Senseonics Holdings, Inc. Provides Update on Eversense 365 Launch
Senseonics Holdings, Inc. Provides Update on Eversense 365 Launch
Strong Eversense 365 early launch indicators illustrated by largest number of new patient shipments and largest number of prescribing providers in any month under Ascensia partnership
Eversense 365強勁的早期啓動因子體現了在Ascensia合作伙伴關係下新患者發貨的最大數量和任何月份處方提供者的最大數量。
GERMANTOWN, Md., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today provided commercial updates related to the Eversense 365 launch.
馬里蘭州日耳曼敦,2024年12月09日(環球新聞)-- senseonics控股公司(紐交所美國:SENS)是一家專注於開發和製造長期植入式連續血糖監測(CGM)系統的醫療科技公司,旨在爲糖尿病患者提供服務,今天提供了關於Eversense 365推出的商業更新。
Eversense 365 Commercial Launch Update
Eversense 365商業發佈更新
- Launched Eversense 365 in October with global commercial partner Ascensia Diabetes Care and began shipping product in November
- Seeing strong interest in Eversense 365, as evidenced by the following early launch performance indicators:
- Direct-to-Consumer (DTC) leads in each of October and November were more than double the number of leads in pre-launch months
- New patient shipments in November were the highest compared to any month since inception of the Ascensia partnership
- Since launch, Eversense 365 has already shown a 42% increase in the number of providers prescribing Eversense and a 69% increase in prescriptions from top prescribers compared to the pre-launch rate in 2024
- One-third of Eversense 365 prescribers are new first-time Eversense prescribers
- The number of patients switching to Eversense monthly from competitive CGMs has increased 47% since Eversense 365 launch
- Remain on-target to achieve annual growth of approximately 50% in patient installed base at the end of 2024 as compared with 2023
- Reiterated full-year 2024 global net revenue guidance of approximately $22 million
- 與全球商業合作伙伴Ascensia Diabetes Care於10月推出Eversense 365,並於11月開始發貨
- Eversense 365受到了強烈的關注,這在以下早期發佈因子中得到了體現:
- 在10月和11月期間,直接面向消費者(DTC)的潛在客戶數量是發佈前幾個月的兩倍以上
- 11月份的新患者發貨量是自Ascensia合作以來的最高記錄
- 自推出以來,Eversense 365已經顯示出處方Eversense的提供者數量增加了42%,而來自主要處方者的處方數量較2024年推出前的比例增加了69%。
- 三分之一的Eversense 365處方者是首次開處方Eversense的新手。
- 自Eversense 365推出以來,每月轉向Eversense的患者人數比競爭性連續血糖監測儀增加了47%。
- 預計到2024年年底,實現患者安裝基礎年增長約50%的目標,較2023年相比。
- 重申2024財年的全球淨營業收入指引約爲2200萬。
Brian Hansen, President of Ascensia's CGM division, commented, "We are thrilled to have a world-class product that so fully addresses patient needs for a long-term CGM, with minimal data disruptions and complete flexibility. Patients have been elated with Eversense 365's reduction in calibration and ease of use, and providers are getting the consistent flow of data required to manage their patients' disease. We believe this is driving the double-digit growth in monthly patients since 365 launch switching from competitive CGMs--and a triple-digit increase in Type 2 basal only patients, the largest market segment opportunity. Eversense 365 is really a win-win for everyone, and our strong early launch performance indicators are showing meaningful improvement in the key metrics we track."
Ascensia CGM部門總裁Brian Hansen評論道:「我們非常高興擁有一款世界級的產品,它充分滿足了患者對長期連續血糖監測儀的需求,數據中斷最小並且完全靈活。患者對Eversense 365減少校準頻率和使用方便感到非常滿意,提供者也獲得了管理患者疾病所需的一致數據流。我們相信這推動了自365發佈以來每月從競爭性連續血糖監測儀轉變的患者的兩位數增長,以及2型基礎患者的三位數增長,這是最大的市場細分機會。Eversense 365對所有人來說確實是雙贏,並且我們強大的早期啓動表現因子顯示出我們追蹤的關鍵指標有顯著改善。」
"2024 has been a landmark year for Senseonics, achieving our long-term goal of commercializing the Eversense 365 product, providing people with diabetes a convenient and accurate solution for monitoring blood glucose for an entire year with a single sensor," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "We are excited to see the strong early performance indicators that we believe reflect the commercial potential of this ground-breaking product. Patient and provider leads and new interest from health systems have all increased significantly following 365 launch, and we expect that a heightened level of interest will drive our results for 2025. We intend to provide updates on the ongoing 365 launch, as well as on our product portfolio development, pump-connectivity, additional health care systems, and our ex-US commercial launch of Eversense 365 over the course of 2025."
