Aspira Women`s Health Stock Price, News & Analysis

Aspira Women's Health Inc. (historically trading under the Nasdaq symbol AWH) is a bio-analytical based women's health company focused on the development, discovery, and commercialization of noninvasive, AI-powered diagnostic tests for gynecologic diseases. The company describes itself as an AI enhanced bio-analytics based women's health company and emphasizes tools that aid in gynecologic disease diagnostics and disease management.

Aspira Women's Health develops blood-based tests that use protein and microRNA biomarkers combined with patient data and AI-enabled algorithms to support clinical decision-making. Its commercial offerings include OvaWatch® and Ova1Plus®, which are offered to clinicians together as OvaSuiteSM. According to the company, OvaSuite provides a portfolio of blood tests to aid in the detection of ovarian cancer risk for more than 1.2 million American women diagnosed with an adnexal mass each year.

OvaWatch is described as a noninvasive test that provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women whose initial clinical assessment suggests that an adnexal mass is indeterminate or benign, where surgery may be premature or unnecessary. Ova1Plus is characterized as a reflex process of two FDA-cleared tests, Ova1® and Overa®, used to assess the risk of ovarian malignancy in women with an adnexal mass who are already planned for surgery.

Beyond its commercial ovarian cancer risk assessment portfolio, Aspira Women's Health highlights an in-development pipeline targeting both ovarian cancer and endometriosis. In ovarian cancer, the company states that it intends to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of its existing tests and expand the indicated population, including women with a family history of ovarian cancer or a germline mutation. In endometriosis, the company reports that it has developed a non-invasive test designed to identify endometriomas, and it is pursuing an ongoing endometriosis development program that combines microRNA and protein biomarkers with patient data with the intent of identifying endometriosis independent of disease location or severity.

Aspira Women's Health has also described a program called ENDOinform™, a non-invasive blood-draw based multi-omics test that utilizes protein and microRNA biomarkers, along with patient-specific data, to power an AI-based algorithm to aid in the diagnosis of endometriosis in patients with symptoms of the disease. The company has referenced a milestone-based award from the Advanced Research Projects Agency for Health (ARPA-H) Sprint for Women's Health program to support ENDOinform development, and has reported the achievement of multiple development milestones under this award and related milestone payments.

The company has reported that its OvaSuite product line has generated product revenue and test volumes, and that it tracks metrics such as the number of OvaSuite tests performed and average unit price. It has also discussed efforts to refine its go-to-market strategy, focus on cost controls, and adjust its operating expenses, as reflected in its reported financial results and commentary from its leadership team.

From a corporate and capital markets perspective, Aspira Women's Health has disclosed that it received a delisting notification from Nasdaq due to noncompliance with stockholders' equity requirements. The company indicated that trading of its common stock on Nasdaq was suspended and that it expected its shares to begin trading on markets operated by OTC Markets Group under the symbol AWH, and later under the symbol AWHL. The company has also reported completing the process of transitioning to the OTCQB marketplace.

In addition to its product and development activities, Aspira Women's Health has reported several governance and financing developments. These include appointments of new directors to its Board of Directors, changes in executive leadership, and capital-raising transactions such as private placements of convertible notes and equity purchase agreements. The company has also reported on its balance sheet, operating expenses, and cash usage in its financial results, highlighting areas such as research and development spending, sales and marketing costs, and general and administrative expenses.

Overall, Aspira Women's Health presents itself as a women's health-focused diagnostics company centered on noninvasive, AI-enabled blood tests for ovarian cancer risk assessment and endometriosis, with a combination of commercial products and an active research and development pipeline. Its disclosures emphasize the use of biomarkers, AI algorithms, and patient data to support gynecologic disease diagnostics and disease management.