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Aspira Women's Health Inc. (Nasdaq: AWH) is a pioneering company focused on the development and commercialization of noninvasive diagnostic tests for gynecologic diseases. The company is at the forefront of women's health, offering innovative solutions that leverage bio-analytical techniques and artificial intelligence.
One of Aspira's flagship products is OvaSuite, a comprehensive portfolio of blood tests designed to assess the risk of ovarian cancer. This suite includes the well-known OvaWatch and Ova1Plus tests. OvaWatch, with a negative predictive value of 99%, is instrumental in evaluating ovarian cancer risk in women with adnexal masses that appear indeterminate or benign, potentially allowing them to avoid unnecessary surgeries. Ova1Plus combines two FDA-cleared tests, Ova1® and Overa®, providing a robust assessment for women scheduled for surgery due to pelvic masses.
In addition to ovarian cancer diagnostics, Aspira is expanding its test pipeline to address other pressing women's health issues. The company is developing EndoCheck, the first-ever noninvasive test for identifying endometriomas, a common form of endometriosis. Another promising test in development is OvaMDx, which combines microRNA and protein biomarkers with patient data to enhance the accuracy of ovarian cancer risk assessments.
The company's commitment to innovation is reflected in its recent achievements. Aspira has published significant clinical studies demonstrating the efficacy of OvaWatch in longitudinal monitoring of ovarian cancer risk, which could significantly reduce surgical backlogs and unnecessary referrals. Furthermore, Aspira has made strides in market access, securing payer coverage from Anthem Blue Cross and expanding its reach to millions of lives across various health plans.
Financially, Aspira has shown remarkable progress. In 2023, the company significantly reduced its operational cash use while increasing revenues and test volumes. These accomplishments were accompanied by important enhancements to their commercial organization and the achievement of key market access milestones. As of December 31, 2023, Aspira had $2.9 million in cash and raised an additional $5.5 million through a registered direct offering and private placement.
The management team, led by CEO Nicole Sandford, has positioned Aspira for substantial growth in 2024 and beyond. The company's forward-looking strategies and robust test pipeline are set to meet the growing demand for noninvasive diagnostics in women's health, offering new hope and improved outcomes for millions of women worldwide.
Aspira Women’s Health reported a 20% year-over-year revenue increase to $8.2 million for 2022, with OvaSuiteSM volume rising 23% to 21,423 units. The fourth quarter revenue was $2.2 million, up 16% from the previous year, driven by an 18% increase in tests performed. However, revenue per test decreased by 3% due to a shift towards Medicaid. The company achieved a gross profit margin of 57% in Q4 and 53% for the year. Aspira successfully launched the OvaWatch test and aims to introduce EndoCheck™ this year. Cash utilization decreased to $7.1 million in Q4 compared to $10.2 million earlier in the year, with projected 2023 cash utilization between $16 million and $19 million.
Aspira Women’s Health (Nasdaq: AWH) has announced it will release its financial results for the year ended December 31, 2022, on March 22, 2023, after market close. Management will host a conference call at 4:30 PM ET to discuss these results and provide updates on corporate developments. The call can be accessed via toll-free and international numbers, with a dedicated conference ID of 13736207. Aspira is focused on innovative testing options for gynecological health, including Ova1Plus®, aimed at detecting ovarian malignancy risks, and EndoCheck™, a test for endometriosis currently in development.
Aspira Women’s Health Inc. (AWH) announced that a leading national health insurance provider has agreed to cover its OvaWatch ovarian cancer test, launched in December 2022. This coverage will minimize out-of-pocket expenses for patients and is based on recent evidence supporting OvaWatch's clinical validation. Nicole Sandford, President and CEO, expressed satisfaction with the recognition of OvaWatch's value in ovarian cancer risk management. OvaWatch features a 99% negative predictive value, assisting physicians in effectively assessing ovarian cancer risk and determining appropriate treatments.
Aspira Women’s Health reported significant growth in preliminary fourth quarter metrics for 2022, with OvaSuite tests increasing 23% year-over-year to 21,424. The number of tests for Q4 rose 18% compared to the previous year, reaching 5,643. Average daily test volume peaked at 86.6. The company met cash utilization guidance for the quarter, estimating between $6 million and $8 million. Aspira aims to save $6 million in 2023 by reducing staff without impacting growth plans.
Aspira Women’s Health has released promising clinical data supporting its OvaWatch assay for assessing ovarian cancer risk in women with adnexal masses. Published in Frontiers in Medicine, the study highlights OvaWatch's high negative predictive value (NPV) of 99%, underscoring its effectiveness in identifying potential malignancies. In a multi-site clinical analysis, OvaWatch identified 18 out of 22 malignancies missed by physicians. The assay aims to reduce unnecessary surgeries and enhance patient care, marking a significant advancement in non-invasive ovarian cancer diagnostics.
Aspira Women’s Health announced expanded Medicare coverage for multi-marker tests for ovarian cancer through the 2023 Omnibus Spending Bill, following a new PLA Code approval for OvaWatch by the AMA. The bill aims to enhance access for women facing pelvic masses and encourages commercial payers to follow suit. Additionally, Medicaid coverage for Ova1Plus has expanded to five states, now totaling 27. This progress underscores Aspira's commitment to improving ovarian cancer diagnostics alongside ongoing legislative advocacy.
Aspira Women’s Health has launched OvaWatch, a non-invasive blood test to assess ovarian cancer risk in women with adnexal masses. Available from December 1, 2022, OvaWatch features a 99% negative predictive value, helping physicians rule out malignancy. This expansion of the OvaSuite portfolio aims to benefit a larger patient population and improve early ovarian cancer detection. The company anticipates strong demand and broad payer coverage for OvaWatch, reinforcing its commitment to women's health diagnostics.
Aspira Women’s Health (AWH) reported a 26% year-over-year increase in product revenue, reaching $2 million, and a 29% rise in product volume to 5,524 units for Q3 2022. The company is set to launch OvaWatch, an ovarian cancer risk assessment tool, and has rebranded its product line as OvaSuite. Aspira has initiated a sponsored research agreement with prominent medical institutions regarding its endometriosis diagnostic tests. The company raised $9 million through a public offering and highlighted a reduction in sales and marketing expenses, increasing sales efficiency amidst ongoing operational improvements.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced it will release its third-quarter financial results for the period ending September 30, 2022, on November 10, 2022. The company will hold a conference call at 8:30 AM ET that day to discuss the results and provide a corporate update. Aspira focuses on women's health through innovative testing options and bio-analytical solutions, aiming to improve gynecologic health outcomes. This includes addressing disparities in ovarian cancer risk assessment and developing solutions for pelvic diseases.
Aspira Women’s Health has announced participation in the MicroCap Rodeo Presents Windy City Roundup 2022 conference in Chicago on October 12-13, 2022. The company will engage in one-on-one meetings and presentations to showcase its innovative women’s health solutions aimed at improving gynecologic health outcomes. Aspira focuses on addressing ovarian cancer risks and developing diagnostics for pelvic diseases. The conference aims to enhance investor relations and can be accessed via webcast. More details are available on their Investor Relations website.
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