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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) has been selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H). This designation acknowledges Aspira's position as an innovator in women's health and provides new opportunities for funding, thought leadership, and networking.
The Investor Catalyst Hub, based in the Greater Boston area and managed by VentureWell, aims to accelerate the commercialization of groundbreaking biomedical solutions. As a spoke, Aspira gains access to potential funding, flexible contracting, and opportunities to provide input on ARPA-H challenge areas and priorities. The company joins a diverse network of organizations aligned with ARPA-H's mission to improve health outcomes through research focus areas such as health science futures, proactive health, scalable solutions, and resilient systems.
Aspira Women's Health Inc. (Nasdaq: AWH) has partnered with Dorsata, a healthcare software company, to develop a protocol workflow tool for the clinical treatment of adnexal masses. This custom care module will be integrated into Dorsata's electronic medical records (EMR) tool, which is used at over 300 clinical sites serving 2,500 clinical users. The module aims to improve the quality and consistency of patient care for women with adnexal masses and is expected to aggregate clinical data from a nationwide network of providers and patients.
Development of the module will begin immediately, with the goal of having the first provider contracted in Q4 2024 and completing all iterative design activities in Q1 2025. This collaboration is expected to help physicians more effectively identify patients who may benefit from innovative tools like biomarker blood tests.
Aspira Women's Health Inc. (Nasdaq: AWH) reported its Q2 2024 financial results. Key highlights include:
- OvaSuiteSM revenue of $2.4 million with 6,471 units sold
- Cash utilization decreased by 16% compared to Q1 2024
- Full year 2024 cash guidance reduced to $13-$14.5 million
- OvaWatch product volume grew 48% year-over-year
- Expanded addressable market to 2-4 million tests per year
- Gross profit margin of 59%
- Raised $4 million through private placement and warrant exercise
- Appointed John Kallassy as interim CFO
The company focuses on developing gynecologic disease diagnostic tools and aims to make OvaSuite the standard of care for adnexal mass diagnosis.
Aspira Women's Health Inc. (Nasdaq: AWH) has announced a poster presentation at the 27th Annual National Association of Nurse Practitioners in Women's Health (NPWH) Women's Healthcare Conference. The event will take place from September 25-28, 2024, in Chicago, IL. Dr. Todd Pappas, VP of Research & Development at Aspira, will present a poster titled 'Association of the Endometriosis Health Profile-5 (EHP-5) with Non-Invasive Biomarkers in Patients with Suspected Endometriosis' on September 26 and 27, from 11:45 am to 1:30 pm CT at the Hilton Chicago.
NPWH represents 13,000 Women's Health Nurse Practitioners and sets standards of excellence in women's healthcare through research, education, and advocacy.
Aspira Women's Health Inc. (Nasdaq: AWH) has announced a poster presentation at the upcoming Annual Meeting of The Menopause Society, scheduled for September 10-14, 2024, in Chicago. The presentation, titled 'Application of Deep Neural Network-Based Algorithm to Provide Additional Information in the Assessment of Adnexal Masses Classified as Indeterminate by Imaging,' will be given by Dr. Christina Kronfel, Senior Scientist at Aspira Women's Health. The poster will highlight data demonstrating OvaWatch's performance in assessing ovarian cancer risk in pre- and post-menopausal women. This presentation aligns with Aspira's focus on developing gynecologic disease diagnostic tools and showcases their commitment to advancing women's health technologies.
Aspira Women's Health Inc. (Nasdaq: AWH), a bio-analytical women's health company focusing on gynecologic disease diagnostic tools, has announced its plans to report second quarter 2024 financial results on Monday, August 12, 2024. The company will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day to discuss the financial results and provide a corporate update.
Investors and interested parties can access the conference call toll-free at 877-407-4018. A webcast of the call will be available, and a replay will be accessible on the Events & Presentation page of Aspira Women's Health's Investor Relations website.
Aspira Women's Health Inc. (Nasdaq: AWH) has appointed Mr. John Ragard to its Board of Directors. Mr. Ragard brings over 46 years of experience in public equity investment and Wall Street. He has successfully managed several billion-dollar portfolios throughout his career. The company's Chairwoman, Ms. Jannie Herchuk, and CEO, Nicole Sandford, both expressed enthusiasm about Mr. Ragard's addition to the board, citing his wealth of experience and understanding of Wall Street as valuable assets for Aspira's growth strategy.
Mr. Ragard's extensive background includes roles as a venture capital investor, public equity buy-side analyst, and portfolio manager. He is currently a Senior Investment Advisor at Wayve Capital Management and has previously held positions at Spouting Rock and Friess Associates, where he consistently outperformed market benchmarks. Mr. Ragard expressed excitement about joining Aspira's board and contributing to the company's future success.
Aspira Women’s Health reported significant growth in its OvaWatch® and OvaSuiteSM product volumes for the second quarter of 2024. OvaWatch volume increased by 24% sequentially and 48% year-over-year, reaching 1,307 units, while OvaSuite volume grew by 11% sequentially and 3% year-over-year to 6,471 units. Aspira has also identified up to 70,000 samples in its biobank for potential secondary research collaborations to generate non-dilutive cash. Additionally, Aspira completed a $1.9 million private placement to support its commercial activities and is focused on reducing cash use for operations.
CEO Nicole Sandford emphasized the commercial success of OvaWatch and its potential for future growth, highlighting the expanded addressable market and robust sales force. President Dr. Sandra Milligan noted the company's progress in molecular test development and the strategic positioning of its biobank.
Aspira Women's Health has successfully closed a $1.9 million private placement equity financing, involving the sale of common stock and warrants. The company, listed on Nasdaq under the ticker AWH, could potentially raise an additional $2.8 million if all warrants are exercised. The funds will be used to support commercial activities and general corporate purposes. The financing saw significant participation from existing shareholders and insiders, signaling strong investor confidence. CEO Nicole Sandford highlighted the positive reception of their OvaWatch expansion and recent clinical data, expressing optimism about the future impact on women's health diagnostics.
Aspira Women's Health (Nasdaq: AWH) announced a $1.935 million private placement equity financing. The agreement, dated June 30, 2024, involves issuing 1,264,739 shares of common stock and warrants to purchase an equal number of shares at $1.53 per share. The warrants have a three-year term and an exercise price of $2.25 per share. The financing is expected to conclude by July 8, 2024, with proceeds supporting ongoing commercial activities and general corporate purposes. CEO Nicole Sandford highlighted the strong shareholder support and focus on commercial growth, following the expansion of the OvaSuite test portfolio and recent clinical data. The issued securities are unregistered and will be registered for resale with the SEC.
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