Photocure agreed to acquire Vesica Health for $30.5 million to expand its bladder cancer diagnostics portfolio. The deal adds AssureMDx, a urine-based molecular test built on methylation-specific PCR and next-generation sequencing to support risk stratification in hematuria patients. Photocure said the test has been validated in multiple prospective multicenter studies and has demonstrated 96% sensitivity and 99.7% negative predictive value. It also cites incorporation into the American Urological Association microhematuria guidance (September 2025), a Medicare PLA code effective January 2026, and February 2026 FDA Breakthrough Device Designation. The structure includes cash and stock at closing, plus milestone payments tied to Medicare reimbursement—an explicit attempt to accelerate commercialization through payor access and urology footprint expansion.
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