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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 has launched a collaboration with BioReference to co-market and distribute Ova1Plus, a blood test aimed at assessing the risk of ovarian malignancy in women with adnexal masses. This partnership will expand access to Ova1Plus across the U.S. healthcare system. Both companies aim to enhance care and market presence, with expectations of increased revenue and improved provider adoption. The alliance marks a significant step for Aspira in its mission to improve women’s health diagnostics.
Aspira Women’s Health Inc. announced a study published in the International Journal of Environmental Research and Public Health confirming the effectiveness of its ovarian cancer test, MIA2G (OVERA), in a non-White population. The research demonstrated OVERA’s sensitivity in detecting early-stage ovarian cancer at 92.4%, outperforming CA-125 at 74.3%. This study emphasizes the potential of OVERA as a preferred diagnostic tool for early cancer detection, especially for Filipino women, potentially influencing clinical assessment standards.
Aspira Women’s Health Inc. (Nasdaq: AWH) has announced the pricing of a public offering of 12,000,000 shares of common stock and 12,000,000 accompanying warrants at a combined price of $0.75 per share. The company expects to raise approximately $9.0 million from the offering, which is set to close on August 25, 2022. Proceeds will be utilized for working capital, product expansion, and strategic partnerships. The offering is registered under SEC File No. 333-252267.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced an underwritten public offering of its common stock and warrants. The offering is subject to market conditions, with no assurance on completion timing or terms. Proceeds will be used for working capital, corporate purposes, product portfolio expansion, and potential strategic investments.
William Blair & Company acts as the sole book-running manager. Details regarding the offering will be filed with the SEC and are available on their website.
Aspira Women’s Health will host a KOL webinar on women's health and ovarian cancer risk assessments on August 24, 2022, at 12:00 PM ET. Executives will present alongside KOLs discussing the OVA1Plus and OVAWatch tests. The OVA1Plus test aids in assessing ovarian cancer risk, while OVAWatch will target women with pelvic masses not scheduled for surgery. This event aims to enhance awareness and understanding of innovative diagnostic tools in women's health.
Aspira Women’s Health Inc. (AWH) reported a 17% increase in product revenue to $2.0 million for Q2 2022, with OVA1plus test volume rising 19% to 5,411 units. The company entered a research agreement with Harvard’s Dana-Farber Cancer Institute and others to develop a diagnostic test for endometriosis. Additionally, cash utilization was reduced by $3.9 million from the prior quarter. Despite these gains, gross profit margin for OVA1plus decreased to 49% from 52% year-over-year. A conference call is scheduled for today at 8:30 a.m. ET.
Aspira Women’s Health announced the upcoming release of its financial results for Q2 2022 on August 10, 2022, before market open. The company will also host a conference call at 8:30 am ET to discuss these results and provide a corporate update. Aspira focuses on innovative testing solutions and bio-analytical products aimed at improving gynecologic health outcomes, specifically in ovarian cancer risk assessment. Their OVA1plus combines FDA-cleared products to assess ovarian malignancy risk. More details are available on their website.
Aspira Women’s Health announces the appointment of two experienced directors, Dr. Robert Auerbach and Ms. Ruby Sharma, to its Board. Dr. Auerbach, former President of CooperSurgical, has significant medical industry experience, while Ms. Sharma brings expertise in finance and governance. The CEO, Nicole Sandford, emphasizes that their diverse skills will enhance Aspira’s strategic execution during challenging times. Aspira focuses on innovative gynecologic testing solutions, aiming to improve women's health outcomes and address disparities in ovarian cancer risk assessment.
Aspira Women’s Health Inc. announced the publication of a paper validating its OvaWatch™ algorithm for detecting ovarian cancer in the June issue of JCO Clinical Cancer Informatics. The study highlights OvaWatch's potential in assessing the risk of ovarian malignancy in patients with pelvic masses, essential for early detection of this deadly gynecologic cancer. The company aims to launch OvaWatch as a valuable tool for physicians, potentially improving health outcomes for women. CEO Nicole Sandford expressed optimism about its future impact on treatment strategies.
Aspira Women’s Health Inc. (Nasdaq: AWH) has announced management participation in two upcoming investor conferences. The MicroCap Rodeo Spring Into Action Conference is scheduled for May 17, 2022 at 12:30pm ET, with a webcast available here. The William Blair 42nd Annual Growth Stock Conference will take place on June 7, 2022, at 8:00am CT (9:00am ET), with a webcast accessible here. One-on-one meetings will also be available on June 7-8.
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