial menstrual fluid, simulated mucus, and simulated seminal fluid. We demonstrated that our device concept has the potential to function as an innovative barrier method.
IN VIVO
Pilot Safety Study in Non-Human Primates
We conducted 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 or vaginal flora, inflammatory markers, or tissue pathology.
EX VIVO
Ongoing Hysterectomy Study
We have tested devices in 20+ excised human tissues after they are removed from patients undergoing hysterectomies for non-cancerous indications. We have demonstrated fit, ease of insertion, and ease of retrieval from ex vivo human tissues across ranges of age and parity (a.k.a. number of vaginal births).
IN VITRO
Ongoing Efficacy Study Using Human Sperm
We have shown complete blockage of human sperm and rat sperm with our device. Note: rat sperm are smaller than human sperm.
Funded By
Women deserve better
As an impact-driven team, we not only want to deliver a solution directly designed for 75% of women in the US, we want to ensure equitable access so all women can achieve their reproductive goals.
