CollaFirm, LLC Announces a Novel Process for Decellularization of Bovine Pericardium
CollaFirm, LLC announces completion of a novel process for decellularization of a bovine pericardium surgical patch that takes less time than conventional protocols, is less expensive, and uses only safe, non-toxic chemical agents. The resulting material is as strong as any bovine, porcine and allograft materials on the market, but with superior handling and conformity characteristics due in large part to the new decellularization process. As noted in an article published in the Journal of the Mechanical Behavior of Biomedical Materials, "The efficacy of a pericardial mesh to function as a scaffold depends on the quality of the decellularization protocol used." The process is well defined and available for use, and can be easily scaled to any production requirements. The company currently has the capacity to produce material for post market studies and pilot scale manufacturing.
The device has also received 510(k) clearance for the surgical repair of soft tissue deficiencies, including but not limited to "buttressing and reinforcing staple lines during lung resection and other incisions and excision of the lung and bronchus, reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass and gastric banding, abdominal and thoracic wall repair, muscle flap reinforcement , rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias." Real time stability data is also available out to one year at ambient storage conditions with no loss of mechanical or handling properties.
Company CEO Dr. Surendra Batra noted, "With all of the recent negative press surrounding the use of synthetic materials for soft tissue repair, biologics are likely to have a more prominent role in that market. We are excited about the opportunity this process and resulting product present for differentiation in a market crowded with otherwise indistinguishable products."