OAKLAND, Calif.--(BUSINESS WIRE)--Koya Medical, a healthcare company focused on developing breakthrough treatments for lymphedema and venous diseases, announced today that its wearable, active compression therapy system for lymphedema—Dayspring™— was issued new billing codes by the Center of Medicare & Medicaid Services (CMS) in accordance with the Healthcare Common Procedure Coding System (HCPCS). Dayspring is the first wearable and mobility-enabling active compression treatment cleared by the U.S. Food & Drug Administration (FDA) to treat lymphedema and other similar conditions. Providers may begin using the new codes on October 1, 2021.
Lymphedema is a serious chronic condition, for which there is no cure. Preexisting reimbursement codes have covered traditional pneumatic or air-based compression systems for more than three decades. Dayspring’s new code addresses this first significant advancement in active compression technology and supports the mobility for the user, by delivering compression through Koya’s proprietary Flexframe™ technology, which uses electromechanical means and a mobile power source to deliver therapeutic pressures while enabling mobility and movements for patients.
Dayspring is unique from other active compression treatments and includes a low-profile active garment made of soft, breathable mesh using 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 individualize treatment options and track utilization.
“Securing codes from CMS is a significant step for advancing new treatment options for lymphedema patients and their caregivers and providers,” said Andy Doraiswamy, Ph.D., Koya founder, president and CEO. “We appreciate the recognition and validation of our innovation and look forward to leveraging this milestone to expand access and to enhance treatment options for people living with lymphedema.”
Published Clinical Data to Support Koya’s Growth in Bringing Dayspring to More Patients
Koya also announced today that the first of its multiple clinical studies has been published in the peer-reviewed journal Lymphatic Research and Biology [1]. A “Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study” evaluated safety, efficacy and quality of life using accepted and validated endpoints in 40 subjects who used Dayspring for four weeks for upper extremity lymphedema.
The results showed Dayspring to be safe and effective—with limb volume maintenance or improvement, significant improvements in overall and functional quality of life (18%, p<0.001) from baseline to study completion, and strong therapy adherence (98%).
“Dayspring is an important new advancement to help treat patients with lymphedema and venous disease,” said Dr. Stanley Rockson, professor and chief of Consultative Cardiology and the director of the Stanford Center for Lymphatic and Venous Disorders at Stanford University, co-founder of Lymphatic Education and Research Network (LE&RN), Director at the American Board of Venous and Lymphatic Medicine, and Koya’s chief medical officer. “There is already a large and growing body of evidence supporting Dayspring’s clinical effectiveness, and the product’s innovative design and features enable a very high level of patient adherence to therapy—addressing an important clinical need.”
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.[2] For most, lymphedema requires lifelong maintenance and various levels of therapy to control swelling and pain. Lymphedema is commonly caused by cancer 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 and only compression therapy option designed to enable movement, mobility, and personalized care that is unavailable with traditional compression therapy. The Dayspring system includes a low-profile active garment made of soft, breathable mesh using Koya’s proprietary FlexframeTM 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 program custom treatment options.
Dayspring is FDA 510(k) cleared to treat lymphedema and other similar conditions that impact lymphatic flow in upper and lower extremities.
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/.
[1] Rockson, SG.; Karaca-Mandic, P.; Skoracki, R.; Hock, K.; Nguyen, M.; Shadduck, K.; Gingerich, P.; Campione, E.; Leifer, A.; Armer, J. Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study. Lymphatic Research and Biology
[2] Dean, S. M., Valenti, E., Hock, K., Leffler, J.,Compston, A., & Abraham, W. T. (2020). The clinical characteristics of lower extremity lymphedema in 440 patients. Journal of Vascular Surgery: Venous and Lymphatic Disorders, 8(5), 851–859. https://doi.org/10.1016/j.jvsv.2019.11.014
