Aspira Receives $1.5 million Milestone Payment from the ARPA-H Sprint for Women’s Health Award
Aspira Women's Health (NASDAQ:AWH) has successfully achieved the second milestone of its $10 million ARPA-H Sprint for Women's Health award, receiving a $1.5 million payment. The milestone focused on scaling up R&D capabilities for developing ENDOinform™, a non-invasive blood test for endometriosis detection.
The project involves developing an AI-enabled algorithm combining protein and microRNA biomarkers with patient data. The second milestone included plans for building a new molecular laboratory, securing patents and licenses, and conducting market research for test positioning.
The company expects to complete the third milestone in Q2 2025, which will trigger another $1.5 million payment upon delivery of a biomarker algorithm technical report and voice of customer study framework. The program will continue through early 2026, providing non-dilutive funding for Aspira's growth.
Aspira Women's Health (NASDAQ:AWH) ha raggiunto con successo il secondo traguardo del suo premio ARPA-H Sprint per la salute delle donne di 10 milioni di dollari, ricevendo un pagamento di 1,5 milioni di dollari. Il traguardo si è concentrato sull'ampliamento delle capacità di R&S per lo sviluppo di ENDOinform™, un test del sangue non invasivo per la rilevazione dell'endometriosi.
Il progetto prevede lo sviluppo di un algoritmo abilitato all'IA che combina biomarcatori proteici e microRNA con i dati dei pazienti. Il secondo traguardo ha incluso piani per la costruzione di un nuovo laboratorio molecolare, il conseguimento di brevetti e licenze, e la conduzione di ricerche di mercato per la posizione del test.
L'azienda prevede di completare il terzo traguardo nel secondo trimestre del 2025, il che attiverà un ulteriore pagamento di 1,5 milioni di dollari al momento della consegna di un rapporto tecnico sull'algoritmo dei biomarcatori e di un framework per lo studio della voce del cliente. Il programma continuerà fino all'inizio del 2026, fornendo finanziamenti non diluitivi per la crescita di Aspira.
Aspira Women's Health (NASDAQ:AWH) ha logrado con éxito el segundo hito de su premio ARPA-H Sprint por la salud de la mujer de 10 millones de dólares, recibiendo un pago de 1,5 millones de dólares. El hito se centró en aumentar las capacidades de I+D para desarrollar ENDOinform™, una prueba de sangre no invasiva para la detección de la endometriosis.
El proyecto implica el desarrollo de un algoritmo habilitado por IA que combina biomarcadores de proteínas y microARN con datos de pacientes. El segundo hito incluyó planes para construir un nuevo laboratorio molecular, asegurar patentes y licencias, y realizar investigaciones de mercado para la posicionamiento de la prueba.
La empresa espera completar el tercer hito en el segundo trimestre de 2025, lo que desencadenará otro pago de 1,5 millones de dólares al entregar un informe técnico sobre el algoritmo de biomarcadores y un marco para el estudio de la voz del cliente. El programa continuará hasta principios de 2026, proporcionando financiamiento no dilutivo para el crecimiento de Aspira.
Aspira Women's Health (NASDAQ:AWH)는 여성 건강을 위한 1천만 달러 ARPA-H 스프린트 상의 두 번째 이정표를 성공적으로 달성하여 150만 달러의 지급을 받았습니다. 이 이정표는 자궁내막증 검사를 위한 비침습적 혈액 검사인 ENDOinform™의 연구 개발 역량을 확대하는 데 초점을 맞추었습니다.
이 프로젝트는 단백질 및 마이크로RNA 바이오마커와 환자 데이터를 결합한 AI 지원 알고리즘 개발을 포함합니다. 두 번째 이정표에는 새로운 분자 실험실 구축, 특허 및 라이센스 확보, 검사 위치 설정을 위한 시장 조사 수행 계획이 포함되었습니다.
회사는 2025년 2분기까지 세 번째 이정표를 완료할 것으로 예상하며, 이는 바이오마커 알고리즘 기술 보고서 및 고객 의견 연구 프레임워크의 제공 시 추가 150만 달러 지급을 촉발할 것입니다. 이 프로그램은 2026년 초까지 계속되며 Aspira의 성장을 위한 비희석 자금을 제공합니다.
Aspira Women's Health (NASDAQ:AWH) a réussi à atteindre le deuxième jalon de son prix ARPA-H Sprint pour la santé des femmes de 10 millions de dollars, recevant un paiement de 1,5 million de dollars. Ce jalon était axé sur l'augmentation des capacités de R&D pour le développement d'ENDOinform™, un test sanguin non invasif pour la détection de l'endométriose.
Le projet implique le développement d'un algorithme habilité par l'IA combinant des biomarqueurs protéiques et des microARN avec des données patients. Le deuxième jalon comprenait des plans pour construire un nouveau laboratoire moléculaire, sécuriser des brevets et des licences, et mener des recherches de marché pour le positionnement du test.
L'entreprise s'attend à terminer le troisième jalon au deuxième trimestre 2025, ce qui déclenchera un autre paiement de 1,5 million de dollars lors de la livraison d'un rapport technique sur l'algorithme de biomarqueurs et d'un cadre pour l'étude de la voix du client. Le programme se poursuivra jusqu'au début de 2026, fournissant un financement non dilutif pour la croissance d'Aspira.
