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Aspira Women's Health Announces Publication of Two OvaWatch Peer-Reviewed Manuscripts

Aspira Women's Health Announces Publication of Two OvaWatch Peer-Reviewed Manuscripts

Aspira Women's Health 宣佈出版兩份 OvaWatch 同行評審手稿
GlobeNewswire ·  05/07 20:00

AUSTIN, Texas, May 07, 2024 (GLOBE NEWSWIRE) -- Aspira Women's Health Inc. ("Aspira" or the "Company") (Nasdaq: AWH), a bio-analytical based women's health company focused on the development of gynecologic disease diagnostic tools, today announced the publication of two peer-reviewed manuscripts.

得克薩斯州奧斯汀,2024年5月7日(GLOBE NEWSWIRE)——專注於開發婦科疾病診斷工具的生物分析女性健康公司Aspira Women's Health Inc.(“Aspira” 或 “公司”)(納斯達克股票代碼:AWH)今天宣佈出版兩份經過同行評審的手稿。

The first manuscript, entitled "Ovarian Cancer Surgical Consideration is Markedly Improved by the Neural Network Powered-MIA3G Multivariate Index Assay" was published in the peer-reviewed journal Frontiers of Medicine on May 2, 2024. The findings of this study demonstrate that use of OvaWatch to stratify risk in patients with an adnexal mass might help to reduce surgical backlogs and unnecessary surgical referrals.

第一份手稿的標題是”基於神經網絡的MIA3G多變量指數測定顯著改善了卵巢癌手術的考慮“發表在同行評審期刊上 醫學前沿 2024 年 5 月 2 日。這項研究的結果表明 OVAWatch 的使用 對附件腫塊患者的風險進行分層可能有助於減少手術積壓和不必要的手術轉診。

The second manuscript, entitled: "Neural Network-derived Multivariate Index Assay Demonstrates Effective Clinical Performance in Longitudinal Monitoring of Ovarian Cancer Risk" was published in the journal Gynecologic Oncology on May 3, 2024. The findings of this study demonstrate that OvaWatch could be an effective tool for the monitoring of ovarian cancer risk over time in women with indeterminate or low risk adnexal masses. Based on common practice for adnexal mass management and consistent with the study, OvaWatch can be drawn by the provider every three to six months for active surveillance of an adnexal mass.

第二份手稿標題爲:”神經網絡衍生的多變量指數分析顯示了縱向監測卵巢癌風險方面的有效臨床表現“發表在雜誌上 婦科腫瘤學 2024 年 5 月 3 日。這項研究的結果表明,OvaWatch可以成爲長期監測附件腫塊不確定或低風險女性卵巢癌風險的有效工具。根據附件腫塊管理的常用做法,並與研究一致,提供者可以每三到六個月抽出OVAWatch來對附件腫塊進行主動監測。

"Today, we mark the publication of additional clinical data to support the use of OvaWatch for the assessment of ovarian cancer risk for women with an adnexal mass," said Nicole Sandford, Chief Executive Officer of Aspira. "We believe these studies will help accelerate the adoption of OvaWatch for initial and ongoing monitoring of patients to provide an alternative to surgical intervention for lower risk cases. Clinicians have long sought a better tool to develop an appropriate care plan for these women, and OvaWatch provides it."

Aspira首席執行官妮可·桑德福德說:“今天,我們紀念更多臨床數據的發佈,以支持使用OVAWatch評估附件腫塊女性的卵巢癌風險。”“我們認爲,這些研究將有助於加速採用OvaWatch對患者進行初步和持續監測,爲低風險病例提供手術干預的替代方案。長期以來,臨床醫生一直在尋找更好的工具來爲這些女性制定適當的護理計劃,OvaWatch提供了該工具。”

"The publication of these manuscripts, along with last week's announcement to make OvaWatch available for testing over time, is the latest example of Aspira keeping its promises to our stakeholders. We are well on our way to achieving our mission to improve outcomes for women with gynecologic diseases."

“這些手稿的發佈,以及上週宣佈將OvaWatch逐漸可供測試,是Aspira信守對利益相關者的承諾的最新例子。我們正在努力實現改善患有婦科疾病的女性預後的使命。”

The total addressable market for OvaSuite, the company's portfolio of ovarian cancer risk assessment blood tests, is 2.0-3.0 million tests per year.

