Acera Surgical, Inc. (“Acera”) is a bioscience company 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 (Cerafix®) in March 2016 and its second product (Restrata™) in April 2017, both via 510(k), granting commercial access to markets exceeding $1.2B in revenue.
Acera’s technology platform allows for the development of fully-synthetic, electrospun scaffolds for regenerative medical applications. Its portfolio of fully synthetic materials is constructed from nano–scale fibers and address the shortcomings of conventional biologic and macro-scale synthetic tissue scaffolds. Due to the structural similarities between Acera’s nano-fiber scaffolds and native extracellular matrix, new cells and vasculature are better able to proliferate throughout the material and integrate into surrounding tissue, persists in the wound bed acting as a protective covering to promote natural wound healing. Acera’s first two products undergo complete resorption in vivo once the tissue defect has had a chance to heal, potentially reducing the risk of long-term infection and/or scarring. The unique architecture offers a combination of strength and flexibility for improved intraoperative handling.
Product Development and Commercialization
Acera Surgical has successfully completed the lab to market process, and received FDA clearances for two products. Acera received FDA clearance in April 2017 for the RestrataTM Wound Matrix, with clinical trials planned for the second half of 2017. Its first product, the Cerafix® Dura Substitute, designed for use in neurosurgical procedures, is currently used in clinics throughout the US.
Acera is strengthening and expanding its product portfolio by: 1) expanding clinical claims for Cerafix® and RestrataTM, 2) securing new clinical indications for its materials in other surgical specialties, and 3) developing and commercializing new material configurations to address clinical needs in targeted clinical specialties.
Acera’s proprietary technology is protected under a growing portfolio of 30+ patent applications including 6 issued/allowed patents. The patent portfolio includes claims from manufacturing to composition and product design, with priority dates beginning in 2010.
Cerafix® Dura Substitute and Restrata™ Wound Matrix are not designed, sold or intended for use except as described in the indications for use document. Please see product insert and instructions for use document for complete product information.