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.

项目概要 申请人 Venova Technologies 是一家女性主导的医疗器械初创公司。维诺瓦科技公司是 申请小型企业技术转让 (STTR) 第一阶段赠款，为发展提供资金 技术里程碑将提高我们正在申请专利的非激素的商业潜力 避孕装置。在美国，一半的怀孕是由于不一致或未使用避孕药而导致的意外怀孕。 避孕药具。目前的避孕药具提供了多种选择，试图满足不同人群的不同需求。 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，而且许多女性 由于与激素相关的副作用，请停止使用。停止使用其他高度药物的女性 有效的方法可能会采取效果较差的避孕措施，并增加意外发生的风险 怀孕。唯一高效的非激素方法是含铜宫内节育器 (IUD)。然而， 带铜宫内节育器会导致月经出血增多和痉挛加剧。其他非激素类 隔膜和避孕套等选择的效果要差得多。虽然很多女性可能更喜欢 非激素方法，避免不必要的副作用的选择会带来更高的怀孕风险。 对可靠、谨慎、负担得起、可接受和可靠的节育方案的迫切需求尚未得到满足。 无不良副作用。 Venova Technologies 正在开发一种非激素长效可逆装置 直接解决缺乏高效且副作用较小的方法的问题。维诺瓦 Technologies的避孕方案不依赖激素或金属来实现避孕，而且它确实 不干扰下丘脑-垂体-性腺轴，也不中断自然月经周期。该设备是 由经过培训的医疗保健专业人员安装和放置，并应为数人提供有效的避孕措施 年。体外研究证实了原理证明，并且设备已成功筛选和测试 使用超现实解剖模型的医生。在 STTR 第一阶段计划中，Venova 技术将使用三种技术进一步完善避孕装置的功能和性能 在日益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 解剖模型和子宫切除术期间切除的离体女性生殖组织。成功 在这个项目中将增加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融资机会。该设备将使女性能够控制自己的生育能力 采用安全、谨慎、长效、可逆、高效的方法，不依赖激素或金属。 Venova Technologies 的使命是解决全球对更多非激素选择的未满足需求 计划生育负担得起且可接受，完全符合 NICHD 2020 年战略计划，并且 对美国和世界各地妇女的健康和社会经济产生巨大的积极影响。