For use in various cranial surgical procedures
Osteotech has submitted a 510(k) application to the FDA to obtain marketing clearance for the use of its Duratech BioRegeneration Matrix to repair or replace the dura mater (the outermost membrane surrounding the brain), in various cranial surgical procedures.
The company claims that this filing is based, in part, on data collected during its human clinical study, which demonstrated the safety and performance of Duratech compared to currently marketed predicate dura substitute devices. Based on available data, Osteotech estimates that the annual market for dura repair substitutes is approximately $100m.
Duratech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. The Duratech 510(k) filing included data on 60 patients who underwent a variety of cranial surgical procedures utilising Duratech, where dura mater repair or replacement was required. The patients were evaluated at 30 and 90 day time points post-operatively, to assess the safety and performance of Duratech, said the company.
Utilising Osteotech’s HCT platform, Duratech is an engineered human collagen biomaterial that provides a semi-permeable scaffold and facilitates cellular in-growth and healing. Duratech is designed to be utilized to repair or replace the dura mater, a fibrous membrane that protects the brain, when the dura mater has been compromised due to injury or surgery. Osteotech’s proprietary collagen technology platform is supported by three pending patent applications.
In addition to Duratech, which is expected to launch immediately after clearance by the FDA, Osteotech plans to introduce additional tissue products based upon its HCT platform over the next several years that address patient needs and expand the addressable market for this technology, including rotator cuff repair, wound care applications and abdominal wall reconstruction, said the company.