Koya Medical, today announces topline results from its TEAYS trial. TEAYS (NCT05507346) is a prospective multi-center, randomized cross-over study comparing lower extremity lymphedema treatment effectiveness of DayspringⓇ, Koya’s non-pneumatic compression device (NPCD) with a traditional advanced pneumatic compression device (APCD).
The study met its primary endpoints, achieving statistically significant differences in limb volume reduction, improvement of quality of life, and treatment adherence, all favoring the Dayspring treatment arm over the APCD treatment arm. In limb volume reduction, the Dayspring arm achieved a mean reduction of 369.9mL from baseline compared to that of 83.1mL for the APCD arm. In quality of life, the Dayspring arm achieved 1.01 point improvement on the LYMQOL survey compared to 0.17 point improvement for APCD. In treatment adherence, rate of adherence was reported to be 81% for the Dayspring arm compared with 56% for the APCD. No adverse events were related to either treatment arm.
Full study results are not yet available. “Koya is committed to continuing its innovation in this disease space. We are pleased with these topline results and will be conducting sub-analyses of the full data set,” said Thomas Maldonado, MD, Chief Medical Officer. The latest TEAYS trial results add to the growing body of evidence for Dayspring, which has had 7 prior publications to date. In 2021, Koya Medical became the first company to receive FDA clearance for its non-pneumatic active compression system Dayspring, which provides patients with gradient sequential compression, mobility and ambulation during treatment.
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 proprietary Flexframe® technology; a rechargeable controller that can be worn on a lanyard; 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.
