Development of a novel, non-hormonal female contraceptive device

项目摘要 申请人Venova Technologies是一家由女性领导的医疗器械创业公司。Venova Technologies是 申请小企业技术转让（STTR）第一阶段赠款，以资助发展， 技术里程碑，将推进我们的专利申请中的非激素的商业潜力， 避孕用具在美国，有一半的怀孕是由于不一致或不使用避孕药具而意外发生的。 避孕药目前的避孕药具提供了一系列的选择，以满足不同的需要， 女性在不同的人生阶段。然而，许多妇女仍然对她们的选择不满意， 停止使用，由于与药物有关的副作用。妇女停止使用其他高度 有效避孕方法很可能采用效果较差的避孕方法， 怀孕唯一高效的非激素方法是铜宫内节育器（IUD）。然而，在这方面， 铜宫内节育器与月经出血量增加和痉挛增加有关。其他非激素类 子宫帽和避孕套等选择的效果要差得多。虽然许多女性可能更喜欢 非激素方法，选择避免不必要的副作用，怀孕的风险更高。 对于可靠、谨慎、负担得起、可接受且 没有副作用。Venova Technologies正在开发一种非激素长效可逆装置 以直接解决具有降低的副作用分布的高度有效的方法的缺乏。韦诺娃 技术的避孕解决方案不依赖于激素或金属来实现避孕， 不干扰下丘脑-垂体-性腺轴，也不中断自然月经周期。该装置 由受过培训的医疗保健专业人员安装和放置，并应提供有效的避孕， 年体外研究证实了原理的证明，并且设备已成功筛选和测试， 一个使用超现实解剖模型的医生。在STTR第一阶段计划中，Venova 技术将进一步完善避孕装置的功能和性能， 在日益逼真的环境中进行筛选：台式体外试验、先进的组织模拟 解剖模型和在外科切除术期间切除的离体雌性生殖组织。成功 将增加进行体内研究所需的器械设计的信心， 寻求未来的赠款和外部资助机会。该设备将使女性能够控制自己的生育能力 一种安全、谨慎、长效、可逆、高效的方法，不依赖于激素或金属。 Venova Technologies的使命是解决全球对更多非激素选择的未满足需求， 负担得起和可接受的计划生育完全符合NICHD战略计划2020， 对美国和世界各地的妇女产生了巨大的积极健康和社会经济影响。

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.