Modern contraceptives not only play a critical role in preventing unplanned pregnancy but also contribute to awoman'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 onecontraceptive method works well for all women all of the time, advances in the contraceptive market over thepast several decades have been incremental. A high-impact driver of the growing contraceptives market is thenumber 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 otherdeveloped 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 wellas significant medical risk, particularly for women at both ends of the reproductive age span who are less likelyto seek adequate preconception care. To meet the need for new contraceptive options for women, DaréBioscience is advancing the development of DARE-LARC1. DARE-LARC1 is an implantable device that deliversthe common contraceptive levonorgestrel over at least ten years. Unlike existing long-acting, reversiblecontraceptives, 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 PhaseI proposal is to demonstrate the feasibility of device insertion and removal. The work undertaken during thefunding period will result in (1) identification of the feasible site(s) of DARE-LARC1 insertion in the upper armand (2) definition of preliminary insertion criteria. The successful accomplishment of all milestones in thisproposal will advance DARE-LARC1 research and development to future studies focused on the developmentof custom tools for DARE-LARC1 insertion and removal.
Public Health Relevance Statement: 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.
Project Terms: Termination of pregnancy ; Adhesions ; Age ; ages ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Animals ; Biological Sciences ; Biologic Sciences ; Bioscience ; Life Sciences ; Birth Intervals ; Birth Spacing ; Cadaver ; capsule ; Capsules ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Clinical Research ; Clinical Study ; Family Planning ; Family Planning Services ; Contraceptive Agents ; Contraceptives ; Contraceptive Availability ; Contraceptive Devices ; non-drug contraceptive ; nondrug contraceptive ; Contraceptive Usage ; contraceptive use ; Couples ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Family ; Family Sizes ; Feasibility Studies ; Female ; Future ; Goals ; Health ; Health Personnel ; Health Care Providers ; Healthcare Providers ; Healthcare worker ; health care personnel ; health care worker ; health provider ; health workforce ; healthcare personnel ; medical personnel ; treatment provider ; Hemorrhage ; Bleeding ; blood loss ; implantable device ; biomedical implant ; implant device ; indwelling device ; Implantation procedure ; implant placement ; implant procedure ; In Vitro ; Infant ; Interview ; Intrauterine Devices ; Intrauterine Contraceptive Devices ; intra-uterine contraception ; intra-uterine contraceptive device ; intra-uterine device ; intra-uterine system ; intrauterine contraception ; intrauterine system ; Levonorgestrel ; D-Norgestrel ; l-Norgestrel ; Methods ; Modernization ; Muscle ; Muscle Tissue ; muscular ; Personal Satisfaction ; well-being ; wellbeing ; Play ; Pregnancy ; Gestation ; Pregnancy Rate ; Prenatal care ; pregnancy care ; prenatal appointment ; prenatal checkup ; prenatal visit ; Progestins ; Corlutina ; Corluvite ; Cyclogest ; Gestagenic Agents ; Gestagens ; Gestiron ; Gestone ; Lipo-Lutin ; Luteohormone ; Lutocyclin ; Lutocylin M ; Lutogyl ; Lutromone ; Progestagenic Agents ; Progestasert ; Progestational Agents ; Progestational Compounds ; Progestational Hormones ; Progesterone Agents ; Progestogel ; Progestogens ; Progestol ; Progeston ; Prolidon ; Proluton ; Syngesterone ; Therapeutic Progestin ; Utrogestan ; Public Health ; research and development ; Development and Research ; R & D ; R&D ; Resources ; Research Resources ; Risk ; Role ; social role ; Safety ; seal ; Silicon ; Si element ; Space Perception ; Spatial Discrimination ; perceptual spatial orientation ; spatial orientation ; spatial perception ; Surveys ; Survey Instrument ; Family suidae ; Pigs ; Suidae ; Swine ; porcine ; suid ; Technology ; Time ; Tissues ; Body Tissues ; United States ; Woman ; Work ; wound healing ; Wound Repair ; wound resolution ; Measures ; Drug Delivery Systems ; Drug Delivery ; Preconception Care ; Medical Care Costs ; medical costs ; Postpartum Period ; Postpartum ; post-partum ; Custom ; improved ; Procedures ; Surgical incisions ; Otomy ; incision ; Medial ; Site ; Clinical ; Phase ; Medical ; Ensure ; Individual ; Reproductive Health ; Funding ; Subcutaneous Tissue ; Hypodermis ; Subcutis ; Superficial Fascia ; Tela Subcutanea ; subdermal tissue ; Collaborations ; Developed Countries ; Industrialized Countries ; Industrialized Nations ; developed country ; developed nation ; developed nations ; Shapes ; tool ; programs ; Event ; subdermal ; subcutaneous ; Upper arm ; System ; Location ; Width ; empowered ; Structure ; skills ; novel ; Categories ; Devices ; Reporting ; Contraception ; Fertility Control ; Inhibition of Fertilization ; Contraceptive methods ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; reproductive ; Device Removal ; Property ; microchip ; pill ; Skin ; Thickness ; Thick ; preventing ; prevent ; Length ; Dose ; Adherence ; Economic Burden ; Reproducibility ; in vivo ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Wireless Technology ; wireless ; Modification ; Development ; developmental ; pregnancy prevention ; prevention of pregnancy ; unintended pregnancy ; Unplanned pregnancy ; Advanced Development ; design ; designing ; Outcome ; migration ; Implant ; arm ; reversible contraceptive ; neurovascular ; neuro-vascular ; postpartum care ; post-partum care ; wound care ; wound assessment ; wound monitoring ;
