Koya Medical has announced the commercial launch of its wearable and mobility-enabled Dayspring active compression system in the US.
The system is meant for the treatment of lymphedema and venous diseases in the lower extremities.
According to Koya, the Dayspring system is the first non-pneumatic active dynamic compression treatment approved by the FDA.
The system consists of a soft, breathable mesh garment, made with the firm’s unique Flexframe technology, to provide regulated and customised compression with natural mobility.
It also includes a smart, rechargeable, Bluetooth-enabled controller, with companion software to personalise therapies and evaluate treatment history.
It is designed to support the body movement for daily activities during treatment, which was not possible in existing pneumatic (air-based) compression pumps that required patients to be stationary and the devices to be plugged into an outlet.
Koya Medical founder and CEO Andy Doraiswamy said: “Daily essential movement helps promote healthy lymph fluid flow, which is important for managing lymphedema, venous insufficiency and other chronic edemas.
“We designed Dayspring active compression to help patients remain mobile, get the treatment they need instead of letting it get in the way.
“We look forward to providing at-home active compression treatment options that allow natural leg movements to help reduce swelling and maintain limb volume for people living with lymphedema and venous insufficiency in their lower extremities.”
Dayspring for the upper extremity is commercially available since 2021.
The system is FDA 510(k) cleared to treat lymphedema and other similar conditions, which affect lymphatic flow in the upper and lower extremities.
Koya medical strategic market access and health economics vice president Kelly Petrucci said: “Securing codes from CMS is a significant step for advancing new treatment options for patients living with lymphedema and their caregivers and providers.
“We appreciate the recognition of the new codes, and this significant milestone is critically important to help ensure patients have access to treatments like Dayspring.”
