Development of ADAM Air: A Non-Hormonal Vas Occlusive Contraceptive Device

PROJECT SUMMARY Unintended pregnancies, which are unwanted or mistimed pregnancies, result from either not using contraception or improper use of available contraceptives. These pregnancies have a significant impact on healthcare costs and the families in which the unintended pregnancies occur. A promising strategy to reduce

unintended pregnancies and subsequent costs is to increase the contraceptive options available to men. Contraline has developed an injectable, long-lasting, vas-occlusive hydrogel called ADAM. ADAM is injected into the vas deferens to block sperm from traveling from the testicles to the ejaculatory duct. Although ADAM has

shown safety and efficacy in a First-in-Human trial, initial studies have shown that the next generation of ADAM (ADAM Air) can reduce manufacturing and procedural complexities, and enable on-demand reversibility should a patient desire their fertility be restored. ADAM Air is an aerogel, or dehydrated version of the ADAM hydrogel.

As a result, ADAM Air is implanted into the vas deferens, rather than injected; however, within minutes, the aerogel absorbs fluid and swells to become a highly effective occlusive hydrogel. The initial formulation of ADAM Air displays >20% terminal swelling and >200% swelling force than ADAM, all while maintaining ideal mechanical

properties for vas occlusion. Moreover, the first generation of ADAM induces azoospermia at implant lengths of ≥ 15 cm, making on-demand reversal prior to implant degradation difficult. ADAM Air can be manufactured at a variety of diameters and lengths (i.e.,