Fibralign Announces Enrollment Initiated for Stanford-Led Clinical Trial for Breast Cancer-Related Lymphedema

Study to evaluate BioBridge™ use in surgical management of secondary
lymphedema

UNION CITY, Calif.–(BUSINESS WIRE)–Fibralign Corporation
announced that Stanford University has started enrollment in its
investigator-led clinical study to evaluate the efficacy of a new
surgical device for treating secondary lymphedema.

The trial will evaluate the effectiveness of Fibralign’s BioBridge™
Collagen Matrix in supporting and guiding lymphatic repair in patients
with acquired lymphedema of upper and lower extremities. Stanford plans
to enroll at least 36 patients into the study, which will utilize
BioBridge as an adjunctive interventional device for vascularized lymph
node transfer (VLNT) surgery. VLNT is an increasingly practiced
micro-surgical procedure for patients with lymphedema, in which an
auxiliary lymph node is autologously transplanted as a tissue flap to
the treatment area.

BioBridge Collagen Matrix

BioBridge is a sterile implantable biocompatible and biodegradable
surgical mesh that has 510(k) clearance from the FDA for use in surgery
to reinforce and repair soft tissue where weakness and deficiencies
exist. The device is not cleared for the treatment of lymphedema. This
novel medical device is made of highly purified collagen and is created
with Fibralign’s patented Nanoweave™ technology. In
a recently published preclinical study
performed at Stanford
University, BioBridge was shown to support and promote the formation of
new lymphatic vessels (lymphangiogenesis) by encouraging endothelial
cell attachment, alignment and migration, which are prerequisites for
new lymphatic vessel formation.

“Based on results from our published successful large animal study, the
research suggests that BioBridge has the potential to facilitate a truly
successful surgical intervention that may restore lymphatic function,
reduce swelling, and dramatically improve the patient’s quality of
life,” said Stanley G. Rockson, MD, the study’s lead investigator. Dr.
Rockson is Professor of Cardiovascular Medicine at Stanford University
and Director of the Stanford Center for Lymphatic and Venous Disorders.

More information about this study and enrollment can be found at www.ClinicalTrials.gov
(Identifier NCT02734979: “Prospective Evaluation of the
BioBridge Scaffold as an Adjunct to Lymph Node Transfer for Upper
Extremity Lymphedema”
).

“First in Woman” Study Presented at NLN Conference

Later this week Fibralign will report preliminary results in a separate
and ongoing pilot clinical study evaluating a new surgical procedure
using BioBridge for treating patients with breast cancer related
lymphedema. This study was initiated in October, 2015 and is being
conducted in cooperation with Instituto Oncológico Dr. Heriberto Pieter
(IOHP), the largest cancer hospital in the Dominican Republic.
Preliminary findings from this study are being presented at the National
Lymphedema Network (NLN) International Conference
being held in
Dallas, Texas on September 1-3, 2016.

“We continue to be impressed and encouraged by the progress that
Fibralign has been making toward providing new treatments for lymphedema
since the NLN first recognized the Fibralign with its 2014 Best New
Innovator Award,” said Patricia Egan, CEO of the National Lymphedema
Network (NLN). “In addition, as a lymphedema patient, I am grateful for
Stanford’s research efforts and their collaboration with companies like
Fibralign in developing new technologies to enable more treatment
options.”

About Secondary Lymphedema

Acquired [secondary] lymphedema is a serious, global, progressive
disease that can develop as a result of cancer treatments. Such
interventions, while life-saving, sometimes destroy enough lymphatic
function that the cancer survivor is left with a condition in the
affected limb that includes painful swelling, frequent infections that
can be life-threatening and, ultimately, irreversible structural changes
in the tissues, which can result in severe deformity, and serious
reduction in function and quality-of-life. Current treatments for
lymphedema are limited, and there is no cure.

About Fibralign

Fibralign Corporation produces advanced therapeutic medical devices that
utilize its patented Nanoweave™ 3D scaffolding technology to meet major
unmet medical needs. http://www.fibralignbio.com

Contacts

Fibralign
Greg King, +1-415-902-4721
gking@fibralignbio.com