Aspira Women's Health (NASDAQ:AWH) hat erfolgreich den zweiten Meilenstein seines 10 Millionen Dollar ARPA-H Sprint für Frauen-Gesundheitspreis erreicht und eine Zahlung von 1,5 Millionen Dollar erhalten. Der Meilenstein konzentrierte sich auf die Erweiterung der F&E-Kapazitäten zur Entwicklung von ENDOinform™, einem nicht-invasiven Bluttest zur Erkennung von Endometriose.
Das Projekt umfasst die Entwicklung eines KI-gestützten Algorithmus, der Protein- und MikroRNA-Biomarker mit Patientendaten kombiniert. Der zweite Meilenstein beinhaltete Pläne zum Bau eines neuen molekularen Labors, zur Sicherung von Patenten und Lizenzen sowie zur Durchführung von Marktforschung zur Positionierung des Tests.
Das Unternehmen erwartet, den dritten Meilenstein im zweiten Quartal 2025 abzuschließen, was eine weitere Zahlung von 1,5 Millionen Dollar auslösen wird, sobald ein technischer Bericht über den Biomarker-Algorithmus und ein Rahmen für die Kundenstimmenstudie geliefert wird. Das Programm wird bis Anfang 2026 fortgesetzt und bietet nicht verwässernde Finanzierung für das Wachstum von Aspira.
- Secured $1.5 million non-dilutive funding from ARPA-H milestone achievement
- On track for additional $1.5 million payment in Q2 2025
- Development of ENDOinform progressing according to schedule
- Expanding R&D capabilities with new molecular laboratory
- Significant investment required for patents, licenses, and laboratory build-out
- Commercial launch timeline dependent on milestone achievements
Insights
Aspira's receipt of the
The successful milestone achievement signals two important aspects: first, that development of the ENDOinform diagnostic tool is progressing on schedule, and second, that the company remains on track to receive the remaining
For a company trading at just
The milestones also create transparent progress markers for investors to track development of their endometriosis diagnostic, which represents a key future revenue opportunity in women's health diagnostics where unmet medical needs remain substantial.
Aspira's milestone achievement demonstrates tangible progress in their ENDOinform diagnostic development program, moving beyond conceptual stages into practical implementation. The second milestone specifically focused on establishing the infrastructure necessary for commercialization, including scaling R&D capabilities and building a molecular laboratory - critical foundations for bringing their endometriosis blood test to market.
The technical approach leverages Aspira's existing expertise in ovarian cancer diagnostics, applying a multi-biomarker methodology that combines protein markers, microRNA signatures, and patient metadata within an AI-enabled algorithm. This builds upon established technology rather than requiring completely novel development, potentially reducing technical risk.
Endometriosis diagnostics represent a substantial market opportunity, as the condition affects approximately
The articulated timeline with the third milestone expected in Q2 2025 and project completion by early 2026 establishes a clear development roadmap. The ARPA-H partnership not only provides funding but likely enhances regulatory pathway conversations, as government collaboration often facilitates more efficient interaction with regulatory bodies - an important consideration for diagnostic test approval.
The Company Successfully Reaches the Second Milestone of ARPA-H
AUSTIN, TX / ACCESS Newswire / March 31, 2025 / 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 the successful completion of the second development milestone of its Advanced Research Projects Agency for Health (ARPA-H) award. As a result of satisfying the second development milestone, Aspira received a
ARPA-H's Sprint for Women's Health was created to address critical unmet challenges in women's health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect women. As previously announced, Aspira won a
"Our entire team is proud to have met this key second milestone under the ARPA-H award program. This is a strong validation of the progress our team is making in developing a groundbreaking new diagnostic for endometriosis through our ENDOinformTM development project. Clearing this second milestone per the terms of the ARPA-H contract and receiving this second payment is a clear and tangible demonstration of the progress our technical team has made in advancing ENDOinform," stated Mike Buhle, CEO of Aspira Women's Health.
Mr. Buhle continued, "This is a vital component of our future development pipeline, and this
Aspira is expected to receive a total of
The second milestone encompassed scaling up of the Company's research and development capabilities to be able to execute on the goal of a non-invasive microRNA, protein, and patient metadata-based blood assay. Investment will start in acquiring necessary patents, licenses, and trademarks to ensure Aspira's freedom to operate in the U.S. market, the building of the new molecular laboratory, and market research into test positioning. Deliverables provided to ARPA-H to support the achievement of the milestone included detailed plans for the build-out of the molecular lab and market feedback on test positioning from payers, providers, and health systems.
The third milestone, which is focused on additional analytical development steps, is expected to be completed in the second quarter of 2025. The next milestone requires the completion of additional deliverables including a biomarker algorithm technical report, as well as the framework for a voice of customer study. Upon successful completion of the third milestone, Aspira will be entitled to receive an additional
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:
investors@aspirawh.com
SOURCE: Aspira Women's Health
View the original press release on ACCESS Newswire
FAQ
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