Koya Medical’s Dayspring Active Compression Device Evaluated in Studies of Lymphedema and Venous Disease Treatments

October 4, 2022—Koya Medical announced two clinical data publications for the treatment of lymphedema and venous disease with its Dayspring nonpneumatic active dynamic compression system, which is designed for patient mobility and cleared by the FDA to treat lymphedema and chronic venous conditions. The results of the studies will be presented at AVLS 2022, the 36th annual congress of the American Vein and Lymphatic Society held October 13-16 in New Orleans, Louisiana.

On August 17, results from a nonrandomized, open-label study of the safety and efficacy of Dayspring for treatment of lymphedema and venous diseases in the lower extremities were published online by Stanley G. Rockson, MD, et al in the open-access journal, Scientific Reports—Nature.

On August 8, results from the NILE study, which evaluated the safety and effectiveness of the Dayspring nonpneumatic device versus an advanced pneumatic compression device (APCD) for treating breast cancer–related lymphedema, were published online by Dr. Rockson et al in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

Additionally, the company announced that the Centers for Medicare & Medicaid Services has confirmed the durable medical equipment benefit category determination, payment schedule, and five final level II Healthcare Common Procedure Coding System codes for the Dayspring active compress system in its final biannual Medicare benefit decisions update.

According to Koya Medical, the study in Scientific Reports—Nature was conducted over 12 weeks and enrolled 24 patients with primary or secondary unilateral lower extremity lymphedema and evaluated changes in limb edema and quality of life following treatment with the Dayspring device.

The company summarized the key results as follows. After 3 months of use, patients experienced mean improvements in lymphedema quality-of-life questionnaire compared with baseline (P < .05). Limb volume improved (up to 50% reduction in edema) with Dayspring use, with an average reduction in affected limb edema of 39.4%.

Next, the company reported that NILE, the multicenter, randomized controlled crossover study, was composed of 50 women with unilateral breast cancer–related lymphedema.

As summarized by Koya Medical, the Dayspring device was found to be more effective than an APCD. There was significantly greater adherence (95.6% vs 49.8%) and greater satisfaction (90% vs 14%) with the Dayspring device versus an ACPD. Also, patients experienced mean improvements in lymphedema quality-of-life questionnaire and significantly greater mean reduction in edema volume (64.6% vs 27.7%; P < .05) with the Dayspring device versus an ACPD.

“Lymphedema is an incurable condition that requires lifelong maintenance, often forcing people to be tied to their compression devices for hours at a time,” commented Dr. Rockson, the NILE study’s Principal Investigator, in the company’s press release, “However, with the mobility-enabled Dayspring system, I’m seeing not only a meaningful reduction in patients’ edema but also a significant improvement in their satisfaction and overall quality of life.”

Dr. Rockson, who is a cardiologist and Professor in the Falk Cardiovascular Research Center at Stanford University School of Medicine in Stanford, California, concluded, “These results highlight the significant benefits the Dayspring system provides in the way we can manage and treat lymphedema and venous disease.”

Thomas Maldonado, MD, who is Medical Director of the Venous Thromboembolic Center at New York University Langone Health in New York, New York, stated in the Koya Medical press release, “These key data publications further expand our body of clinical evidence supporting the use of the Dayspring active compression system for people living with lymphedema and chronic venous conditions. We look forward to continuing to advance evidence supporting Dayspring and helping even more people with lymphedema and venous diseases maintain mobility while continuing to experience effective compression treatment.”

Koya Medical announced the United States launch of the Dayspring system for the treatment of lymphedema and venous diseases in the lower extremities in April 2022.

In May 2021, the company announced FDA clearance of Dayspring for treatment of the lower extremities. The device was cleared for treatment of the upper extremities in 2020 and commercially launched for this indication in 2021.

Dayspring has received FDA 510(k) clearance to treat lymphedema, primary lymphedema, postmastectomy edema, edema following trauma and sports injuries, postimmobilization edema, venous insufficiency, venous stasis ulcers, arterial and diabetic leg ulcers, lipedema, phlebolymphedema, and other similar conditions that impact lymphatic flow in the upper and lower extremities. Dayspring is also indicated to reduce wound healing time and treatment and assist in healing stasis dermatitis, advised Koya Medical.