Koya Medical’s Dayspring Lymphedema Treatment Supported by Interim Data

October 11, 2021—Koya Medical announced the recent presentation of data from the prospective, multicenter, randomized, crossover NILE study comparing the company’s Dayspring active compression treatment for lymphedema to a traditional pneumatic compression pump.

According to Koya Medical, patients in the study reported significantly greater adherence to Dayspring treatment in comparison to the use of a pneumatic compression pump. Additionally, patients in the Dayspring arm demonstrated greater reduction in limb volume, improvement in quality of life, and patient preference. The Dayspring, which enables movement and mobility, was cleared by the FDA to treat lymphedema and other similar conditions.

The data were presented by Koya’s Chief Medical Officer Stanley G. Rockson, MD, at AVLS 2021, the American Vein and Lymphatic Society’s 35th Annual Congress held October 6-9 in Aurora, Colorado. Dr. Rockson is also Professor of Cardiovascular Medicine, Chief of Consultative Cardiology, and Director of the Center for Lymphatic and Venous Disorders at Stanford University in Stanford, California.

As summarized in the company’s announcement, the head-to-head NILE trial has enrolled 52 participants thus far who were treated in the home sequentially, in random order, with either a Dayspring device or a leading pneumatic compression pump. Study participants were instructed to use the assigned randomized device at home for 4 weeks, 1 hour every day. After a 4-week “wash-out” period, they were instructed to use the comparator device at home for 4 weeks, 1 hour every day.

The interim data presented at AVLS represents 37 participants who have completed both arms of the study. Limb volume, quality-of-life outcomes, adherence, and patient preference were evaluated. Quality-of-life outcomes were assessed using the Lymphedema Quality-of-Life Questionnaire.

The primary endpoint of the study is noninferiority for limb volume reduction against the comparator pneumatic compression pump.

The company stated that the interim analysis demonstrated the following:

• Greater, statistically significant improvement in limb volume reduction (P < .05)
• Statistically significant higher scores in the quality-of-life measure for Dayspring compared to the pneumatic compression pump (P < .05)
• Stronger treatment adherence for Dayspring, with 95% of the study participants adhering to the prescribed treatment course versus 48% of participants in the comparator group (P < .01)
• The majority of patients (89%) preferred Dayspring over the pneumatic compression pump (P < .01) because of movement, mobility, and improved function in their daily lives

The Dayspring has received FDA 510(k) clearance to treat lymphedema and other similar conditions that impact lymphatic flow in upper and lower extremities, advised the company.

“For people with lymphedema, movement is important from both a clinical perspective and a quality-of-life perspective,” commented Dr. Rockson in Koya Medical’s press release. “These data illustrate the Dayspring treatment’s ability to provide that essential movement while still delivering the clinical outcomes we need from compression therapy.”

Dr. Rockson continued, “Traditional pneumatic compression pumps have long represented an important and effective tool for lymphedema patients to self-manage a lifelong chronic condition. It is rewarding to see this much-needed innovation coming to market; it provides patients with an additional option, especially this one that enables movement and improves adherence.”