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

> **NIH NIH R44** · CONTRALINE, INC. · 2024 · $291,440

## Abstract

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., <5 cm) making on-demand reversal safer and more reliable. In this SBIR
proposal, we will develop three optimized formulations of ADAM Air to screen for enhanced occlusive
performance and commercial potential. The ADAM Air formulation that demonstrates superior physicochemical
properties will be selected and undergo preliminary biocompatibility studies in vitro and in vivo (rabbit model).
After establishing initial biocompatibility, implant delivery and reversal feasibility will be tested and optimized in
a human cadaver model. After completion of Phase I, Contraline will perform GLP compliant FDA IDE-enabling,
starting with detailed mechanical and chemical characterization of ADAM Air. Next, the full suite of
biocompatibility studies will be executed based on FDA requirements. Finally, in vivo canine studies will be
performed to evaluate ADAM Air implantation and reversal safety and efficacy. Upon completion of these aims,
Contraline will have demonstrated the overall feasibility of using an aerogel for male contraception, the first
product of its kind. ADAM Air will be shown to be safe, effective, and reversible across a variety of benchtop, ex
vivo, and in vivo models. This will allow Contraline to submit an IDE application to pursue a First-in-Human
clinical trial for ADAM Air. Following completion of the First-in-Human trial, a pivotal trial will be initiated to support
FDA approval. These aims...

## Key facts

- **NIH application ID:** 10929569
- **Project number:** 1R44HD115509-01
- **Recipient organization:** CONTRALINE, INC.
- **Principal Investigator:** Yelena Tropsha
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $291,440
- **Award type:** 1
- **Project period:** 2024-09-10 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10929569

## Citation

> US National Institutes of Health, RePORTER application 10929569, Development of ADAM Air: A Non-Hormonal Vas Occlusive Contraceptive Device (1R44HD115509-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10929569. Licensed CC0.

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