First Patient Enrolled in Restrata® Randomized Controlled Trial
ST. LOUIS, June 14, 2021 /PRNewswire/ -- Acera Surgical, Inc. (Acera), a leading bioscience company developing and commercializing a portfolio of fully synthetic materials for regenerative medical applications, today announced its first patient enrollment in a clinical study evaluating Restrata, Acera's leading wound care product, for the treatment of non-healing diabetic foot ulcers (DFUs). The study will generate level 1 clinical evidence to support coverage and reimbursement from US health insurers for Restrata's use in outpatient wound clinics and physician office settings.
Non-healing foot ulcers are among the most debilitating outcomes affecting people with diabetes in the United States. Roughly 1 out of 3 people with diabetes will develop a foot ulcer over the course of their lifetime1. More than 50% of diabetic foot ulcers become infected, and roughly 20% of diabetic foot infections result in amputation. That means that almost every 20 seconds, a lower limb is amputated due to complications associated with diabetes2. In the United States, an estimated $237 billion is spent annually on direct costs for diabetes, and as much as one third of that will be spent to treat lower extremity complications3.
Dr. Khalid Husain of Midwest Foot and Ankle Clinics will serve as the lead investigator. Dr. Husain commented, "As the first synthetic wound graft modeled after native tissue, Restrata is a game changer. It offers versatility. Whether I'm treating difficult-to-heal chronic wounds or complex surgical wounds, I have seen excellent results and expect to save many limbs with this revolutionary treatment option."
The study consists of a prospective 48-patient randomized controlled trial of Restrata versus the standard of care and will be initiated at Midwest Foot and Ankle Clinic in Chicago, Ill. Full patient enrollment is expected by August 2021, with results collected by the end of this year.
Nick Gallucci, Acera's Chief Commercial Officer, said, "Since inception, we've seen Restrata offer significant healing benefits to patients with non-healing chronic wounds. We are pleased to partner with Dr. Husain to deliver the first level 1 evidence reinforcing our observations and generate the first data set to support our reimbursement strategy."
About Restrata®
Restrata is a fully synthetic hybrid-scale fiber matrix, indicated for use in a variety of wounds including surgical wounds, trauma wounds, and chronic wounds such as diabetic foot ulcers and venous leg ulcers. Restrata is manufactured with synthetic bioresorbable polymers and possesses a fibrous structure with high porosity. The product architecture, which is similar to native extracellular matrix, allows for cell ingress and retention, as well as neovascularization of the newly forming tissue without the need for added growth factors. As the wound healing process progresses, Restrata completely degrades via hydrolysis, leaving native tissue in its place. Restrata is shelf stable and carries a two-year shelf life.
About Acera Surgical, Inc.
Born from research and bold patient-focused innovation, Acera is a bioscience company developing and commercializing groundbreaking soft-tissue repair products. Acera's synthetic hybrid-scale fiber matrices are designed to be structurally similar to human tissue, resist enzymatic degradation, offer both flexibility and strength, and allow more effective healing before completely resorbing. At Acera, we are Revolutionizing Healing, Changing Lives. Additional information about Acera, its technology and products may be found at www.acera-surgical.com.
1 Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367-2375.
2 Edmonds M, Manu C, Vas P. The current burden of diabetic foot disease. J Clin Orthop Trauma. 2021 Feb 8;17:88-93. doi: 10.1016/j.jcot.2021.01.017. PMID: 33680841; PMCID: PMC7919962.
3 Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
SOURCE Acera Surgical, Inc.
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