Research Demonstrates Faster VLU Time to Healing with Organogenesis Apligraf

New comparative effectiveness research from Organogenesis Inc. demonstrates faster time to healing and greater healing rates with Apligraf for the treatment of venous leg ulcers (VLUs). The research, “Comparative effectiveness of a bilayered living cellular construct and an acellular fetal bovine collagen dressing in the treatment of venous leg ulcers,” was e-published ahead of print in the peer-reviewed Journal of Comparative Effectiveness Research.
 
“This is the first Comparative Effectiveness Research study that compares the clinical outcomes of a bilayer living cellular construct (BLCC) and an acellular fetal bovine collagen dressing (FBCD) for the treatment of VLUs in a real world setting,” said Michael Sabolinski, M.D., lead author of the study. “Improvements in the probability, speed, and incidence of wound closure in VLUs treated with BLCC suggest a greater clinical benefit as well as a potential cost savings benefit.”
 
Using real-world data from the Net Health WoundExpert database—the largest independent source of chronic wound benchmarking data in the industry— researchers compared clinical outcomes for the treatment of VLUs among two treatment modalities: Apligraf, a BLCC that is approved by the U.S. Food and Drug Administration for the treatment of VLUs, and an acellular fetal bovine collagen dressing.
 
The study found that VLUs treated with Apligraf experienced a 37 percent faster median time to wound closure and that treatment with Apligraf increased the probability of healing by 45 percent when compared to VLUs treated with the acellular fetal bovine collagen dressing.
 
Chronic venous insufficiency affects approximately 2.5 million Americans, with up to 20 percent developing venous ulceration. Individuals who develop VLUs can often experience delayed healing and VLU recurrence. The impact on the patient’s quality of life and the economic cost of this disease can be significant; care for VLUs in the United States has been estimated to cost up to $3 billion annually.¹
 
“Apligraf is the first approved bioengineered, living cell based product in the United States, and the only PMA approved skin substitute with the indication of healing venous leg ulcers,” said Shabnam Vaezzadeh, M.D., MPA, vice president of Global Medical and Clinical Affairs for Organogenesis Inc. “Organogenesis is committed to empowering healing for patients with VLUs, elevating the global dialogue on health outcomes, and offering therapeutic solutions that facilitate positive clinical outcomes and reduce total cost of care.”
 
The leading global professional society for health economics and outcomes research, ISPOR is an international, multidisciplinary society dedicated to advancing the policy, science and practice of pharmacoeconomics and health outcomes research. An unbiased organization comprised of more than 9,500 members from 114 countries, ISPOR and its membership represent the entire field including research, academia, decision and policymaking, payer and patient communities.
 
Organogenesis Inc. is a regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s portfolio is designed to treat a variety of patients with repair and regenerative needs.
 
Reference
1. https://vascular.org/news-advocacy/venous-ulceration-minimally-invasive-treatment-big-problem, June 15, 2017 Dr. Paul DiMuzio – accessed on May 15, 2018.