Tactile Medical Launches Next-Generation Nimbl™ Lymphedema Platform
Tactile Medical (Nasdaq: TCMD) has launched Nimbl, its next-generation pneumatic compression platform, for treating upper extremity lymphedema across the United States. Nimbl, which received FDA 510(k) clearance in June 2024 and CMS PDAC approval in September 2024, is 68% lighter, 40% smaller, and uses 33% less hosing than the company's current basic pneumatic compression device.
The device is indicated for treating both upper and lower extremity lymphedema, chronic edema, venous insufficiency, and wound healing. Nimbl offers connectivity to the free Kylee digital application for tracking usage and symptoms. The company plans to expand Nimbl's availability for lower extremity conditions in the coming months.
Tactile Medical (Nasdaq: TCMD) ha lanciato Nimbl, la sua piattaforma di compressione pneumatica di nuova generazione, per il trattamento del linfedema dell'arto superiore negli Stati Uniti. Nimbl, che ha ricevuto l'approvazione FDA 510(k) a giugno 2024 e l'approvazione CMS PDAC a settembre 2024, è il 68% più leggero, il 40% più piccolo e utilizza il 33% in meno di tubazioni rispetto all'attuale dispositivo di compressione pneumatica di base dell'azienda.
Il dispositivo è indicato per il trattamento sia del linfedema degli arti superiori che inferiori, edema cronico, insufficienza venosa e guarigione delle ferite. Nimbl offre connettività all'applicazione digitale gratuita Kylee per il monitoraggio dell'uso e dei sintomi. L'azienda prevede di espandere la disponibilità di Nimbl per le condizioni degli arti inferiori nei prossimi mesi.
Tactile Medical (Nasdaq: TCMD) ha lanzado Nimbl, su plataforma de compresión neumática de nueva generación, para el tratamiento de linfedema en las extremidades superiores en los Estados Unidos. Nimbl, que recibió la aprobación 510(k) de la FDA en junio de 2024 y la aprobación del CMS PDAC en septiembre de 2024, es un 68% más liviano, un 40% más pequeño y utiliza un 33% menos de manguera que el dispositivo básico de compresión neumática actual de la compañía.
El dispositivo está indicado para el tratamiento del linfedema de las extremidades superiores e inferiores, edema crónico, insuficiencia venosa y curación de heridas. Nimbl ofrece conectividad a la aplicación digital gratuita Kylee para el seguimiento del uso y los síntomas. La empresa planea expandir la disponibilidad de Nimbl para las condiciones de las extremidades inferiores en los próximos meses.
택타일 메디컬(Nasdaq: TCMD)은 미국 전역에서 상지 림프부종 치료를 위한 차세대 공기압 압축 플랫폼인 Nimbl을 출시했습니다. Nimbl은 2024년 6월 FDA 510(k) 승인을 받았고 2024년 9월에는 CMS PDAC 승인을 받았으며, 현재 회사에서 제공하는 기본 공기압 압축 장치에 비해 68% 더 가볍고, 40% 더 작으며, 33% 더 적은 호스를 사용합니다.
이 장치는 상지와 하지를 포함한 림프부종, 만성 부종, 정맥 기능 부전 및 상처 치유를 치료하는 데 적합합니다. Nimbl은 사용량 및 증상 추적을 위해 무료 Kylee 디지털 애플리케이션과의 연결성을 제공합니다. 회사는 향후 몇 달 내에 하체 질환에 대한 Nimbl의 가용성을 확장할 계획입니다.
Tactile Medical (Nasdaq: TCMD) a lancé Nimbl, sa plateforme de compression pneumatique de nouvelle génération, pour traiter le lymphœdème des membres supérieurs à travers les États-Unis. Nimbl, qui a reçu l'homologation FDA 510(k) en juin 2024 et l'approbation CMS PDAC en septembre 2024, est 68 % plus léger, 40 % plus petit et utilise 33 % de tuyauterie en moins que l'appareil de compression pneumatique de base actuel de l'entreprise.
L'appareil est indiqué pour traiter à la fois le lymphœdème des membres supérieurs et inférieurs, l'œdème chronique, l'insuffisance veineuse et la cicatrisation des plaies. Nimbl offre une connectivité à l'application numérique gratuite Kylee pour le suivi de l'utilisation et des symptômes. L'entreprise prévoit d'élargir la disponibilité de Nimbl pour les conditions des membres inférieurs dans les mois à venir.
