Current and foreseeable birth control methods require users to make life choices involving safety, reliability, or permanent sterilization. The proposed solution is a fallopian tube occlusion device inserted via a hysteroscopic, transcervical procedure. This new device will add a safe, reliable and reversible choice of birth control methods. The device technology is based on modification of an existing shape-memory, thermal-sensitive material, which will be rigid at room temperature for easy insertion and become soft and adaptive to the anatomy at body temperature. As this softening occurs, the material will expand to occlude the fallopian tube to prevent the passage of eggs and sperm rendering the patient infertile. The device may be removed to reestablish fertility. In Phase I we developed a family of material formulations, selected a single formulation, and successfully conducted limited feasibility testing in rabbit and porcine fallopian tube tissue. In Phase II we will conduct biocompatibility studies of the material, develop the full delivery system, conduct animal functionality studies, and file a submission with the USFDA for clearance to conduct human studies in Phase II. Commercialization of this device would be expected to command a significant share of the $3 billion contraceptive market. ? ?
