ScarDx

Solution overview

ScarScan is a software layer that processes conventional B-mode ultrasound images to produce a quantitative, real-time fibrosis score for solid organs. The initial indication is chronic kidney disease (CKD): ScarScan gives nephrologists a non-invasive biopsy alternative that can be performed at the bedside, repeated as often as needed, and reported in under five minutes.

Scientific progress to date

In a prospective cohort study, ScarScan fibrosis scores correlated strongly with kidney biopsy fibrosis grade (the current gold standard), and scores at baseline predicted eGFR one year post-scan — establishing clinical utility beyond diagnosis. The FDA has issued a Letter of Support for the regulatory pathway. Validation study endpoints are planned for 2027 (Canadian cohort) and 2028 (US multi-centre).

Benefit to the Canadian health-care system

Kidney biopsy carries a complication rate of 1–3%, is expensive, and cannot be repeated frequently enough to guide treatment decisions in real time. An estimated 4 million Canadians have CKD. Replacing or complementing biopsy with a fast, non-invasive, repeatable test would reduce procedure-related harm, support earlier therapeutic intervention, and lower the cost of disease monitoring across the healthcare system.

Proposed use of funds

The $1M–$2M raise funds the Canadian clinical validation study (2027 endpoint), ISO 13485 quality-system implementation, and regulatory package preparation for Health Canada and FDA 510(k) submission. Secondary use supports hiring a regulatory affairs lead and a clinical study coordinator.

Team