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Aspira Women’s Health Selected to Receive $10 Million Award from ARPA-H’s Sprint for Women’s Health

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Aspira Women's Health (Nasdaq: AWH) has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program. The funding, distributed over two years through milestone-based payments, will support the development of EndoMDx, a multi-marker miRNA blood test for endometriosis detection. Selected from over 1,700 submissions, Aspira will collaborate with ARPA-H Program Manager and Investor Catalyst Hub for test development and commercial launch. The project addresses a critical need, as endometriosis affects up to six million women in the US, currently requiring invasive laparoscopic surgery for diagnosis, with patients typically facing 7-10 years delay in diagnosis.

Aspira Women's Health (Nasdaq: AWH) è stata selezionata per ricevere un premio di 10 milioni di dollari dal programma Sprint for Women's Health di ARPA-H. I fondi, distribuiti nell'arco di due anni attraverso pagamenti basati su traguardi, supporteranno lo sviluppo di EndoMDx, un test del sangue multi-marker miRNA per la rilevazione dell'endometriosi. Selezionata tra oltre 1.700 candidature, Aspira collaborerà con il Program Manager di ARPA-H e il Catalyst Hub per lo sviluppo e il lancio commerciale del test. Il progetto risponde a un bisogno critico, poiché l'endometriosi colpisce fino a sei milioni di donne negli Stati Uniti, che attualmente devono affrontare interventi chirurgici laparoscopici invasivi per la diagnosi, con pazienti che tipicamente affrontano un ritardo di 7-10 anni nella diagnosi.

Aspira Women's Health (Nasdaq: AWH) ha sido seleccionada para recibir un premio de 10 millones de dólares del programa Sprint for Women's Health de ARPA-H. La financiación, distribuida durante dos años a través de pagos basados en hitos, apoyará el desarrollo de EndoMDx, una prueba de sangre de miRNA multi-marcador para la detección de endometriosis. Seleccionada entre más de 1.700 postulaciones, Aspira colaborará con el Program Manager de ARPA-H y el Catalyst Hub para el desarrollo y lanzamiento comercial de la prueba. El proyecto aborda una necesidad crítica, ya que la endometriosis afecta hasta a seis millones de mujeres en EE. UU., quienes actualmente requieren una cirugía laparoscópica invasiva para el diagnóstico, enfrentando típicamente un retraso de 7-10 años en la diagnosis.

Aspira Women's Health (Nasdaq: AWH)는 ARPA-H의 여성 건강 프로그램인 Sprint for Women's Health로부터 1천만 달러의 지원금을 받기로 선정되었습니다. 이 자금은 이정표 기반의 지불 방식으로 2년에 걸쳐 분배되며, EndoMDx라는 다중 표지자 miRNA 혈액 검사 개발을 지원할 것입니다. 1,700건 이상의 후보자 중에서 선택된 Aspira는 테스트 개발 및 상업적 출시를 위해 ARPA-H 프로그램 관리자 및 투자 촉진 허브와 협력할 것입니다. 이 프로젝트는 미약증이 미국에서 최대 600만 명의 여성에게 영향을 미친다는 중요한 필요를 다루고 있으며, 현재 진단을 위해 침습적인 복강경 수술이 필요하고, 환자들은 일반적으로 7-10년의 진단 지연을 겪고 있습니다.

Aspira Women's Health (Nasdaq: AWH) a été sélectionnée pour recevoir une aide de 10 millions de dollars du programme Sprint for Women's Health de l'ARPA-H. Ce financement, distribué sur deux ans par le biais de paiements basés sur des jalons, soutiendra le développement d'EndoMDx, un test sanguin multi-marqueurs de miARN pour la détection de l'endométriose. Sélectionnée parmi plus de 1 700 candidatures, Aspira collaborera avec le responsable de programme de l'ARPA-H et le Catalyst Hub pour le développement du test et son lancement commercial. Ce projet répond à un besoin crucial, l'endométriose touchant jusqu'à six millions de femmes aux États-Unis, qui nécessitent actuellement une chirurgie laparoscopique invasive pour le diagnostic, avec des patientes faisant généralement face à un retard de 7 à 10 ans pour obtenir un diagnostic.

Aspira Women's Health (Nasdaq: AWH) wurde ausgewählt, einen Preis von 10 Millionen Dollar vom Sprint for Women's Health-Programm von ARPA-H zu erhalten. Die Finanzierung, die über zwei Jahre hinweg in Meilenstein-basierten Zahlungen verteilt wird, wird die Entwicklung von EndoMDx, einem Multi-Marker-miRNA-Bluttest zur Erkennung von Endometriose, unterstützen. Aus über 1.700 Einsendungen ausgewählt, wird Aspira mit dem Programm-Manager von ARPA-H und dem Investor Catalyst Hub zur Testentwicklung und kommerziellen Markteinführung zusammenarbeiten. Das Projekt spricht einen kritischen Bedarf an, da Endometriose bis zu sechs Millionen Frauen in den USA betrifft und diese derzeit invasive laparoskopische Chirurgie zur Diagnose benötigen, wobei die Patienten typischerweise mit einer Verzögerung von 7-10 Jahren bei der Diagnose konfrontiert sind.

