CA-FIBRALIGN
14.9.2020 20:25:12 CEST | Business Wire | Press release
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 standards applicable in the region. The certification mark confirms that BioBridge meets the requirements of the European Medical Devices Directive , which now allows Fibralign to market BioBridge across the European Union and other CE mark countries.
Fibralign also received an updated ISO 13485:2016 certification of its quality management system. This certification demonstrates the company's focus on quality and its ability to meet the global International Standards Organization (ISO) requirements and standards for the design, manufacture and distribution of medical devices.
About BioBridge Collagen Matrix
BioBridge is a sterile, biocompatible and biodegradable surgical mesh made of highly purified collagen and is created with Fibralign’s patented Nanoweave® 3D scaffolding technology. This novel medical device is commercially available in the US and has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and repair soft tissue. Published preclinical studies and early clinical usage have shown that BioBridge supports the repair of damaged lymphatic vessels that causes lymphedema. BioBridge has not been approved in the US by the FDA for treating lymphedema.
About Lymphedema
Lymphedema is a serious, global, progressive disease that can develop as a result of cancer treatments. Such interventions, while life-saving, can also destroy enough lymphatic function that the cancer survivor is left with a condition in the affected limb that includes painful swelling and frequent infections. Lymphedema can ultimately lead to irreversible structural changes in the tissues, which can result in severe deformity, serious reduction in function and have a profound impact on quality-of-life. Existing treatments for lymphedema are limited and not curative.
About Fibralign Corporation
Fibralign Corporation is a commercial stage healthcare company that develops and manufactures advanced therapeutic biomedical devices designed to address significant unmet medical needs by utilizing its patented Nanoweave® 3D scaffolding technology. http://www.fibralignbio.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005790/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Imagine Dragons to Perform at Abu Dhabi Grand Prix21.5.2026 17:51:00 CEST | Press release
Ethara, organiser of the Formula 1 Etihad Airways Abu Dhabi Grand Prix, have announced that one of the world’s biggest bands, Imagine Dragons, will headline the Saturday After-Race Concerts at the F1 Season Finale in Abu Dhabi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521214839/en/ Imagine Dragons to perform at Formula 1 Etihad Airways Abu Dhabi Grand Prix (Photo: AETOSWire) The announcement is another landmark moment for the Abu Dhabi Grand Prix, whose thrilling Yasalam presented by e& fan entertainment offering has become synonymous with the F1 Championship finale in Abu Dhabi and is recognised as one of the most compelling sports and entertainment crossovers globally. The global chart-toppers join Lewis Capaldi and Zara Larsson, who are set to kick off a blockbuster line-up of performances on Yas Island on Thursday, 3 December, with more major international artists to be revealed. With their popular top hits, Ima
Carnegie Mellon University and Cleveland Clinic Develop AI System to Interpret Cardiac MRI Scans with Enhanced Accuracy21.5.2026 14:05:00 CEST | Press release
Trained on more than 13,000 patient studies, novel system significantly outperforms existing models by up to 35% A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s Cardiovascular Innovation Research Center, has developed an artificial intelligence (AI) system capable of interpreting some of the most complex heart scans in medicine, cardiac magnetic resonance imaging (MRI), without the need for manually labeled training data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521762286/en/ A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s Cardiovascular Innovation Research Center, has developed an artificial intelligence (AI) system capable of interpreting some of the most complex heart scans in medicine, cardiac magnetic resonance imaging (MRI), without the need for manually labeled training data. The novel system, called CMR-CLIP, is d
Otovo Hits 30,000 Customers in Under a Year, Tackling the Growing ‘Solar Service Crisis’21.5.2026 14:00:00 CEST | Press release
A growing wave of unsupported solar systems and rising electricity prices are creating strong demand for Otovo’s energy service platform Otovo ASA (“Otovo”), a leading global energy service provider for residential and commercial customers, today announced it has reached 30,000 customers across the U.S. and Europe. A total of 20,000 customers have enrolled in Otovo Care, the Company’s membership-based home and commercial energy service, which is powered by Otovo’s industry-leading AI platform, Endurance™. “Reaching 30,000 customers in less than year is proof positive that home and business owners value their power systems,” said William J. (John) Berger, CEO of Otovo. “The ‘solar service crisis’ that is leaving millions of orphaned energy systems without support is driving strong interest in our Otovo Care membership program. Every day your home or commercial power system is not working, you are throwing money away. Otovo’s rapid response service platform keeps you up and running, ensu
The Live Moment Effect: Genius Sports and MediaScience Study Finds Specific Moments in Live Sports Can Double Unaided Brand Recall21.5.2026 14:00:00 CEST | Press release
New research shows that brands aligned with emotionally heightened moments in live sports can improve ad effectiveness Genius Sports Limited (NYSE: GENI), a global leader in real-time sports data, today released new biometric research conducted with MediaScience showing that ads delivered immediately after emotionally heightened moments in live sports can double unaided brand recall. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521475265/en/ The Live Moment Effect report from Genius Sports and MediaScience. The study, The Live Moment Effect, finds that advertising effectiveness is significantly influenced by a viewer’s emotional state immediately before an ad is shown. In controlled biometric testing, ads shown after high-intensity sporting moments, such as near-scoring plays or crucial momentum shifts, delivered approximately double the unaided brand recall of baseline conditions. The Moment Before the Ad Matters The r
Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer21.5.2026 14:00:00 CEST | Press release
Precemtabart tocentecan (Precem-TcT) is investigated as a potential first-in-class anti-CEACAM5 ADC, for the treatment of metastatic CRC (mCRC) CEACAM5 is overexpressed in the majority of colorectal tumors (~90%), and requires no patient selection Significant unmet need remains for clinically meaningful innovation in colorectal cancer (CRC), the second leading cause of cancer death worldwide Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced that the first patient has been dosed in the Phase 3 PROCEADE®-CRC-03 trial (NCT07549412). The study is evaluating precemtabart tocentecan (Precem‑TcT), a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer (mCRC). “Leveraging our novel payload‑linker technology, Precem‑TcT is the first CEACAM5‑targeted ADC in clinical studies with an exatecan payload, rationally designed for stability and enhanced cancer
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom