ISTO TECHNOLOGIES — Department of Health and Human Services SBIR Phase I: NIAMS

Description

DESCRIPTION provided by applicant The goal of this project is to provide a synthetic biomaterial capable of giving long term repair of full thickness chondral lesions with the aim of helping to reduce the joint replacements carried out each year in the USA Our company has developed a synthetic biomaterial technology with proven biocompatibility in treating over patients for bone repair This highly biocompatible technology is designed to provide an in situ organized environment for the regeneration of new tissue and has recently been shown to provide excellent repair in a pre clinical osteochondral model In this study the regenerate tissue not only repaired the subchondral bone but also produced well integrated hyaline cartilage and re established the tide mark zone Building on the preliminary results from the pre clinical osteochondral study and our patent protected position on the materialandapos s use with microfracture Phase I of this proposal seeks initially to establish proper surgical method for implantation of the biomaterial in lesions with sizes spanning those normally treated by microfracture to cm An ovine model is chosen to conform to preferences expressed by the FDA Having established proper fixation technique in Phase I the Phase II of the proposal derives data for use in a pre clinical safety and efficacy study Data from this accepted ovine model will form the basis of approach to the FDA to obtain an investigational device exemption IDE necessary to enter human clinical trials to support Pre Market Authorization PMA for the commercial product This treatment modality represents a safe cost effective long term solution to an increasing patient population PUBLIC HEALTH RELEVANCE Cartilage lesions are known to often progress to osteoarthritis which is the leading cause of disability among U S adults affecting an estimated million individuals at a cost of more than $ billion per year in health care expenses and lost productivity An estimated million arthroscopies are performed annually with approximately involving microfracture procedures The research presented in this proposal aims to solve the major deficiency in first line surgical repair of chondral defects by providing a means of regenerating hyaline cartilage using a synthetic biocompatible and fully resorbable implant