Tactile Medical (Nasdaq: TCMD) hat Nimbl, seine nächste Generation von pneumatischen Kompressionsplattformen, zur Behandlung von lymphatischem Ödem der oberen Extremitäten in den Vereinigten Staaten eingeführt. Nimbl erhielt im Juni 2024 die FDA 510(k)-Genehmigung und im September 2024 die CMS PDAC-Zulassung und ist 68% leichter, 40% kleiner und benötigt 33% weniger Schläuche als das aktuelle Basisgerät des Unternehmens.
Das Gerät ist zur Behandlung von lymphatischem Ödem der oberen und unteren Extremitäten, chronischem Ödem, venöser Insuffizienz und Wundheilung geeignet. Nimbl bietet die Möglichkeit zur Verbindung mit der kostenlosen digitalen Anwendung Kylee zur Verfolgung der Nutzung und der Symptome. Das Unternehmen plant, die Verfügbarkeit von Nimbl für Erkrankungen der unteren Extremitäten in den kommenden Monaten auszubauen.
- Launch of next-generation Nimbl platform for lymphedema treatment
- FDA 510(k) clearance and CMS PDAC approval obtained for Nimbl
- Nimbl is 68% lighter, 40% smaller, and uses 33% less hosing than previous device
- Connectivity to free Kylee digital application for tracking usage and symptoms
- Planned expansion to lower extremity conditions in coming months
- None.
Insights
The launch of Nimbl represents a significant advancement in lymphedema treatment technology. Its 68% lighter and 40% smaller design addresses key patient concerns about device portability and ease of use. This could potentially lead to improved patient adherence and better clinical outcomes, especially for breast cancer survivors who make up a large portion of upper extremity lymphedema patients.
The FDA clearance and CMS PDAC approval are important regulatory milestones that pave the way for widespread adoption and insurance coverage. The planned expansion to lower extremity treatments in the coming months suggests a strong product pipeline and potential for market share growth.
The integration with the Kylee™ digital app adds value through patient engagement and data tracking, which could lead to improved patient outcomes and potentially valuable real-world data for the company. However, the impact on revenue and market share will depend on successful commercialization and adoption rates among clinicians and patients.
While the Nimbl launch is a positive development for Tactile Medical, its immediate financial impact may be The initial focus on upper extremity lymphedema targets a specific subset of the market. The real financial potential lies in the upcoming expansion to lower extremity conditions, which could significantly broaden the addressable market.
Investors should monitor key performance indicators in the coming quarters, including:
- Adoption rates among clinicians
- Revenue growth in the lymphedema segment
- Gross margins, as the new product may have different cost structures
- Impact on operating expenses, particularly in sales and marketing
With a market cap of
Initial Launch Focused on Treating Patients Suffering from Upper Extremity Lymphedema
MINNEAPOLIS, Oct. 02, 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 Nimbl, its next-generation pneumatic compression platform, is now commercially available throughout the United States for the treatment of upper extremity lymphedema. Nimbl, which is significantly smaller and lighter than previous device iterations, is indicated as a treatment option for patients with both upper and lower extremity lymphedema, chronic edema, venous insufficiency, and wound healing. Nimbl received U.S Food & Drug Administration (FDA) 510(k) clearance in June 2024 and Pricing, Data Analysis, and Coding (PDAC) approval from the Centers for Medicare & Medicaid Services (CMS) in September 2024. The Company expects to make Nimbl commercially available for patients with lower extremity conditions in the coming months.
“We are excited to announce the commercial launch of Nimbl, an important addition to our leading portfolio of patient-focused, clinically proven lymphedema therapy solutions,” said Sheri Dodd, Chief Executive Officer at Tactile Medical. “This first phase of Nimbl’s introduction, targeted specifically for upper extremity treatment, is well-timed as we recognize Breast Cancer Awareness Month and the many thousands of patients in need of better treatment solutions. Up to
Nimbl is
“Patients and clinicians alike will appreciate the introduction of Nimbl as a compelling treatment option designed to increase adherence and improve clinical outcomes”, said Tony Gasparis, MD, Chief Medical Officer at Tactile Medical. “Patients can now more easily fit therapy into their daily routine resulting in long-term relief and increased confidence for clinicians.”
About Tactile Systems Technology, Inc. (DBA Tactile Medical)
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.
Investor Inquiries:
Sam Bentzinger
Gilmartin Group
investorrelations@tactilemedical.com
FAQ
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