Diality

Executive Summary

Diality is a privately held medical device and digital health company founded in 2018 and headquartered in Irvine, California. The company is dedicated to transforming hemodialysis care through its innovative Moda-flx Hemodialysis System. This platform integrates clinical flexibility, advanced water purification, and an intuitive user interface, aiming to empower patients, providers, and clinicians across various care settings including in-center and potentially home dialysis. By addressing key pain points in traditional dialysis—such as complexity, limited portability, and high infrastructure costs—Diality seeks to improve patient outcomes and expand access to life-sustaining therapy. The company operates in the growing dialysis market, which is driven by rising chronic kidney disease prevalence and a shift toward value-based care and home-based treatments. Diality's Moda-flx system is currently under development and has not yet received regulatory clearance. The company's progress will depend on successful clinical validation, regulatory approvals, and commercialization partnerships. While no funding or revenue details are publicly available, the innovative nature of its technology positions Diality as a potential disruptor in the dialysis space. Key upcoming milestones include FDA submission and clearance, clinical study results, and potential strategic partnerships. Investors and industry observers will monitor the company's ability to navigate the rigorous regulatory pathway and secure the resources needed to bring its product to market.

Upcoming Catalysts (preview)

• Q3 2026FDA 510(k) Submission or Clearance for Moda-flx System60% success
• 2026Pivotal Clinical Study Results50% success
• 2026Strategic Partnership or Series A/B Funding Announcement70% success