GRAFIX PL and GRAFIX Membranes are human placental tissue products composed of native living cells, growth factors and an intact extracellular matrix
Smith+Nephew's GRAFIX Cryopreserved Placental Membrane and GRAFIX PL Lyopreserved Placental Membrane. (Credit: Smith & Nephew plc.)
Smith+Nephew (LSE: SN,NYSE: SNN), the global medical technology business, announces the publication of a peer-reviewed study in the Advances in Wound Care Journal reporting outcomes for Medicare patients with a diabetic foot ulcer (DFU) that shows GRAFIX Cryopreserved Placental Membrane cut DFU recurrence rates in half compared to leading cellular and tissue-based product (CTP) competitors.
DFUs affect 3 million people annually in the US, and Medicare spending for the treatment of DFUs has been estimated to be $6-18 billion annually.2 This study reviewed over 1.3 million Medicare patients with lower limb chronic ulcers, and analyzed 7,849 claims for patients treated between 2013 and 2017 in an outpatient setting who presented with a DFU and received a CTP. It compared ulcer recurrence rates, patient mortality, and other outcomes at 30-, 90-, 180-, and 365-days for GRAFIX Membrane vs. Cellular CTPs and vs. Acellular CTPs. Examples of leading competitors included in this study are Apligraf® (Organogenesis, a Cellular CTP) and EpiFix® (MiMedx, a devitalized Acellular CTP).1,3
The study found a statistically significant reduction in ulcer recurrence and/or new ulcer formation, for patients presenting with a DFU at all time periods for GRAFIX compared to either Cellular or Acellular CTP groups, ranging from 36.7% reduction at 30-days compared to Cellular CTPs, and 58.5% reduction at 365-days compared to Acellular CTPs (p < 0.001). Mortality rates were also reviewed at each time point and differences noted were favorable. The cohorts were risk-adjusted to ensure appropriate comparisons.
A similar study of Medicare patient claims from 2015-2018 was recently published that found CTPs, including GRAFIX Membranes, performed better than standard of care where performance measures were reductions in major and minor amputations, emergency department use, and hospital readmission, and were estimated to lead to millions of dollars in healthcare cost savings in that time (n=12,676 episodes per cohort).4 The study announced here expands upon that analysis of the class of CTPs to demonstrate the enhanced value GRAFIX Membranes can offer patients with DFU compared to leading competitors.
Dr. Charles Ananian, DPM commented, “This new study cements what I have seen in my practice with the GRAFIX Membrane products. In conjunction with standard of care, GRAFIX has led to a higher percentage of closed wounds, faster wound closure, and less ulcer recurrence than many competitors.5,6 In indicated wounds, GRAFIX has proven itself as a high-performing therapy for difficult-to-treat wounds.”
“Smith+Nephew is committed to helping patients with chronic wounds live a Life Unlimited. Backed by evidence, GRAFIX delivers on this promise by helping patients with chronic wounds as an advanced therapy shown to be clinically superior to standard of care and leading competitors.5,6,7 Because of the strong body of clinical evidence for GRAFIX, Medicare and all of the top 50 commercial payers now cover GRAFIX for DFU, including recent positive coverage by the largest payer in the US,7” said Simon Fraser, Smith+Nephew President of Global Advanced Wound Management.
Source: Company Press Release