UChicago Medicine Enrolling Patients in Lymphbridge™ Clinical Study For Surgical Treatment Of Breast Cancer-Related Lymphedema

Apr 15, 2021

NCI-funded study evaluating Fibralign’s BioBridge® as an adjunct to microsurgical treatment

 

April 14, 2021 – The University of Chicago Medicine has announced today that it is now enrolling patients into LymphBridge™, a randomized clinical study to evaluate a novel investigational surgical device for the treatment of breast cancer-related lymphedema. This study is sponsored by Fibralign Corporation with funding provided by the National Cancer Institute (NCI) and being led by world-renowned microsurgeon Dr. David W. Chang, Professor of Surgery at UChicago Medicine.

LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema is an FDA approved clinical study that will assess Fibralign’s BioBridge® Collagen Matrix for use in improving outcomes of surgical treatment of lymphedema. BioBridge is a sterile, biocompatible and biodegradable device made of medical-grade collagen that has 510(k) clearance from the FDA for use as a surgical mesh to reinforce and support soft tissue repair. In this study BioBridge will be implanted as part of the lymph node transplant surgery to support repair of damaged lymphatic tissue.

The study plans to enroll 60 patients that have been diagnosed with upper extremity lymphedema resulting from breast cancer intervention. Participants will be randomized between the investigational BioBridge treatment group and a surgical control group that will receive standard lymph node transfer surgery.

UChicago Medicine is designated a Comprehensive Center of Excellence by the Lymphatic Education & Research Network (LE&RN), one of a select few centers in the United States to achieve this honor. This important distinction signifies that UChicago Medicine sets the standard for best practice multidisciplinary care in the treatment of lymphatic diseases. Institutions designated as a Center of Excellence have been evaluated by international leaders in an extensive review process. Dr. Chang leads this effort at UChicago Medicine and has an international reputation as a pioneer and an innovator in reconstructive surgery and microsurgical treatment of lymphedema. His work in this field was instrumental in introducing lymphaticovenular bypass and lymph node transfer to U.S. operating rooms.

For more information about enrolling in LymphBridge please visit: https://www.uchicagomedicine.org/find-a-clinical-trial or email surgerytrials@bsd.uchicago.edu

Additional information can also be found at: https://clinicaltrials.gov/ct2/show/NCT04606030

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 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. https://www.fibralignbio.com

Contact:
Enrollment: Farah Ahmed, research coordinator: surgerytrials@bsd.uchicago.edu

Fibralign: Greg King, gking@fibralignbio.com, tel: 415 902 4721

 

Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign announced today that it has been awarded a Small Business Innovation Research (SBIR) Sequential Phase II (Phase IIS) from the Department of Defense (DoD) Defense Health Program (DHP). This two-year grant provides $996,609 in funding to continue advancing...

read more
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