「2024年對於senseonics來說是一個重要的里程碑年,我們實現了將Eversense 365產品商業化的長期目標,爲糖尿病患者提供了一種便捷而準確的血糖監測解決方案,僅需一個傳感器即可監測整整一年,」 senseonics的總裁兼首席執行官Tim Goodnow博士表示。「我們很高興看到強勁的早期表現因子,這反映了該開創性產品的商業潛力。患者和供應商線索及來自醫療系統的新興趣在365推出後顯著增加,我們預計,興趣的高度將推動我們在2025年的業績。我們計劃在2025年期間提供關於持續的365推出、我們的產品組合發展、泵連接性、其他醫療保健系統及我們Eversense 365在美國以外的商業推出的更新。」
"Additionally, in an effort to enhance Senseonics' appeal to institutional and other investors, we are seeking to execute a reverse stock split, pending shareholder approval, in January 2025," continued Dr. Goodnow. "We understand that many institutional investors and other funds have internal policies and practices that limit their ability to invest in low-priced stocks, and we are seeking a reserve stock split to overcome these limitations, which we believe will address this impediment and make it easier for these investors to invest in Senseonics stock."
「此外,爲了增強senseonics對機構和其他投資者的吸引力,我們計劃在2025年1月進行一次反向股票拆分,等待股東批准,」Goodnow博士繼續說。「我們理解許多機構投資者和其他基金有內部政策和實踐限制了他們投資低價股票的能力,我們正在尋求反向股票拆分以克服這些限制,我們相信這將解決這個障礙,使這些投資者更容易投資於senseonics股票。」
About Senseonics
Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems Eversense 365 and Eversense E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
關於Senseonics:Senseonics Holdings, Inc.("Senseonics")是一家醫療技術公司,專注於開發和製造用於在全球糖尿病社區中改變生活的葡萄糖監測產品,其不同於其它長期植入葡萄糖管控技術。Senseonics的CGM系統Eversense E3包括一個完全插入皮膚下的小傳感器,與穿戴在傳感器上方的智能發射器進行通訊,葡萄糖數據每5分鐘自動發送到用戶手機上的移動應用程序。
Senseonics Holdings, Inc.("Senseonics")是一家醫療科技公司,專注於開發和製造用於改變全球糖尿病社區生活的葡萄糖監測產品的差異化、長期可植入的葡萄糖管理技術。Senseonics的CGM系統Eversense 365和Eversense E3包括一個完全插入皮膚下的小傳感器,該傳感器與佩戴在傳感器上方的智能發射器進行通信。葡萄糖數據每5分鐘自動發送到用戶智能手機上的移動應用程序。
About Eversense
The Eversense Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense 365 and 180 days for Eversense E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense 365 and one time per day after day 21 for Eversense E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see .
關於Eversense
Eversense連續葡萄糖監測(CGm)系統適用於18歲及以上糖尿病患者,可持續測量高達365天的Eversense 365和180天的Eversense E3的葡萄糖水平。該系統適用於替換指尖抽血葡萄糖(BG)測量,用於糖尿病治療決策。Eversense 365在第14天后主要每週校準一次,Eversense E3在第21天后每天校準一次。當症狀與CGm信息不符或服用四環素類藥物時仍需要進行指尖抽血BG測量。傳感器的植入和拆卸程序由醫療提供者執行。Eversense CGm系統屬於處方器械;患者應諮詢醫療提供者以了解更多信息。有關重要的安全信息,請查看。
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives.
關於Ascensia Diabetes Care
Ascensia Diabetes Care是一家全球公司,專注於幫助糖尿病患者。我們的使命是通過創新解決方案使糖尿病患者能夠簡化和改善他們的生活。
We are home to the world-renowned CONTOUR portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense Continuous Glucose Monitoring Systems from Senseonics. These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.
