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The company has launched its first product, the BioBridge Collagen Matrix, which has FDA 510(k) clearance for use in soft tissue repair and recently received CE mark as a Class III device for use in the surgical management of lymphedema.
To date BioBridge has been used in over 60 surgical procedures as an implant at select leading medical centers, providing valuable clinical feedback on its safety and effectiveness.
Fibralign is currently engaging KOLs in Europe as it prepares for an EU launch at the beginning of 2021.
Fibralign is currently conducting three clinical studies to further demonstrate clinical benefit for addressing lymphedema, a global chronic disease that currently has no cure:
1. LYMPHBRIDGE is a multi-site blinded clinical study evaluating the use of BioBridge in the treatment of acquired breast cancer-related lymphedema being conducted in the United States. This study, which is funded by a $3M SBIR Phase IIB Bridge grant by the National Cancer Institute (NCI), began enrollment in November 2020 and is being led by University of Chicago Medicine and Stanford Medicine.
2. A pilot clinical study is being conducted in Europe to evaluate using BioBridge as a preventative treatment for patients who are at high risk of developing lymphedema from required surgery to address advanced stage breast cancer. This multi-site, blinded study began enrollment in September 2020 and is based on strong preclinical studies that demonstrated BioBridge was effective in providing an infrastructure that supported lymphatic tissue repair before lymphedema would develop.
3. Fibralign is working with Terumo Corporation to prepare a clinical study in Japan scheduled for 2021 to evaluate the treatment of acquired lymphedema using BioBridge as a surgical implant. This study, which is being funded and managed by Terumo, will be used to gather clinical data to support PMDA regulatory engagement to market BioBridge in Japan.
Lymphedema* is a progressive global disease that develops when the lymphatic system is unable to carry large proteins and lymph fluid away from a region of the body. This painful and disfiguring condition is characterized by gross swelling of the affected limb and caused by a blockage in the lymphatic system, a critical part of the immune and circulatory systems. Untreated, lymphedema can lead to irreversible skin changes, fibrosis, frequent and serious infections, reduced mobility, severe deformity (elephantiasis), resulting in a profound impact on quality of life.
Lymphedema in western countries is most commonly caused by lymph node removal or damage due to cancer treatment. Metastatic tumor cells (particularly breast cancer and melanoma) can frequently spread via the lymphatic vascular system and colonize in lymph nodes, necessitating radical surgery and radiation treatment that often destroys lymphatic vessel networks and leads to impairment of afferent lymphatic flow.
The World Health Organization (WHO) estimates that 15 million patients worldwide suffer from cancer-related lymphedema. It is reported that there are over 150,000 new cases each year in western countries of breast cancer related-lymphedema. Lymphatic filariasis is a far greater global threat. This occurs from a parasitic insect-transmitted infection that is prevalent in tropical regions. The WHO estimated the global burden of filariasis to be 120 million cases, with one third of these patients being incapacitated.
* BioBridge has not been approved by the FDA for treating secondary lymphedema
A selection of publications related to Fibralign BioBridge® and Nanoweave® technology:
Dionyssiou, Dimitrios & Demiri, Efterpi. (2021). A comprehensive treatment algorithm for patients requiring simultaneous breast and lymphedema reconstruction based on lymph node transfer. Annals of Breast Surgery. 10.21037/abs-20-142.
Zaitseva T, Yang G, Dionyssiou D, et al. Delivery of hepatocyte growth factor mRNA from nanofibrillar scaffolds in a pig model of peripheral arterial disease. Regen Med. 2020;15(6):1761-1773. doi:10.2217/rme-2020-0023 [https://pubmed.ncbi.nlm.nih.gov/32772903/]
Hu C, Zaitseva TS, Alcazar C, et al. Delivery of Human Stromal Vascular Fraction Cells on Nanofibrillar Scaffolds for Treatment of Peripheral Arterial Disease. Front Bioeng Biotechnol. 2020;8:689. Published 2020 Jul 17. doi:10.3389/fbioe.2020.00689 [https://doi.org/10.3389/fbioe.2020.00689]
Rochlin, D, Inchauste S, Zelones J, Nguyen DH. The role of adjunct nanofibrillar collagen scaffold implantation in the surgical management of secondary lymphedema: Review of the literature and summary of initial pilot studies. Journal of Surgical Oncology, 2020. 121(1): p. 121-128 [https://onlinelibrary.wiley.com/doi/full/10.1002/jso.25576]
Inchauste S, Zelones J, Rochlin D, Nguyen DH. Successful treatment of lymphedema in a vasculopath and neuropathic patient. J Surg Oncol. 2020;121(1):182-186. doi:10.1002/jso.25590 [https://pubmed.ncbi.nlm.nih.gov/31228351/]
Rockson SG. Lymphedema after Breast Cancer Treatment. N Engl J Med. 2018;379(20):1937-1944. doi:10.1056/NEJMcp1803290 [https://pubmed.ncbi.nlm.nih.gov/30428297/]
Hadamitzky, C., Zaitseva, T. S., Bazalova-Carter, M., Paukshto, M. V., Hou, L., Strassberg, Z., et al. (2016). Aligned nanofibrillar collagen scaffolds – Guiding lymphangiogenesis for treatment of acquired lymphedema. Biomaterials 102, 259–267. doi: 10.1016/j.biomaterials.2016.05.040 [https://pubmed.ncbi.nlm.nih.gov/27348849/]
Nakayama KH, Hong G, Lee JC, Patel J, Edwards B, Zaitseva TS, Paukshto MV, Dai H, Cooke JP, Woo YJ, Huang NF. Aligned-Braided Nanofibrillar Scaffold with Endothelial Cells Enhances Arteriogenesis. ACS Nano. 9(7):6900-8 (2015). doi: 10.1021/acsnano.5b00545. Epub 2015 Jun 17.
Huang NF, Okogbaa JN, Lee JC, Paukshto M, Zaitseva T, Cooke JP. The modulation of endothelial cell morphology, function, and survival using anisotropic nanofibrillar collagen scaffolds. Biomaterials. 34:4038-4047. (2013) [https://pubmed.ncbi.nlm.nih.gov/23480958/]
Denning D, Paukshto MV, Habelitz S, Rodriguez BJ. Piezoelectric properties of aligned collagen membranes. J Biomed Mater Res B Appl Biomater. 2014;102(2):284-292. doi:10.1002/jbm.b.33006 [https://pubmed.ncbi.nlm.nih.gov/24030958/]
Muthusubramaniam L, Peng L, Zaitseva T, Paukshto M, Martin GR, Desai TA. Collagen fibril diameter and alignment promote the quiescent keratocyte phenotype. J Biomed Mater Res A. 2012;100(3):613-621. doi:10.1002/jbm.a.33284 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266477/]