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Aspira Women’s Health Announces Fourth Quarter Operational Metrics and Provides Updates on Its OvaWatch and EndoCheck Programs

Aspira Women’s Health Announces Fourth Quarter Operational Metrics and Provides Updates on Its OvaWatch and EndoCheck Programs

ASPiRA婦女健康公司宣佈第四季度運營指標,並提供其OvaWatch和EndoCheck計劃的最新情況
GlobeNewswire ·  2022/01/05 21:07

Fourth quarter OVA1 volume grew 23.4% to 4,750 units

第四季度OVA1銷量增長23.4%,達到4750輛

Plans underway for staged launches of EndoCheck and OvaWatch

EndoCheck和OvaWatch的分階段發佈計劃正在進行中

AUSTIN, Texas, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Aspira Women's Health Inc. (Nasdaq: AWH), a bioanalytical-based women's health company, today announced preliminary fourth quarter operational results and provided a corporate update.

得克薩斯州奧斯汀,2022年1月5日(環球社)--以生物分析為基礎的婦女保健公司阿斯皮拉婦女保健公司(納斯達克代碼:AWH)今天宣佈了第四季度的初步經營業績,並提供了公司最新情況。

Operational Metrics Update

運營指標更新

  • OVA1® volume in the fourth quarter of 2021 grew approximately 23.4% year over year to 4,750 units compared to 3,849 units in the fourth quarter of 2020. The number of tests for the fourth quarter represented a quarterly record and a 11% increase sequentially compared to the third quarter test volume of 4,281.
  • The number of ordering physicians increased to approximately 3,211 for the fourth quarter of 2021, representing a year over year increase of 22.8% and a sequential increase of 10.2% for the quarter. The number of new physician additions increased 31% from third quarter of 2021 vs fourth quarter of 2021. The increase was largely driven by the improved productivity of sales representatives gaining tenure and the conversion of physicians who are engaging through the use of the Synergy platform, which was just launched in October 2021.
  • 2021年第四季度OVA1®銷量同比增長約23.4%,達到4750台,而2020年第四季度為3849台。第四季度的測試次數創下了季度紀錄,與第三季度的4281次測試相比,環比增長了11%。
  • 2021年第四季度,訂購醫生的數量增加到約3211名,同比增長22.8%,該季度環比增長10.2%。與2021年第四季度相比,2021年第三季度新增醫生數量增加了31%。這一增長在很大程度上是由於獲得終身職位的銷售代表生產率的提高,以及通過使用2021年10月剛剛推出的Synergy平臺參與的醫生的轉換。

Pipeline Update

管道更新

  • OvaWatch: We plan to launch our laboratory developed test (LDT) OvaWatch in two stages – single use and serial monitoring. For the single use test, we submitted the analytical validation manuscript in late November and will be submitting the clinical validation manuscript to a peer reviewed publication. We plan to launch the single use test following acceptance of both manuscripts.
    • Launch of the serial monitoring test is currently planned for the end of 2022/early 2023 though the timing will ultimately depend upon the outcome of our publication of data from the ongoing prospective serial monitoring clinical study.
    • Ultimately launch under the LDT pathway will be driven by our ongoing test validation activities and by our continuing evaluation of the regulatory landscape with respect to LDTs.
  • EndoCheck: We are developing an LDT with the specimens provided by our collaborators, ObsEva S.A. and AbbVie Inc., while simultaneously seeking FDA Breakthrough Designation for EndoCheck with the first FDA "Principles for Good Machine Learning Practices."
  • This dual track approach pursues the commercialization of an EndoCheck LDT, whereby real-world clinical utility data will be developed that also should support the data needed for an FDA marketing authorization, subsequent to any Breakthrough Designation decision by the FDA.
    • Estimates for the number of LDTs in the U.S. range from 60,000 to 100,000+,¹ with 15,000 to 20,000 of these LDTs falling under moderate or high risk per FDA classification.² There are much fewer FDA cleared moderate to high-risk tests on the market.
    • The LDT validation process allows us to improve our machine-learning algorithms in a dynamic fashion as we continue to expand our diverse biobank of valuable clinical specimens and collaborate with industry leading specialists.
  • We plan to hold a key opinion leader (KOL) event in the first quarter of 2022 with top thought leaders in the field to discuss the disease, the clinical gaps, the regulatory opportunity with LDT's, and our science.
  • OvaWatch:我們計劃分兩個階段推出實驗室開發的測試(LDT)OvaWatch-一次性使用和串行監控。對於一次性試驗,我們在11月下旬提交了分析驗證手稿,並將向同行評議的出版物提交臨牀驗證手稿。我們計劃在兩份手稿被接受後啟動一次性使用測試。
    • 目前計劃在2022年底/2023年初啟動系列監測測試,但時間最終將取決於我們公佈正在進行的前瞻性系列監測臨牀研究數據的結果。
    • 最終,LDT途徑下的推出將受到我們正在進行的測試驗證活動以及我們對LDT監管環境的持續評估的推動。
  • EndoCheck:我們正在用我們的合作者ObsEva S.A.和艾伯維公司提供的樣本開發LDT,同時為EndoCheck尋求FDA的突破性稱號,同時尋求FDA的第一個“良好機器學習實踐原則”。
  • 這種雙軌方法追求的是EndoCheck LDT的商業化,在FDA做出任何突破性指定決定後,將開發實際的臨牀實用數據,該數據也應支持FDA營銷授權所需的數據。
    • 據估計,美國的LDT數量在60,000到100,000+之間,?根據FDA的分類,其中15,000到20,000種LDT屬於中風險或高風險。²FDA批准市場上進行的中風險到高風險測試的數量要少得多。
    • LDT驗證過程使我們能夠以動態的方式改進我們的機器學習算法,因為我們繼續擴大我們有價值的臨牀標本的多樣化生物庫,並與行業領先的專家合作。
  • 我們計劃在2022年第一季度與該領域的頂級思想領袖舉行一次關鍵意見領袖(KOL)活動,討論疾病、臨牀差距、LDT的監管機會以及我們的科學。

