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Advanced BioHealing Earns Accreditation from the American Association of Tissue Banks

Accreditation affirms Advanced BioHealing’s commitment to patient safety and ethics in the manufacturing and marketing of Dermagraft for treatment of diabetic foot ulcers


Westport, CT – December 9, 2009 – Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, has been awarded accreditation by the American Association of Tissue Banks (AATB). This prestigious accreditation affirms that the Company meets or exceeds AATB standards required for processing, packaging, labeling, storage and distribution of Dermagraft®, a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process in patients with diabetic foot ulcers. AATB accreditation is the latest addition to ABH’s international and domestic certifications and licenses.

“This important accreditation from AATB demonstrates ABH's continued commitment to providing the highest possible quality tissue-based product and services to wound care specialists across the country,” said Shawn M. Schaffer, Ph.D., SM (NRCM), Executive Director of Quality for ABH and its Tissue Bank Director. “We sought AATB accreditation because they are the recognized standard organization for tissue banking. Obtaining AATB accreditation further exhibits our commitment to excellence in providing our customers and their patients with an extraordinary product.”

The AATB, which has been accrediting tissue banks since 1986, has established an Accreditation Program and a set of Standards for Tissue Banking within the United States. AATB accreditation follows an intensive nine-month process, including on-site inspection by an AATB inspector, and assists tissue banks in determining whether methods, procedures, personnel knowledge, equipment and facilities meet established requirements. AATB-accredited organizations are recognized as the leaders in their field and pivotal voices in the dialogue through which consensus-based, voluntary standards are developed and implemented. ABH joins nearly 100 accredited tissue banks internationally that have earned AATB accreditations.

Dermagraft is regulated by the U.S. Food and Drug Administration (FDA) as a medical device containing human cells because it is manufactured from cultured human fibroblast cells derived from newborn foreskin tissue. In accordance with this classification, Dermagraft is manufactured in compliance with 21 CFR Part 820 (Quality Systems Regulation). In addition, ABH complies with all relevant tissue bank regulations as described by the FDA, and the States of California, New York, Maryland and Florida.  In June 2008, ABH also received certification for ISO 13485:2003, a quality-management standard for medical device manufacturing developed by the International Organization for Standardization.

ABH’s AATB accreditation number is 00179.

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.

About Diabetic Foot Ulcers
In 2007, 23.6 million people, or 7.8% of the American population, had diabetes. Referred to as the “epidemic of our time” by the U.S. Centers for Disease Control and Prevention, incidence of diabetes is expected to increase 165% by 2050. The World Health Organization estimates 171 million people have diabetes globally and that number is expected to double by 2030. As a chronic medical condition among many diabetes patients, it is estimated that 15-25% will develop a foot ulcer in their lifetime, putting them at a 14-24% risk for lower limb amputation, and a 45% chance of death within five years if not managed properly. Also generating a significant financial impact, each new incidence of diabetic foot ulcers (DFU) in the U.S. costs nearly $40,000 to treat in the first two years. In the U.S. and Europe combined, DFU incidence is estimated to be between 1.7 to 2.5 million annually. Risk of death from unhealed neuropathic ulcers like DFUs is greater than both breast cancer and prostate cancer combined.

Media Contacts:

  • Lindsey Hart
    • Advanced BioHealing
    • lhart@abh.com
    • Direct: (773) 697-3838
    • Cell: (206) 335-0114
  • Mike Lizun