OAKLAND, Calif.–(BUSINESS WIRE)–Koya Medical, a healthcare company with a mission to transform lymph and vein care through a comprehensive suite of innovative people-centered platforms, today announced two clinical data releases for the treatment of lymphedema and venous disease with its Dayspring® active compression system, including results from the multicenter, randomized, crossover (NILE) trial published in the Journal of Vascular Surgery. The results of an open-label study of the Dayspring System for the treatment of lymphedema and venous diseases of the lower extremities have been published in Scientific reports, Nature. The results of the studies will be presented at the 2022 Annual Meeting of the American Vein and Lymphatic Society (AVLS), to be held October 13-16, 2022 in New Orleans, Louisiana. The company also announced that the Centers for Medicare & Medicaid Services (CMS) has confirmed the determination of the Durable Medical Equipment (DME) benefit category, payment schedule and five final procedure coding system codes. Level II Healthcare Commons (HCPCS) for the Dayspring Active Compression System. in its final semi-annual Medicare benefit rulings update.
Dayspring is the first non-pneumatic active dynamic compression therapy designed for patient mobility and cleared by the United States Food and Drug Administration (FDA) to treat lymphedema and chronic venous conditions.
“The recognition and establishment of the new CMS HCPCS final codes, determination of benefit categories and payment decision is an important milestone that provides a new class of options for patients,” said Andy Doraiswamy, Ph.D., founder and CEO of Koya Medical. “We are excited to expand access to more treatment choices for people with lymphedema and chronic venous disease.
“These key data releases further expand our body of clinical evidence supporting the use of the Dayspring Active Compression System for people with lymphedema and chronic venous disease,” said Thomas Maldonado, MD, Medical Director of Venous New York University Langone Health Thromboembolic Center. “We look forward to continuing to advance the evidence supporting Dayspring and helping even more people with lymphedema and venous disease maintain mobility while continuing to receive effective compression therapy.
Safety and Efficacy of a Novel Nonpneumatic Active Compression Device for the Treatment of Breast Cancer-Related Lymphedema, Results of a Multicenter Randomized Crossover (NILE) Trial
Posted 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 effectiveness of the Dayspring device for treating lymphedema compared to an advanced pneumatic compression device (APCD) in 50 women with unilateral breast cancer-related lymphedema.
Summary of main results:
The Dayspring device was found to be more effective than an APCD.
Significantly higher adherence (95.6% vs. 49.8%) and greater satisfaction (90% vs. 14%) with the Dayspring device compared to an ACPD.
Participants experienced mean improvements on the Lymphedema Quality of Life Questionnaire (LYMQOL) and a significantly greater mean reduction in volume of edema (swelling caused by excess fluid trapped in body tissues) (64.6 % versus 27.7%; p
“Lymphedema is an incurable condition that requires lifelong maintenance, often requiring people to be strapped into their compression devices for hours on end. However, with the Dayspring Reduced Mobility System, I see not only a significant reduction in patient edema, but also a significant improvement in patient satisfaction and overall quality of life,” said Stanley Rockson, MD, Cardiologist and professor at 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 of the Dayspring System in how we can manage and treat lymphedema and venous disease.
Journal of Vascular Surgery the publication is available online at: https://www.jvsvenous.org/article/S2213-333X(22)00338-9/fulltext
A Non-Randomized, Open-Label Study of the Safety and Efficacy of a Novel Nonpneumatic Compression Device (NPCD) for Lower Extremity Lymphedema Outcomes
Posted 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 12-week, open-label, multicenter clinical study involving 24 patients with or secondary unilateral lower extremity (LEL) which assessed changes in limb edema and quality of life (QoL) after treatment with the Dayspring device.
Summary of main results:
After three months of use, patients experienced mean improvements in the Lymphedema Quality of Life Questionnaire (LYMQOL) from baseline (p
Limb volume improved (up to 50% reduction in edema) with the use of Dayspring, with an average reduction of 39.4% in affected limb edema.
Nature the publication is available online at: https://www.nature.com/articles/s41598-022-17225-9
An estimated 20 million Americans live with lymphedema, a progressive and incurable disease in which a buildup of protein-rich fluid causes painful swelling in the arm, leg, and/or other areas of the body. For the most part, lymphedema requires lifelong maintenance and varying levels of treatment to control swelling and pain. Lymphedema is usually caused by cancer – such as breast cancer, cancer of the uterus, cancer of the prostate, cancer of the vulva, cancer of the ovary, lymphoma, melanoma and cancers of the head and neck – and its treatment due to damage to the lymphatic system from the tumor itself, radiation therapy or surgical alteration of the lymph nodes.1
About the Dayspring® System
The Dayspring System is the first wearable, mobility-friendly active compression system designed with real life in mind. It is the first compression therapy option designed to enable movement, mobility and personalized care not available with existing traditional pneumatic compression. The Dayspring System features a low-profile active garment in soft, breathable mesh using Koya’s exclusive Flexframe® technology; a smart, rechargeable handheld controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to track treatment 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 affect lymphatic flow in the upper and lower limbs. Dayspring is also indicated to reduce wound healing time and treatment and to aid in the healing of stasis dermatitis.
About Koya Medical
Koya Medical is a transformative healthcare company developing breakthrough treatments for lymphedema and venous disease to increase movement, mobility, and personalized care not available with traditional compression therapy. The private company was founded in 2018 with a mission to transform lymph and vein care through innovative patient-centric platforms. For any company or product inquiries, contact [email protected] Follow us on LinkedIn at www.linkedin.com/company/koyamedical/.
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.