Koya Medical Dayspring Compression Device Evaluated in TEAYS Study for Lower Extremity Lymphedema

September 4, 2024—Koya Medical announced the publication of full results from the TEAYS clinical study evaluating treatment effectiveness and patient adherence of the company’s Dayspring nonpneumatic compression device (NPCD) versus advanced pneumatic compression devices (APCDs) for lower extremity lymphedema swelling.

TEAYS is a prospective, multicenter, randomized, single-crossover clinical trial conducted at nine sites in the United States and composed of 71 patients with confirmed lower extremity lymphedema.

According to Koya Medical, the data highlight superior efficacy and improved quality of life for patients treated with the Dayspring compared to APCDs. Dayspring met the study’s primary and secondary outcome measures and showed a broad range of superior clinical benefits for patients compared to APCD.

As outlined in the company’s press release, key findings from the TEAYS study included the following:

• Efficacy: Mean limb volume reduction of 369.9 mL with Dayspring versus 83.1 mL with APCD
• Quality of Life: Mean improvement of 1.01 with Dayspring versus 0.17 for APCD in Lymphedema Quality of Life Questionnaire overall score; key functional subscores such as symptoms, appearance, and function also favored Dayspring
• Adherence: Dayspring users demonstrated an adherence rate of 81% versus 56% adherence with APCD
• Safety: No device-related adverse events were reported for either treatment

The TEAYS study findings were published by Michael Barfield, MD, et al online ahead of print in Journal of Vascular Surgery.

Dr. Barfield is the TEAYS lead investigator and Associate Professor of Surgery at the University of Tennessee Health Science Center in Nashville, Tennessee.

“The introduction of Dayspring represents a clinically differentiated and therapeutically distinct advancement in the treatment of lower extremity lymphedema,” commented Dr. Barfield in Koya Medical’s press release. “Patients participating in the TEAYS study expressed a strong preference for the Dayspring treatment over APCDs. The ability for patients to remain mobile while receiving effective treatment is a game changer in improving adherence and overall quality of life.”

The company noted that these results are consistent with previous studies’ findings associated with Dayspring for treatment of lymphedema. TEAYS is the company’s eighth clinical study evaluating Dayspring for lymphedema since its FDA clearance.

In May 2021, Koya Medical announced that Dayspring received FDA clearance for treatment of lymphedema and venous diseases that impact lymphatic flow in the lower extremities. The Dayspring NPCD system is available for upper and lower extremity care. It integrates compression, muscle pump activation, and mobility, noted the company.

The device is indicated to treat lymphedema, primary lymphedema, postmastectomy edema, edema following trauma and sports injuries, postimmobilization edema, venous insufficiency, venous stasis ulcers, 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, advised Koya Medical.