我們是世界著名的CONTOUR血糖監測系統系列的提供商,並且是Senseonics的全球獨家分銷合作伙伴,提供Eversense持續血糖監測系統。這些產品將先進的技術與用戶友好的功能結合在一起,幫助糖尿病患者管理他們的病情,並對他們的生活產生積極的影響。作爲糖尿病社區的值得信賴的合作伙伴,我們與醫療保健專業人士和其他合作伙伴緊密合作,確保我們的產品符合最高的準確性、精確性和可靠性標準,並以合規和誠信的方式開展業務。
Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries. Ascensia has around 1,400 employees and operations in 29 countries.
Ascensia是PHC Group的成員,成立於2016年,通過收購PHC Holdings Corporation的Bayer Diabetes Care而成立。Ascensia產品在100多個國家銷售。Ascensia在29個國家擁有大約1,400名員工和業務。
For further information, please visit the Ascensia Diabetes Care website at: .
欲獲取更多信息,請訪問Ascensia Diabetes Care網站:.
About PHC Holdings Corporation
PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group's consolidated net sales in FY2023 were JPY 353.9 billion with global distribution of products and services in more than 125 countries.
2024 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.
關於PHC控股公司
PHC控股公司(TSE 6523)是一家全球醫療保健公司,使命是通過積極影響社會並改善人們生活的醫療解決方案來爲社會的健康做貢獻。其子公司(統稱爲PHC集團)包括PHC公司、Ascensia Diabetes Care控股公司、Epredia控股有限公司、LSI Medience公司、Mediford公司和Wemex。它們共同開發、製造、銷售和服務於糖尿病管理、醫療解決方案、生命科學和診斷領域的解決方案。PHC集團在2023財年的合併淨銷售額爲3539億日元,產品和服務在125多個國家進行全球分銷。
2024年Ascensia糖尿病護理控股公司。保留所有權利。Ascensia,Ascensia糖尿病護理標識和Contour是Ascensia糖尿病護理控股公司的商標和/或註冊商標。
Forward Looking Statements
前瞻性聲明
Any statements in this press release about the expectations regarding the success of the commercial product launch of Eversense 365, trends of interest in, and market acceptance and adoption of, Eversense 365 by patients and prescribers, revenue expectations, product development plans and/or growth of Eversense, the potential implementation of the proposed reverse stock split and the potential that the reverse stock split may make the company's stock more appealing to institutional investors, and other statements containing the words "believe," "expect," "intend," "may," "projects," "will," "planned," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the new product launch and ongoing commercialization of Eversense 365, uncertainties inherent in the reliance on the commercialization efforts and investment of Ascensia and its commercial initiatives, uncertainties in prescriber and patient decisions and responses to new technology or initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology, uncertainties in the development of and competition in the overall CGM market, the potential inability to receive requisite stockholder approval of the proposed reverse stock split, the risk that the share price resulting from a reverse stock split may not attract institutional or other investors, may not satisfy the investing guidelines of these investors, or otherwise may not result in increased investor interest in Senseonics' stock or improved trading liquidity in the company's stock, and such other factors as are set forth in the risk factors detailed in Senseonics' Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent quarterly reports on Form 10-Q filed with the SEC under the heading "Risk Factors" and the Definitive Proxy Statement filed with the SEC on November 29, 2024 under the heading "Certain Risks and Potential Disadvantages Associated with a Reverse Stock Split." In addition, the forward-looking statements included in this press release represent Senseonics' views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics' views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics' views as of any date subsequent to the date hereof.
