Aspira Women’s Health Inc.

Overview

Aspira Women’s Health develops and commercializes noninvasive diagnostic tests for gynecologic diseases, beginning with ovarian cancer. The company uses multivariate biomarker approaches that combine protein biomarkers, microRNA (miRNA), and clinical data to create Multivariate Index Assays (MIAs).

Core products and offerings

• Ova1Plus workflow
  • Ova1: FDA de novo clearance (2009) for pre-operative assessment of ovarian masses.
  • Overa: FDA 510(k) clearance (2016) to complement Ova1 and improve specificity.
  • Ova1Plus combines Ova1 with Overa (via OvaCalc software) to provide a higher-sensitivity, high-specificity assessment of malignancy risk.
• OvaWatch
  • Noninvasive risk assessment test for women with adnexal masses that are indeterminate or benign by initial clinical assessment.
  • Performed in Aspira Labs as part of the company’s CLIA lab operations and offered via the OvaSuite platform.
• OvaSuite platform
  • Suite of tests and workflows (including Ova1Plus and OvaWatch) marketed to physicians and laboratory partners.
  • Distributed through an in-house sales force, distributors, and laboratory partners (examples: BioReference Health, ARUP; Mayo Clinic Laboratories as of December 2025).
• ENDOinform
  • Endometriosis diagnostic program combining serum proteins, miRNA, and metadata.
• OVAinform
  • Development program to assess ovarian cancer risk, with potential expansion to asymptomatic women at elevated genetic risk or with an affected first-degree relative.
• Aspira Labs
  • CLIA-certified clinical laboratory in Austin, Texas that performs Ova1, Overa, and OvaWatch testing.
  • ISO 13485-certified; CE marks for Ova1 and Overa. Roche Diagnostics is the principal supplier of component reagents.

Target customers and channels

• Primary customers: U.S. physicians, physician office laboratories, national and regional laboratories.
• Distribution: direct national sales force and inside sales, laboratory partnerships, and distributor channels.
• Channel partners include BioReference Health, ARUP, and Mayo Clinic Laboratories (distribution of Ova1 and OvaWatch as of December 2025).

Regulatory status and manufacturing

• Ova1: FDA de novo (2009). Overa: FDA 510(k) clearance (2016).
• OvaWatch is offered as a lab-developed test (LDT) performed in Aspira Labs (CLIA); PLA code 0375U implemented for billing (February 2023).
• Applicable quality and regulatory frameworks include FDA oversight for IVDs, CLIA, CAP accreditation, ISO 13485, and CE marking for EU markets.
• Platform analyses use Roche Cobas systems and Roche component reagents.

Intellectual property

• Portfolio includes 14 issued U.S. patents and 8 U.S. patent applications at the time of filing, plus international filings and trademarks/service marks.

Market opportunity

• OvaWatch mass monitoring: estimated addressable market of roughly 2–4 million tests per year based on an estimated 1.5 million women with indeterminate adnexal masses.
• Potential OVAinform expansion to asymptomatic high-risk women could increase the addressable population to about 4 million women.

Lab and quality infrastructure

• Aspira Labs operates as a CLIA-certified laboratory with CAP accreditation and state licenses (California, Maryland, New York, Pennsylvania, Rhode Island).
• Maintains ISO 13485 certification and CE marks in Europe for Ova1 and Overa.
• Roche Diagnostics Corporation is the principal supplier of component reagents.

Financial and corporate highlights

• Headcount (as of December 31, 2025): 36 full-time employees and 2 part-time employees.
• Test volume: 22,515 OvaSuite tests performed in 2025 (24,305 in 2024). Revenue primarily derives from Ova1 and OvaWatch tests, including private payer arrangements and client billings.
• Reimbursement and billing:
  • Novitas Solutions is the Medicare Administrative Contractor for Ova1.
  • LCD L35396 (Biomarkers for Oncology) governs coverage.
  • OvaWatch and Ova1 tests meeting coverage requirements have a Medicare reimbursement rate of $897 per test effective January 1, 2024.
• Corporate and financing events:
  • March 5, 2025: private placement for Senior Secured Convertible Promissory Notes to raise approximately $1.365 million.
  • March 11, 2025: conversion of convertible notes into units.
  • April 15, 2025: Nasdaq delisted the company; trading moved to OTC Markets (OTC QX Best Market) under ticker AWHL.
  • June 9, 2025: ARPA-H contract for ENDOinform was terminated.
  • September 19, 2025: amendment to a securities agreement to adjust warrants.
• The company continues efforts to raise capital and pursue strategic alternatives to fund operations beyond 2026 and to grow the OvaSuite platform.

Headquarters and website

• Headquarters: 12117 Bee Caves Road, Building III, Suite 100, Austin, TX 78738
• Website: www.aspirawh.com

Summary

Aspira Women’s Health focuses on noninvasive diagnostic tests for gynecologic conditions, anchored by the OvaSuite family (Ova1, Overa, Ova1Plus) and OvaWatch, with additional programs targeting endometriosis and ovarian cancer risk. The company operates a CLIA-certified laboratory, maintains regulatory and quality certifications, and distributes tests through direct and partner channels while pursuing capital and strategic options.