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
2026 World Cup Triggers Corporate Travel Boom in Canada and U.S.3.6.2026 15:00:00 CEST | Press release
Navan data reveals Canadian business bookings have tripled, while U.S. hotel prices spike 30% as global enterprises lock in client entertainment Navan (NASDAQ: NAVN), the global AI-powered business travel and expense management platform, today released year-over-year data revealing global enterprises are leaning in heavily to the upcoming 2026 World Cup, with hotel and flight bookings for business travel to World Cup host cities up 46% to the U.S. and a massive 295% to Canada. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602020779/en/ Navan data reveals Canadian business bookings have tripled, while U.S. hotel prices spike 30% as global enterprises lock in client entertainment “While headlines right now are focusing on softer-than-expected tourism demand and lagging leisure hotel bookings, our corporate data tells a different story,” said Dane Molter, SVP, Navan Group Travel Marketplace. “Companies are embracing the Wor
Onimusha: Way of the Sword Set to Release on September 25, 2026!3.6.2026 15:00:00 CEST | Press release
– A playable demo will be released ahead of the game’s launch – Capcom Co., Ltd. (TOKYO:9697) today announced that Onimusha: Way of the Sword, the latest title in the Onimusha series, is scheduled for release on September 25, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603903549/en/ Onimusha: Way of the Sword key art Onimusha: Way of the Sword, which marks the first new title in the series in over 20 years, is a Japanese-inspired dark fantasy game that features Miyamoto Musashi as the protagonist and is set in an Edo-era Kyoto that has been twisted by malevolent clouds of Malice. Capcom is developing the title with the aim of appealing to a wide range of players through its exhilarating sword-based action and highly-unique characters. Ahead of launch, the company released a playable demo today*, June 3, 2026, titled Onimusha: Way of the Sword DEMO, to give players an opportunity to enjoy the appeal of the game as
Private Markets Firms Face SPV Execution Pressure as LP Demands Rise3.6.2026 14:30:00 CEST | Press release
86% of private markets professionals report rising LP requests for tailored SPV arrangementsTransparency and reporting rank as the top LP priority, cited by 76% of respondents82% report increased demand for single-asset SPVs amid growing liquidity and execution pressures As private markets firms navigate a more challenging fundraising and exit environment, limited partners (LPs) are demanding greater transparency, stronger governance rights, and more flexible SPV arrangements from fund managers. In fact, 86% of private markets professionals report increased LP requests for tailored SPV structures over the past 12 months, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC¹ surveyed 410 senior private markets practitioners across private equity, private credit, real estate, and infrastructure to examine how investor demands are reshaping SPV structures, operating models, and execution requirements. The findings are detail
NetApp and Cisco Accelerate and Secure AI Innovation3.6.2026 14:00:00 CEST | Press release
New FlexPod solutions deliver proven performance, security, and unified management for AI NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, and Cisco (NASDAQ: CSCO) today announced that they have collaborated to offer new validated solutions for secure, scalable, and simplified AI. Expanding the proven success of FlexPod, the new solutions provide a simple, reliable path for enterprises to address the specific challenges AI workloads place on compute, network, and storage infrastructure. “As IT teams are tasked with delivering reliable, consistent performance across environments, AI workloads are placing increasing demands on their data infrastructure,” said Dallas Olson, Chief Commercial Officer at NetApp. “NetApp and Cisco’s longstanding partnership on FlexPod has already proven effective, saving customers up to 20 percent of their time in infrastructure management and maintenance. Now, we are applying our combined expertise to modern challenges to accelerate AI ad
New Evidence Offers Hope for Ketogenic Therapy in Treatment of Anorexia Nervosa3.6.2026 14:00:00 CEST | Press release
Peer-reviewed feasibility pilot trial reports reduced eating disorder and depressive symptoms in difficult-to-treat psychiatric condition A pilot study published today in Communications Medicine demonstrates the potential of a new approach to treating anorexia nervosa — a disorder for which effective treatments have been significantly limited. The research from UC San Diego School of Medicine reports that a ketogenic nutritional intervention — a high-fat, low-carbohydrate, moderate-protein diet — was feasible and safe for patients with weight-normalized and mildly underweight anorexia nervosa. The ketogenic intervention was well-tolerated by participants, with high adherence rates and no significant weight loss observed throughout the program. Furthermore, significant improvements were observed in eating disorder symptoms, with nearly 3 in 4 of study completers in the recovered range at study end, no longer meeting criteria for an anorexia nervosa diagnosis, and all completers experien
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