該公司的卵巢癌風險評估血液檢查產品組合OvaSuite的總潛在市場爲每年200萬至300萬次檢測。

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.

關於 Aspira 女性健康公司
Aspira Women's Health Inc. 致力於發現、開發和商業化基於人工智能的無創檢測,以幫助診斷婦科疾病。

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 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 a reflex process of two FDA-cleared tests, Ova1 and Overa, to assess the risk of ovarian malignancy in women planned for surgery.

OvaWatch 還有 Ova1Plus 作爲 ovaSuite 提供給臨床醫生軍士長。他們共同提供唯一全面的血液檢查產品組合,以幫助每年被診斷患有附件腫塊的120多萬美國女性發現卵巢癌。OVAWatch提供的陰性預測值爲99%,用於評估女性的卵巢癌風險,初步臨床評估表明腫塊不確定或良性,因此手術可能爲時過早或不必要。Ova1Plus 是兩項經美國食品藥品管理局批准的測試的反射過程,即 Ova1 和 Overa,以評估計劃接受手術的女性患卵巢惡性腫瘤的風險。

Our in-development test pipeline is designed to expand our ovarian cancer portfolio and addresses the tremendous need for noninvasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, our OvaMDxSM risk assessment is designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, EndoCheckSM is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. The EndoMDxSM test is designed to combine microRNA and protein biomarkers with patient data to identify all endometriosis.

我們正在開發的測試管道旨在擴大我們的卵巢癌產品組合,滿足對子宮內膜異位症無創診斷的巨大需求,子宮內膜異位症是一種影響全球數百萬女性的使人衰弱的疾病。在卵巢癌中,我們的 OvamdX軍士長 風險評估旨在將microRNA和蛋白質生物標誌物與患者數據相結合,以進一步提高我們當前測試的靈敏度和特異性。在子宮內膜異位症中,EndoCheck軍士長 是有史以來第一項旨在識別子宮內膜瘤的無創檢測,子宮內膜瘤是最常見的子宮內膜異位症形式之一。EndomDX軍士長 該測試旨在將microRNA和蛋白質生物標誌物與患者數據相結合,以識別所有子宮內膜異位症。

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. 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.

前瞻性陳述
本新聞稿包含前瞻性陳述,定義見1995年《私人證券訴訟改革法》。前瞻性陳述涉及許多風險和不確定性。此類前瞻性陳述包括有關任何在研產品的時間和完成時間的陳述,以及其他本質上具有預測性的陳述。由於已知和未知的風險、不確定性和其他因素,實際結果可能與所討論的結果存在重大差異。這些前瞻性陳述通常可以通過使用 “設計”、“期望”、“計劃”、“預期”、“可能”、“打算”、“打算”、“將”、“繼續”、“未來” 等詞語以及使用未來日期來識別。本新聞稿中的前瞻性陳述以及其他可能導致此類差異的因素包括與本次發行相關的慣例成交條件的滿意度以及預期的發行結束時間。公司向美國證券交易委員會提交的文件中對這些以及其他風險和不確定性進行了更全面的描述,包括我們在截至2023年12月31日財年的最新10-K表年度報告中被確定爲 “風險因素” 的因素。如果這些風險中的任何一個成爲現實,或者我們的假設被證明不正確,則實際結果可能與這些前瞻性陳述所暗示的結果存在重大差異。可能還有其他風險,這些風險是Aspira目前不知道的,或者Aspira目前認爲這些風險並不重要,這些風險也可能導致實際業績與前瞻性陳述中包含的結果有所不同。此外,前瞻性陳述反映了截至本新聞稿發佈之日Aspira對未來事件和觀點的預期、計劃或預測。隨後的事件和事態發展可能會導致公司的評估發生變化。但是,儘管Aspira可能會選擇在未來的某個時候更新這些前瞻性陳述,但除非法律要求,否則Aspira明確表示不承擔任何更新前瞻性陳述的義務。不應將這些前瞻性陳述視爲Aspira對本新聞稿發佈之日後任何日期的評估。因此,不應過分依賴前瞻性陳述。

Investor Relations Contact:
Torsten Hombeck, Ph.D.
Chief Financial Officer
Aspira Women's Health
Investors@aspirawh.com

投資者關係聯繫人:
託斯滕·霍姆貝克博士
首席財務官
Aspira 女性健康
Investors@aspirawh.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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