Aspira Women`s Health Inc Stock Price, News & Analysis

Aspira Women's Health Inc. (Nasdaq: AWH) has received approval from the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for OvaWatch®. This non-invasive blood test assesses ovarian cancer risk in women with adnexal masses initially determined as indeterminate or benign. The CLEP approval, required for all lab-developed tests in New York, ensures compliance with state regulatory standards and includes a comprehensive review of Quality Management Systems.

CEO Nicole Sandford highlighted the significance of this approval, stating it opens doors to one of the nation's largest healthcare markets with over 10 million women in New York state. The CLEP approval is viewed as a validation of the test's rigorous science, potentially strengthening Aspira's credibility in other markets and positioning the company well for future regulatory pathways.

Aspira Women's Health (Nasdaq: AWH) has published data in Gynecologic Oncology demonstrating improved performance of its in-development blood test for assessing malignancy risk in adnexal masses. The study shows that combining miRNA with protein biomarkers, age, and menopausal status offers the most accurate classification for identifying early-stage ovarian cancer.

Key findings include:

• 92% sensitivity at 80% specificity overall
• 80% sensitivity for early-stage cancers
• 100% sensitivity for later-stage cancers
• 78% sensitivity for early-stage, serous ovarian cancers
• 82% sensitivity for early-stage, non-serous cancers

The combined model improved ROC AUC on internal (0.9) and external (0.95) validation sets compared to miRNA alone or proteins plus metadata without miRNA.

Aspira Women's Health (Nasdaq: AWH), a bio-analytical women's health company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel. CEO Nicole Sandford will deliver a presentation, available on-demand from September 9 at 7:00 am ET for registered attendees.

Company management will be available for in-person one-on-one meetings on September 10 and 11. Interested investors should contact H.C. Wainwright representatives. A replay of the presentation will be posted on the Events page of Aspira's Investors section on their website when available.

Aspira Women's Health Inc. (Nasdaq: AWH) has been selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H). This designation acknowledges Aspira's position as an innovator in women's health and provides new opportunities for funding, thought leadership, and networking.

The Investor Catalyst Hub, based in the Greater Boston area and managed by VentureWell, aims to accelerate the commercialization of groundbreaking biomedical solutions. As a spoke, Aspira gains access to potential funding, flexible contracting, and opportunities to provide input on ARPA-H challenge areas and priorities. The company joins a diverse network of organizations aligned with ARPA-H's mission to improve health outcomes through research focus areas such as health science futures, proactive health, scalable solutions, and resilient systems.

Aspira Women's Health Inc. (Nasdaq: AWH) has partnered with Dorsata, a healthcare software company, to develop a protocol workflow tool for the clinical treatment of adnexal masses. This custom care module will be integrated into Dorsata's electronic medical records (EMR) tool, which is used at over 300 clinical sites serving 2,500 clinical users. The module aims to improve the quality and consistency of patient care for women with adnexal masses and is expected to aggregate clinical data from a nationwide network of providers and patients.

Development of the module will begin immediately, with the goal of having the first provider contracted in Q4 2024 and completing all iterative design activities in Q1 2025. This collaboration is expected to help physicians more effectively identify patients who may benefit from innovative tools like biomarker blood tests.

Aspira Women's Health Inc. (Nasdaq: AWH) reported its Q2 2024 financial results. Key highlights include:

- OvaSuiteSM revenue of $2.4 million with 6,471 units sold

- Cash utilization decreased by 16% compared to Q1 2024

- Full year 2024 cash guidance reduced to $13-$14.5 million

- OvaWatch product volume grew 48% year-over-year

- Expanded addressable market to 2-4 million tests per year

- Gross profit margin of 59%

- Raised $4 million through private placement and warrant exercise

- Appointed John Kallassy as interim CFO

The company focuses on developing gynecologic disease diagnostic tools and aims to make OvaSuite the standard of care for adnexal mass diagnosis.

Aspira Women's Health Inc. (Nasdaq: AWH) has announced a poster presentation at the 27th Annual National Association of Nurse Practitioners in Women's Health (NPWH) Women's Healthcare Conference. The event will take place from September 25-28, 2024, in Chicago, IL. Dr. Todd Pappas, VP of Research & Development at Aspira, will present a poster titled 'Association of the Endometriosis Health Profile-5 (EHP-5) with Non-Invasive Biomarkers in Patients with Suspected Endometriosis' on September 26 and 27, from 11:45 am to 1:30 pm CT at the Hilton Chicago.

NPWH represents 13,000 Women's Health Nurse Practitioners and sets standards of excellence in women's healthcare through research, education, and advocacy.

Aspira Women's Health Inc. (Nasdaq: AWH) has announced a poster presentation at the upcoming Annual Meeting of The Menopause Society, scheduled for September 10-14, 2024, in Chicago. The presentation, titled 'Application of Deep Neural Network-Based Algorithm to Provide Additional Information in the Assessment of Adnexal Masses Classified as Indeterminate by Imaging,' will be given by Dr. Christina Kronfel, Senior Scientist at Aspira Women's Health. The poster will highlight data demonstrating OvaWatch's performance in assessing ovarian cancer risk in pre- and post-menopausal women. This presentation aligns with Aspira's focus on developing gynecologic disease diagnostic tools and showcases their commitment to advancing women's health technologies.

Aspira Women's Health Inc. (Nasdaq: AWH), a bio-analytical women's health company focusing on gynecologic disease diagnostic tools, has announced its plans to report second quarter 2024 financial results on Monday, August 12, 2024. The company will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day to discuss the financial results and provide a corporate update.

Investors and interested parties can access the conference call toll-free at 877-407-4018. A webcast of the call will be available, and a replay will be accessible on the Events & Presentation page of Aspira Women's Health's Investor Relations website.