Development of a novel, non-hormonal female contraceptive device to submit IDE

PROJECT SUMMARY Venova Technologies is a women-led medical device startup, developing an innovative non-hormonal female contraceptive device designed to be long acting and side effect free. Venova Technologies is applying for a Small Business Innovation Research (SBIR) Phase II grant to advance the development of our patent-pending technology in anticipation of future primate 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 over 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 available methods do not meet their needs. 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, reversible, non-hormonal method in the US is the copper intrauterine device (IUD) which can be 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 have high failure rates. Although many women prefer hormone-free methods, the choice to avoid side effects comes with a higher risk of pregnancy. Venova Technologies 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 in simulation models, an ongoing ex vivo study using excised human uterine tissues, a pilot preclinical study in primates, and an ongoing sperm efficacy study that our device: (1) functions under simulated physiological conditions; (2) can be easily placed and retained ex vivo in human tissues; (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; and (4) provides contraceptive protection by completely blocking sperm in vitro. In this Phase II project, Venova Technologies will proceed with optimizing the device and manufacturing process towards clinical production and conduct the FDA-required biocompatibility testing. The expected outcomes of this Phase II program are a finalized clinical device and a complete biocompatibility data package, which will enable Venova Technologies to proceed with FDA approval to conduct a first-in-human Pilot Study. Our mission fully aligns with the NICHD Strategic Plan 2020 and the Contraception Research Branch priorities to address the unmet needs in women’s health with improved methods of female contraception. Providing more user-focused and acceptable methods of contraception will have immense positive health and socioeconomic benefits for women and their families.