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
Lenovo Brings Production-Scale AI to Hannover Messe 2026, Delivering Up to 85% Faster Lead Times for Manufacturers21.4.2026 09:00:00 CEST | Press release
With 94% of manufacturers increasing AI investment in 2026, Lenovo enables the shift from pilot to production with solutions already delivering measurable gains in cost, quality, and operational performance Manufacturers are under increasing pressure to improve efficiency, resilience, and responsiveness in the face of ongoing supply chain volatility and rising operational complexity. In this environment, AI is no longer a future ambition but an operational necessity. With 94% planning to increase AI investment in 20261 and an expected $2.86 return for every dollar spent2, the priority has shifted from experimentation to execution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421992136/en/ ThinkStation PGX and Lenovo ThinkEdge Solution 2 At Hannover Messe 2026, Lenovo in partnership with NVIDIA are demonstrating how manufacturers can close that gap by deploying AI solutions already proven at scale across its own global o
Barnes Molding Solutions Becomes SPECTRIX21.4.2026 07:00:00 CEST | Press release
Barnes Molding Solutions is now SPECTRIX. The new Brand offers the full Spectrum of injection molding capabilities delivered by its leading brands - Männer, Foboha, Synventive, Priamus, Thermoplay, and Gammaflux. The change, announced at Chinaplas 2026, reflects the integration of core technologies within a single organization: part design, material science, hot runner and mold technology, sensors & controls and injection molding. Day-to-day operations remain unchanged, including contacts, contracts, and processes. Focused on global growth Under President Marcello Vendemiati, SPECTRIX is strengthening its global market focus and expanding its footprint. This strategy is already visible with the opening of a new manufacturing facility in Pune, India. Another production site near Detroit, USA, is set to open soon. The name SPECTRIX combines “spectrum” and “plastics,” while reflecting the company’s core strengths: expertise, experience, and excellence. Its tagline, “Enduring Advantage, En
Bringg Welcomes Chris Conway as Senior Vice President and General Manager, EMEA21.4.2026 07:00:00 CEST | Press release
Conway, who scaled one of the UK’s largest delivery operations as a Bringg customer, joins to lead the company’s European expansion Bringg, the last-mile performance leader, today announced Chris Conway's appointment as Senior Vice President and General Manager, EMEA. Conway will lead Bringg's commercial strategy, customer relationships, and go-to-market operations across the region. Conway brings more than 20 years of experience in eCommerce, digital commerce, and operational transformation at three of the UK's largest grocery retailers. Most recently, he served as Managing Director of Quick Commerce and Food Operating Board Member at Co-op, where he built and scaled a £500 million-plus q-commerce operation delivering from nearly 2,000 stores. He also founded Peckish, a rapid delivery app that gave independent retailers access to q-commerce technology. He also led Asda's online grocery business to more than £1 billion in revenue and 20% market share, and ran the online commercial team
Edge Home Finance Announces Strategic Investment from Presidio Investors and Promotion of Tom Ahles to President21.4.2026 06:06:00 CEST | Press release
Edge Home Finance today announced a strategic investment from Presidio Investors (“Presidio”), marking a major milestone in the company’s continued expansion and leadership within the mortgage broker channel. As part of this transaction, Tom Ahles has been promoted to President of Edge Home Finance, reinforcing the company’s commitment to strong leadership as it enters its next phase of growth. The investment from Presidio represents a powerful alignment focused on accelerating Edge’s momentum through enhanced investment in technology, operational infrastructure, and strategic acquisitions. Presidio brings a track record of partnering with high-growth companies and scaling them through disciplined capital deployment and operational expertise. “This strategic investment is a direct reflection of the strength of our platform and the momentum we’ve built,” said Tom Ahles, President of Edge Home Finance. “With Presidio’s backing, we are positioned to move faster, invest more aggressively i
JPMorganChase Expands Security and Resiliency Initiative Across Europe21.4.2026 06:00:00 CEST | Press release
Broader geographic focus builds on momentum in the U.S. and reinforces commitment to strengthening critical supply chains, economic resilience and shared security across trading partners JPMorganChase today announced the expansion of its $1.5 trillion, 10-year Security and Resiliency Initiative (SRI) — which seeks to facilitate, finance and invest in industries vital to economic security — across Europe. Building on the initiative’s momentum in the U.S. and previously announced intention to expand to the U.K., the announcement underscores JPMorganChase’s commitment to strengthening supply chains and supporting industries critical to innovation and growth. “The national and economic security of countries depends on strong, resilient and reliable supply chains, and robust critical industries,” said Jamie Dimon, Chairman and CEO of JPMorganChase. “For too long, the U.S. and Europe have relied on unpredictable sources for things like critical minerals that are essential to collective secur
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