Koya Medical (“Koya”), a medical technology company advancing evidence-based therapies for venous and lymphatic disease, today announced the publication of two new subgroup analyses from the TEAYS randomized controlled trial.
The analyses demonstrated significantly greater limb volume reduction, improvement in disease-specific quality of life, treatment adherence and patient preference with Dayspring® compared with the advanced pneumatic compression device (APCD) evaluated in TEAYS.
As the category of mobility-enabled compression therapies continues to evolve, these analyses reinforce the importance of evaluating individual therapies based on demonstrated clinical outcomes, treatment adherence and evidence in clinically relevant patient populations—not product design or form factor alone.
The findings expand the evidence available to clinicians, health systems and payers when evaluating mobility-enabled compression therapies based on clinical outcomes, treatment adherence and performance in defined patient populations.
The analyses extend the overall TEAYS findings to two clinically important populations: adults aged 65 years and older and patients with phlebolymphedema, a form of secondary lymphedema associated with chronic venous insufficiency.
Compression garments and other conservative measures remain foundational in the management of lymphedema. When active compression therapy is clinically appropriate, the TEAYS analyses provide comparative evidence to inform treatment selection based on patient characteristics, expected outcomes and ability to adhere to treatment.
Key Findings in Adults Aged 65 Years and Older
- Limb Volume: Dayspring produced a mean limb volume reduction of 353.9 mL, compared with a mean change of –10.7 mL with the APCD comparator (p < 0.05)
- Quality of Life: Dayspring produced a 1.43-point improvement in LYMQOL, exceeding the threshold for a clinically meaningful change, compared with a 0.10-point decline with the APCD comparator (p < 0.05)
- Treatment Adherence: Patients completed 86% of prescribed Dayspring treatments, compared with 55% of prescribed APCD treatments (p < 0.001).
- Patient Preference: At the conclusion of the comparative treatment periods, 77% of participants preferred Dayspring, compared with 23% who preferred the APCD.
“Older adults may face particular barriers to treatments that restrict mobility or are difficult to incorporate into daily life,” said Thomas Maldonado, MD. “These findings demonstrate that mobility during treatment and superior clinical outcomes are not mutually exclusive. Dayspring delivered significantly greater adherence, limb volume reduction and quality-of-life improvement than the APCD comparator in this important patient population.”
The peer-reviewed analysis is available in Lymphatics: https://doi.org/10.3390/lymphatics3030027
Key Findings in Patients with Phlebolymphedema
- Limb Volume: Dayspring produced a mean limb volume reduction of 424.4 mL, compared with 50.8 mL with the APCD comparator (p = 0.0085).
- Quality of Life: Dayspring produced a 1.39 point improvement in LYMQOL, exceeding the threshold for a clinically meaningful change, compared with 0.18 points with the APCD comparator (p = 0.01).
- Treatment Adherence: Patients completed 81% of prescribed Dayspring treatments, compared with 49% of prescribed APCD treatments (p ≤ 0.001).
- Patient Preference: At the conclusion of the comparative treatment periods, 85% of participants preferred Dayspring, compared with 15% who preferred the APCD.
“Phlebolymphedema reflects the interaction of chronic venous hypertension and lymphatic dysfunction, making disease-specific clinical evidence particularly important,” said Michael Barfield, MD, lead investigator and Fellow of Cardiothoracic Surgery at New York-Presbyterian/Weill Cornell Medical Center. “In this subgroup, Dayspring demonstrated significantly greater limb volume reduction, quality-of-life improvement and adherence than the APCD comparator. These findings provide clinicians with population-specific comparative evidence when selecting active compression therapy for patients with phlebolymphedema.”
The peer-reviewed analysis is available in Annals of Vascular Surgery: https://doi.org/10.1016/j.avsg.2026.02.039
