Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric solutions, presented two newly published clinical studies for the treatment of lymphedema and venous disease with its Dayspring® active compression system that showed significant improvements in patient outcomes.
Stanley Rockson, M.D., cardiologist and professor in the Falk Cardiovascular Research Center at Stanford University School of Medicine and principal investigator of the studies, presented the multi-center, randomized, crossover head-to-head trial (NILE) published in the Journal of Vascular Surgery and an open-label study of the Dayspring system for the treatment of lymphedema and venous diseases in the lower extremities in Scientific Reports, Nature at the American Vein and Lymphatic Society (AVLS) 2022 Annual Congress, held October 13-16, 2022, in New Orleans, Louisiana.
Dayspring is the first non-pneumatic active dynamic compression treatment designed for patient mobility and cleared by the U.S. Food and Drug Administration (FDA) to treat lymphedema and chronic venous conditions.
Safety and Effectiveness of a Novel Non-Pneumatic Active Compression Device for Treating Breast Cancer-Related Lymphedema, a Multi-center Randomized, Crossover Trial (NILE) Results
Evaluated the safety and efficacy of the Dayspring nonpneumatic compression device (NPCD) for treating lymphedema versus an advanced pneumatic compression device (APCD) in 50 women with unilateral breast cancer-related lymphedema.
Summary of Key Results:
- Statistically significant difference in overall QoL (LYMQOL) with NPCD (Dayspring) 2.44 points improvement compared to APCD at Day 28 (p<0.05)
- Statistically significant difference in mean reduction in edema volume with NPCD 64.6% compared with 27.7% for APCD at Day 28 (p < 0.05)
- Statistically significant difference in overall response rate with NPCD 88% compared with 42% for APCD at Day 28 (p<0.05)
- Statistically significant difference in treatment adherence, 95.6% for NPCD compared with 49.8% for APCD (p<0.01)
- 86% of participants reported reduced use of compression sleeves when treated with NPCD compared with 0% when using APCD
- Overall patient satisfaction 90% for NPCD compared with 14% for APCD
- No device-related adverse events were reported during the study
Full manuscript published in the Journal of Vascular Surgery Venous and Lymphatic Disorders. Open access here
A Non-Randomized, Open-Label Study of the Safety and Effectiveness of a Novel Non-Pneumatic Compression Device (NPCD) for Lower Limb Lymphedema Results
A multi-center, open-label, 12-week clinical study of 24 patients with primary or secondary unilateral lower extremity lymphedema (LEL) that evaluated changes in limb edema and quality of life (QoL) following treatment with the Dayspring device.
Summary of Key Results:
- After three months of use, patients experienced mean improvements in lymphedema quality of life questionnaire (LYMQOL) compared with baseline (p<0.05).
- Limb volume improved (up to 50% reduction in edema) with Dayspring use, with an average reduction in affected limb edema of 39.4%
- No device-related adverse events were reported during the study
Full manuscript published in the Nature, Scientific Reports. Open access here
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 is commonly caused by cancer—such as breast cancer, uterine cancer, prostate cancer, vulvar cancer, ovarian cancer, lymphoma, melanoma and cancers of the head and neck—and its treatment due to damage of the lymph system from the tumor itself, radiation treatment or the surgical impairment of lymph nodes.
About the Dayspring® System
The Dayspring system is the first wearable and mobility-enabled active compression system designed with real life in mind. It is the first compression treatment option designed to enable movement, mobility, and personalized care that is unavailable with existing traditional pneumatic compression. The Dayspring system includes a low-profile active garment made of soft, breathable mesh using Koya's patented Flexframe® technology; a smart, mobile controller; and a companion app that allows users or their clinicians to track treatments and customize options.
Dayspring is FDA 510(k) cleared 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 inquiry, contact info@koyamedical.com. Follow us on LinkedIn here
Reference:
1. What is lymphedema? American Cancer
Society. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/lymphedema/what-is-lymphedema.html. Accessed September 26, 2022.
