Acera’s technology platform allows for the development of fully synthetic, fully resorbable tissue scaffolds for soft-tissue repair. Existing materials in today’s soft-tissue repair market are either biologic in nature or made from non-resorbable macro-scale synthetic materials. Biologic materials carry a risk of immunological response, have a high cost of production, and offer poor mechanical strength during intraoperative use. Macro-scale synthetic materials can result in scarring, inflammation, and poor clinical outcomes. Both materials illicit in vivo responses including fibrosis and adhesions and neither offers rapid tissue ingrowth, resulting in prolonged healing times. Acera’s solution is to produce a portfolio of fully synthetic materials constructed from resorbable polymeric fibers that address the shortcomings of conventional biologic and macro-scale synthetic tissue scaffolds. Due to the structural similarities between Acera’s scaffolds and native extracellular matrix (ECM), new cells are able to penetrate the material and integrate into surrounding tissue, thus promoting effective tissue repair and regeneration1. Acera’s products undergo complete resorption in vivo once the tissue defect has had a chance to heal, thus eliminating the risk of long-term infection and/or scarring. The unique architecture also offers a combination of strength and flexibility for improved intraoperative handling2.
Acera Surgical is utilizing its technology to develop surgical materials for soft tissue repair within multiple clinical specialties, initially focusing on neurosurgery and advanced wound care. The Company’s initial product, Cerafix® Dura Substitute (“Cerafix®”), is designed for use in surgical closure following routine neurosurgical procedures. Cerafix®” is currently used in neurosurgical clinics throughout the US following its FDA clearance under a 510(k) application in 2016.
Acera is simultaneously working to expand the breadth and depth of its product portfolio. FDA clearance of the Restrata™ Wound Matrix, designed for use in cutaneous wound management, is pending.
Cerafix® Dura Substitute is 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.
1, 2 – Data on file at Acera Surgical