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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.
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