CANTON, Mass., May 6, 2013 /PRNewswire/ -- Organogenesis Inc., a commercial leader in the field of regenerative medicine, announced today key findings demonstrating the speed and incidence of wound closure for venous leg ulcer (VLU) patients who were treated with Apligraf®. The oral presentation of the abstract, titled "A Retrospective Analysis of a Bilayered Living Cellular Construct and a Porcine Collagen Wound Dressing for the Treatment of Venous Leg Ulcers in a Real World Setting," was presented at the Symposium of Advanced Wound Care Meeting (SAWC Spring) in Denver, Colorado by Nathan Parsons, director of medical affairs, Organogenesis Inc.
These data represent the largest real-world comparative effectiveness analysis conducted with Apligraf.
Apligraf is a living-cell-based product for the treatment of chronic wounds, and is the only product with FDA approval to treat both VLUs and diabetic foot ulcers (DFUs). VLUs affect approximately 2.5 million patients in the U.S., often persisting for months or even years without healing. Apligraf consists of keratinocytes, keratinocyte stem cells, fibroblasts and collagen, which play important roles in wound healing. By delivering these components directly to a wound, Apligraf induces the body to generate the tissue necessary to heal.
This retrospective analysis included data from 1,489 VLU patients who were treated at wound care facilities across the U.S. during a three-year period. The analysis was conducted on treatment records collected from the WoundExpert (Net Health) electronic medical record database.
Patients were either treated with Apligraf (n=1,187 patients with 1,451 VLUs) or a non-interactive collagen wound dressing (n=302, which included 350 VLUs). Baseline demographics and wound characteristics, including size and duration, were similar between groups.
This comparative effectiveness analysis showed that when compared to a non-interactive collagen wound dressing, Apligraf healed more wounds (61% vs. 46% by 36 weeks p=0.01) and healed wounds 44% faster (24 weeks vs. 43 weeks p=0.01). Analysis of all data over the three-year period demonstrated an increased probability of healing by 29% with Apligraf (p=0.01).
"These groundbreaking data demonstrate the real-world effectiveness of Apligraf in the treatment of chronic venous ulcer patients, many of whom have struggled with debilitating, non-healing wounds for extended periods of time," stated Geoff MacKay, president and chief executive officer, Organogenesis Inc. "These comparative effectiveness research data provide key information to inform wound care practitioners on their choice of treatment for venous leg ulcers in their specific clinical practice setting. By delivering living cells to the site of the wound, including components that stimulate the body's natural healing abilities, Apligraf improved the speed of healing and the incidence of wound closure."
In addition to the oral presentation, Organogenesis presented scientific data from its continued research with Apligraf, which is summarized as follows:
- "The Importance of Stem Cells in a Bilayered Living Cellular Construct Used to Heal Chronic Wounds" (M Carlson, et al.) – This study demonstrated the importance of keratinocyte stem cells as a contributor to the presence and production of key cytokines and growth factors in Apligraf, which may influence chronic wound healing outcomes.
- "A Bilayered Living Cellular Construct Responds to TNF-alpha Stimulation with Active Cytokine & Growth Factor Secretion" (A Wojtowicz, et al.) – This in vitro study characterized the cytokine/growth factor response to the inflammatory cytokine tumor necrosis factor-alpha in a chronic wound, and demonstrated that viable cells in Apligraf actively produced cytokines/growth factors in response to TNF-alpha, while a non-interactive collagen wound dressing did not.
- "Healthcare Resource Utilization and Economic Burden of Diabetic Foot Ulcers in Medicare and Privately-insured Populations" (JB Rice, et al.) – This study evaluated the incremental resource utilization and economic burden imposed by DFUs on the healthcare system and payers above that of standard diabetes treatment, and suggests an annual payer burden associated with DFUs of $11-$17 billion.
- "Healthcare Resource Utilization and Economic Burden of Venous Leg Ulcers in Medicare and Privately-insured Populations" (JB Rice, et al.) – This study is the first to assess VLU patient characteristics, resource use and costs using a large, real-world analysis of Medicare and privately-insured patients. The findings suggest an annual payer burden associated with VLUs of $18 billion.
- "The Importance of Two Cell Types in a Bilayered Living Cellular Construct in Response to TNF-alpha Stimulus" (M. Fakharzadeh, et al.) – This study also demonstrated that both the fibroblasts and keratinocytes in Apligraf respond uniquely to TNF-alpha compared to one cell type alone (either fibroblasts or keratinocytes), producing relevant growth factor/cytokines important in wound healing.
Apligraf contains two layers of human living cells: a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix. When placed on a wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix and other proteins and has been demonstrated to promote healing. In controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments alone.
Important Safety Information:
Apligraf is FDA-approved for the treatment of diabetic foot ulcers lasting longer than three weeks, and venous leg ulcers lasting longer than one month, that have not adequately responded to conventional therapy. It contains living cells, proteins produced by the cells, and collagen. Complications may include suspected wound or non-wound infection, skin inflammation, wound drainage, swelling, a skin tear or cut, pain, a new ulcer, red, flaky skin, bone infection, rash, low or high blood sugar, bruising, swelling, worsening ulcer, and dry skin. Apligraf should not be used if your wound is infected or if you are allergic to cow collagen or the agarose shipping medium. For more information, please read the complete prescribing information available at www.Apligraf.com.
About Organogenesis Inc.
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active wound healing and oral regeneration. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit www.organogenesis.com.
SOURCE Organogenesis Inc.