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Spatiotemporally Controlled Keratin Biomaterial Delivery System for Functional Tissue Regeneration

Award Information
Agency: Department of Defense
Branch: Defense Health Agency
Contract: W81XWH-15-C-0084
Agency Tracking Number: H2-0098
Amount: $999,999.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: OSD10-H03
Solicitation Number: 10.3
Timeline
Solicitation Year: 2010
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-12
Award End Date (Contract End Date): 2021-01-31
Small Business Information
200 East First Street Suite 102 Box #4
Winston-Salem, NC 27101-3074
United States
DUNS: 827054219
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Seth Tomblyn
 Principal Scientist
 (336) 725-0621
 Seth.Tomblyn@KeraNetics.com
Business Contact
 Alexis Gabard
Phone: (336) 725-0621
Email: alexis.gabard@keranetics.com
Research Institution
N/A
Abstract

Currently, no commercial products exist for the repair of large injuries to muscle, particularly volumetric muscle loss (VML). In Phase I of this project, data demonstrated that keratin biomaterials can provide temporal release of growth factors while maintaining cell viability in vitro and in vivo. In Phase II, the biomaterial formulation was optimized for spatio-temporal delivery of cells and growth factors. In evaluating the efficacy of a variety of formulations, keratin hydrogels alone demonstrated statistically significant improvements in functional outcomes over those observed in injuries left unrepaired or repaired with bladder acellular matrix (BAM). In a 20-30% rat tibialis anterior defect VML injury, treatment with keratin hydrogels achieved approximately 90% of the maximal possible functional recovery possible. This Phase II effort seeks to complete the pre-clinical work necessary for an Investigative Device Exemption, including final development work and ISO 10993 testing, and execute a 5 patient human clinical trial. The trial will examine safety for repair of VML of the anterior compartment associated with a high-energy open tibia fracture Type II-IIIA.

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

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