Tactile Medical Receives PDAC Approval for Nimbl™ Lymphedema Platform
Rhea-AI Summary
Tactile Medical (Nasdaq: TCMD) has received PDAC approval for its Nimbl™ Lymphedema Platform, allowing Medicare billing under HCPCS code E0651. This approval follows the FDA's 510(k) clearance in June 2024. Nimbl, the next-generation pneumatic compression device for lymphedema treatment, offers significant improvements:
- 40% size reduction and 68% weight reduction, enhancing portability
- Integration with the Kylee™ digital app for therapy tracking
- Indicated for lymphedema, chronic edema, venous insufficiency, and wound healing
CEO Sheri Dodd emphasized Nimbl's potential to improve patient acceptance and adherence. The device is set for full commercial launch in the coming weeks, reflecting Tactile Medical's commitment to innovative at-home therapies for chronic conditions.
Positive
- Received PDAC approval for Nimbl™ Lymphedema Platform, enabling Medicare billing
- Nimbl offers 40% size reduction and 68% weight reduction compared to previous generations
- Integration with Kylee™ digital app for improved therapy tracking and sharing
- Expanded indications including lymphedema, chronic edema, venous insufficiency, and wound healing
- Full commercial launch expected in the coming weeks
Negative
- None.
News Market Reaction
On the day this news was published, TCMD gained 0.94%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Next-Generation System Significantly Reduces Device Size and Weight and Enables Integration with Kylee™ Digital App
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.
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
“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.”
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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