AMBIGUOUS RESULTS

Koya's Dayspring beats pneumatic device in TEAYS lymphedema subgroups

Published subgroup analyses of the randomized TEAYS trial show Dayspring outperformed an advanced pneumatic device on limb volume, quality of life and adherence in older adults and phlebolymphedema patients.

Koya Medical published two peer-reviewed subgroup analyses from its randomized TEAYS trial showing its Dayspring non-pneumatic compression device produced greater limb volume reduction, quality-of-life gains, and adherence than an advanced pneumatic compression device (APCD) in adults 65 and older and in patients with phlebolymphedema.

By AppliedXLJuly 23, 2026Trial NCT05507346

Executive Summary

Koya Medical published subgroup data from its completed, non-registrational compression-device trial showing its wearable device outperformed a pneumatic comparator on limb volume, quality of life, and adherence in two specific patient populations.
The published results are subgroup analyses carved from the trial's 121-patient population rather than the full randomized cohort, and the trial's three registered primary endpoints were not reported as a complete set alongside them.
The device stands as the only non-pneumatic compression system with completed comparative data in a lower extremity lymphedema trial landscape that is otherwise small and thinly populated.
Adherence and patient preference favored the device by wide margins in both subgroups, a secondary finding that reinforces the core comparative claim independent of the volume-reduction result.

What was published

Koya Medical, Inc. announced on July 23, 2026 the publication of two subgroup analyses from its TEAYS randomized trial (NCT05507346), which compared its Dayspring non-pneumatic active compression device against an advanced pneumatic compression device (APCD) in patients with lower extremity lymphedema and phlebolymphedema. In patients with phlebolymphedema, a secondary lymphedema tied to chronic venous insufficiency, Dayspring produced a mean limb volume reduction of 424.4 mL compared with 50.8 mL for the APCD (p=0.0085). In adults aged 65 and older, Dayspring produced a mean reduction of 353.9 mL versus a mean change of -10.7 mL with the APCD (p<0.05). NCT05507346+1

Probability of Success

Endpoint Met40%

Completes95%

Clinical Significance5%

Regulatory69%

Quality of life and adherence

Quality of life, measured by the LYMQOL instrument, improved by 1.39 points in the phlebolymphedema subgroup with Dayspring against 0.18 points with the APCD (p=0.01), and by 1.43 points in the 65-and-older subgroup against a 0.10-point decline with the APCD (p<0.05). Treatment adherence reached 81% of prescribed sessions with Dayspring versus 49% with the APCD in the phlebolymphedema group (p≤0.001), and 86% versus 55% in the older-adult group (p<0.001). Patient preference favored Dayspring by 85% to 15% in the phlebolymphedema group and 77% to 23% in the older-adult group. "Older adults may face particular barriers to treatments that restrict mobility or are difficult to incorporate into daily life," said Thomas Maldonado, MD, noting that Dayspring delivered greater adherence, limb volume reduction and quality-of-life improvement than the APCD comparator in that population. Published

The design

TEAYS was an open-label, randomized, two-arm trial in 121 adults with lower extremity lymphedema or phlebolymphedema, run at a single U.S. site with Dayspring compared against an APCD. The trial registered three primary endpoints, LYMQOL, therapy adherence tracking, and limb volume reduction or maintenance, plus patient-preference and safety secondary measures, with a primary completion date of January 9, 2024. The subgroup analyses published now report on a phlebolymphedema cohort of 35 patients and an older-adult cohort drawn from the same 121-patient trial. Full-population results across all three registered primary endpoints were not presented as a single set in this disclosure. NCT05507346+1

The landscape

Lower extremity lymphedema draws a small, mechanism-mixed trial field: seven active or recent studies span pneumatic devices, wound-care products, and neurostimulation, with a combined enrollment of 608 patients. Within that field, Dayspring is the only non-pneumatic active compression device with completed comparative data; Koya's own prior single-arm trial of the device enrolled 52 patients and also completed. Tactile Medical's Advanced Pneumatic Compression Device remains in an early-stage trial nearing completion in September 2026, the closest identifiable comparator by modality. Given that sparsity, a device claiming an adherence and outcomes edge over the pneumatic standard has room to be tested against the full randomized population before the comparison can be read as settled.

Registry signals

The trial's enrollment target rose from 50 to 121 patients between its initial registration and its 2024 completion update, a change the operational model classifies as within the routine band for a completed device trial of this design. The registry also shows no update between that February 2024 completion entry and the current disclosure, a gap during which these subgroup analyses moved through peer review before publication. NCT05507346

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