本新聞稿中關於對Eversense 365商業產品推出成功的期望、對Eversense 365在患者和處方醫生中的市場接受度和採用趨勢、營業收入預期、產品開發計劃和/或Eversense的增長的任何聲明,以及關於擬議的反向股票拆分的潛在實施和反向股票拆分可能使該公司的股票對機構投資者更具吸引力的潛力,以及包含"相信"、"預計"、"意圖"、"可能"、"項目"、"將"、"計劃"等類似表達的其他聲明,構成了1995年《私人證券訴訟改革法案》意義下的前瞻性陳述。由於各種重要因素,實際結果可能與這些前瞻性陳述所表明的結果有實質性差異,包括:Eversense 365新產品推出和持續商業化固有的不確定性,依賴Ascensia及其商業化努力和投資的新商業化倡議的固有不確定性,處方醫生和患者對新技術或倡議的決定和反應的不確定性,保險公司、監管和行政程序及決策的不確定性,新技術的開發和註冊的固有不確定性,整體CGM市場的開發和競爭的不確定性,以及未能獲得擬議反向股票拆分的必要股東批准的潛在風險,反向股票拆分導致的股價可能無法吸引機構或其他投資者,可能不滿足這些投資者的投資指導方針,或者可能不會導致對Senseonics股票的投資者興趣增加或該公司股票的交易流動性改善,及其他在Senseonics截至2023年12月31日的年度報告Form 10-K和隨後向SEC提交的Form 10-Q季度報告中詳細列出的風險因素,以及2024年11月29日提交的SEC的官方代理聲明中關於"與反向股票拆分相關的某些風險和潛在缺陷"的標題所列出的風險。此外,本新聞稿中包含的前瞻性陳述代表Senseonics截至本日的觀點。Senseonics預計後續事件和發展將導致其觀點發生變化。然而,雖然Senseonics可能會選擇在未來某個時候更新這些前瞻性陳述,Senseonics特別聲明在法律要求的情況下才有此義務。這些前瞻性陳述不應被依賴爲代表Senseonics在本日期之後任何日期的觀點。
Important Additional Information
重要的附加信息
The Company, its directors and executive officers, are deemed to be "participants" (as defined in Section 14(a) of the Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company's stockholders in connection with the Special Meeting of Stockholders (the "Special Meeting") scheduled for January 10, 2025. The Company filed its definitive proxy statement (the "Definitive Proxy Statement") with the SEC on November 29, 2024 in connection with such solicitation of proxies from the Company's stockholders. STOCKHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH DEFINITIVE PROXY STATEMENT, ACCOMPANYING PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY AS THEY CONTAIN IMPORTANT INFORMATION ABOUT THE SPECIAL MEETING. The Definitive Proxy Statement contains information regarding the identity of the participants, and their direct and indirect interests, by security holdings or otherwise, in the Company's securities and can be found in the section titled "Security Ownership of Certain Beneficial Owners and Management" of the Definitive Proxy Statement. Information regarding subsequent changes to their holdings of the Company's securities can be found in the SEC filings on Forms 3, 4, and 5, which are available on the Company's website available here or through the SEC's website at www.sec.gov. Stockholders will be able to obtain the Definitive Proxy Statement, any amendments or supplements thereto and other documents filed by the Company with the SEC at no charge at the SEC's website at www.sec.gov. Copies will also be available at no charge at the Company's website at .
The Company, its directors and executive officers, are deemed to be "participants" (as defined in Section 14(a) of the Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company's stockholders in connection with the Special Meeting of Stockholders (the "Special Meeting") scheduled for January 10, 2025. The Company filed its definitive proxy statement (the "Definitive Proxy Statement") with the SEC on November 29, 2024 in connection with such solicitation of proxies from the Company's stockholders. STOCKHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH DEFINITIVE PROXY STATEMENt, ACCOMPANYING PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY AS THEY CONTAIN IMPORTANt INFORMATION ABOUt THE SPECIAL MEETING. The Definitive Proxy Statement contains information regarding the identity of the participants, and their direct and indirect interests, by security holdings or otherwise, in the Company's securities and can be found in the section titled "Security Ownership of Certain Beneficial Owners and Management" of the Definitive Proxy Statement. Information regarding subsequent changes to their holdings of the Company's securities can be found in the SEC filings on Forms 3, 4, and 5, which are available on the Company's website available 這裏 or through the SEC's website at www.sec.gov. Stockholders will be able to obtain the Definitive Proxy Statement, any amendments or supplements thereto and other documents filed by the Company with the SEC at no charge at the SEC's website at www.sec.gov. Copies will also be available at no charge at the Company's website at .
Senseonics Investor Contact
Jeremy Feffer
LifeSci Advisors
investors@senseonics.com
Senseonics投資者聯繫方式
Jeremy Feffer
LifeSci顧問
investors@senseonics.com
譯文內容由第三人軟體翻譯。