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
Haleon Invests in India to Deliver Better Everyday Health to Rural Communities8.6.2026 11:11:00 CEST | Press release
£175m for first Haleon manufacturing site in Madhya Pradesh, central IndiaFast-growing India key to Haleon reaching one billion more consumers by 2030India’s consumer health market to reach over £23bn by 20301Accelerated rural distribution to access 3 million outletsAffordable Sensodyne packs and investment to double ‘last-mile’ reach in rural areas Haleon, a consumer company that is solely focused on better everyday health, today announces plans to expand its business in India, one of its fastest-growing markets and key to Haleon delivering its strategy and ambitions to reach one billion more consumers by 2030. Haleon will invest approximately £175 million2 in building a new oral health manufacturing site in Madhya Pradesh, central India and accelerate distribution efforts in rural India to meet rising demand. The new site will also support supply for wider Asia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608753094/e
Diabetology’s Breakthrough Clinical Data From Oraglutide™ Oral GLP-18.6.2026 10:56:00 CEST | Press release
Oraglutide™ Once Weekly, Low Dose, Low side-effect, Oral GLP-1 Glucose and Insulin Response Over 6 days: Clinical Data Posted at World ADA Diabetes & Obesity Conference Diabetology Limited (Jersey) poster presentation (https://diabetology.co.uk/ada-poster) 1724-P at the ADA 86th Scientific Session, New Orleans, reporting first human data from Oraglutide™ — small capsule intestinally-released oral semaglutide, formulated using the proprietary Axcess™ delivery technology. KEY HIGHLIGHTS 6-day glucose control: A single 4 mg oral dose of Oraglutide™ produced a sustained fall in glucose. Measuring 14% at Day 6 (p=.046), the longest duration presented from a single oral GLP-1 dose in a human IVGTT study. 28% increase in insulin secretion: Relative to placebo, insulin percent AUC increased by 12% day 0, (p=0.02) & 28% Day 1 (p = 0.025). Novel intestinal depot effect: Blood levels of semaglutide were higher on Day 1 than dosing on Day 0, consistent with lipid associated depot effect in the int
Reply at VivaTech 2026: Making AI, Agents and Robotics Happen Across the Enterprise8.6.2026 10:00:00 CEST | Press release
Reply[EXM, STAR: REY] is taking part in VivaTech 2026, Europe's largest innovation and technology event, held from June 17 to 20 at Paris Expo Porte de Versailles. At the event, Reply will showcase its latest innovations around AI for software engineering, AI-powered experiences, data and AI, and industrial AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608667672/en/ At VivaTech 2026 Reply will showcase its latest innovations around AI for software engineering, AI-powered experiences, data and AI, and industrial AI. Industries are being reshaped by AI, autonomous agents, robotics and new digital experiences. From strategy to execution, Reply helps companies move beyond experimentation and innovative ideas into concrete business value. Visitors can meet Reply in Hall 7.1, booth 1G12, and explore how, through real use cases, scalable solutions and live demonstrations, the group makes innovation happen. This year, Reply'
Cardiolife Partners with Bhutan Ministry of Health to Strengthen Nationwide Cardiac Care8.6.2026 10:00:00 CEST | Press release
Cardiolife is proud to partner with the Ministry of Health of Bhutan to roll out its advanced AI-powered ECG diagnostics system nationwide. The collaboration will provide access to early ECG diagnosis and prevention, marking a major step forward in the country’s effort to strengthen heart health and preventive care. Bhutan has a population of just over 700,000 people and heart failure and other cardiac conditionsare among the leading causes of death. Following constructive meetings in Thimphu, His Excellency, the Health Minister, officially endorsed the national rollout of Cardiolife’s solution and expressed appreciation for Cardiolife’s commitment to advancing cardiac care through the provision of free software and ECG equipment in Bhutan. “We are grateful to the Cardiolife team for their commitment to improving heart health in Bhutan. With cardiovascular diseases on the rise, this collaboration marks an important milestone in our journey to strengthen early detection and prevention a
Cegid Closes Acquisition of Shine to Create Europe's First Complete AI-Driven Platform for SMBs and Accountants8.6.2026 09:28:00 CEST | Press release
Accelerates Cegid’s trajectory to become the leading European financial solutions hub integrating e-invoicing, accounting, digital finance, payment services and accounts, and HR solutionsTransaction supported by new €1.1 billion debt financing facility secured from leading direct credit funds, underscoring Cegid’s strong business performance and unique leadership positioning in rapidly evolving software sector Cegid, a European leader in cloud management solutions for professionals in the finance (treasury, tax, ERP), human resources (payroll, talent management), accountancy, retail and entrepreneurship sectors, today announced the completion of its acquisition of Shine. The transaction creates the first fully integrated, cloud-native and AI-driven financial hub for SMBs and accounting professionals in Europe. Shine – a fast-growing European fintech unicorn providing electronic invoicing, accounting, business accounts, and payroll software to small and medium-sized businesses across Eu
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