Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced two clinical data publications for the treatment of lymphedema and venous disease with its Dayspring® active compression system, including results from the multi-center, randomized, crossover head-to-head trial (NILE) published in the Journal of Vascular Surgery. Results from an open-label study of the Dayspring system for the treatment of lymphedema and venous diseases in the lower extremities were published in Scientific Reports, Nature. The results of the studies will be presented at the American Vein and Lymphatic Society (AVLS) 2022 Annual Congress, being held October 13-16, 2022, in New Orleans, Louisiana. The company also announced that the Centers for Medicare & Medicaid Services (CMS) has confirmed the durable medical equipment (DME) benefit category determination, payment schedule and five final Level II Healthcare Common Procedure Coding System (HCPCS) codes for the Dayspring active compression system in its final biannual Medicare benefit decisions update.
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.
“The recognition and establishment of the new final CMS HCPCS codes, benefit category determination and payment decision is a significant milestone that provides a new category of options for patients,” said Andy Doraiswamy, Ph.D., Koya Medical founder and CEO. “We are thrilled to expand access to more treatment choices for people living with lymphedema and chronic venous conditions.”
“These key data publications further expand our body of clinical evidence supporting the use of the Dayspring active compression system for people living with lymphedema and chronic venous conditions,” said Thomas Maldonado, M.D., medical director of the Venous Thromboembolic Center at New York University Langone Health. “We look forward to continuing to advance evidence supporting Dayspring and helping even more people with lymphedema and venous diseases maintain mobility while continuing to experience effective compression treatment.”
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
Published in the Journal of Vascular Surgery Venous and Lymphatic Disorders, "Safety and Effectiveness of a Novel Non-Pneumatic Active Compression Device for Treating Breast Cancer-Related Lymphedema, a Multi-center Randomized, Crossover Trial (NILE)” evaluated the safety and efficacy of the Dayspring device for treating lymphedema versus an advanced pneumatic compression device (APCD) in 50 women with unilateral breast cancer-related lymphedema.
Summary of KeyResults:
- The Dayspring device was found to be more effective than an APCD.
- Significantly greater adherence (95.6% vs. 49.8%), and greater satisfaction (90% vs. 14%) with the Dayspring device versus an ACPD.
- Participants experienced mean improvements in lymphedema quality of life questionnaire (LYMQOL) and significantly greater mean reduction in edema (swelling caused by excess fluid trapped in the body's tissues) volume (64.6% vs. 27.7%; p<0.05) with the Dayspring device versus an ACPD.
“Lymphedema is an incurable condition that requires lifelong maintenance, often forcing people to be tied to their compression devices for hours at a time. However, with the mobility-enabled Dayspring system, I’m seeing not only a meaningful reduction in patients’ edema, but also a significant improvement in their satisfaction and overall quality of life,” said Stanley Rockson, M.D., cardiologist and professor in the Falk Cardiovascular Research Center at Stanford University School of Medicine and principal investigator of the NILE clinical study. “These results highlight the significant benefits the Dayspring system provides in the way we can manage and treat lymphedema and venous disease.”
Journal of Vascular Surgery publication can be accessed online at: https://www.jvsvenous.org/article/S2213-333X(22)00338-9/fulltext
A Non-Randomized, Open-Label Study of the Safety and Effectiveness of a Novel Non-Pneumatic Compression Device (NPCD) for Lower Limb Lymphedema Results
Published in Nature, "A Non-Randomized, Open-Label Study of the Safety and Effectiveness of a Novel Non-Pneumatic Compression Device (NPCD) for Lower Limb Lymphedema” is 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%.
Nature publication can be accessed online at: https://www.nature.com/articles/s41598-022-17225-9
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 proprietary Flexframe® technology; a smart, rechargeable, hand-held controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to track therapy and customize treatment 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 at www.linkedin.com/company/koyamedical/.
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.
