Tactile Medical Receives PDAC Approval for Nimbl Lymphedema Platform
Tactile Medical Receives PDAC Approval for Nimbl Lymphedema Platform
"The receipt of PDAC approval for Nimbl comes earlier than expected, and we are pleased that CMS recognizes the potential health and quality-of-life enhancing benefits this device offers for Medicare patients struggling with lymphedema and chronic venous insufficiency," said Sheri Dodd, Chief Executive Officer at Tactile Medical. "Nimbl's new sleeker design and technical advancements reflect our commitment to meaningful product innovation that seeks to meet the patient wherever they are in the treatment pathway. I am proud of the work our team has accomplished in developing this new platform, which I believe will elevate lymphedema therapy and increase patient acceptance and adherence. We look forward to Nimbl's upcoming full commercial launch in the weeks ahead."Next-Generation System Significantly Reduces Device Size and Weight and Enables Integration with Kylee Digital App
下一代系統顯著減小了設備的體積和重量，並實現了與Kylee數字應用程序的集成
MINNEAPOLIS, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. ("Tactile Medical"; the "Company") (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced that the Pricing, Data Analysis, and Coding (PDAC) contractor for the Centers for Medicare & Medicaid Services (CMS) has approved the use of Healthcare Common Procedure Coding System (HCPCS) code E0651 for billing the Durable Medical Equipment Medicare Administrative Contractors for Nimbl, the Company's next-generation pneumatic compression platform. PDAC approval is subsequent to the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in June 2024. The Company will make Nimbl commercially available in the United States in the coming weeks.
明尼阿波利斯，2024年9月16日（環球新聞社）-- 醫療觸覺系統技術公司（"Tactile Medical"；"公司"）（納斯達克股票代碼：TCMD），一家爲慢性疾病患者提供療法的醫療技術公司，今天宣佈，美國康哲藥業（CMS）的定價、數據分析和編碼（PDAC）承包商已批准使用衛生保健通用程序編碼系統（HCPCS）代碼E0651，爲公司的下一代氣動壓縮平台Nimbl向耐用醫療設備醫療保險承包商進行計費。PDAC批准是在該公司於2024年6月獲得美國食品和藥物管理局（FDA）510(k)清關後進行的。該公司將在未來幾周內在美國推出Nimbl的商業產品。
Nimbl is the next generation of the Company's basic lymphedema compression solution and is indicated for the treatment of lymphedema, chronic edema, venous insufficiency, and wound healing. The device features several key patient-friendly enhancements over prior generations, including a 40% and 68% reduction in size and weight, respectively, making it more portable and ideal for active lifestyles. Nimbl offers connectivity to the Company's Kylee digital application, enabling patients to actively track their therapy progress and share results with their care team.
Nimbl是該公司基本淋巴水腫壓縮解決方案的下一代產品，適用於治療淋巴水腫、慢性水腫、靜脈功能不全和傷口癒合。該設備在與先前世代相比具有幾項關鍵的患者友好增強功能，包括體積和重量分別減小40%和68%，使其更易攜帶，非常適合積極的生活方式。Nimbl可連接到該公司的Kylee數字應用程序，使患者能夠積極跟蹤他們的治療進展，並與他們的護理團隊分享結果。
"The receipt of PDAC approval for Nimbl comes earlier than expected, and we are pleased that CMS recognizes the potential health and quality-of-life enhancing benefits this device offers for Medicare patients struggling with lymphedema and chronic venous insufficiency," said Sheri Dodd, Chief Executive Officer at Tactile Medical. "Nimbl's new sleeker design and technical advancements reflect our commitment to meaningful product innovation that seeks to meet the patient wherever they are in the treatment pathway. I am proud of the work our team has accomplished in developing this new platform, which I believe will elevate lymphedema therapy and increase patient acceptance and adherence. We look forward to Nimbl's upcoming full commercial launch in the weeks ahead."
「Nimbl獲得PDAC批准的時間比預期提前，我們很高興CMS意識到這款設備爲患有淋巴水腫和慢性靜脈功能不全的醫保患者所帶來的潛在健康和生活質量改善的好處，」Tactile Medical首席執行官Sheri Dodd表示，「Nimbl新的時尚設計和技術進步反映了我們致力於有意義的產品創新，旨在滿足患者在治療路徑中的任何階段。我爲我們團隊在開發這一新平台所取得的成就感到自豪，我相信Nimbl將提升淋巴水腫治療，並增加患者對治療的接受和依從性。我們期待Nimbl在未來幾周內全面商業化推出。」
About Tactile Systems Technology, Inc. (DBA Tactile Medical)
關於Tactile Systems Technology，Inc.（DBA觸覺醫療） Tactile Medical是一家爲患有未得到滿意照顧的慢性病人開發和營銷家庭治療的領先公司，包括淋巴水腫，脂肪水腫，慢性靜脈功能不全和慢性肺病患者，幫助他們在家中更好地生活和照顧自己。Tactile Medical與臨床醫生合作，以擴大臨床證據，提高意識，增加護理的獲取，降低整體醫療保健成本，並改善每年數以萬計的患者的生活質量。
Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. Tactile Medical collaborates with clinicians to expand clinical evidence, raise awareness, increase access to care, reduce overall healthcare costs and improve the quality of life for tens of thousands of patients each year.
本新聞稿包含前瞻性聲明。前瞻性聲明通常可識別出使用類似「可能」、「將」、「應該」、「可以」、「預期」、「期望」、「估計」、「相信」、「打算」、「繼續」、「有把握」、「前景」、「指引」、「項目」、「目標」、「期待」、「就位」、「設計」、「計劃」、「回報」、「專注」、「前景」等詞或這些詞的負面形式或其他變體，類似的術語。閱讀者被警告不要過度依賴這些前瞻性聲明，因爲這些聲明受到公司無法控制的衆多因素和不確定性的影響，這些因素和不確定性可能會使這些聲明失誤，其中包括但不限於，公司能否從第三方支付方獲得其產品的回報；通貨膨脹，利率上漲或經濟衰退的影響；公司的流動性足以追求其業務目標；不良的經濟狀況或激烈的競爭；供應品和組件價格的上漲；工資和組件價格的通貨膨脹；關鍵供應商的利潤；新的競爭對手和產品的進入；遵守和可能發生的聯邦，州和地方政府監管的變化；關鍵高管的離職或退休，包括與公司即將到來的首席執行官更換有關的過渡事項；公司的產品技術過時；公司研究和產品的技術問題；公司能否通過戰略收購擴大業務；公司整合收購和相關業務的能力；目前和未來的美國和外國貿易政策和關稅行動的影響；否則不能執行研究，開發和商業化計劃。此外，可能導致實際結果與上述情況不同的其他因素在公司的SEC備案文件中進行了討論。投資者和證券持有者被敦促在SEC的網站（http://www.sec.gov）免費閱讀這些文件。公司無需因新信息、未來事件或其他原因公開更新或修改其前瞻性聲明。
Investor Inquiries:
Sam Bentzinger
Gilmartin Group
investorrelations@tactilemedical.com
投資者諮詢：
Sam Bentzinger
吉爾馬汀集團
investorrelations@tactilemedical.com
譯文內容由第三人軟體翻譯。
