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
Andersen Global lancerer Andersen in Pakistan16.4.2026 22:57:00 CEST | Pressemeddelelse
Andersen Global fortsætter sin regionale vækst i Sydasien med tilføjelsen af Andersen in Pakistan som det seneste medlemsfirma, der slutter sig til den globale organisation. Efter overgangen til Andersen-brandet tilbyder virksomheden – tidligere kendt som Saafin Global Consulting – en bredt funderet praksis, der betjener kunder på tværs af brancher, herunder fremstillingsindustri, energi, finansielle tjenester, telekommunikation, sundhedsvæsen, fast ejendom og private equity. Med hovedkvarter i Islamabad leverer Andersen in Pakistan integreret support inden for skat, virksomhedsrådgivning og HR-tjenester til nationale og internationale organisationer. "Vores service er forankret i etik, styret af gennemsigtighed og bevist gennem et vedholdende engagement i præcision," udtalte Rashid Ibrahim, ledende partner hos Andersen in Pakistan. "At tage Andersen-brandet til os er en vigtig milepæl for vores firma. Det afspejler vores forpligtelse til at levere praktiske løsninger af høj kvalitet,
BTG Pactual Timberland Investment Group Completes First Close of US$ 370 Million to Newest Core Latin American Timberland Strategy16.4.2026 22:04:00 CEST | Press release
BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland investment managers, announced today that it has completed the first close of US$ 370 million in commitments to its newest core Latin America strategy. Targeting investment of US$ 1.5 billion over 5 years, the strategy focuses on large-scale, sustainably managed, core timberland assets across Chile, Uruguay and Brazil, and seeks diversification across geography, climatic zones, species, and end-markets. BTG Pactual TIG has operated in Latin America for over two decades, and has built and managed a series of scaled timberland platforms through this strategy, including the creation of three platform companies, Lumin, Vista Hermosa, and Plateau, forming part of the firm’s global US$ 7.5 billion portfolio. The formation of Plateau, announced in August 2025, marked the first acquisition under this new strategy. Created in partnership with Klabin S.A. (Klabin) and British Columbia Investment Mana
Multi-Color Corporation Announces Confirmation of Plan of Reorganization16.4.2026 19:55:00 CEST | Press release
Company Expects to Emerge from Prepackaged Chapter 11 in Coming Weeks With Significantly Deleveraged Balance Sheet Including Approximately $3.8 Billion Reduction in Outstanding Funded DebtSignificant New Money Investment Will Establish Strong Liquidity Position to Support Long-Term Growth and Investment Multi-Color Corporation (“MCC” or the “Company”), a global leader in prime label solutions, today announced that the United States Bankruptcy Court for the District of New Jersey (the “Court”) has confirmed the Company’s prepackaged plan of reorganization (the “Plan”). MCC expects to emerge from prepackaged Chapter 11 in the coming weeks. Under the terms of the Plan, MCC will complete a comprehensive restructuring transaction that significantly deleverages the Company’s balance sheet and recapitalizes the business. The restructuring reduces net debt by approximately $3.8 billion, reduces annualized cash interest expense by more than $330 million, and extends long‑term debt maturities to
Visa Opens the Door to AI-Driven Shopping for Businesses Worldwide8.4.2026 18:00:00 CEST | Press release
Part of the Visa Intelligent Commerce portfolio, Intelligent Commerce Connect will enable more ways for agents to pay and merchants to accept agentic transactions in a single integrationCurrently in pilot with select partners including Aldar, AWS, Diddo, Highnote, Mesh, Payabli, Sumvin, and rolling out to more partners this year Visa Inc. (NYSE: V) today unveiled Intelligent Commerce Connect, a new solution that makes it easier for businesses to connect to and participate in AI-powered commerce. Intelligent Commerce Connect acts as a network, protocol, and token vault-agnostic ‘on ramp’ to agentic commerce for agent builders, merchants, and enablers. As consumers increasingly rely on AI agents to make purchases, businesses – whether they are building agents, selling to them, or processing transactions – need a simple way to get started. Intelligent Commerce Connect, part of the Visa Intelligent Commerce portfolio, meets that need. Through a single integration via the Visa Acceptance Pl
Sumitomo Corporation, SMBC Aviation Capital, Apollo and Brookfield Complete the Acquisition of Air Lease Corporation8.4.2026 15:13:00 CEST | Press release
Sumitomo Corporation, SMBC Aviation Capital, Apollo-managed funds (“Apollo”) and Brookfield today announced that they have completed the previously announced acquisition of Air Lease Corporation (“Air Lease”) and have renamed the business Sumisho Air Lease Corporation (“Sumisho Air Lease”). This transformational transaction improves the financial position of the business with long term support and aviation expertise from co-investors Sumitomo Corporation, SMBC Aviation Capital, Apollo and Brookfield. Sumisho Air Lease’s strong foundation as an established aircraft lessor, supported by SMBC Aviation Capital’s industry‑leading capabilities as servicer, creates a platform with the scale and financial strength needed to meet the fast‑changing and increasingly complex requirements of airline customers. Sumisho Air Lease will also benefit from the deep expertise and long-standing commitment that both Sumitomo Corporation and SMBC Aviation Capital bring to the global aviation leasing sector.
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