Zero Candida Scales Production to 250 ISO 13485 Clinical-Grade Prototypes of ZC-001 Therapeutic Device

Executive Summary

• Zero Candida Technologies announced scaling production to 250 ISO 13485‑certified clinical‑grade prototypes of its ZC‑001 therapeutic device.
• The additional units will support GLP preclinical testing and keep the company on track for a Q4 2026 clinical study involving at least 100 women.
• Completion of the 250‑unit run is expected within 90 days, marking a key step toward human trials and market entry.

Key Details

• Production Scale‑Up: Manufacturing increased to 250 clinical‑grade prototypes under ISO 13485 quality standards.
• Timeline: All 250 units to be completed within the next 90 days.
• Regulatory Pathway: Prototypes will support Good Laboratory Practice (GLP) preclinical testing, a prerequisite for IND filing and subsequent human trials.
• Clinical Study Plan: Targeted Q4 2026 clinical study enrolling ≥100 women to evaluate efficacy of ZC‑001 in treating recurrent vulvovaginal candidiasis (VVC).
• Preclinical Performance: Prior laboratory tests demonstrated 99.999% fungal eradication under controlled conditions.
• Device Overview: ZC‑001 is a SMART, AI‑enabled therapeutic device combining precision blue‑light therapy, targeted drug delivery, and wireless diagnostics for at‑home treatment of VVC.
• Market Context: VVC treatment market projected to exceed US $2 billion by 2030; recurrent cases are increasingly drug‑resistant.

Notable Quotes

“Scaling volume helps us transition from laboratory validation to human studies more efficiently and demonstrates our commitment to medical‑grade excellence,” – Eli Ben‑Haroosh, CEO.