Fibralign receives ISO 13485:2012 Certification

Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it’s management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012.

The scope of the certification is for the design, development, manufacture and distribution of porcine collagen scaffold implants used for soft tissue repair and support, nerve repair, wound/scar management, orthopedics, vascular, ophthalmic and lymphatic therapeutic areas.

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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