About

Vesica Health Overview

Vesica Health, Inc., headquartered in Irvine, California, is redefining the early detection of bladder cancer with a clear mission: to improve patient outcomes through precision, noninvasive testing.

Our flagship product, AssureMDx, is a clinically validated, urine-based liquid biopsy designed to optimize the triage of hematuria patients and enable earlier detection of bladder cancer. In the largest multicenter study to date (n=838), AssureMDx demonstrated 96% sensitivity and a negative predictive value greater than 99%, offering best-in-class accuracy. These results empower clinicians to make more confident decisions, reduce unnecessary procedures, and lower associated healthcare costs.

Value Proposition

Vesica Health offers a unique investment opportunity in the rapidly expanding precision oncology market. By addressing critical unmet needs in bladder cancer diagnosis and management, we are transforming clinical pathways, improving survival rates, and creating efficiencies across the healthcare system.

Our technology is built on cutting-edge multi-omics science and proprietary biomarkers, validated in more than 26 peer-reviewed studies involving over 8,500 patients. This robust body of evidence provides a strong foundation for both clinical adoption and commercial success.

Historical Achievements

2025 has been a transformative year for Vesica Health. We achieved CAP Accreditation for our CLIA-certified and California-licensed laboratory, further strengthening our operational foundation. Our lead assay, AssureMDx, was formally included in the American Urological Association (AUA) Clinical Guidelines for the evaluation of patients with microscopic hematuria — a pivotal milestone establishing its role in standard of care. In addition, the American Medical Association awarded a Proprietary Laboratory Analysis (PLA) code for AssureMDx, creating a clear pathway for reimbursement and broader adoption.

Clinical Opportunity

Bladder cancer is among the most prevalent and costly cancers worldwide. In the United States alone, approximately 17 million adults present with hematuria each year, yet only 12% are referred to a urologist — resulting in an estimated 20,000 missed or delayed diagnoses annually.

Standard diagnostic tools such as cytology, cystoscopy, and CT scans are limited by invasiveness, low sensitivity, or radiation exposure. These limitations underscore the urgent need for noninvasive solutions like AssureMDx to improve risk stratification, enable earlier detection, and reduce the burden of unnecessary procedures. The market opportunity for hematuria management and early detection is estimated at $6 billion.

Management Team

Vesica Health is led by an experienced management team with deep expertise in diagnostics, precision oncology, and commercialization. The leadership team combines scientific rigor, operational excellence, and strategic vision to deliver on Vesica Health’s ambitious growth trajectory.

Looking Ahead

With a strong operational foundation, recent regulatory milestones, and market-ready solutions, Vesica Health is poised to expand the adoption of AssureMDx, pursue reimbursement through its newly awarded PLA code, and advance additional products across the bladder cancer continuum. International expansion and next-generation diagnostic solutions remain key priorities as we build on our mission to redefine bladder cancer diagnostics.

This moment represents a compelling opportunity to invest in Vesica Health and support our mission to improve early detection, expand access to noninvasive diagnostics, and deliver lasting value to patients, providers, and stakeholders.

For additional information or partnership inquiries, please contact: public.relations@vesicahealth.com.