Aspira Women's Health Provides Update on ARPA-H Sprint Program Partnership to Advance Women's Health
- Company has already received $3.5 million in milestone payments from ARPA-H
- Management confirms continued development of ENDOinform despite contract termination
- Removal of ARPA-H compliance requirements may accelerate development timeline
- Company maintains 2026 completion target for ENDOinform program
- Loss of remaining $6.5 million in ARPA-H funding due to contract termination
- Failure to meet Milestone 3 specifications according to ARPA-H
- Company will need to secure alternative funding sources to complete development
Insights
ARPA-H terminated Aspira's $10M ENDOinform funding after $3.5M paid; company disputes milestone failure and continues development independently.
The termination of Aspira Women's Health's
This development raises several critical concerns. First, the loss of
Particularly notable is the apparent disconnect between ARPA-H's assessment and Aspira's internal evaluation of milestone achievement. The company's strong assertion that they "fully achieved all specifications requirements" and are "well underway in achieving Milestone 4" suggests either miscommunication between the parties or fundamental disagreement about technical standards or evidence of achievement.
While management expresses confidence in continuing development with support from shareholders and research partners, the timeline implications remain uncertain. Though CEO Buhle suggests reduced ARPA-H compliance requirements might accelerate development toward 2026 completion goals, the funding gap will likely necessitate operational adjustments and potentially a modified development approach for this diagnostic tool targeting the millions of women suffering from endometriosis.
AUSTIN, TX AND WASHINGTON, DC / ACCESS Newswire / June 11, 2025 / Aspira Women's Health Inc., ("Aspira") (OTCQB:AWHL), an AI enhanced bio-analytics based women's health company focused on delivering leading noninvasive gynecologic disease diagnostic and disease management tools, announces an update from the Advanced Research Projects Agency for Health's ( ARPA-H ) Sprint for Women's Health program initiative to address critical unmet needs in women's health.
Aspira was originally awarded a
This test, leveraging technology and expertise originally developed by Aspira for ovarian cancer risk assessment diagnostics, promises the potential to non-invasively confirm presence of suspected endometriosis in patients, enabling physicians to identify patients who may benefit from endometriosis-controlling therapeutics currently available.
The original ARPA-H contract was announced on October 24, 2024, and reflected
Aspira's CEO, Mike Buhle, commented, "While we are certainly disappointed in ARPA-H's termination notice, we are highly confident that our team fully achieved all specifications requirements in the Milestone 3 scope of work provisions. We achieved these requirements in early May and are well underway in achieving Milestone 4 targeted specifications. We are confident in our quality of work, and even more so in our understanding of the technical requirements to complete the ENDOinform program."
Buhle further commented, "Our R&D team has been excited about the progress we have made, as well as the early indications of our potential success with the ENDOinform program overall. We plan to continue development of this critical women's health program with the help and support of our shareholders, our research & collaboration partners, and the ongoing dedication of our highly talented and missional teammates. ENDOinform promises a dramatic improvement in health outcomes and quality of life for millions of women suffering from endometriosis, both in the U.S. and abroad. The program remains targeted for 2026 completion goals. We look forward to continuing our development work to completion. In fact, compliance with the ARPA-H program involved significant time investment for our R&D team, and this may well offer us a material acceleration in the pace of achieving our goals."
About Aspira Women's Health Inc.
Aspira Women's Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases. OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer risk for the 1.2+ million American women diagnosed with an adnexal mass each year.
OvaWatch provides a negative predictive value of
Our in-development test pipeline will expand our ovarian cancer portfolio and address the tremendous need for non-invasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, we intend to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, we have developed the first-ever non-invasive test designed to identify endometriomas, one of the most commonly occurring forms of severe endometriosis. Through our ongoing endometriosis development program, we are combining microRNA and protein biomarkers with patient data, with the intent of identifying all endometriosis independent of disease location or severity.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the development pipeline and other statements that are predictive in nature, and whether the marketing of the OvaSuite portfolio will prove successful. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as "designed to," "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," and other words of similar meaning and the use of future dates. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission (SEC), including those factors identified as "Risk Factors" in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira's expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company's assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira's assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Investor Relations Contact:
SOURCE: Aspira Women's Health
View the original press release on ACCESS Newswire
FAQ
Why did ARPA-H terminate its contract with Aspira Women's Health (AWHL)?
How much funding did Aspira Women's Health (AWHL) receive from ARPA-H before termination?
What is Aspira's ENDOinform test?
When does Aspira Women's Health plan to complete the ENDOinform program?
How much total funding was originally awarded to Aspira by ARPA-H?
