Advanced BioHealing Initiates Largest Prospective Clinical Trial for Venous Leg Ulcers Planned to Date

WESTPORT, Conn., Nov 17, 2009 (BUSINESS WIRE) --
SFE | Quote | Chart | News | PowerRating -- Advanced
BioHealing, Inc. (ABH), a leader in commercializing the promise of
regenerative medicine, announced that it has initiated a pivotal trial
of Dermagraft(R)
in subjects with venous leg ulcers (DEVO-Trial) to assess the product's
safety and efficacy in the promotion of healing venous leg ulcers
(VLUs). Dermagraft is a bio-engineered skin substitute that assists in
restoring damaged tissue and supports the body's natural healing
process. It is FDA-approved for the treatment of diabetic foot ulcers
(DFUs) and used in over 1,000 wound care and outpatient clinics in the
U.S.

"We are very eager to begin evaluating the efficacy of Dermagraft in the
treatment of VLUs," said Jan
Lessem, M.D., Ph.D., Vice President and Chief Medical Officer of
ABH. "Dermagraft has been applied over 150,000 times to speed the
healing process in DFUs. The success of this pivotal trial will mean
adding an additional indication for Dermagraft and furthering our
customers' ability to use regenerative medicine to help heal their
patients."

The international pivotal trial will enroll more than 400 patients in
eight countries, making it the largest randomized, controlled clinical
study on a skin graft and/or bioengineered skin replacement planned to
date.(1) It is designed as a prospective, multicenter,
randomized, controlled clinical study, in which subjects are assigned
into one of two groups. The experimental group receives weekly
applications of Dermagraft and four-layer compression dressings while
the active comparator group receives weekly applications of four-layer
compression dressings only.

The Company has initiated patient enrollment and activated 30 clinical
centers globally. ABH expects to complete the study in May 2011.
Principal investigators for the study are:

--
William Marston, MD, Associate Professor of Surgery, Division of
Vascular Surgery at the University of North Carolina at Chapel Hill

--
Keith Harding, MD, Professor, Department of Wound Healing at the
Cardiff University School of Medicine in Wales, UK

--
David Bergqvist, MD, Ph.D., Department of Surgery at the Uppsala
University Hospital in Sweden

"I am excited to be involved in testing the efficacy and safety of
Dermagraft to improve the healing of venous leg ulcers," said lead U.S.
investigator, William Marston, MD, Professor of Surgery and Chief of the
Division of Vascular Surgery at the University of North Carolina at
Chapel Hill. "As a vascular surgeon, I see a significant number of lower
extremity chronic wounds that either do not heal or heal too slowly,
often leading to increased risk of amputation, increased patient
morbidity and greater cost to the patient and health care system. Based
on the proven clinical efficacy of Dermagraft in improving the healing
of chronic DFUs, Dermagraft may be well suited for additional
indications, including treatment of VLUs."(2)

VLUs are the most common type of chronic wound with an incidence of 2.5
million each year in the U.S. alone. They occur in about 70% of leg
ulcer cases and develop in about 2 out of 1,000 people as a result of
vascular insufficiency. When leg veins do not properly return blood back
to the heart, as is the case in people with chronic venous disease, it
causes blood to travel in the wrong direction (venous reflux) and pool
within the veins. The blood may then leak out of the vein and into the
surrounding tissue, ultimately leading to a breakdown of tissue and the
onset of an ulcer, typically on the sides of the lower leg between the
calf and ankle.

VLUs are usually very slow to heal and limited treatments are available.
Conventional therapy can be costly and inefficient, with VLUs that heal
with current available therapies likely to recur within five years.
Current standard therapy, including elevation of the leg and compression
bandaging, does not efficiently support new skin growth to fully close
deep venous ulcers in all patients. The healing process may require an
advanced therapy, like Dermagraft, to promote a healthy viable ulcer bed
for supporting and stimulating the growth of new tissue. Based on the
proven clinical efficacy of Dermagraft to heal chronic DFUs, the Company
believes that Dermagraft will support the growth of new tissue in VLU
wound beds, resulting in full wound closure.

For more information or to track the progress of the study, please visit clinicaltrials.gov.

About Advanced BioHealing, Inc.

Advanced
BioHealing develops and commercializes living cell technologies that
repair damaged human tissue and enable the body to heal itself. A
privately held company with more than 200 employees, Advanced BioHealing
maintains corporate offices in Westport, CT and a 70,000 sq. ft.
manufacturing facility in La Jolla, CA. To meet Advanced BioHealing's
executives and learn more about the Company, please visit the Company's
web site at www.ABH.com.

About Dermagraft(R)

Dermagraft is a bio-engineered skin substitute that assists in restoring
damaged tissue and supports the body's natural healing process. It is
currently FDA approved to treat diabetic foot ulcers and is the focus of
an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to
assess the product's safety and efficacy in the promotion of healing
VLUs. More than 150,000 applications of Dermagraft have been
administered in over 1,000 wound care centers and outpatient clinics
nationwide. For videos of Dermagraft in action, case studies, research
and more, visit www.Dermagraft.com.

References:

1. Jones JE, Nelson EA. Skin grafting for venous leg ulcers. Cochrane
Database of Systematic Reviews 2007, Issue 2. Art. No.: CD001737.
DOI: 10.1002/14651858.CD001737.pub3.

2. Marston WA, Hanft J, Norwood P, Pollak R, for the Dermagraft Diabetic
Foot Ulcer Study Group. The efficacy and safety of Dermagraft in
improving the healing of chronic diabetic foot ulcers. Diabetes Care.
2003;26:1701-1705.

SOURCE: Advanced BioHealing, Inc.

Advanced BioHealing 
Lindsey Hart, 773-697-3838 
Cell: 206-335-0114 
lhart@abh.com 
or 
Gregory FCA 
Kristy DelMuto, 610-228-2118 
Cell: 484-686-4775 
Kristy@GregoryFCA.com

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