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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 (AWH) will release its second quarter financial results for the period ending June 30, 2021, on August 12, 2021, after market close. An investor conference call will follow at 4:30 p.m. ET, where important updates and performance metrics will be discussed. Aspira is focused on women’s health, particularly in ovarian cancer risk assessment, offering FDA-cleared products like OVA1® and OVERA®. The company aims to develop innovative bio-analytical solutions to improve gynecologic health outcomes.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced that its OVA1® ovarian cancer risk assessment test is now recognized as medically necessary by AIM Specialty Health. This new guideline facilitates the preoperative evaluation of pelvic masses, enhancing surgical decisions and patient care. With recent endorsements including New York State Medicaid, the accessibility of OVA1® has significantly increased, particularly among Black women. Aspira aims to address ethnic disparities in ovarian cancer risk assessment, highlighting its commitment to improving women's health outcomes.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced that its OVA1® ovarian cancer risk assessment test is now deemed medically necessary per AIM Specialty Health's guidelines.
This move enhances access for women with pelvic masses and aligns with AIM's efforts to improve healthcare quality. Positive coverage expansions, such as New York State Medicaid, have increased access to OVA1® technology. CEO Valerie Palmieri emphasized the commitment to improving care standards for women.
Aspira Women’s Health Inc. (NASDAQ: AWH) announced promising initial clinical data for its blood-based test OVASight, aimed at assessing the risk of ovarian cancer in women with suspected benign pelvic masses. In a low prevalence population (3.8%), OVASight achieved 89% specificity, 91% sensitivity, and a negative predictive value of 99.6%. These results outperform traditional CA-125 testing in early-stage disease. The data was released during the American Society of Clinical Oncology (ASCO) 2021 virtual meeting, emphasizing the company's commitment to improving women's health.
Aspira Women’s Health, Inc. (Nasdaq: AWH) announced its participation in the William Blair Growth Stock Conference from June 1-3, 2021. The company will present on June 3 at 9:00 am ET. Aspira focuses on innovative testing solutions for women's health, particularly in ovarian cancer risk assessment and pelvic diseases. Their product portfolio includes OVA1® plus and ASPIRA GenetiX™ testing, aimed at improving gynecologic health outcomes. For more details, visit their website.
Aspira Women’s Health Inc. (Nasdaq: AWH) reported Q1 2021 financial results, highlighting a 23% increase in total product and genetics revenue to $1.496 million. OVA1plus tests performed rose by 3% to 3,775. The company initiated a large prospective clinical study with Northwell Health and established a significant commercial agreement with a major women's health network. However, R&D expenses surged by 121% compared to Q1 2020, indicating increased investment in product development. The firm ended the quarter with approximately $59.4 million in cash.
Aspira Women’s Health (Nasdaq: AWH) announced the analytical and initial clinical validation of its OVASight™ blood-based biomarker test for assessing ovarian malignancy risk in women with adnexal masses. The abstract detailing this test will be presented at the ASCO 2021 meeting from June 4-8. The OVASight™ test showcases a high negative predictive value, enhancing clinician confidence in monitoring suspected benign masses. The product is expected to be available in Q4 2021, aiming to replace the CA-125 test.
Aspira Women’s Health (Nasdaq: AWH) announced a new clinical study focused on ovarian cancer risk detection, in partnership with Northwell Health. The study aims to enroll over 600 women with adnexal masses and more than 2000 high-risk patients, utilizing both CA125 and the proprietary OVASight algorithm. The primary goal is to validate the algorithm for serial monitoring, while the secondary goal is to develop a proteogenomic test for early-stage ovarian cancer detection. This initiative reinforces Aspira’s commitment to enhancing diagnostic options for women's health.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced the appointment of Greg Richard as the new Head of Corporate Strategy, Reimbursement, and Managed Care, reporting to President and CEO Valerie Palmieri. Greg Richard brings over 20 years of experience in developing strategies for diagnostics coverage and reimbursement. His role includes leading corporate strategy, enhancing reimbursement processes, and managing the Revenue Cycle Management team. Aspira aims to improve women’s health outcomes, especially concerning ovarian cancer detection and risk assessment.
Aspira Women’s Health, Inc. (Nasdaq: AWH) will announce its first-quarter financial results for the period ending March 31, 2021, on May 13, 2021, after market close. A conference call and webcast will be held at 4:30 p.m. ET the same day, with domestic and international dial-in numbers provided for investor participation.
The company focuses on innovative testing options and bio-analytical solutions aimed at improving women's health outcomes, including addressing ethnic disparities in ovarian cancer risk assessment.
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