Advanced BioHealing Enrolls First Patient In Celaderm(TM) Pilot Venous Leg Ulcer Clinical Trial

Advanced BioHealing, Inc. (ABH)
announced today that it has enrolled the first patient in its initial
Celaderm(TM) pilot study. The study, whose primary purpose is to evaluate
the safety of Celaderm in humans, will also assess the potential for
Celaderm to accelerate healing of venous leg ulcers compared with optimal
standard therapy. The study is designed to enroll 55 patients who will be
evaluated throughout a 12-week healing period and then be observed for an
additional three months to assess the safety of the product. Separately,
ABH announced that it has requested permission from the U.S. Food and Drug
Administration (FDA) to add two more clinical sites to facilitate
enrollment, bringing the number of clinical sites to eight.


"We are very pleased to officially begin evaluating the safety of
Celaderm, our next-generation bioengineered tissue product, in humans,"
said David Eisenbud, M.D., Executive Vice President and Chief Medical
Officers of Advanced BioHealing. "This marks the first clinical trial with
our own internally-developed product, allowing us to expand on our existing
product portfolio that currently includes two FDA approved wound healing
products. Celaderm utilizes a proprietary cryopreservation technology which
we believe will provide doctors and patients with advancement over earlier
bioengineered products."



"When first-generation bioengineered tissue products were introduced,
physicians who treat wounds were provided a tremendous option that changed
our approach to wound care," said William Marston, MD, Associate Professor
of Surgery, Division of Vascular Surgery at the University of North
Carolina at Chapel Hill. "As an investigator in the Celaderm study, I am
thrilled to test this next-generation product that could significantly
expand the market for advanced wound therapy by being both highly effective
and immediately available at the point-of-care."



Success in this clinical study would allow Celaderm, which is regulated
as a medical device, to move directly into a pivotal trial of clinical
efficacy and this would culminate in a subsequent PreMarket Approval (PMA)
submission. If approved for sale, Celaderm would complement ABH's current
portfolio of approved products: Dermagraft(R) (Dermagraft,) which
is approved for diabetic foot ulcers and TransCyte(R) for the treatment of
full and partial- thickness burns.



About Advanced BioHealing, Inc.



Advanced BioHealing is a leader in regenerative medicine. The company
is focused on the development and marketing of cell-based and
tissue-engineered products. Privately held, ABH has two approved products:
Dermagraft and TransCyte. The company's development pipeline also includes
a next-generation bioengineered wound therapy for which two Investigational
Device Exemption (IDE) exemptions have been approved by the FDA. The
company's manufacturing and corporate offices are located in La Jolla, CA
with research and development offices in New York, NY.



For more information visit AdvancedBioHealing.


Advanced BioHealing, Inc.

AdvancedBioHealing