OAKLAND, Calif.--(BUSINESS WIRE)--Koya Medical, a healthcare company with a mission to transform venous and lymphatic treatments through novel, people-centric solutions, 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.
About the TEAYS Study
The TEAYS (Treatment Effectiveness of a Non-Pneumatic Compression Device versus an Advanced Pneumatic Compression Device for Lower Extremity Lymphedema Swelling) study is Koya Medical’s eighth clinical study evaluating Dayspring for the treatment of lymphedema since its FDA clearance in 2021. The TEAYS study was a prospective, multicenter, randomized, single crossover clinical trial conducted across nine sites in the U.S. It involved 71 patients with confirmed lower extremity lymphedema, comparing the treatment effectiveness and patient adherence between Dayspring and APCDs.
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
The Dayspring compression system, available for upper and lower extremity care, is a non-pneumatic treatment that integrates compression, muscle pump activation, and mobility in one easy-to-use solution. The Dayspring system includes a low-profile active garment made of soft, breathable mesh using patented Flexframe® technology; a rechargeable controller; and a mobile app.
Dayspring is indicated to treat lymphedema, primary lymphedema, post mastectomy edema, edema following trauma and sports injuries, post immobilization edema, venous insufficiency, venous stasis ulcers, or arterial and diabetic leg ulcers, lipedema and phlebolymphedema and other similar conditions that impact lymphatic flow in the upper and lower extremities. Dayspring is also indicated to reduce wound healing time and treatment and assist in healing stasis dermatitis.
About Koya Medical
Koya Medical is a transformative healthcare company developing breakthrough treatments for lymphedema and venous diseases to increase movement, mobility, and personalized care that is unavailable with traditional compression therapy. The privately held company was founded in 2018 with the mission to transform lymphatic and vein care through innovative patient-centric platforms. For company or product inquiries, contact info@koyamedical.com. Follow us on LinkedIn at www.linkedin.com/company/koyamedical/.
