Learn medical, a California-based medical technology company, has developed the Dayspring Active Compression System for the treatment of lymphedema. The company received FDA approval for the use of Dayspring on the upper extremities in June 2020 and recently announced the 510 (k) authorization to use it on the lower extremities.
Lymphedema involves a deterioration of the lymph drainage that causes painful inflammation and usually occurs after surgical procedures, such as the removal of cancerous lymph nodes. Currently, the disease is treated by manual manipulation of the lymphatic system by a healthcare professional or by means of a compression device. Pneumatic compression devices are usually connected to an electrical outlet, which means that a patient must remain in place for significant periods of time, and therefore these devices interfere with daily life.
The Dayspring compression system allows patients to move around and includes a hand-held rechargeable control unit and a breathable mesh that is worn on the affected limb. The system also includes an app that allows patients and doctors to customize treatment and track their progress.
Medgadget He had the opportunity to speak with Andy Doraiswamy, CEO, President and Founder of Koya Medical about technology.
Conn Hastings, Medgadget: Please give us an overview of lymphedema and who it affects.
Andy Doraiswamy, Koya Medical: An estimated 20 million Americans live with lymphedema, a chronic, progressive, and incurable condition in which the accumulation of protein-rich fluid causes painful inflammation in the arm, legs, and other regions of the body. The condition occurs when the body’s lymphatic system is damaged or blocked, often by treatment for cancer, surgery, trauma, infection, venous insufficiency, or obesity. One in five women who survive breast cancer develop lymphedema.
Lymphedema is severely weakening both physically and emotionally. People living with lymphedema experience a decrease in quality of life and functional capacity due to the inflammation and pain associated with the disease. If left untreated or mismanaged, lymphedema can cause permanent changes in skin tissues, infection, severe physical and functional impairment, significant pain, and in some cases may even require amputation of the limbs.
Medgadget: How is the state currently treated?
Andy Doraiswamy: Lymphedema is treated with manual lymphatic drainage (MLD) provided by certified lymphedema therapists, along with daily self-administered compression therapy and lifestyle management strategies, such as exercise. Applying pressure to the affected limbs increases blood flow and reduces pain and inflammation. Traditionally, active compression therapy is administered using pneumatic compression devices (PCDs). These devices improve lymphatic flow in a manner similar to MLD, although they connect to a wall, restricting patient movement and mobility, and in turn limit adhesion.
Medgadget: What inspired you to develop a new treatment for lymphedema?
Andy Doraiswamy: We set out to solve a problem I identified when my father was being treated for lymphedema after treatment for prostate cancer. After overcoming his cancer, he was still in “patient” mode for a long time due to his diagnosis of lymphedema. His treatment sessions forced him to take a break from life and stay still for an hour every day, often away from family and activities he used to enjoy. He knew there had to be a better option for him and for other patients who didn’t force them to put their daily lives on hold for treatment.
Medgadget: Please give us an overview of Dayspring Therapy and how it works.
Andy Doraiswamy: Dayspring is the first portable and mobility-enabled compression solution designed with real life in mind. The system includes a low-profile piece made of soft, breathable mesh that uses Koya’s patented Flexframe ™ technology, which allows movement and mobility during treatment. It includes a smart, rechargeable handheld controller that can be carried on a cord and a mobile app that allows doctors and their patients to customize treatment options.
Our active piece provides compression levels similar to those of traditional PCD pumps, while allowing for movement and mobility during treatment that patients did not have before.
Medgadget: How does the app work and how does it help improve patient experiences and outcomes?
Andy Doraiswamy: The Koya app allows users and / or their doctors to engage in treatment by scheduling personalized options, such as pre-treatment clarification. The Koya app also allows you to view the history of therapies and access advanced treatment parameters, such as custom pressure ranges. The application and digital health support are part of Koya’s overall ambition to support personalized therapy inside and outside the clinic to improve compliance and outcomes. In clinical studies, we observed 98% adherence to therapy. The app is available for iOS and Android.
Medgadget: Congratulations on receiving FDA approval for the use of Dayspring on the lower extremities. How does this differ from the upper extremities in terms of patient experience and device use? Need a bigger device?
Andy Doraiswamy: Lymphedema in the lower extremities accounts for 80% of cases of lymphedema. Dayspring devices for the upper and lower limbs are similar. They share the same design philosophy, user interface, and underlying Flexframe technology with the goal of enabling meaningful movement and mobility for patients. Similar to the upper limb device, the lower limb system consists of a low-profile active piece, a smart controller, and the Koya app that allows patients and their doctors to customize treatment options. The piece element for the lower limbs is larger to fit the larger limbs, but it generally works in the same way that it allows movement and mobility.