Clinical Research Proves Improved Results with New Lymphedema Treatment Option

Tigris

Near-IR Lymphofluoroscopy for Evaluation of UpperExtremity Lymphedema using a Non-Pneumatic ActiveCompression Device

14%

14% reduction in edema

Statistically meaningful reduction (14%) was observed in the mean limb volume within one month of use (p<0.05)

Statistically meaningful reduction (14%) was observed in the mean limb volume within one month of use (p<0.05)
Statistically significant improvement of 2.7 points in overall QoL (LYMQOL) (p<0.001)
Improvement was observed in all study participants across all stages (1-3) of the disease

1Stanford Medicine Symposia and in preparation for publication. Authors: Dung Nguyen, MD, PharmD1, Peter Deptula1, Halley Darrach1, Victoria Posternak, MSN1, Hui He, PA-C1

Lower Limb Lymphedema Study

A Non-Randomized, Open-Label Study of the Safety and Effectiveness of a Novel Non-Pneumatic CompressionDevice (NPCD) for Lower Limb Lymphedema (N=24)¹

39.4%

Up to 50% reduction in edema

Limb volume improved (up to 50% reduction in edema)with Dayspring use

0.83

Improvement in Quality of life

After 3 months of use, subjects had improvement in overall QoL compared with baseline (p<0.05)

1Stanley G. Rockson, MD, Pinar Karaca-Mandic, PhD, Michelle Nguyen, DPT, CLT, Kristin Shadduck, PT, Phyllis Gingerich, RN,BSN, CLT, Elizabeth Campione, DPT, CLT, and Heather Hettrick, PhD, DPT, CLT. Scientific Reports, Nature. August 2022 .

Neda

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

100%

Lymphatic transport was observed in all subjects and visualized with NIR

Within an 1-hour treatment application period, all subjects demonstrated decrease in volume of limb as well as reduced TDC % tissue water content.
No device related adverse events were reported

1Journal of Vascular Surgery. American Venous and Lymphatic Society. 2022. Authors: S Jane Wigg, RGN, MSc, Elizabeth Campione, DPT, CLT, Anand Doraiswamy, PhD, and Stanley G. Rockson, MD

1 DAYSPRING®

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

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

Stanley G Rockson, Pat W. Whitworth, Andrea Cooper, Sarah Kania, Heidi Karnofel, Michelle Nguyen, Kristin Shadduck, Phyllis Gingerich, Jane Armer

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2 INDUS

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

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

Jane Wigg, Elizabeth Campione, Anand Doraiswamy, Pand Stanley G. Rockson,

3 NILE

Safety and Effectiveness of a Novel Non-PneumaticActive Compression Device for Treating BreastCancer-Related Lymphedema, a Multi-CenterRandomized, 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

Stanley G Rockson, Pat W. Whitworth, Andrea Cooper, Sarah Kania, Heidi Karnofel, Michelle Nguyen, Kristin Shadduck, Phyllis Gingerich, Jane Armer,

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4 TIGRIS

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

~1.8 years from lymphedema surgery. Unilateral UE lymphedema secondary to breast cancer treatment
Daily Dayspring use within 1-month improved QoL and limb volumetrics in patients with long-standing lymphedema not resolved by surgery

Dung Nguyen, Peter Deptula1, Halley Darrach1, Victoria Posternak, Hui He

5 TIBER

A Non-Randomized, Open-Label Study of the Safety andEffectiveness of a Novel Non-Pneumatic CompressionDevice (NPCD) for Lower Limb Lymphedema

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

Stanley G. Rockson, Pinar Karaca-Mandic, Michelle Nguyen, Kristin Shadduck, Phyllis Gingerich, Elizabeth Campione, and Heather Hettrick

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6 NEDA

Near-IR Lymphofluoroscopy of Lower Extremity Lymphoedema Treatment with Novel Active Compression

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

S Jane Wigg, Elizabeth Campione, Andy Doraiswamy, and Stanley G. Rockson

7 SMA

Active Wearable Compression with Shape Memory Actuators for Treating Chronic Edema

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

John Pamplin, Jarren Baldwin, Julia Rodrick, and Anand Doraiswamy

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Research & Publications

Tigris

14% reduction in edema

Lower Limb Lymphedema Study

Up to 50% reduction in edema

Improvement in Quality of life

Neda

1 DAYSPRING®

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

2 INDUS

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

3 NILE

Safety and Effectiveness of a Novel Non-PneumaticActive Compression Device for Treating BreastCancer-Related Lymphedema, a Multi-CenterRandomized, Crossover Trial (NILE)

4 TIGRIS

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

5 TIBER

A Non-Randomized, Open-Label Study of the Safety andEffectiveness of a Novel Non-Pneumatic CompressionDevice (NPCD) for Lower Limb Lymphedema

6 NEDA

Near-IR Lymphofluoroscopy of Lower Extremity Lymphoedema Treatment with Novel Active Compression

7 SMA

Active Wearable Compression with Shape Memory Actuators for Treating Chronic Edema