DENVER, September 14, 2017 (Newswire.com) – Telos Partners, LLC, a firm providing scientific, regulatory and publication services to the life sciences industry, has been selected by Acera Surgical to lead its Restrata™ wound matrix study titled: “Clinical Outcomes after Treatment with Restrata™ in Diabetic Foot Ulcers (DFU): A Case Series of Initial Effectiveness and Safety Measures.”
The clinical trial is a multi-center, single-arm study designed to evaluate 12-week outcomes after applying Acera’s Restrata™ Wound Matrix to patients with diabetic foot ulcers (DFU). Restrata™ is a next generation, fully synthetic wound matrix which was FDA cleared for wound indications in April 2017.
At least five U.S.-based clinical sites will be included in the trial. All patients will receive Restrata after enrollment, followed by weekly visits to assess the extent and quality of healing. A confirmation visit will be used to ensure durable wound closure has been observed. Reimbursement-related data will also be collected, which may be used for future coding and coverage decision-making. Acera plans to use the trial data for publication and presentation of clinicians’ early experience as part of its comprehensive wide market launch strategy. In addition, the trial data will be used to inform the hypotheses of a future randomized controlled trial.
“As a fine-tuned material, Restrata™ is designed to match the architecture of native extracellular matrix,” said Joel Batts, Telos Partners LLC. “As a fully-synthetic material, it also has the potential to improve the health economics over existing treatment options. Telos Partners is privileged to partner with the Acera team in characterizing wound healing after Restrata™ application. We look forward to the future presentation of high-quality evidence in diabetic wound patients from this clinical trial.”
“Our team selected Telos to lead our investigation of Restrata™ due to their long-standing reputation as clinical experts within the regenerative medicine space,” stated Dr. Matthew MacEwan, Acera Surgical, Inc. “Telos has provided our team with expert guidance while maintaining constant focus on achieving our goals as a client. Furthermore, Telos’ high standards and ability to execute greatly complements the pace at which we plan to bring Acera’s innovative products and technology to U.S. clinics.”
About Restrata™ Wound Matrix
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. Restrata™ is a porous matrix made from synthetic biocompatible materials that provide a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space/wound bed. The device does not contain any human or animal-based materials or tissues.
About Acera Surgical Inc.
Acera Surgical Inc. (“Acera,” St. Louis, Missouri) is a bioscience company developing and commercializing a portfolio of fully synthetic electrospun scaffolds for regenerative medical applications. Acera’s products exhibit a structure similar to native extracellular matrix (ECM) and thus support rapid and effective healing. The FDA cleared Acera’s first product in March 2016 and its second product in April 2017, both via 510(k). Acera is currently raising Series A financing, as well as seeking strategic partners for product development and commercialization.