SBIR-STTR Award

Biomaterial Augmented Microfracture Repair of Full-Thickness Chondral Defects04
Profile last edited on: 1/24/2018

Program
SBIR
Agency
NIH | NIAMS
Total Award Amount
$1,543,518
Award Phase
2
Principal Investigator
Anthony John Ward
Activity Indicator

Company Information

ISTO Biologics Inc (AKA:ISTO Technologies, Inc)

1155 Olivette Executive Parkway Suite 200
St Louis, MO 63132
   (314) 995-6049
   info@istotech.com
   www.istotech.com
Multiple Locations:   
Congressional District:   01
County:   St. Louis

Phase I

Phase I year
2015
Phase I Amount
$224,960
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 600,000 joint replacements carried out each year in the USA. Our company has developed a synthetic biomaterial technology with proven biocompatibility in treating over 33,000 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 material'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 (1 to 4cm2). 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 Statement:


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 50 million individuals at a cost of more than $282 billion per year (2010) in health care expenses and lost productivity. An estimated 1.2 million arthroscopies are performed annually with approximately 120,000 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.

Project Terms:
Adoption; Adult; Affect; Anatomy; Animals; Arthroscopy; articular cartilage; Authorization documentation; Autopsy; base; Biocompatible; Biocompatible Materials; biomaterial compatibility; Biomechanics; Birefringence; Blood; bone; Bone Regeneration; Caliber; Cartilage; cartilage repair; Cells; Cicatrix; Clinical; Clinical Trials; Coagulation Process; commercial application; cost; cost effective; crosslink; cytokine; Data; Defect; Degenerative polyarthritis; Deposition; design; Devices; disability; Drops; Effectiveness; Employee Strikes; Environment; experience; Fibrin Tissue Adhesive; Fibrinogen; Fibrocartilages; Goals; Harvest; Healed; healing; Healthcare; Human; Hyaline Cartilage; Hyaluronic Acid; Implant; implantation; In Situ; in vivo; Individual; Infiltration; innovation; Legal patent; Lesion; lymph nodes; Magnetic Resonance Imaging; Marketing; Marrow; Mechanics; Medial; Mesenchymal Stem Cells; Methods; Microscopic; Modality; Modeling; Natural regeneration; Operative Surgical Procedures; Organ; osteochondral tissue; Outcome; patient population; Patients; Peripheral; Phase; polarized light; Positioning Attribute; pre-clinical; preference; Procedures; Product Approvals; Productivity; public health relevance; Relative (related person); repaired; Replacement Arthroplasty; Reporting; Research; Safety; sample fixation; scaffold; Serum; Sheep; Site; Solutions; Stifle joint; Supporting Cell; Techniques; Technology; Thick; Thrombin; tissue repair; Tissues; Tourniquets; Work

Phase II

Phase II year
2016 (last award $$: 2017)
Phase II Amount
$1,318,558
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 600,000 joint replacements carried out each year in the USA. Our company has developed a synthetic biomaterial technology with proven biocompatibility in treating over 33,000 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 material'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 (1 to 4cm2). 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 Statement:


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 50 million individuals at a cost of more than $282 billion per year (2010) in health care expenses and lost productivity. An estimated 1.2 million arthroscopies are performed annually with approximately 120,000 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.

Project Terms:
No Project Terms available.