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.
