Koya's Dayspring beats pneumatic compression in older, phlebolymphedema patients
Subgroup analyses from the randomized TEAYS trial show Koya Medical's Dayspring device cut limb volume and lifted adherence versus an advanced pneumatic compression device in two lymphedema populations.
Executive Summary
- Subgroup analyses of a completed, randomized device trial show a non-pneumatic compression wearable outperformed an advanced pneumatic compression device on limb-volume reduction, quality of life, and adherence in two lymphedema populations.
- The result extends comparative evidence for device selection in lower-extremity lymphedema, a chronic condition where compression garments and pneumatic devices are the mainstay of conservative management.
- The findings come from subgroup populations carved out of a Not Applicable, non-registrational trial, so they inform clinical practice and device positioning rather than a regulatory pathway.
- The device landscape in lower-extremity lymphedema is sparse and dominated by Koya's own prior studies, with no independent head-to-head comparator identified for this readout.
The result
In adults aged 65 and older, Dayspring produced a mean limb-volume reduction of 353.9 mL, compared with a mean change of -10.7 mL with the advanced pneumatic compression device (APCD) comparator (p<0.05). Quality of life measured by LYMQOL improved by 1.43 points with Dayspring, exceeding the threshold for a clinically meaningful change, against a 0.10-point decline with the APCD (p<0.05). Patients completed 86% of prescribed Dayspring treatments versus 55% of prescribed APCD treatments (p<0.001), and 77% of participants preferred Dayspring at the end of the comparative period versus 23% who preferred the APCD. PublishedPublished Randomized Comparative Data Demonstrate Superior Outcomes with Dayspring in Adults Aged 65 and Older and Patients with PhlebolymphedemaJul 23, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The second subgroup
In patients with phlebolymphedema, a form of secondary lymphedema tied to chronic venous insufficiency, Dayspring produced a 424.4 mL mean limb-volume reduction versus 50.8 mL with the APCD (p=0.0085). LYMQOL improved 1.39 points with Dayspring versus 0.18 points with the APCD (p=0.01), again exceeding the clinically meaningful change threshold. Adherence reached 81% for Dayspring versus 49% for the APCD (p<=0.001), and 85% of participants preferred Dayspring versus 15% for the APCD. Thomas Maldonado, MD, said older adults "may face particular barriers to treatments that restrict mobility or are difficult to incorporate into daily life," and that the data show "mobility during treatment and superior clinical outcomes are not mutually exclusive". PublishedPublished Randomized Comparative Data Demonstrate Superior Outcomes with Dayspring in Adults Aged 65 and Older and Patients with PhlebolymphedemaJul 23, 2026
How it was done
The parent TEAYS trial (NCT05507346) is a randomized, open-label study that enrolled 121 adults with lower-extremity lymphedema or phlebolymphedema across a single U.S. site, comparing Dayspring against an advanced pneumatic compression device. It completed in January 2024, and its registered primary endpoints spanned LYMQOL, therapy adherence, and limb-volume reduction or maintenance, with patient preference and safety as secondary measures. The phlebolymphedema subanalysis drew on 35 of the trial's participants. Safety outcomes from the subgroup analyses were not reported in the disclosed material. NCT05507346+1A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity LymphedemaNCT05507346Published Randomized Comparative Data Demonstrate Superior Outcomes with Dayspring in Adults Aged 65 and Older and Patients with PhlebolymphedemaJul 23, 2026
Trial and competitive context
NCT05507346 is a Not Applicable, non-registrational device study, meaning it was not designed to support an FDA marketing application on its own. Enrollment rose from an anticipated 50 to an actual 121 by the time the trial completed, a change the operational model treats as within the routine band for a study of this design. Dayspring's only other identified trial is a completed, single-arm, open-label safety and effectiveness study, also run by Koya Medical, which is not eligible as a direct comparator. No independent competitor trial for Dayspring or a matched compression device was identified in the lower-extremity lymphedema field beyond Koya's own studies. NCT05507346A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity LymphedemaNCT05507346
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.