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

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.The availability of a contraceptive device that can be used for at least ten years and has the convenience of starting and stopping pregnancy protection wirelessly will be an important advance in expanding the contraceptive options available to women. The work described in this proposal is focused on developing safe, reliable, and reproducible criteria for the insertion of a first-in-class contraceptive device, the microchip contraceptive system, under the skin of the upper arm.