Investor Relations

Information provided on this page is intended for potential investors
and not intended for patient use or product promotion.

Fibralign Corp. is a commercial stage venture that has launched its first product. BioBridge Collagen Matrix has received FDA 510(k) clearance (Class II device) for use in soft tissue repair, CE mark (Class III device) for use in the surgical management of lymphedema, and received KFDA approval in 2024.

BioBridge has been used in over 750 surgical procedures to date, demonstrating safety and clinical effectiveness. Key Opinion Leaders from 19 countries have used BioBridge in the treatment of upper and lower limb lymphedema, facial/neck lymphedema and in surgical prevention of secondary lymphedema. This clinical experience has demonstrated effectiveness in reducing limb volume and restoring lymphatic function (shown by ICG imaging).

Clinical Studies

Several investigator-initiated and prospective clinical studies have been completed, are ongoing, and planned for the treatment of lymphedema and lymphatic disorders. Data from completed studies have been published that demonstrated safety and clinical benefit of BioBridge in the treatment of lymphedema. Ongoing studies include:

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 in part by a $3M SBIR Phase IIB Bridge grant by the National Cancer Institute (NCI), is currently completing enrollment at clinical sites University of Chicago, Stanford University and MD Anderson.

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. This multi-site, blinded study completed enrollment and is pending two-year outcome. The study was used to gain experience for a planned large pivotal clinical study (n=300) at 20 international sites for prevention of breast cancer related lymphedema. 

3. Terumo Corporation recently reported top line data from a multi-site prospective clinical study completed in Japan. This study was funded and managed by Terumo and evaluated using BioBridge in a minimally invasive procedure for treatment of patients with acquired breast cancer-related lymphedema. The study has shown through ICG imaging that new lymphatic vessels formed along implanted BioBridges and restored lymphatic function. Final report is pending and will be used in submission for PMDA approval in 2026, with a planned post market pivotal clinical study to follow. 

Lymphedema

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

Publications

Over 40 peer-reviewed papers have been published regarding BioBridge preclinical and clinical findings, with over 25 additional publications related to Fibralign’s BioBridge® and Nanoweave® technology.

A subset of selected papers are listed below:

