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

Westport, CT – November 17, 2009 – Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that it has initiated a pivotal trial of Dermagraft® 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®
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.

Media Contacts:

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

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.