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Research & Publications

Koya Medical is committed to transforming venous and lymphatic care. We are actively developing clinical evidence and partnering with leading clinicians, researchers, and institutions around the world as we continue to bring innovations to this space.

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1 DAYSPRING®

Clinical study

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study (DAYSPRING)

  • Significant improvement in LYMQOL
  • Significant improvement in Individual QoL domains, and limb volume improved with therapy
  • Adherence was 98% over the course of the study

All publications
Dayspring-studies, 2021, clinical-studies, all-publications

Stanley G Rockson, Pat W. Whitworth, Andrea Cooper, Sarah Kania, Heidi Karnofel, Michelle Nguyen, Kristin Shadduck, Phyllis Gingerich, Jane Armer Original Article published in Lymphat Res Biol. 2021 https://doi.org/10.1089/lrb.2020.0126

2 INDUS

Clinical study

Near-IR Lymphatic Transport Imaging to Evaluate Response to an Ambulatory Smart Wearable Device (INDUS)

  • NIR Imaging demonstrated lymph movement in all subjects with improvement of lymphatic function from use of Dayspring device

All publications
dayspring-studies, clinical-studies, 2022, all-publications

Jane Wigg, Elizabeth Campione, Anand Doraiswamy, and Stanley G. Rockson, Original article presented at: International Lymphodema Framework (ILF) Conference. 2021. Copenhagen, Denmark and Journal of Wound Care. 2022

3 NILE

Clinical study

Safety and Effectiveness of a Novel Non-Pneumatic Active Compression Device for Treating Breast Cancer-Related Lymphedema, a Multi-Center Randomized, Crossover Trial (NILE)

  • Dayspring was found to be more effective than an APCD
  • Significantly greater adherence (95.6% vs. 49.8%), and greater satisfaction (90% vs. 14%)
  • Significantly greater mean reduction in edema volume(64.6% vs. 27.7%) and mean improvements in LYMQOL

All publications
dayspring-studies, clinical-studies, 2022, all-publications

Stanley G Rockson, Pat W. Whitworth, Andrea Cooper, Sarah Kania, Heidi Karnofel, Michelle Nguyen, Kristin Shadduck, Phyllis Gingerich, Jane Armer, Journal of Vascular Surgery. 2022 https://doi.org/10.1016/j.jvsv.2022.06.016

4 TIGRIS

Clinical study

Near-IR Lymphofluoroscopy for Evaluation of Upper Extremity Lymphoedema using a Non-Pneumatic Active Compression Device (TIGRIS)

All publications
dayspring-studies, clinical-studies, 2022, all-publications

Dung Nguyen, Peter Deptula, Halley Darrach, Victoria Posternak, Hui He Stanford Medicine Symposia and in preparation for publication

5 TIBER

Clinical study

A Non-Randomized, Open-Label Study of the Safety and Effectiveness of a Novel Non-Pneumatic Compression Device (NPCD) for Lower Limb Lymphedema (TIBER)

  • After 3 months of use, subjects had improvement in overall QoL compared with baseline (p<0.05)
  • Limb volume improved (up to 50% reduction in edema) with Dayspring use

All publications
all-publications, clinical-studies, dayspring-studies, 2022

Stanley G. Rockson, Pinar Karaca-Mandic, Michelle Nguyen, Kristin Shadduck, Phyllis Gingerich, Elizabeth Campione, and Heather Hettrick Scientific Reports, Nature. 2022 https://doi.org/10.1038/s41598-022-17225-9

6 NEDA

Clinical study

Near-IR Lymphofluoroscopy of Lower Extremity Lymphedema Treatment with Novel Active Compression (NEDA)

  • NIR Imaging demonstrated lymph movement in all subjects
  • Improvement of lymphatic function from use of Dayspring device

All publications
all-publications, dayspring-studies, clinical-studies, 2022

Jane Wigg, Elizabeth Campione, Andy Doraiswamy, and Stanley G. Rockson Original article in Preparation for Journal of Vascular Surgery. American Venous and Lymphatic Society. 2022

7 SMA

Clinical study

Active Wearable Compression with Shape Memory Actuators for Treating Chronic Edema (SMA)

  • Comparison and characterization of compression between NPCD and APCD
  • Both NPCD and APCD provide comparable compression pressure ranges
  • NPCD appears to provide more uniform compression than APCD
  • Potential for SMA-based NPCD to address current treatment challenges for chronic edema

All publications
all-publications, clinical-studies, dayspring-studies, 2022

John Pamplin, Jarren Baldwin, Julia Rodrick, and Anand Doraiswamy Shap. Mem. Superelasticity. ASM International. 2022. https://doi.org/10.1007/s40830-022-00379-w

