Press & Announcements
Comparative Effectiveness Analyses Report Faster Healing Times, Improved Probability of Chronic Wound Closure with Apligraf® and Dermagraft®
Canton, Mass (October 8, 2015) – Three new real-world, comparative effectiveness analyses reporting the clinical outcomes of Apligraf® for the treatment of hard-to-heal venous leg ulcers (VLUs), and Dermagraft® for the treatment of chronic diabetic foot ulcers (DFUs), were recently presented at the Fall Symposium for Advanced Wound Care (SAWC) annual medical meeting in Las Vegas, Nev. Apligraf® and Dermagraft® are the only living cell-based products in the "skin substitute" category to have received FDA approval for chronic wound healing. They are both manufactured by Organogenesis Inc., a global leader in regenerative medicine for wound healing.
The findings of these studies report the effectiveness of Apligraf and Dermagraft living cell-based therapies, compared to Epifix, Primatrix and Theraskin, including a reduction in healing times for chronic wounds when advanced, FDA-approved Apligraf and Dermagraft products were utilized.
"The results of these comparative effectiveness studies provide further evidence of the real world effectiveness of our FDA-approved biotherapeutics for chronic and sometimes life-threatening wounds like DFUs and VLUs, showing how they work in the hands of hundreds of clinicians in routine clinical settings across the United States," said Gary S. Gillheeney, Sr., president and CEO of Organogenesis Inc. "As the number of people living with diabetes continues to grow, along with the increased prevalence of patients suffering from chronic wounds, it's critical we continue researching and promoting effective advanced wound care treatments."
Highlights from the analyses in diabetic foot ulcers (DFUs):
"Comparative Effectiveness of a Human Fibroblast Dermal Substitute vs. a Dehydrated Human Amniotic Membrane Allograft for the Treatment of Diabetic Foot Ulcers in a Real World Setting" evaluated the real-world comparative effectiveness of Dermagraft versus Epifix for the treatment of DFUs. The analysis assessed real-world outcomes in 122 DFU patients receiving treatment at 72 wound care centers in 2014. Major findings:
- Use of Dermagraft had improved outcomes compared to Epifix for the treatment of DFUs in real‐world settings, as Dermagraft-treated wounds were found to have a significantly higher incidence of wound closure compared with Epifix-treated wounds.
- The median time to closure for patients treated with Dermagraft was 12 weeks compared to 19.4 weeks for patients treated with Epifix, or 38% sooner.
- The probability of healing with Dermagraft was twice as high as the probability of healing with Epifix.
"Comparative Effectiveness of a Human Fibroblast‐derived Dermal Substitute vs. a Fetal Bovine Collagen Dressing for the Treatment of Diabetic Foot Ulcers in a Real World Setting" assessed real-world outcomes in 206 patients with 208 DFUs receiving treatment in 2014 at 93 wound care centers with either Dermagraft or Primatrix. Major findings:
- Use of Dermagraft was significantly more effective than Primatrix for the treatment of DFUs in real-world settings, and patients treated with Dermagraft healed on average 42% faster than patients treated with Primatrix (14.6 weeks versus 25 weeks, respectively).
- Treatment with Dermagraft increased the probability of healing by 77% compared to Primatrix collagen dressing.
"A Comparative Effectiveness Analysis of a Bioengineered Living Cellular Construct and Cryopreserved Cadaveric Skin Allograft for the Treatment of Venous Leg Ulcers in a Real World Setting" looked at healing times for patients using Apligraf versus Theraskin to treat venous leg ulcers (VLUs). Major findings:
- Data for 717 patients with 799 VLUs receiving treatment at 177 wound care centers found the median time to closure with the use of Apligraf was 52% faster than for Theraskin (15 weeks versus 31 weeks, respectively).
- The probability of healing increased by 97% with the use of Apligraf, when compared to treatment with Theraskin.
The three studies presented at SAWC are the latest in a series from Organogenesis' major ongoing program to analyze the Net Health WoundExpert database , the largest electronic medical record (EMR) system in the wound care field, in order to evaluate the clinical performance and comparative effectiveness of Organogenesis' products in a real-world setting. The efficacy of Organogenesis products has been established through rigorous premarket approval studies required for FDA approval.
These analyses follow a June 2015 study, utilizing the same WoundExpert national EMR system and published in the peer-reviewed Wound Repair & Regeneration, which found that the probability of healing diabetic foot ulcers (DFUs) increases by 97% when treated with Apligraf when compared with Epifix. DFUs treated with Apligraf closed twice as fast as those treated with Epifix, according to the comparative effectiveness study.1
Additionally, a March 2015 study, published in the peer-reviewed Journal of Medical Economics, assessed the real-world medical resource utilization and Medicare costs associated with the use of Apligraf and Dermagraft relative to conventional wound care in DFU patients. The data showed significantly improved outcomes and economic benefits of both Apligraf and Dermagraft in the treatment of DFUs, utilizing de-identified patient records from the Medicare database.2
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.
- Kirsner RS, Sabolinski ML, Parsons NB, Skornicki M, Marston WA. 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. Wound Repair Regen. 2015 doi: 10.1111/wrr.12332
- Rice JB, Desai U, Ristovska L, Cummings AK, Birnbaum HG, Skornicki M, Margolis, DJ, Parsons NB. Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers. Journal of Medical Economics. 2015 Apr 22:1-10. [Epub ahead of print]