Development of a novel, non-hormonal female contraceptive device

开发一种新型非激素女性避孕装置

• 批准号: 10602355
• 负责人: Emily Man
• 金额: $ 30.01万
• 依托单位: VENOVA TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-21 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10602355
• 关键词: Address; Adolescent; Affect; Anatomic Models; Anatomy; Barrier Contraception; Businesses; Cervix Uteri; Clinical Trials; Collaborations; Contraceptive Agents; Contraceptive Devices; Contraceptive methods; Copper Intrauterine Devices; Data; Development; Device Designs; Devices; Environment; Family Planning; Female; Female Contraceptive Devices; Fertility; Fertilization; Funding; Funding Opportunities; Future; Goals; Grant; Health; Health Professional; Hemorrhage; High-Risk Pregnancy; Hormonal; Hormones; Human; Hysterectomy; In Vitro; Interruption; Intrauterine Devices; Investigation; Lead; Legal patent; Low income; Measures; Medical; Medical Device; Menstrual cycle; Menstrual fluid; Metals; Methods; Mission; Muscle Cramp; National Institute of Child Health and Human Development; Operative Surgical Procedures; Outcome; Pain; Patients; Performance; Persons; Phase; Physiological; Pregnancy; Property; Reproductive Health; Research; Resort; Respiratory Diaphragm; Retrieval; Risk; Safety; Screening Result; Seminal; Seminal fluid; Side; Strategic Planning; Technology; Technology Transfer; Test Result; Testing; Tissues; Training; United States; United States Dept. of Health and Human Services; United States Food and Drug Administration; Uterus; Vacuum; Vagina; Validation; Woman; base; biomaterial compatibility; birth control; commercialization; condoms; design; female fertility; first-in-human; hypothalamic pituitary gonadal axis; improved; in vitro testing; in vivo; innovation; models and simulation; multidisciplinary; novel; pregnancy prevention; preservation; pressure; prevent; programs; reproductive; screening; side effect; socioeconomics; success; unintended pregnancy; women of color

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.

项目总结 申请者Venova Technologies是一家由女性领导的医疗器械初创公司。Venova Technologies是 申请小型企业技术转让第一阶段资助，以资助 技术里程碑，将推进我们正在申请专利的非荷尔蒙产品的商业潜力 避孕器。在美国，一半的怀孕是由于不一致或没有使用 避孕药。目前的避孕药提供了一系列的选择，试图满足不同的需求 处于人生不同阶段的女性。然而，许多女性仍然对自己的选择不满意，许多 由于激素相关的副作用而停止使用。停止使用其他高度敏感药物的女性 有效的方法可能会求助于效果较差的避孕措施，并增加他们意外的风险 怀孕了。唯一高效的非激素性方法是铜质宫内节育器(IUD)。然而， 铜质宫内节育器与月经出血和痉挛增加有关。其他非荷尔蒙 选择，如避孕套和避孕套，效果要差得多。尽管许多女性可能更喜欢 非激素方法，选择避免不想要的副作用伴随着更高的怀孕风险。 对可靠、谨慎、负担得起、可接受和 没有副作用。Venova Technologies正在开发一种非荷尔蒙长效可逆设备 直接解决缺乏高效且副作用减少的方法。维诺娃 科技公司的避孕解决方案不依赖荷尔蒙或金属来实现避孕，它确实做到了 不干扰下丘脑-垂体-性腺轴，也不干扰自然月经周期。该设备是 由训练有素的保健专业人员安装和放置，并应为几个人提供有效的避孕措施 好几年了。体外研究证实了原理的证据，设备已经成功地进行了筛选和测试 使用超逼真解剖模型的医生。在这一STTR第一阶段计划中，Venova 技术将进一步完善避孕器的功能和性能，使用三个 在越来越现实的环境中进行筛选步骤：台式体外测试、先进的组织模拟 解剖模型，以及在外科子宫切除术中切除的体外女性生殖组织。成功 这个项目将增加人们对进行体内研究所需的设备设计的信心 寻求未来的赠款和外部资金机会。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、不依赖激素或金属的高效方法。 Venova Technologies的使命是满足全球对更多非激素选择的未得到满足的需求 负担得起和可接受的计划生育完全符合《2020年消除对妇女一切形式歧视公约》战略计划，并 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。