Fibralign Corporation news
The UCSF Rosenman Institute is proud to announce the 2021 cohort of the Rosenman Innovators, a group of early-stage health technology companies chosen for their innovative technologies and patient impact.
2021 is the sixth year for the Rosenman Innovator selection cycle, which has the goal of identifying promising companies seeking funding from seed stage to Series A. The number of companies applying was a 20% increase over the numbers for 2020, itself a record year.
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The University of Chicago Medicine has announced today that it is now enrolling patients into LymphBridge, a randomized clinical study to evaluate a novel investigational surgical device for the treatment of breast cancer-related lymphedema. This study is sponsored by Fibralign Corporation with funding provided by the National Cancer Institute (NCI) and being led by world-renowned microsurgeon Dr. David W. Chang, Professor of Surgery at UChicago Medicine. Ly
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.
The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and require axillary lymph node dissection (ALND), a common surgical intervention that involves rem
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first product, the BioBridge Collagen Matrix. BioBridge is classified as a Class III device with an indication for use to support lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema.
CE mark is a certification symbol in Europe that signals conformity to patient safety and device performance
Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced today that it has executed a long term distributor agreement with Terumo Corporation to market and distribute the BioBridge® Collagen Matrix in Japan for treating and preventing secondary lymphedema.
BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh made of highly purified collagen and is created with Fibralign’s patented
Fibralign announced today that it has been awarded a Small Business Innovation Research (SBIR) Sequential Phase II (Phase IIS) from the Department of Defense (DoD) Defense Health Program (DHP). This two-year grant provides $996,609 in funding to continue advancing Fibralign’s development of a novel treatment of volumetric muscle loss.
Project Title: Aligned Nanofibrillar Scaffold Activate
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.
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, orth