Koya Medical (“Koya”), a medical technology company advancing evidence-based therapies for vascular disease, today announced that the full results from the TEAYS (Treatment Effectiveness of a Non-Pneumatic Compression Device versus an Advanced Pneumatic Compression Device for Lower Extremity Lymphedema Swelling) clinical study were published in the Journal of Vascular Surgery (JVS). The data highlight superior efficacy and improved quality of life for patients suffering from lower extremity lymphedema with Dayspring®, a novel non-pneumatic compression device (NPCD), compared to advanced pneumatic compression devices (APCDs).
Dayspring met the study’s primary and secondary outcome measures and showed a broad range of superior clinical benefits for patients using the device compared to using an APCD.
These results are consistent with prior studies’ findings associated with Dayspring for the treatment of lymphedema.
“The introduction of Dayspring represents a clinically differentiated and therapeutically distinct advancement in the treatment of lower extremity lymphedema,” said Dr. Michael Barfield, lead investigator and Associate Professor of Surgery at the University of Tennessee Health Science Center, Nashville, TN. “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.”
Key Findings from the TEAYS Study:
- Efficacy: Patients using Dayspring experienced a mean limb volume reduction of 369.9 mL, significantly greater than the 83.1 mL reduction observed in the APCD treatment arm.
- Quality of Life: Significant improvements were noted in the overall Lymphedema Quality of Life Questionnaire (LYMQOL) scores for Dayspring users, with a mean improvement of 1.01 compared to 0.17 for APCD users. Key functional sub-scores such as symptoms, appearance, and function also favored Dayspring.
- Adherence: Dayspring users demonstrated an adherence rate of 81%, significantly higher than the 56% adherence observed in the APCD group.
- Safety: No device-related adverse events were reported for either treatment, highlighting the safety of Dayspring.
Click here to read the full article in the Journal of Vascular Surgery.
About the TEAYS Study
TEAYS was a prospective, multicenter, randomized, crossover clinical trial conducted at nine U.S. sites in 71 patients with confirmed lower-extremity lymphedema. The study directly compared Dayspring with an advanced pneumatic compression device across limb volume reduction, disease-specific quality of life, treatment adherence and patient preference.
About Lymphedema
An estimated 20 million Americans live with lymphedema, a progressive, incurable condition where a buildup of protein-rich fluid causes painful swelling in the arm, leg, and/or other regions of the body. For most, lymphedema requires lifelong maintenance and various levels of therapy to control swelling and pain. Lymphedema can result from a variety of factors, including cancer, chronic venous disease, infection, and surgery.
About Dayspring®
Dayspring is a prescription, non-pneumatic compression system designed to deliver customizable active compression while allowing patients to remain mobile during treatment.
Dayspring is the only non-pneumatic compression therapy supported by published randomized head-to-head comparative evidence demonstrating superior limb volume reduction, disease-specific quality of life, treatment adherence and patient preference versus an advanced pneumatic compression device.
Dayspring is FDA-cleared for the treatment of lymphedema, phlebolymphedema, venous insufficiency and other chronic edema-related conditions affecting the upper and lower extremities.
About Koya Medical
Founded in 2018 and headquartered in Dallas, Koya Medical is a medical technology company developing a portfolio of evidence-based treatments designed to improve clinical outcomes and patient experience in vascular disease.
