Subcutaneous insertion and removal of a user-controlled, long-acting, and reversible contraceptive device

现代避孕药具不仅在预防意外怀孕方面发挥着关键作用， 通过赋予妇女控制自身生殖健康的必要资源， 包括子女的数目和间隔。尽管越来越多的人认识到 避孕方法对所有妇女都有效，避孕市场的进步超过了 在过去的几十年里，不断增长的避孕药具市场的一个高影响力驱动因素是 意外怀孕的数量，如果避孕药具使用不当，意外怀孕的风险会增加， 不一致，或者根本不一致。美国的意外怀孕率明显高于其他许多国家。 在发达国家，每年有近5%的育龄妇女意外怀孕。 在美国，意外怀孕每年造成的直接医疗费用高达数十亿美元，以及 作为重大的医疗风险，特别是对于处于生育年龄跨度两端的妇女， 寻求充分的孕前护理为了满足妇女对新的避孕选择的需要， 生物科学正在推进DARE-LARC 1的开发。DARE-LARC 1是一种植入式器械， 服用普通避孕药左炔诺孕酮至少十年。与现有的长效、可逆 避孕药，交付可以无线打开和关闭，从而为妇女和夫妇提供一个安全， 方便，有效的避孕选择的时间和空间怀孕。本SBIR阶段的目标 我的建议是证明器械插入和取出的可行性。在联合国系统内开展的工作 资助期将导致（1）确定上臂DARE-LARC 1插入的可行部位 （2）初步插入标准的定义。所有里程碑的成功完成， 该提案将推进DARE-LARC 1的研究和开发，以促进未来的研究，重点是发展 用于DARE-LARC 1插入和取出的定制工具。

Modern contraceptives not only play a critical role in preventing unplanned pregnancy but also contribute to a woman’s well-being by empowering her with the necessary resources to control her own reproductive health, including the number of, and spacing between, children. Despite the growing recognition that no one contraceptive method works well for all women all of the time, advances in the contraceptive market over the past several decades have been incremental. A high-impact driver of the growing contraceptives market is the number of unintended pregnancies, the risk of which is increased when contraceptives are used incorrectly, inconsistently, or not at all. The unintended pregnancy rate in the U.S. is significantly higher than in many other developed countries, with nearly 5% of reproductive-age women having an unintended pregnancy each year. Unintended pregnancy is associated with annual direct medical costs in the billions of dollars in the U.S., as well as significant medical risk, particularly for women at both ends of the reproductive age span who are less likely to seek adequate preconception care. To meet the need for new contraceptive options for women, Daré Bioscience is advancing the development of DARE-LARC1. DARE-LARC1 is an implantable device that delivers the common contraceptive levonorgestrel over at least ten years. Unlike existing long-acting, reversible contraceptives, delivery can be turned on and off wirelessly, thereby providing women and couples with a safe, convenient, and effective contraceptive option to time and space pregnancies. The objective of this SBIR Phase I proposal is to demonstrate the feasibility of device insertion and removal. The work undertaken during the funding period will result in (1) identification of the feasible site(s) of DARE-LARC1 insertion in the upper arm and (2) definition of preliminary insertion criteria. The successful accomplishment of all milestones in this proposal will advance DARE-LARC1 research and development to future studies focused on the development of custom tools for DARE-LARC1 insertion and removal.