LifeNet Health's DermACELL® Acellular Dermal Matrix receives Anthem® coverage
Published: Feb 23, 2018
VIRGINIA BEACH, Va., Feb. 23, 2018 /PRNewswire-USNewswire/ -- Insurance provider Anthem, Inc. now covers LifeNetHealth's Dermacell for the treatment of both chronic diabetic foot ulcers (DFUs) and breast-reconstruction surgery.
The determination means approximately 40 million people insured by Anthem gain access to dermal grafts developed through LifeNet Health's innovations and backed by clinical data.
"LifeNet Health is focused on applying our technologies and advanced processing methods to provide effective therapies, such as Dermacell, for patients around the world," said LifeNet Health President and CEO Rony Thomas. "Anthem's decision reflects the impact of our innovations, as shown in the growing body of evidence that supports Dermacell's efficacy in wound repair and post-surgery healing."
In May 2017, findings from a randomized clinical trial of Dermacell were published in the Journal Wound Repair and Regeneration. The study included 168 patients with chronic DFUs who were tracked for 24 weeks after treatment. Patients who received a single application of Dermacell experienced higher rates of wound-size reduction and wound closure compared to standard care, with 98 percent reaching closure by 12 weeks. The study was the largest of its kind to date.
A 58-patient retrospective comparison study in 2016 showed superior clinical outcomes for breast-reconstruction patients who received Dermacell compared to another ADM. Patients implanted with Dermacell experienced zero incidence of Red Breast Syndrome and demonstrated statistically significant improvements in time to drain removal.
"The introduction of superior biomaterials like Dermacell provides reconstructive surgeons with the tools needed to perform cutting edge breast reconstruction in a safe and reproducible way," said Troy Pittman, MD, lead investigator and author of the study. "The elimination of 'red breast' and faster incorporation minimizes complications and ultimately leads to faster recovery for the patients."
Dermacell, an acellular human dermis, is treated as human tissue for transplantation under the FDA's HCT/P process. It is decellularized using Matracell®, a patented technology that removes more than 97 percent of the donor's DNA without compromising the graft's biomechanical or biochemical properties and enables rapid cellular infiltration and re-vascularization. LifeNet Health's Preservon® technology allows the graft to be stored fully hydrated at ambient temperature, eliminating the need for refrigeration and rehydration processes. Dermacell is sterilized to medical device-grade standards, with a sterility assurance level of 10-6.
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SOURCE LifeNet Health