Fibralign receives ISO 13485:2016 upgrade certification

Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. V. that the Company’s management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. 

ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

Fibralign has developed and established an end-to-end manufacturing system for production of its BioBridge Collagen Matrix in its GMP facility located in Union City, California.

BioBridge Symposium held at 30th World Congress of the International Society of Lymphology (ISL)

BioBridge Symposium held at 30th World Congress of the International Society of Lymphology (ISL)

Fibralign Corp. and leading physicians presented an update on clinical findings and case studies during the 30th World Congress of the International Society of Lymphology (ISL), which was held 15-19 October 2025 in Antalya, Turkey. As part of this session, Dr. Corrado Campisi, incoming President of ISL, presented his prospective randomized clinical study (n=34) using BioBridge with advanced microsurgerical procedures.

This was the second time that ISL hosted a BioBridge-focused session during their bi-annual congress meeting, with the previous session held in Genoa, Italy in September, 2023.

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Good Moonwha Hospital completes 100th BioBridge surgical case milestone.

Good Moonwha Hospital completes 100th BioBridge surgical case milestone.

Fibralign Corp. and leading physicians presented an update on clinical findings and case studies during the 30th World Congress of the International Society of Lymphology (ISL), which was held 15-19 October 2025 in Antalya, Turkey. As part of this session, Dr. Corrado Campisi, incoming President of ISL, presented his prospective randomized clinical study (n=34) using BioBridge with advanced microsurgerical procedures.

This was the second time that ISL hosted a BioBridge-focused session during their bi-annual congress meeting, with the previous session held in Genoa, Italy in September, 2023.

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Japan BioBridge PMDA Study Completion

Japan BioBridge PMDA Study Completion

Terumo Corporation announced that the first clinical trial conducted in Japan for evaluation the BioBridge® Collagen Matrix in the surgical treatment of lymphedema has reached its endpoint. Terumo is managing and funding clinical studies in Japan which are being used...

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