Press & Announcements
Landmark New Data: Apligraf® Closes Significantly More Diabetic Foot Ulcers in Half the Time When Compared to Epifix
CANTON, MASS. (June 22, 2015) – A new real-world comparative effectiveness analysis, published online this week in the peer-reviewed journal Wound Repair & Regeneration, reported that Apligraf® has demonstrated improved outcomes over Epifix by a wide margin. The large-scale analysis, the first of its kind, examined healing rates of patients with diabetic foot ulcers (DFUs) who were treated either with Organogenesis' Apligraf® or with Epifix, made by MiMedx Group, Inc.
The article, "Comparative Effectiveness of a Bioengineered Living Cellular Construct vs. a Dehydrated Human Amniotic Membrane Allograft for the Treatment of Diabetic Foot Ulcers in a Real World Setting," is the largest and most robust comparative effectiveness study examining outcomes of Apligraf and Epifix for the treatment of DFUs. This analysis was conducted in collaboration with top academic researchers in the field of wound healing, Robert Kirsner MD, PhD, William Marston MD, and Michael Sabolinski MD.
Researchers found that DFUs treated with Apligraf had significantly higher rates of healing in significantly less time compared to those treated with Epifix, increasing the probability of healing by 97%. These results indicate cost savings with Apligraf based on application frequency and faster time to healing. The report can be found online at: http://onlinelibrary.wiley.com/doi/10.1111/wrr.12332/abstract and will be published in an upcoming issue of the journal.
- When compared to Epifix, Apligraf:
- Improved frequency of wound closure at 12 weeks (48% vs. 28%), and at 24 weeks (72% vs. 47%).
- Healed wounds faster (median weeks: 13.3 vs. 26.0).
- Increased the probability of healing by 97%.
- These real world data demonstrate that Apligraf significantly improves the speed and incidence of wound closure. (p=0.01)
"Diabetes mellitus affects more than 22 million people in the U.S., and diabetic foot ulcers are one of the most severe and costly complications. With health care reform, real world comparative effectiveness studies are increasingly important, to better understand which products work best in large and diverse patient populations typically encountered in clinical practice. Product efficacy in controlled clinical trials may not equate to effectiveness in general clinical practice, which is why these types of analyses are so valuable," said lead study author Robert S. Kirsner, M.D., PhD, Harvey Blank Professor and Interim Chair, Department of Dermatology & Cutaneous Surgery at the University of Miami Miller School of Medicine, and Chief of Dermatology for the University of Miami Hospital.
The study, a retrospective analysis of all available data in 2014 from participating treatment centers using Net Health's electronic medical record database, Wound Expert,1 looked at frequency of and time to closure for recalcitrant DFU wounds (N=226) treated at 99 wound care centers around the U.S. A total number of 163 wounds (155 patients) were treated with Apligraf and 63 wounds (63 patients) were treated with Epifix.
"Throughout our company's history, Organogenesis has demonstrated our commitment to advancing the science of wound healing through rigorous research. Over the years we've worked with top clinicians and scientists to ensure patients and providers have evidence-based tools and information. With this new first-of-its kind analysis, we are proud to continue contributing to the ongoing scientific discussion of wound healing by studying the real world effectiveness of our products," said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis Inc. "We look forward to continuing the conversation."
Unlike a number of human tissue products on the market, Organogenesis' products Apligraf® and Dermagraft® have been reviewed and approved by the U.S. Food and Drug Administration (FDA) through a rigorous premarket review process which included scrutiny of clinical data. Apligraf is a bioengineered living, cell-based product for the treatment of chronic wounds, and is the only product with FDA approval to treat both venous leg ulcers (VLUs) and DFUs. Apligraf consists of keratinocytes, fibroblasts and collagen, and when applied directly to a wound, Apligraf has been proven to actively stimulate wound healing. The results of this comparative effectiveness study validate in a real-world setting the data from the Apligraf trials conducted for FDA approval.
"Apligraf and Dermagraft have FDA approval for wound healing, and are the two products with the highest level of evidence. Our products heal debilitating chronic wounds and bring relief to patients who are suffering and at risk of amputation," continued Mr. Gillheeney. "Using proven, evidence-based, FDA-approved products for wound healing is the better option for both patients and clinicians."
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.
Apligraf is FDA-approved for the treatment of venous leg ulcers and diabetic foot 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 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 soft tissue 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.
- WoundExpert®, Net Health, Pittsburgh, Pennsylvania. De-identified patient data released to Organogenesis. Net Health was not involved in any way in the analysis, interpretation, or reporting of the data.