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Aspira Women's Health Enhances Its Commercial Offering With the Formal Launch of Longitudinal Monitoring Feature of OvaWatch

Aspira Women's Health Enhances Its Commercial Offering With the Formal Launch of Longitudinal Monitoring Feature of OvaWatch

Aspira Women's Health通過正式推出OvaWatch的縱向監測功能來增強其商業產品
GlobeNewswire ·  05/02 20:00

AUSTIN, Texas, May 02, 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 formal launch of an updated OvaWatch ovarian cancer risk assessment test following the completion of all appropriate pre-launch activities.

得克薩斯州奧斯汀,2024年5月2日(GLOBE NEWSWIRE)——專注於開發婦科疾病診斷工具的生物分析型女性健康公司Aspira Women's Health Inc.(“Aspira” 或 “公司”)(納斯達克股票代碼:AWH)今天宣佈,在完成所有適當的啓動前活動後,正式啓動最新的OvaWatch卵巢癌風險評估測試。

Adnexal masses develop near the uterus, usually in or around the ovaries, fallopian tubes, and neighboring connective tissues. Most adnexal masses do not pose a serious threat to the health of a woman and resolve on their own within a few months. Others will require treatment or surgery. OvaWatch utilizes an AI-powered algorithm to assess malignancy risk of adnexal masses when initial clinical assessment indicates the mass is indeterminant or benign. With a negative predictive value of 99%, OvaWatch can help physicians confidently determine the appropriate care plan over time.

附件腫塊在子宮附近生長,通常位於卵巢、輸卵管和鄰近結締組織內或周圍。大多數附件腫塊不會對女性健康構成嚴重威脅,會在幾個月內自行消退。其他人則需要治療或手術。當初臨床評估表明附件腫塊不確定或良性時,OVAWatch 利用人工智能驅動的算法來評估附件腫塊的惡性腫瘤風險。OvaWatch的負預測值爲99%,可以幫助醫生隨着時間的推移自信地確定適當的護理計劃。

"We are proud to be able to meaningfully enhance the OvaWatch offering with the longitudinal monitoring feature," said Dr. Sandra Milligan, President of Aspira Women's Health. "More than 1.2 million women will present with an adnexal mass each year, and OvaWatch offers doctors and their patients a powerful tool to assess malignancy risk when it is identified and over time. We believe OvaWatch will help improve care decisions for women with adnexal masses, especially when surgery may be unnecessary or premature."

Aspira女性健康總裁桑德拉·米利根博士說:“我們很自豪能夠通過縱向監測功能切實增強OvaWatch的產品。”“每年將有超過120萬名女性出現附件腫塊,OVAWatch爲醫生及其患者提供了一個強大的工具,可以在發現惡性腫瘤時和一段時間內評估惡性腫瘤的風險。我們相信,OVAWatch將幫助改善附件腫塊女性的護理決策,尤其是在可能不必要或過早進行手術的情況下。”

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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