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Tactile Medical Receives PDAC Approval for Nimbl Lymphedema Platform

Tactile Medical Receives PDAC Approval for Nimbl Lymphedema Platform

Tactile Medical获得Nimbl淋巴水肿平台的PDAC批准
GlobeNewswire ·  09/16 08:00

Next-Generation System Significantly Reduces Device Size and Weight and Enables Integration with Kylee Digital App

下一代系统显著减小了设备的体积和重量,并实现了与Kylee数字应用程序的集成

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(环球新闻社)-- 医疗触觉系统技术公司("Tactile Medical";"公司")(纳斯达克股票代码:TCMD),一家为慢性疾病患者提供疗法的医疗技术公司,今天宣布,美国康哲药业(CMS)的定价、数据分析和编码(PDAC)承包商已批准使用卫生保健通用程序编码系统(HCPCS)代码E0651,为公司的下一代气动压缩平台Nimbl向耐用医疗设备医疗保险承包商进行计费。PDAC批准是在该公司于2024年6月获得美国食品和药物管理局(FDA)510(k)清关后进行的。该公司将在未来几周内在美国推出Nimbl的商业产品。

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是该公司基本淋巴水肿压缩解决方案的下一代产品,适用于治疗淋巴水肿、慢性水肿、静脉功能不全和伤口愈合。该设备在与先前世代相比具有几项关键的患者友好增强功能,包括体积和重量分别减小40%和68%,使其更易携带,非常适合积极的生活方式。Nimbl可连接到该公司的Kylee数字应用程序,使患者能够积极跟踪他们的治疗进展,并与他们的护理团队分享结果。

"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获得PDAC批准的时间比预期提前,我们很高兴CMS意识到这款设备为患有淋巴水肿和慢性静脉功能不全的医保患者所带来的潜在健康和生活质量改善的好处,”Tactile Medical首席执行官Sheri Dodd表示,“Nimbl新的时尚设计和技术进步反映了我们致力于有意义的产品创新,旨在满足患者在治疗路径中的任何阶段。我为我们团队在开发这一新平台所取得的成就感到自豪,我相信Nimbl将提升淋巴水肿治疗,并增加患者对治疗的接受和依从性。我们期待Nimbl在未来几周内全面商业化推出。”

About Tactile Systems Technology, Inc. (DBA Tactile Medical)

关于Tactile Systems Technology,Inc.(DBA触觉医疗) Tactile Medical是一家为患有未得到满意照顾的慢性病人开发和营销家庭治疗的领先公司,包括淋巴水肿,脂肪水肿,慢性静脉功能不全和慢性肺病患者,帮助他们在家中更好地生活和照顾自己。Tactile Medical与临床医生合作,以扩大临床证据,提高意识,增加护理的获取,降低整体医疗保健成本,并改善每年数以万计的患者的生活质量。

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.

本新闻稿包含前瞻性声明。前瞻性声明通常可识别出使用类似“可能”、“将”、“应该”、“可以”、“预期”、“期望”、“估计”、“相信”、“打算”、“继续”、“有把握”、“前景”、“指引”、“项目”、“目标”、“期待”、“就位”、“设计”、“计划”、“回报”、“专注”、“前景”等词或这些词的负面形式或其他变体,类似的术语。阅读者被警告不要过度依赖这些前瞻性声明,因为这些声明受到公司无法控制的众多因素和不确定性的影响,这些因素和不确定性可能会使这些声明失误,其中包括但不限于,公司能否从第三方支付方获得其产品的回报;通货膨胀,利率上涨或经济衰退的影响;公司的流动性足以追求其业务目标;不良的经济状况或激烈的竞争;供应品和组件价格的上涨;工资和组件价格的通货膨胀;关键供应商的利润;新的竞争对手和产品的进入;遵守和可能发生的联邦,州和地方政府监管的变化;关键高管的离职或退休,包括与公司即将到来的首席执行官更换有关的过渡事项;公司的产品技术过时;公司研究和产品的技术问题;公司能否通过战略收购扩大业务;公司整合收购和相关业务的能力;目前和未来的美国和外国贸易政策和关税行动的影响;否则不能执行研究,开发和商业化计划。此外,可能导致实际结果与上述情况不同的其他因素在公司的SEC备案文件中进行了讨论。投资者和证券持有者被敦促在SEC的网站(http://www.sec.gov)免费阅读这些文件。公司无需因新信息、未来事件或其他原因公开更新或修改其前瞻性声明。

Investor Inquiries:
Sam Bentzinger
Gilmartin Group
investorrelations@tactilemedical.com

投资者咨询:
Sam Bentzinger
吉尔马汀集团
investorrelations@tactilemedical.com


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