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Cartilage Regeneration with Tunable Inflammation Resistance

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AG059310-03
Agency Tracking Number: R44AG059310
Amount: $4,773,722.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PAR19-335
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-30
Award End Date (Contract End Date): 2024-05-31
Small Business Information
2609 N DUKE STREET, SUITE 303A
Durham, NC 27704-3048
United States
DUNS: 783502466
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 BRADLEY ESTES
 (919) 912-9839
 bradley.estes@cytextherapeutics.com
Business Contact
 FARSHID GUILAK
Phone: (919) 684-2521
Email: cytex.therapeutics@gmail.com
Research Institution
N/A
Abstract

Abstract: Femoroacetabular impingement or FAI is a commonly diagnosed condition affecting a younger patient population than the general osteoarthritis (OA) population. Untreated, FAI invariably leads to OA and, ultimately, total hip arthroplasty (THA). The fact that most FAI diagnoses are made in patients under the age of 40, with many in their late teens and twenties, makes FAI all the more clinically challenging to treat. Due to the limited life span of currently available hip implants, hip replacement in younger patients most often will require at least one and possibly several revision surgeries later in life. Each revision surgery leaves the hip joint with less native bone, resulting in a far less stable joint. FAI arises from abnormalities or defects in the bony structure of the hip, typically taking the form of either asphericity of the femoral head or bony overgrowth of the acetabulum itself. While a surgical intervention to remove the bony overgrowth addresses the painful impingement between the two joint components (femoral head and acetabulum), it does not repair the chondral defect caused by the bony malformation, which, over time, will progress and eventually lead to the need for THA. Mosaicplasty or microfracture have been used in an effort to stimulate the re-growth of damaged cartilage, but these procedures have not proven successful. Similarly, biological interventions utilizing stem cells or platelet rich plasma preparations have not proven to have reliable clinical utility. It is clear that there is an unmet need for an intervention that addresses the challenge of repairing damaged cartilage in patients with FAI. In response to this need, Cytex has developed a therapeutic biphasic device consisting of a high- performance 3D woven textile (cartilage phase) thermally bonded to an 3D printed scaffold (bone phase). This implant immediately performs the functions of the replaced osteochondral tissues and provides a conducive environment for native tissue integration and regeneration, demonstrated through multiple prior and ongoing in vitro and in vivo studies. The goals of this application are as follows: (1) finalize all of the manufacturing (cGMP) processes for the device, (2) file an investigational Device Exemption (IDE) with FDA to enable a clinical study, and (3) conduct a single site feasibility (safety) study enrolling up to 15 patients diagnosed with FAI. The patients to be enrolled will be qualified as surgical candidates for treatment of their FAI and must meet a stringent set of inclusion/exclusion criteria in order to ensure participation in the study at the lowest possible risk, while maximizing the possibility of a successful outcome. We have engaged several partners in this application in order to maximize the possibility of a successful outcome. Our partners include both regulatory and clinical development expertise in orthopaedic device trials and a Clinical Advisory Board of experts in the diagnosis and management of hip preservation surgeries to treat FAI. We expect that positive outcomes will move this technology closer to clinical practice by enabling a pivotal trial, but, also, positive results will establish the role of our implants for other disease states requiring joint restoration surgery.

* Information listed above is at the time of submission. *

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