illi News - Vesica Health Receives FDA Breakthrough Device Designation for AssureMDx

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Noninvasive Urine-Based Assay Supporting Early Detection of Bladder Cancer

IRVINE, Calif. - illiNews -- VESICA HEALTH®, INC., a molecular diagnostics company focused on improving the early detection and management of bladder cancer and urothelial carcinoma, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to its AssureMDx test.

The designation applies to AssureMDx for its intended use as a non‑invasive, urine‑based molecular assay to aid in the evaluation of patients with hematuria who are assessed for bladder cancer and upper tract urothelial carcinoma. The Breakthrough Devices Program is intended to expedite the development and review of innovative medical devices and to support sponsors in obtaining future marketing authorization. Breakthrough Device Designation does not constitute FDA marketing authorization, clearance, or approval.

Vesica Health congratulates its Scientific Team, and importantly its collaborators, for the rigor and discipline that made this important milestone possible. This achievement reflects years of focused translational research and careful regulatory preparation.

"Receiving Breakthrough Device Designation is a meaningful validation of the scientific and clinical foundation underlying AssureMDx," stated Christopher Thibodeau, Chief Executive Officer of Vesica Health. "We believe this recognition underscores the clinical utility of our assay in enabling more informed evaluation of patients with hematuria and supporting earlier detection of bladder cancer, when there is the greatest opportunity for cure. The designation enables structured, prioritized engagement with the FDA as we continue advancing our development program. We remain committed to a rigorous and disciplined regulatory strategy."

Manuel Krispin, PhD, Chief Scientific Officer of Vesica Health, added: "AssureMDx integrates DNA methylation and somatic mutation biomarkers associated with urothelial carcinoma. Our development program has been grounded in analytical rigor, robust clinical validation, and careful assay optimization. The FDA's recognition of the technology's potential through the Breakthrough Devices Program reflects both the strength of the underlying science and the clinical need it addresses."

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About Breakthrough Device Designation
The FDA Breakthrough Devices Program is intended to provide prioritized interaction and more efficient communication between the Agency and sponsors of designated devices, including opportunities for timely feedback, interactive review, and discussion of development plans. While the program is designed to expedite development and review, it does not change the statutory standards for marketing authorization and does not constitute FDA clearance or approval.

About AssureMDx^™
AssureMDx is a proprietary, noninvasive urine-based DNA test clinically validated to improve the early detection of bladder cancer. The assay integrates genomic and epigenetic biomarkers, including DNA methylation of TWIST1, OTX1, and ONECUT2, and somatic mutations in FGFR3, HRAS, and TERT, to stratify hematuria patients for expedited urologic evaluation while safely ruling out those at very low risk.

Vesica Health's genes and technology have been reported in more than 26 peer-reviewed publications involving over 8,500 patients across detection, prognostic, and predictive applications. This body of evidence includes three prospective clinical validation studies evaluating the final six-gene configuration of the AssureMDx assay for early detection. In the largest multicenter study (n=838; van Kessel et al., Journal of Urology, 2020), AssureMDx demonstrated an overall sensitivity of 96%, a negative predictive value greater than 99%, and an AUC of 0.96 for bladder cancer detection. Answering the clinical community's call for earlier, more accurate detection, AssureMDx achieved a combined sensitivity of 95.9% for Stage 0 (Ta and Tis/CIS) and Stage I disease, underpinning its unique ability to identify patients at increased risk for bladder cancer at its earliest and most treatable stages.

AssureMDx has been recognized in the AUA Clinical Guidelines as a validated urine-based genomic test for the evaluation of patients with intermediate-risk microscopic hematuria, further reinforcing its clinical utility within the standard of care. AssureMDx is currently offered as a laboratory developed test (LDT) and is performed in a CLIA-certified and CAP-accredited laboratory. The test has not been cleared or approved by the U.S. Food and Drug Administration.

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About Vesica Health®, Inc.
Vesica Health is a privately held precision diagnostics company pioneering noninvasive solutions for the early detection and management of bladder cancer. Hematuria, or blood in the urine, affects more than 17 million U.S. adults annually, yet only 12% are referred for urologic evaluation, resulting in an estimated 20,000 missed bladder cancer diagnoses each year.

Headquartered in Irvine, California, Vesica operates a CAP-accredited, CLIA-certified laboratory and holds worldwide commercialization rights for AssureMDx. The company is led by an experienced team with a proven track record in diagnostic development, clinical evidence generation, and commercial execution. In addition to its flagship assay, Vesica is advancing a pipeline that includes recurrence monitoring, prognostic, and predictive companion diagnostics.

Vesica Health is positioned to lead in the $6 billion bladder cancer diagnostics market, with a mission to improve survival and patient care through earlier detection, precision diagnostics, and expanded access to noninvasive solutions. Learn more at: www.vesicahealth.com.

Media Contact:
Vesica Health Corporate Communications: public.relations@vesicahealth.com

Forward-Looking Statements: This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the potential benefits of Breakthrough Device Designation, anticipated interactions with the U.S. Food and Drug Administration, the future regulatory pathway for AssureMDx, and the potential clinical and market impact of the assay. These forward-looking statements are based on current expectations, assumptions, and assessments of known and unknown risks and uncertainties that management believes to be reasonable but that may prove to be incorrect. Actual results and outcomes may differ materially due to a variety of factors, including regulatory developments, clinical and scientific results, operational execution, reimbursement dynamics, market adoption, and other risks beyond the company's control. Breakthrough Device Designation does not constitute marketing authorization and does not guarantee eventual FDA clearance or approval. Vesica Health undertakes no obligation to update or revise any forward-looking statements contained in this release to reflect subsequent events or circumstances, except as required by applicable law or regulation.

NOTE: The Vesica Health wordmarks and logos, including Vesica Health and AssureMDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners.