Lymphedema is tissue swelling caused by an accumulation of protein-rich fluid that’s usually drained through the body’s lymphatic system. Credit: JulieK2 via Shutterstock.

Koya Medical has shared data highlighting that its non-pneumatic compression device (NPCD) demonstrated better efficacy and improved quality of life in patients with lower extremity lymphedema.

The NPCD device, dubbed Dayspring, is a non-pneumatic treatment that provides continuous, static compression to manage lymphedema. The system comes with a mesh garment made from Koya’s patented Flexframe technology, a rechargeable controller, and a mobile app.

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Data from the TEAYS study (NCT05507346), published in the Journal of Vascular Surgery, found that Dayspring outperformed advanced pneumatic compression device (APCD) – the standard of care for treating lymphedema – in several areas. Patients using Dayspring saw a significantly greater reduction in limb volume (369.9mL versus 83.1mL) and experienced improved quality of life, with a mean lymphedema quality of life questionnaire (LYMQOL) score increase of 1.01 compared to 0.17 for APCD.

According to US-based company Koya, TEAYS is the eighth study investigating Dayspring since its Food and Drug Administration (FDA) clearance in May 2021. The study enrolled 71 patients with confirmed lower extremity lymphedema, comparing Dayspring with APCDs.

The gold standard for lymphedema treatment, APCDs use air-filled chambers to deliver intermittent pneumatic pressure in cycles, compared to the continuous, static compression provided by NPCDs. This mechanism actively pumps fluid away from the limb. However, NPCDs may be more comfortable and easier to use compared to APCDs, promoting better long-term adherence in some patients. Data from this study demonstrated that Dayspring showed superior adherence of 81%, compared to 56% with APCD.

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The TEAYS study’s lead investigator and associate professor of surgery at the University of Tennessee Health Science Center Michael Barfield said: “The introduction of Dayspring represents a clinically differentiated and therapeutically distinct advancement in the treatment of lower extremity lymphedema.

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“Patients participating in the TEAYS study expressed a strong preference for the Dayspring treatment over advanced pneumatic compression devices. The ability for patients to remain mobile while receiving effective treatment is a game-changer in improving adherence and overall quality of life.” 

In November 2023, Koya secured $30m in financing led by healthcare investment company OrbiMed, to support the expansion and strategic growth of Dayspring. This followed on from a February 2022 Series B funding round where Koya secured $26m, led by 3×5 Partners.