Clinically Proven Technology

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Publications Backing Fibralign Technology

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The Origins of Lymphatic Reconstruction

1908

Artificial lymphatic channels

In 1908, W. S. Handley introduced one of the earliest concepts of artificial lymphatic channels. By implanting sterile silk threads subcutaneously in lymphedematous limbs, he demonstrated temporary improvement of lymphatic drainage and reduction of swelling, attributed to capillary action along the threads.

W. S. Handley
2003

Lymphatic vessel formation follows established fluid flow pathways.

A preclinical murine study demonstrated that interstitial fluid drainage pathways are essential for lymphangiogenesis and can direct its formation.

PRECLINICAL STUDIES

BioBridge Scaffolds support lymphangiogenesis in a porcine model

Treatment with BioBridge scaffolds, both as a standalone approach and in conjunction with autologous lymph node transfer, has been shown to support lymphangiogenesis.

In a porcine model of induced secondary lymphedema, three months after implantation, the nanofibrillar scaffold demonstrated high biocompatibility, accompanied by substantial cellular infiltration within the scaffold structure. Immunofluorescent analysis revealed a significant increase in the number of lymphatic collectors in close proximity to the scaffold.

This was associated with restoration of lymphatic drainage, reflected by improved bioimpedance measurements and a reduction in tissue fluid accumulation.

Histological analysis of lymphedema sites three months after BioBridge implantation. Arrows indicate the folds of the scaffold integrated into the surrounding tissue. Cellular infiltration is observed throughout the internal structure of the scaffold.

Histological analysis of the BioBridge scaffold

Confocal microscopy images of immunofluorescent staining demonstrate the presence of newly formed lymphatic structures, characterized by LYVE1-positive vessel-like formations with defined lumens.

Confocal microscopy of newly formed lymphatic structures

Changes in the average bioimpedance ratio in treatment and untreated control groups. A reduction in bioimpedance following BioBridge implantation indicates decreased interstitial fluid accumulation at three months post-treatment.

Bioimpedance ratio chart

Human Studies Show Edema Reduction and Newly Formed Collectors

2017

First-in-Human Study Demonstrates BioBridge Supports Lymphatic Tissue Repair

Six out of eight patients treated with BioBridge responded within six months, with an average limb volume reduction of approximately 20%.

2021

BioBridge Enhances Outcomes in LVA and VLNT

BioBridge was associated with greater edema reduction versus controls and increased newly formed lymphatic collectors.

Edema reduction was significantly greater in the BioBridge cohort compared to controls.
Edema reduction chart
Lymphatic mapping following BioBridge implantation showed a statistically significant increase in newly formed lymphatic collectors.
New lymphatic collectors chart
2024

BioBridge Enhances Outcomes in VLNT

Observational studies demonstrated significantly greater limb volume reduction in the BioBridge group.

BioBridge implantation was associated with the formation of new lymphatic vessels that orientated in the implantation site, as demonstrated by indocyanine green imaging.
Lymphatic imaging before and after treatment
GLOBAL PROGRAMS

A Growing Global Body of Clinical Evidence

Published

Lymphedema Surgical Treatment Using BioBridge: A Preliminary Experience

A preliminary clinical experience combining BioBridge with microsurgical lymphedema treatment.

Published
Published

Lymphatic regeneration after implantation of aligned nanofibrillar collagen scaffolds

Preclinical and clinical results demonstrating lymphatic regeneration after scaffold implantation.

Published
Published

Nanofibrillar Collagen Scaffold Enhances Edema Reduction and Formation of New Lymphatic Collectors after Lymphedema Surgery

Long-term outcomes of nanofibrillar collagen scaffold implantation with lymphatic surgery.

Published
Published

Combined Liposuction and Physiologic Treatment Achieves Durable Limb Volume Normalization in Class II–III Lymphedema

A treatment algorithm combining liposuction with physiologic lymphatic procedures to normalize limb volume.

Published
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Clinical Study: LymphBridge™ Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema

Enroll in the LymphBridge™ study to be part of the solution.

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References

  1. Handley W. S. Two cases of lymphangioplasty for the brawny arm of breast cancer. 1908.
  2. Boardman, Kendrick C., and Melody A. Swartz. Interstitial flow as a guide for lymphangiogenesis. Circulation Research 92.7 (2003): 801–808.
  3. Hadamitzky C. et al. Aligned nanofibrillar collagen scaffolds–Guiding lymphangiogenesis for treatment of acquired lymphedema. Biomaterials. 2016; 102: 259–267.