  • Bae A, Loening A, Carrion K, Posternak V, He H, Leong S, Nguyen, D. Lymphatic regeneration visualized on MRI after placement of aligned nanofibrillar collagen scaffolds for treatment of lymphedema. Ann Plast Surg. 2025 Jun 13.
  • Lazar SV, Song S, Eggert GR, Cheng MH, Nguyen DH. Single-Malt Whisky Versus Cocktail? Approaches to Surgical Lymphedema Management. J Surg Oncol. 2025 Jan 05
  • Dimitrios Dionyssiou, Antonios Tsimponis, Eleni Georgiadou, Konstantina Mamaligka, Efterpi Demiri. Long-term results of lymphedema treatment with Combined lymph node transfer and collagen scaffolds: An Observational Study. JPRAS. Open 43 (2025) 328-339.
  • Barrantes S, de la Torre S, Visconti G, Blasi M, López-Ojeda A. Treatment of Genital Lymphedema With Lymphatic System Pedicled SCIP Transfer in Combination With Nanofibrillar Collagen Scaffolds. Plast Reconstr Surg Glob Open. 2024 Nov;12(11):e6335.
  • Mohan AT and Nguyen DH. BioBridge in Lymphatic Surgery. Chapter in book by Giuseppe Visconti et al. (Eds): Supermicrosurgical Lymphaticovenular Anastomosis. Springer Nature. 2024.
  • Drobot D, Leitner Shemy O, Zeltzer AA. Biomaterials in the clinical treatment of lymphedema – a systematic review. J Vasc Surg Venous Lymphat Disord. 2024 Jan;12(1):101676.
  • Szymanski K, Chun Fat S, Brazio PS. Surgical Treatment of Breast Lymphedema: A Distinct Pathology With Unique Challenges. Ann Plast Surg. 2024 May 01;92(5S Suppl 3):S315-S319.
  • Chaker SC, James AJ, King D, Karagoz H. Lymphedema: Current Strategies for Diagnostics and Management. Ann Plast Surg. 2024 Dec 01;93(6S Suppl 3):S167-S171.
  • Salibian AA, Yu N, Patel KM. Staging Approaches to Lymphatic Surgery: Techniques and Considerations. J Surg Oncol. 2024 Nov 18
  • Cè M, Menozzi A, Soresina M, Giardini D, Martinenghi C, Cellina M. Lymphedema Surgical Treatment Using BioBridge: A Preliminary Experience. Appl. Sci. 2023, 13, 11571
  • Campos JL, Pons G, Al-Sakkaf AM, Luse IL, Pires L, Vela FJ, Ramos E, Crisóstomo V, Sánchez-Margallo FM, Abellán E, Masiá J. Lymphatic Regeneration after Popliteal Lymph Node Excision and Implantation of Aligned Nanofibrillar Collagen Scaffolds: An Experimental Rabbits Model. J. Funct. Biomater. 2024, 15, 235.
  • Witt M., Ring A., Stricker I., Fruth E. The Fate of Implanted BioBridge Collagen Matrix – Findings in Histology, Scanning, and Transmission Electron Microscopy. Lymphology 56 (2023) 121-124
  • Nguyen D, Dionyssiou D, Zaitseva TS, Zhou AT, Sue G, Deptula P, Moroz MA, Tabada P, Rockson SG, Paukshto MV, Cheng MH, Huang NF. Development of a rat model of lymphedema and the implantation of a collagen-based medical device for therapeutic intervention. Front Cardiovasc Med. 2023;10:1214116.
  • Dimitrios Dionyssiou, Dung Nguyen, Anastasios Topalis, Peter Deptula, Michael Paukshto, Tatiana Zaitseva, Efterpi Demiri, Aggeliki Cheva, Stanley Rockson. Treatment of Rat Lymphedema by Propeller Lymphatic Tissue Flap Combined with Nanofibrillar Collagen Scaffolds. J Reconstr Microsurg. 2024 Feb;40(2):145-155.
  • Bernas, M., Al-Ghadban, S., Thiadens, S.R.J., Ashforth K, Lin WC, Safa B, Buntic R, Paukshto M, Rovnaya A, McNeely ML. Etiology and treatment of cancer-related secondary lymphedema. Clin Exp Metastasis Springer Nature, 2023 Sep 30. https://doi.org/10.1007/s10585-023-10232-8
  • Bianchi LMG, Irmici G, Cè M, D’Ascoli E, Della Pepa G, Di Vita F, Casati O, Soresina M, Menozzi A, Khenkina N, Cellina M. Diagnosis and Treatment of Post-Prostatectomy Lymphedema: What’s New? Curr Oncol. 2023 Apr 25;30(5):4512-4526.
  • Inchauste SM, Nguyen DH, and Ming-Huei Cheng. Animal Study and Cadaver Dissection of Lymphedema. In book: Principle of Lymphatic System. Elsevier, 2022.
  • Chin‐Yu Yang, Ines E. Tinhofer, Dung Nguyen, Ming‐Huei Cheng. Enhancing lymphangiogenesis and lymphatic drainage to vascularized lymph nodes with nanofibrillar collagen scaffolds. J Surg Oncol. 2022;1‐
  • Deptula P, Zhou A, Posternak V, He H, Nguyen D. Multimodality Approach to Lymphedema Surgery Achieves and Maintains Normal Limb Volumes: A Treatment Algorithm to Optimize Outcomes. J Clin Med. 2022 Jan 25;11(3):598.
  • Nguyen DH, Zhou A, Posternak V, Rochlin DH. Nanofibrillar Collagen Scaffold Enhances Edema Reduction and Formation of New Lymphatic Collectors after Lymphedema Surgery. Plast Reconstr Surg. 2021 Dec 1;148(6):1382-1393.
  • Nguyen D, Zaitseva TS, Zhou A, Rochlin D, Sue G, Deptula P, Tabada P, Wan D, Loening A, Paukshto M, Dionyssiou D. Lymphatic regeneration after implantation of aligned nanofibrillar collagen scaffolds: Preliminary preclinical and clinical results. J Surg Oncol. 2021 Sep 21. doi: 10.1002/jso.26679. Epub ahead of print. PMID: 34549427. https://pubmed.ncbi.nlm.nih.gov/34549427/
  • 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. [https://pubmed.ncbi.nlm.nih.gov/26061869/]
  • 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/]