8 INSIGHT

Clinical study

A Novel Handheld Spectroscopy Tool for Detection of Lymphedema (INSIGHT)

  • Use of NPCD and a novel diagnostic multimodalspectroscopy tool demonstrates effectiveness of the therapy during a 3-month period across all functions

All publications
all-publications, clinical-studies, 2023

Jennifer Sibley, Jarren Baldwin, John Pamplin, Julia Rodrick, Charles Liu, Heather Hettrick, and Anand Doraiswamy Biomedical Materials & Devices (2023). https://link.springer.com/article/10.1007/s44174-023-00070-3

9 TEAYS

Clinical study

A Clinical Study to Evaluate the Effectiveness of Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) versus an Advanced Pneumatic Compression Device (APCD) for Treating Lower Extremity Lymphedema (TEAYS)

The study met its primary and secondary endpoints


• Reduction in limb volume: 369.9 ± 68.19 mL vs. 83.1 ± 67.99 mL, P<0.005* (subjects on Dayspring treatment removed greater than 4 times the fluid compared to when they were on the APCD treatment)
• Improvement in overall Quality of Life (LYMQOL): 1.01 ± 0.23 vs. 0.17 ± 0.18, P<0.05*,
• Treatment adherence: 81% ± 2.9% vs. 56% ± 4.2%, P<0.001*
• Study participants prefer NPCD treatment over APCD: 78% vs. 22%

All publications
all-publications, clinical-studies, dayspring-studies, 2024

* indicates statistical significance. Topline results presented at American Venous Forum VENOUS 2024. NCT05507346

Publication

The Economic Savings of Successful Lymphedema Self-Care

Novel self‑care solutions that are more convenient and that interfere less with daily activities couldincrease self‑care adherence and ultimately reduce complication‑related costs of BCRL.

All publications
other-publications, 2023, all-publications

Karaca‑Mandic et al. Cost Effectiveness and Resource Allocation (2023) 21:47 https://doi.org/10.1186/s12962‑023‑00455‑7

Publication

Active Dynamic Compression: A New Look at VLU and Lymphedema Treatment

Innovations in compression therapy such as the Dayspring device may prove useful in this at-risk patient population, with benefits including fewer amputations and medical transfers, lower wound recidivism, and higher treatment completion rates.

All publications
other-publications, 2023, all-publications

https://podiatrym.com/Clinical_Innovations2.cfm?id=3103

Publication

A Novel Multi-Modal At-Home Non-pneumatic Compression Treatment for Lymphedema and Chronic Venous Insufficiency

Using a nonpneumatic compression device that combines multiple treatment modalities demonstrates improved efficacy, quality of life, and patient adherence.

All publications
other-publications, 2024, all-publications

https://journals.lww.com/aswcjournal/ fulltext/2024/04000 /various_therapies_for_lymphedema_and_chronic.7.aspx

Publication

It is Time to Curb the Dogma in Lymphedema Management

This commentary is a call to action to embrace innovation to better manage lymphedema and expand educational opportunities by leveraging technology to properly train healthcare providers to manage this disease.

All publications
other-publications, 2023, all-publications

https://www.mdpi.com/2813-3307/1/3/16

Publication

Real Time Visualization of Enhanced Lymphatic Flow Using a Non-Pneumatic Active Compression Device (NPCD)

Lipedema and lymphedema remain misunderstood and underappreciated diseases. While the conditions appear similar, each presents with unique pathophysiology. In consideration of this, a novel ambulatory Non-Pneumatic Compression Device (NPCD) was utilized in this study to support lymphatic flow and improve tissue health while permitting and enabling movement.

All publications
other-publications, 2023, all-publications

https://www.gavinpublishers.com/article/view/real-time-visualization-of-enhanced-lymphatic-flow-when-using-a-non-pneumatic-active-compression-device-npcd

Publication

Live to Move and Move to Live

This article will highlight the significance of the venous pump and review the functional anatomy and physiology of the foot and calf, integrating the connection to venous and lymphatic health.

All publications
other-publications, 2024, all-publications

https://www.mdpi.com/2813-3307/2/2/4

Publication

Evaluation of a Novel Wearable Non-Pneumatic Compression Device for the Treatment of Breast Cancer-Related Lymphedema

This study highlights the potential benefits of wearable NPCD treatment for patients managing their condition independently. The approach integrates treatment into daily routines, potentially improving long-term adherence to therapy for breast cancer-related lymphedema (BCRL). By focusing on practical functionality, NPCD allows patients to maintain mobility and engage in necessary exercises during treatment, representing a significant advancement in lymphedema management.

All publications
All-publications, Other-publications, 2024

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