"Early results indicate a solid performance in our test volumes this quarter. We are focused on continuing to execute and are pleased by the progress in the development of our OvaWatch and EndoCheck programs," said Valerie Palmieri, Chief Executive Officer of Aspira. "We look forward to 2022 and to providing financial results on our fourth quarter and full year 2021 earnings call in March."

Aspira首席執行官瓦萊麗·帕爾米耶裏(Valerie Palmieri)説:“初步結果顯示,本季度我們的測試量表現穩健。我們專注於繼續執行,並對我們的OvaWatch和EndoCheck計劃的開發進展感到高興,”Aspira首席執行官瓦萊麗·帕爾米耶裏(Valerie Palmieri)説。我們期待着2022年,並在3月份的2021年第四季度和全年收益電話會議上提供財務業績。“

About Aspira Women's Health Inc.
Aspira Women's Health Inc. is transforming women's health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women. Aspira Women's Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1plus™ combines our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. Aspira GenetiX™ testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women's Health is working to deliver a portfolio of pelvic mass products over a patient's lifetime with our cutting-edge research. The next generation of products in development include OVAWatch™ and EndoCheck™. To improve patient accessibility, Aspira Women's Health has recently launched our Aspira Synergy technology transfer platform to empower health systems, academics, regional labs, and physician group labs to conduct genetic and specialty tests in-house. Visit our website for more information at .

關於阿斯皮拉婦女健康公司(Aspira Women‘s Health Inc.)
ASPiRA婦女健康公司正在通過發現、開發創新的測試選項和生物分析解決方案並將其商業化來改變婦女的健康狀況,幫助醫生評估風險、優化患者管理並改善婦女的婦科健康結果。ASPiRA婦女健康特別側重於縮小卵巢癌風險評估方面的種族差異,並開發盆腔疾病的解決方案,如盆腔腫塊風險評估和子宮內膜異位症。OVA1 PLUS™結合了我們獲得美國食品和藥物管理局批准的產品OVA1®和OVRA®,可檢測有附件腫塊的女性患卵巢惡性腫瘤的風險。ASPiRA GenetiX™檢測以婦科為重點,提供有針對性和綜合性的基因檢測選項。憑藉在卵巢癌風險評估方面超過10年的專業經驗,Aspira Women‘s Health致力於通過我們的尖端研究在患者的一生中提供盆腔腫塊產品組合。正在開發的下一代產品包括OVAWatch™和Endocheck™。為了改善患者的可及性,Aspira Women‘s Health最近推出了我們的Aspira Synergy技術轉移平臺,使醫療系統、學者、地區實驗室和醫生小組實驗室能夠在內部進行基因和專科測試。有關更多信息,請訪問我們的網站。

Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the expected launch of OvaWatch single use and serial monitoring tests, the anticipated submission of manuscripts and the planned key opinion leader event. These statements involve a number of risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as "may," "expects," "intends," "anticipates," "believes," "estimates," "plans," "seeks," "could," "should," "continue," "will," "potential," "projects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties, and assumptions, including the risks and uncertainties described in the section entitled "Risk Factors" in Aspira Women's Health's Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. The events and circumstances reflected in Aspira Women's Health's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Aspira Women's Health expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.

前瞻性陳述
本新聞稿包含1995年“私人證券訴訟改革法”規定的前瞻性陳述,包括有關預期推出OvaWatch一次性使用和系列監測測試、預期提交手稿以及計劃中的關鍵意見領袖活動的陳述。這些聲明涉及許多風險和不確定因素。本新聞稿中除有關歷史事實的陳述外的所有陳述均為前瞻性陳述。諸如“可能”、“預期”、“打算”、“預期”、“相信”、“估計”、“計劃”、“尋求”、“可能”、“應該”、“繼續”、“將會”、“潛在”、“項目”等詞語以及類似的表述旨在識別前瞻性陳述。這些前瞻性聲明僅限於截至本新聞稿發佈之日的聲明,會受到大量風險、不確定性和假設的影響,包括在Aspira Women‘s Health在截至2020年12月31日的10-K表格年度報告和截至2021年6月30日的10-Q表格季度報告中題為“風險因素”的章節中描述的風險和不確定因素。Aspira Women‘s Health前瞻性陳述中反映的事件和情況可能無法實現或發生,實際結果可能與前瞻性陳述中預測的大不相同。ASPiRA女性健康明確表示,除非法律要求,否則沒有義務更新、修改或澄清任何前瞻性陳述,以反映本新聞稿發佈之日之後發生的事件、新信息或情況。

Investor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-430-7577
Arr@lifesciadvisors.com

投資者關係聯繫人:
阿什利·R·羅賓遜
LifeSci Advisors,LLC
電話:617-430-7577
郵箱:arr@lifescivisors.com

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