Development of a novel, non-hormonal female contraceptive device
开发一种新型非激素女性避孕装置
基本信息
- 批准号:10602355
- 负责人:
- 金额:$ 30.01万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressAdolescentAffectAnatomic ModelsAnatomyBarrier ContraceptionBusinessesCervix UteriClinical TrialsCollaborationsContraceptive AgentsContraceptive DevicesContraceptive methodsCopper Intrauterine DevicesDataDevelopmentDevice DesignsDevicesEnvironmentFamily PlanningFemaleFemale Contraceptive DevicesFertilityFertilizationFundingFunding OpportunitiesFutureGoalsGrantHealthHealth ProfessionalHemorrhageHigh-Risk PregnancyHormonalHormonesHumanHysterectomyIn VitroInterruptionIntrauterine DevicesInvestigationLeadLegal patentLow incomeMeasuresMedicalMedical DeviceMenstrual cycleMenstrual fluidMetalsMethodsMissionMuscle CrampNational Institute of Child Health and Human DevelopmentOperative Surgical ProceduresOutcomePainPatientsPerformancePersonsPhasePhysiologicalPregnancyPropertyReproductive HealthResearchResortRespiratory DiaphragmRetrievalRiskSafetyScreening ResultSeminalSeminal fluidSideStrategic PlanningTechnologyTechnology TransferTest ResultTestingTissuesTrainingUnited StatesUnited States Dept. of Health and Human ServicesUnited States Food and Drug AdministrationUterusVacuumVaginaValidationWomanbasebiomaterial compatibilitybirth controlcommercializationcondomsdesignfemale fertilityfirst-in-humanhypothalamic pituitary gonadal axisimprovedin vitro testingin vivoinnovationmodels and simulationmultidisciplinarynovelpregnancy preventionpreservationpressurepreventprogramsreproductivescreeningside effectsocioeconomicssuccessunintended pregnancywomen of color
项目摘要
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
项目成果
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