Development of a novel, non-hormonal female contraceptive device

PROJECT SUMMARY The applicant, Venova Technologies, is a woman-led medical device startup company. Venova Technologies is applying for a Small Business Technology Transfer (STTR) Phase I grant to fund development towards technical milestones that will advance the commercial potential of our patent-pending non-hormonal contraceptive device. Half of pregnancies in the United States are unintended due to inconsistent or non-use of contraceptives. Current contraceptives offer a range of options in an attempt to meet the varying needs of women at different stages of their lives. Yet many women remain dissatisfied with their options, and many discontinue use due to hormonally-related side effects. Women who discontinue use of an otherwise highly effective method are likely to resort to less effective contraceptives and increase their risk of unintended pregnancy. The only highly effective non-hormonal method is the copper intrauterine device (IUD). However, the copper IUD is associated with heavier menstrual bleeding and increased cramping. Other non-hormonal options, such as diaphragms and condoms, are considerably less effective. Although many women may prefer non-hormonal methods, the choice to avoid unwanted side effects comes with a higher risk of pregnancy. There is a critical unmet need for birth control options that are reliable, discreet, affordable, acceptable, and without adverse side effects. Venova Technologies is developing a non-hormonal long-acting reversible device to directly address the paucity of methods that are highly effective with a reduced side effective profile. Venova Technologies’ contraceptive solution does not rely on hormones or metals to achieve contraception, and it does not interfere with the hypothalamic-pituitary-gonadal axis nor interrupt natural menstrual cycles. The device is fitted and placed by a trained healthcare professional and should provide effective contraception for several years. In vitro studies confirmed proof of principle, and devices have been successfully screened and tested by a medical practitioner using hyper-realistic anatomical models. In this STTR Phase I program, Venova Technologies will further refine the functionality and performance of the contraceptive device using three screening steps in increasingly realistic environments: benchtop in vitro tests, advanced tissue-mimicking anatomical models, and ex vivo female reproductive tissues excised during surgical hysterectomies. Success in this project will increase confidence in the device design needed to proceed with in vivo studies and to pursue future grants and external funding opportunities. The device will offer women control over their fertility with a safe, discreet, long-acting, reversible, highly effective method that does not rely on hormones or metals. Venova Technologies’ mission to address the global unmet need for more non-hormonal options that are affordable and acceptable for family planning fully aligns with the NICHD Strategic Plan 2020 and has immense positive health and socioeconomic implications for women in the United States and around the world.PROJECT NARRATIVE Contraceptive innovation is urgently needed to help women manage their fertility and mitigate the risks of unintended pregnancy. Venova Technologies is developing a highly effective long-acting female barrier method that does not rely on hormones or metal to prevent pregnancy. This STTR Phase I project will accelerate the design development and refinement of Venova’s novel device enabling progress towards first-in-human clinical trials and a successful commercialization program.