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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 Inc. (Nasdaq: AWH) announced its subsidiary, Aspira Labs, has achieved credentialing with New York State’s Medicaid program, covering an estimated 6.5 million lives starting April 1, 2021. This credentialing expands the total covered lives for Aspira's OVA1® test to 179 million nationwide, enhancing access for ovarian cancer risk assessment. Aspira Labs is now credentialed in the top 9 U.S. states by Medicaid population, totaling nearly 60 million lives. The company aims to address health disparities in ovarian cancer risk detection.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced the appointment of Ms. Nicole Sandford to its Board of Directors. With extensive experience in regulatory leadership and corporate governance, Sandford is expected to play a crucial role in the company's growth. She previously served at Deloitte and is passionate about improving women’s health, particularly in ovarian cancer. Sandford aims to leverage her skills to aid Aspira in achieving its mission. Aspira focuses on innovative testing solutions for gynecologic health and is known for its FDA-cleared products, OVA1 and OVERA.
Aspira Women's Health Inc. (Nasdaq: AWH) emphasizes its commitment to mitigating racial disparities in ovarian cancer risk assessment during Black History Month. The company aims to enhance testing access for women of all backgrounds, particularly those at high risk. Notably, Black women face significantly lower 5-year survival rates—36% compared to 46% for White women. Aspira's product OVA1plus is designed to improve risk detection in Black women through its advanced multi-biomarker algorithm. CEO Valerie Palmieri highlights the urgent need for equitable healthcare solutions.
Aspira Women's Health, Inc. (Nasdaq: AWH) announced its participation in the 2021 BTIG Virtual MedTech, Digital Health, Life Science and Diagnostic Tools Conference happening from February 17-19. The company will present on February 18 at 9:30 am Eastern Time. Aspira focuses on innovative testing solutions for women's health, particularly in ovarian cancer risk assessment. Their product portfolio includes FDA-cleared tests like OVA1® and OVERA®, and they aim to address ethnic disparities in health outcomes. For more details, visit www.aspirawh.com.
Aspira Women’s Health (Nasdaq: AWH) announced the integration of National Comprehensive Cancer Network® (NCCN®) management recommendations into its Aspira GenetiX Clinical reports. This personalized hereditary cancer genetic risk testing service focuses on gynecologic cancers such as endometrial, ovarian, and cervical cancers. The inclusion of NCCN guidelines strengthens the product's position in the market and enhances support for healthcare providers managing high-risk patients.
Aspira Women’s Health Inc. (Nasdaq: AWH) announced a public offering of 6,000,000 shares at $7.50 per share, with a potential increase of 900,000 shares via underwriter option. The offering, managed by William Blair & Company and Truist Securities, aims to raise approximately $45 million, potentially $51.75 million if the option is fully exercised. Funds will support sales, marketing, working capital, and R&D. The offering is set to close on February 8, 2021. The shares are offered under an effective shelf registration statement with the SEC.
Aspira Women’s Health Inc. (Nasdaq: AWH) has initiated an underwritten public offering of its common stock, with market conditions influencing its completion. The offering will include a 30-day underwriter option for an additional 15% of shares. Proceeds are intended for sales and marketing, working capital, strategic hires, product expansion, and potential acquisitions. The offering is backed by a previously filed shelf registration statement with the SEC, though no specific commitments for acquisitions are currently in place.
Aspira Women’s Health Inc. (Nasdaq: AWH) has announced its expansion as a participating laboratory network provider for Highmark’s commercial health insurance products in Pennsylvania and West Virginia. This initiative will enhance access to OVA1® and OVERA® tests, which assess ovarian malignancy risks in women with adnexal masses. Aspira now provides network access to over 154 million individuals, crucial for improving healthcare access for women, according to CEO Valerie Palmieri. The company aims to close ethnic disparities in ovarian cancer risk assessment and advance gynecologic health outcomes.
Aspira Women’s Health (Nasdaq: AWH) will participate in the 10th Annual LifeSci Advisors Corporate Access Event from January 6-8 and 11-14, 2021, along with the 2021 Biotech Showcase from January 11-15. Management, including President Valerie Palmieri and CFO Robert Beechey, will hold 1x1 meetings and present on Innovations in Cancer Diagnostics on January 7. The conference aims to foster investor relationships and partnerships in therapeutic development. More details and registration links are available in the full announcement.
Aspira Women's Health, Inc. (Nasdaq: AWH) has partnered with Baylor Genetics to co-develop a novel early-detection test for ovarian cancer, which has a mortality rate exceeding 50%. This collaboration aims to leverage both companies' strengths, focusing on the OVA360 clinical study to establish an ovarian cancer molecular profile. Aspira brings over a decade of experience in ovarian cancer detection and has developed multiple FDA-cleared products, while Baylor Genetics contributes advanced genomic testing expertise. The partnership seeks to enhance early detection and improve clinical outcomes for women.
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