# A novel, non-hormonal, long-acting female contraceptive device

> **NIH NIH R43** · VENOVA TECHNOLOGIES, INC. · 2024 · $383,114

## Abstract

PROJECT SUMMARY
Venova Technologies is a women-led and minority-led medical device startup company, developing an
innovative non-hormonal female contraceptive device designed to be long-acting and side-effect-free. Venova
is applying for a Small Business Innovation Research (SBIR) Phase I grant to advance the development of our
patent-pending technology in anticipation of future biocompatibility testing and clinical trials. Over the past
several decades, contraceptive innovation has primarily targeted new delivery modes of hormones that follow
the same mechanism of action as the birth control pill, which was FDA approved sixty years ago. Despite the
availability of numerous types of contraception, many women remain dissatisfied and will discontinue birth
control use; in many cases, the side effects are unacceptable, and the available methods do not meet their
needs and preferences. The majority of effective contraceptive methods contain hormones and are associated
with menstrual changes, such as irregular or prolonged bleeding or amenorrhea. The only highly effective,
non-hormonal method in the US is the copper intrauterine device (IUD) which is associated with increased
menstrual bleeding and painful menstruation. Although other non-hormonal options (such as condoms, cervical
caps, diaphragms, and spermicides) do not alter menstruation, they tend to have high failure rates. Although
many women prefer non-hormonal methods, the choice to avoid side effects comes with a higher risk of
pregnancy. Venova is developing a first-in-class, long-acting, reversible solution to address the critical unmet
need for birth control options without hormonal and copper side effects. Our device does not interfere with the
hypothalamic-pituitary-gonadal axis nor interrupt natural menstrual cycles, and it acts prior to fertilization. We
have demonstrated, through proof-of-concept studies in simulation models, ex vivo studies using excised
human uterine tissues, and a pilot preclinical study in nonhuman primates, that our device (1) functions under
simulated physiological conditions, (2) can be placed and retained in human tissues, and (3) can be tolerably
worn in vivo during menses and will not alter the vaginal microbiome, induce an inflammatory response, nor
cause uterine and cervical tissue necrosis. In this SBIR Phase I program, Venova will continue to improve and
de-risk their contraceptive innovation through iterative design cycling using robust acceptance criteria to
enhance its barrier efficiency and insertion reliability. Success in this project will enable Venova to continue with
biocompatibility testing and apply for FDA approval to conduct pilot clinical studies in a future SBIR Phase II
program. Pilot clinical data will provide justification to partner with an established industry company to manage
pivotal clinical trials, navigate regulatory approvals, and market and distribute the devices to providers and
patients. Venova’s mission fully aligns with th...

## Key facts

- **NIH application ID:** 11006653
- **Project number:** 1R43HD116640-01
- **Recipient organization:** VENOVA TECHNOLOGIES, INC.
- **Principal Investigator:** Emily Man
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $383,114
- **Award type:** 1
- **Project period:** 2024-09-13 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11006653

## Citation

> US National Institutes of Health, RePORTER application 11006653, A novel, non-hormonal, long-acting female contraceptive device (1R43HD116640-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/11006653. Licensed CC0.

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