Fibralign Announces Start of European Lymphedema Prevention Clinical Study

Feb 9, 2021

Multi-site clinical study to evaluate BioBridge®
as prophylactic treatment for at-risk patients

 

UNION CITY, Calif.–(BUSINESS WIRE)–Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema.

The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and require axillary lymph node dissection (ALND), a common surgical intervention that involves removal of compromised lymph nodes to address the spread of cancer. Peer reviewed publications have estimated that 15-25% of patients who undergo ALND develop breast cancer-related lymphedema (BCRL) due to the surgery. ALND combined with radiation therapy increases the likelihood of BCRL further up to 40%.

Led by Dr. Dimitris Dionysiou, Associate Professor in Plastic Surgery at the Aristotle University of Thessaloniki (Greece) and principal investigator, the trial aims to demonstrate the effectiveness of BioBridge as a prophylactic remedy for reducing patient risk in development of lymphedema. This off-the-shelf solution would provide a much-needed treatment that could be utilized as a simple adjunct procedure in support of current cancer interventions, significantly advancing the quality of care for patients.

About Lymphedema

Lymphedema is a serious, global, progressive disease that can develop as a result of cancer treatments. Such interventions, while lifesaving, 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 BioBridge® Collagen Matrix

BioBridge is a sterile, biocompatible and biodegradable surgical mesh that recently received CE mark for use in the surgical support of lymphatic tissue repair. The certification mark confirms that BioBridge meets the requirements of the European Medical Devices Directive, which now allows Fibralign to market the product across the European Union and other CE mark countries. BioBridge is also 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.

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

Link: https://www.businesswire.com/news/home/20210209005103/en/Fibralign-Announces-Start-of-European-Lymphedema-Prevention-Clinical-Study

Contacts

In Europe: Albert Huttenga, ahuttenga@fibralignbio.com +31 651 750 078
Greg King, CEO/President Fibralign Corp. gking@fibralignbio.com, +1 415 902 4721

Fibralign receives ISO 13485:2016 upgrade certification

Fibralign receives ISO 13485:2016 upgrade certification

Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. V. that the Company's management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management...

read more
Fibralign receives ISO 13485:2012 Certification

Fibralign receives ISO 13485:2012 Certification

Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it's management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012. The scope of the certification is for the design, development,...

read more
AngelMD Closes Syndicate Funding Round in Fibralign

AngelMD Closes Syndicate Funding Round in Fibralign

AngelMD,an investment and networking platform connecting innovative medical startups, physicians, investors, and industry partners, today announced that it has completed a Syndicate funding round for Fibralign, Inc. Fibralign produces therapeutic medical devices that...

read more