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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通过正式推出OvaWatch的纵向监测功能来增强其商业产品
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.

得克萨斯州奥斯汀,2024年5月2日(GLOBE NEWSWIRE)——专注于开发妇科疾病诊断工具的生物分析型女性健康公司Aspira Women's Health Inc.(“Aspira” 或 “公司”)(纳斯达克股票代码:AWH)今天宣布,在完成所有适当的启动前活动后,正式启动最新的OvaWatch卵巢癌风险评估测试。

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.

附件肿块在子宫附近生长,通常位于卵巢、输卵管和邻近结缔组织内或周围。大多数附件肿块不会对女性健康构成严重威胁,会在几个月内自行消退。其他人则需要治疗或手术。当初临床评估表明附件肿块不确定或良性时,OVAWatch 利用人工智能驱动的算法来评估附件肿块的恶性肿瘤风险。OvaWatch的负预测值为99%,可以帮助医生随着时间的推移自信地确定适当的护理计划。

"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女性健康总裁桑德拉·米利根博士说:“我们很自豪能够通过纵向监测功能切实增强OvaWatch的产品。”“每年将有超过120万名女性出现附件肿块,OVAWatch为医生及其患者提供了一个强大的工具,可以在发现恶性肿瘤时和一段时间内评估恶性肿瘤的风险。我们相信,OVAWatch将帮助改善附件肿块女性的护理决策,尤其是在可能不必要或过早进行手术的情况下。”

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.

关于 Aspira 女性健康公司
Aspira Women's Health Inc. 致力于发现、开发和商业化基于人工智能的无创检测,以帮助诊断妇科疾病。

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 还有 Ova1Plus 作为 ovaSuite 提供给临床医生军士长。他们共同提供唯一全面的血液检查产品组合,以帮助每年被诊断患有附件肿块的120多万美国女性发现卵巢癌。OVAWatch提供的阴性预测值为99%,用于评估女性的卵巢癌风险,初步临床评估表明肿块不确定或良性,因此手术可能为时过早或不必要。Ova1Plus 是两项经美国食品药品管理局批准的测试的反射过程,即 Ova1 和 Overa,以评估计划接受手术的女性患卵巢恶性肿瘤的风险。

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.

我们正在开发的测试管道旨在扩大我们的卵巢癌产品组合,满足对子宫内膜异位症无创诊断的巨大需求,子宫内膜异位症是一种影响全球数百万女性的使人衰弱的疾病。在卵巢癌中,我们的 OvamdX军士长 风险评估旨在将microRNA和蛋白质生物标志物与患者数据相结合,以进一步提高我们当前测试的灵敏度和特异性。在子宫内膜异位症中,EndoCheck军士长 是有史以来第一项旨在识别子宫内膜瘤的无创检测,子宫内膜瘤是最常见的子宫内膜异位症形式之一。EndomDX军士长 该测试旨在将microRNA和蛋白质生物标志物与患者数据相结合,以识别所有子宫内膜异位症。

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.

前瞻性陈述
本新闻稿包含前瞻性陈述,定义见1995年《私人证券诉讼改革法》。前瞻性陈述涉及许多风险和不确定性。此类前瞻性陈述包括有关任何在研产品的时间和完成时间的陈述,以及其他本质上具有预测性的陈述。由于已知和未知的风险、不确定性和其他因素,实际结果可能与所讨论的结果存在重大差异。这些前瞻性陈述通常可以通过使用 “设计”、“期望”、“计划”、“预期”、“可能”、“打算”、“打算”、“将”、“继续”、“未来” 等词语以及使用未来日期来识别。本新闻稿中的前瞻性陈述以及其他可能导致此类差异的因素包括与本次发行相关的惯例成交条件的满意度以及预期的发行结束时间。公司向美国证券交易委员会提交的文件中对这些以及其他风险和不确定性进行了更全面的描述,包括我们在截至2023年12月31日财年的最新10-K表年度报告中被确定为 “风险因素” 的因素。如果这些风险中的任何一个成为现实,或者我们的假设被证明不正确,则实际结果可能与这些前瞻性陈述所暗示的结果存在重大差异。可能还有其他风险,这些风险是Aspira目前不知道的,或者Aspira目前认为这些风险并不重要,这些风险也可能导致实际业绩与前瞻性陈述中包含的结果有所不同。此外,前瞻性陈述反映了截至本新闻稿发布之日Aspira对未来事件和观点的预期、计划或预测。随后的事件和事态发展可能会导致公司的评估发生变化。但是,尽管Aspira可能会选择在未来的某个时候更新这些前瞻性陈述,但除非法律要求,否则Aspira明确表示不承担任何更新前瞻性陈述的义务。不应将这些前瞻性陈述视为Aspira对本新闻稿发布之日后任何日期的评估。因此,不应过分依赖前瞻性陈述。

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

投资者关系联系人:
托斯滕·霍姆贝克博士
首席财务官
Aspira 女性健康
Investors@aspirawh.com


译文内容由第三方软件翻译。


以上内容仅用作资讯或教育之目的,不构成与富途相关的任何投资建议。富途竭力但不能保证上述全部内容的真实性、准确性和原创性。
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