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
Boomi and Guru Partner to Deliver AI-Powered Enterprise Knowledge Enriched by Real-Time Data Activation14.5.2026 16:30:00 CEST | Press release
Guru becomes a launch partner for Boomi Connect, integrating with Boomi’s managed connector service and MCP Registry to transform fragmented enterprise data into governed, actionable intelligence for AI agents Boomi, the data activation company for AI, and Guru, the AI-powered enterprise knowledge platform, today announced a technology partnership to help organizations unlock the full value of their enterprise data for AI-driven decision-making. Unveiled at Boomi World 2026, the partnership makes Guru a launch partner for Boomi Connect, Boomi’s new managed connector service, and integrates Guru’s knowledge agents with Agentstudio and the Boomi MCP Registry to deliver richer, more accurate, and more actionable insights to knowledge workers and AI agents alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514440755/en/ Guru was selected as a Boomi Connect launch partner because its AI-powered knowledge platform represents
IQM and Real Asset Acquisition Corp. Announce Public Filing of Form F-4 Registration Statement with the SEC14.5.2026 15:55:00 CEST | Press release
This filing marks an important milestone in the transaction, moving IQM closer to becoming the first European quantum computing company to go public. Global commercial leader with 23 systems sold to customers to date – including 4 out of the top 10 supercomputing centres and increasing adoption by enterprise customers. Industrial leader with 15 systems delivered (largest number publicly disclosed by selected quantum companies1), 30+ computers built, own chip factory, assembly line and quantum data centre. The transaction values IQM at a pre-money equity valuation of approximately USD 1.8 billion. With the close of this transaction, IQM’s cash position is expected to be up to EUR 397 million (USD 465 million).2 Significant business momentum, with 2025 revenue of USD 36 million3 or over EUR 31 million. IQM intends to apply for its shares to be admitted to trading on Nasdaq Helsinki following the Business Combination. IQM Finland Oy, a global leader in full-stack superconducting quantum c
MOBX to Acquire U.S. Defense Rare Earth, Critical Minerals Company14.5.2026 15:40:00 CEST | Press release
Mobix Labs (Nasdaq: MOBX) today announced a non-binding Letter of Intent to acquire Special Project Delivery LLC ("SPD"), a U.S. company building sovereign supply chains for rare earth elements, critical minerals, and energy storage. The proposed acquisition would extend Mobix Labs' national security work — already supplying U.S. and allied fighter jets, missiles, submarines, and satellites — directly into one of the world's most strategically important industrial sectors. MOBX is moving directly into the supply chain powering modern defense, aerospace, and AI infrastructure. Forward-Looking Statements This press release contains forward-looking statements regarding the proposed acquisition of Special Project Delivery LLC ("SPD"), which are subject to risks and uncertainties described in Mobix Labs' SEC filings and similar provisions under applicable non-U.S. securities laws. The Letter of Intent is non-binding, and there can be no assurance that a definitive agreement will be executed
Flick Raises $6M Seed Round to Redefine How AI Films Are Created14.5.2026 15:19:00 CEST | Press release
Backed by True Ventures, GV (Google Ventures), and Y Combinator, Founded by Award-Winning Filmmaker Zoey Zhang and Instagram Stories Founding Engineer Ray Wang Flick (flick.art), an AI-native filmmaking platform founded by award-winning filmmaker Zoey Zhang and founding Instagram engineer Ray Wang, today announced it has raised $6 million in a seed round from True Ventures, GV (Google Ventures), Y Combinator, Lightspeed, Formosa Capital, Pioneer Fund, Olive Tree Capital, and N1 in addition to angel investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514408256/en/ Flick was built around a simple belief: AI should enhance filmmaking, not replace it. Instead of another one-click video generator, Flick gives filmmakers cinematic control through an AI-native creative workflow designed for storytelling, iteration, and artistic direction. Flick will use the seed funding to accelerate product development, expand its core cr
PIF Named as Official Tournament Supporter of FIFA World Cup 2026™14.5.2026 15:08:00 CEST | Press release
PIF strengthens partnership with FIFA at FIFA World Cup 2026™ as Official Tournament Supporter, incorporating PIF companies, Savvy Games Group and Qiddiya City Announcement builds on successful FIFA Club World Cup 2025™ partnership and reflects PIF’s and FIFA’s shared commitment to driving growth and engagement in football Partnership reinforces PIF’s ongoing commitment to sport as priority sector PIF and FIFA has announced PIF as an Official Tournament Supporter in North America and Asia of the FIFA World Cup 2026™. The partnership reflects a shared commitment to expanding the growth of football at every level, from the grassroots to elite competition, as well as enabling greater participation in sport by unlocking new opportunities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514974404/en/ 14 May, 2026: Front row (L-R), Romy Gai, Chief Business Officer, FIFA and Kevin Foster, Managing Director and Head of Corporate A
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