Positive
  • Secured $10 million in milestone-based funding over 2 years
  • Selected from 1,700+ submissions for ARPA-H funding
  • Access to ARPA-H expertise and resources for product development
  • Targeting large market opportunity with 6 million affected women in US
Negative
  • Milestone-based payments subject to performance requirements
  • Product still in development phase with no guaranteed success

Insights

The $10 million ARPA-H award represents a significant milestone for Aspira Women's Health's EndoMDx development program. The selection from over 1,700 submissions validates the company's scientific approach and market potential. The milestone-based funding structure over 2 years, combined with ARPA-H's expert support, substantially de-risks the development pathway.

The endometriosis diagnostic market represents a substantial opportunity, affecting approximately 6 million women in the US. Current diagnostic delays of 7-10 years and reliance on invasive procedures create a clear market need. A successful blood-based test could revolutionize the standard of care and capture significant market share.

The combination of financial backing, expert support and clear commercialization timeline strengthens AWH's position in the women's health diagnostics space. The upcoming investor day may provide important details about development milestones and market strategy.

Aspira aims to develop a multi-marker miRNA blood test to aid in the detection of endometriosis

AUSTIN, Texas, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health to address critical unmet challenges in women’s health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect women. Aspira will receive $10 million in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions.

Funding from the project will support the continued development of Aspira’s ground-breaking multi-marker blood test to aid in the detection of endometriosis, known by its working name EndoMDx. Aspira will receive milestone-based payments of up to $10 million over a 2-year period. Additionally, Aspira will work with an ARPA-H Program Manager and the ARPA-H Investor Catalyst Hub in the design, development and commercial launch of the non-invasive test to identify endometriosis. The award is intended to provide access to a team of world-class subject matter experts and advisors to help ensure the successful completion and commercial launch of the test before the end of the contract term.   

“We are honored to be an ARPA-H Sprint for Women’s Health awardee. The selection process was extremely competitive, with over 1,700 submissions vying for funding. I am extraordinarily proud of our team for this achievement; we have worked tirelessly to advance endometriosis diagnostic research for many years, and I believe our experience was the key differentiator in the selection process,” said Nicole Sandford, CEO of Aspira Women’s Health. “Our strong scientific foundation, unwavering focus on operational excellence and the successful enhancement of our commercial capabilities were instrumental in our selection.”

Dr. Sandra Milligan, Aspira’s President, and Dr. Todd Pappas, Vice President of Research & Development, led the project proposal and successful presentation and will serve as the executive leaders responsible for the ARPA-H project. Dr. Milligan stated, “Endometriosis is a devastating, chronic gynecologic condition that affects as many as six million women in the United States alone. The lives of these women are impacted medically, economically, and socially. Many experience intense pain, starting as early as 12 years old, resulting in chronic absences from work or school. Women with endometriosis also have an increased risk of infertility and certain cancers. Endometriosis costs the American economy billions of dollars in lost productivity and healthcare expense each year.”

“Currently this condition can only be identified definitively through laparoscopic surgery and most women remain undiagnosed for 7 to 10 years,” continued Dr. Milligan. “Many also face repeated invasive procedures over the course of their lives. There is a tremendous need for a non-invasive test like ours, and we are excited to move this project forward.”

Ms. Sandford concluded, “We will be holding a virtual Investor Day on October 29th at 3:00 pm ET to provide highlights from our successful ARPA-H presentation and an update of our development pipeline.”

Investors interested in registering for this event can email investors@aspirawh.com.

About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of non-invasive, 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 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is comprised of two FDA-cleared tests, Ova1® and Overa®, to assess the risk of ovarian malignancy in patients with adnexal masses planned for surgery.

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 pipeline development and other statements that are predictive in nature. 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,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release and other factors that may cause such differences include the satisfaction of customary closing conditions related to the offering and the expected timing of the closing of the offering. These and additional risks and uncertainties are described more fully in the company’s filings with the 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, 2023, 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: 
Jamie Sullivan
Director of Corporate Communications
Investors@aspirawh.com


FAQ

What is the value of ARPA-H's funding award to Aspira Women's Health (AWH)?

Aspira Women's Health (AWH) will receive $10 million in milestone-based funding over a two-year period from ARPA-H's Sprint for Women's Health program.

What is the purpose of Aspira Women's Health's (AWH) EndoMDx test?

EndoMDx is a multi-marker miRNA blood test being developed to aid in the non-invasive detection of endometriosis, replacing the current need for laparoscopic surgery.

How many submissions competed for the ARPA-H Sprint for Women's Health award won by AWH?

Over 1,700 submissions competed for the ARPA-H Sprint for Women's Health award that Aspira Women's Health (AWH) won.

When is Aspira Women's Health (AWH) hosting its virtual Investor Day?

Aspira Women's Health is hosting its virtual Investor Day on October 29th at 3:00 pm ET.

Aspira Women's Health Inc.

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