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Designed Bioactive Scaffolds for Mandibular Reconstruction

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93683
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
DE019979
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
TISSUE REGENERATION SYSTEMS, INC.
5400 Carillon Point Kirkland, WA 98033-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: Designed Bioactive Scaffolds for Mandibular Reconstruction
Agency: HHS
Contract: 1R43DE019979-01
Award Amount: $121,338.00
 

Abstract:

DESCRIPTION (provided by applicant): Craniomaxillafacial (CMF) reconstruction remains a significant challenge due to the complex geometry and the need to restore both esthetics and function, especially for large mandibular segmental defects resulting from tumor resection, trauma or congenital defects. The current clinical gold standard, vascularized free bone flap (VBF), still suffers significant drawbacks. Among these are the inability to restore defect geometry, the inability to restore complete mandibul ar function, and the significant surgical and functional morbidity associated with harvesting the graft. Indeed this surgical morbidity precludes the use of VBF in some patients. The ability to create a customized, functional and degradable synthetic scaff old that would enhance tissue regeneration would be a significant advance in CMF reconstruction in general and mandibular reconstruction specifically. The specific focus of this phase I SBIR is to demonstrate the feasibility of designing, manufacturing and placement of an osteoconductive coating customized for mandibular reconstruction scaffolds directly from patient image data. We will specifically show that scaffolds capable of withstanding functional masticatory loads can be reproducibly manufactured and osteoconductively coated directly from patient specific CT scans. We will create these scaffolds directly from domestic pig, macaca fasicicularis monkey, and human patient CT data. A phase II SBIR testing these scaffolds in both the domestic pig and Macac a fasicicularis monkey would follow on to demonstrate both functional and regenerative capability of these scaffolds in large functional animals models, leading to an eventual clinical trial. PUBLIC HEALTH RELEVANCE: Repair of damage and deformity of the b ones in the face and head is problematic because both aesthetics and function must be restored. TRS now has the capability to take patient specific anatomical data from CT scans and design and manufacture custom implants to repair and regenerate damaged ti ssue. Successful clinical introduction of these implants would allow patients to receive degradable scaffolds that mimic the contours of their own bone, can bear the mechanical forces of chewing, and encourage the growth of new tissue. Thus, patients could be spared the risk of autografts and still obtain immediate return of aesthetic and mechanical function. Long term, the degradable implant will be totally replaced by native bone.

Principal Investigator:

Rachel Schek

Business Contact:

Jim Adox
Small Business Information at Submission:

TISSUE REGENERATION SYSTEMS, INC.
201 SOUTH MAIN STREET SUITE 900 ANN ARBOR, MI 48104

EIN/Tax ID: 161164531
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No