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

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 the NICHD Strategic Plan 2020 to address the unmet needs in women’s reproductive health. Providing more user-focused and acceptable methods of contraception will have immense positive health and socioeconomic benefits for women and their families.