Computer Surgical Simulation for Craniofacial Surgery

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R42DE016171-02A1
Agency Tracking Number: DE016171
Amount: $394,846.00
Phase: Phase II
Program: STTR
Awards Year: 2007
Solicitation Year: 2007
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
MEDICAL MODELING, LLC, 17301 W COLFAX AVE, STE 300, GOLDEN, CO, 80401
DUNS: 176553907
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 JAMES XIA
 (713) 441-5576
 jxia@tmhs.org
Business Contact
 ANDREW CHRISTENSEN
Phone: (303) 273-5344
Email: andy!medicalmodeling.com
Research Institution
 METHODIST HOSPITAL RESEARCH IN
 METHODIST HOSPITAL RESEARCH INSTITUTE
6565 FANNIN, STB1-14
HOUSTON, TX, 77030 2704
 Domestic nonprofit research organization
Abstract
DESCRIPTION (provided by applicant): The field of cranio-maxillofacial (CMF) surgery involves the correction of congenital and acquired deformities of the skull and face. These include dentofacial deformities, congenital deformities, and defects after tumor ablation, post-traumatic defects, and deformities of the temporomandibular joint (TMJ). In the United States each year, a significant number of patients undergo reconstructive surgery for these types of defects and deformities. Due to the complex nature of the craniofacial skeleton, craniofacial reconstructive surgery usually requires extensive pre-surgical planning. Traditional surgical planning methods for this type of the surgery involve a physical examination, plain radiographs (cephalometric radiographs), plaster dental models, three-dimensional (3D) computed tomography (CT) scans, and occasionally CT-based 3D physical models. Unfortunately, these methods are often not adequate for planning complex cranio-maxillofacial deformities. Over the last six years, our Surgical Planning Laboratory has developed a prototype system for computer- aided surgical simulation (CASS). The accuracy of our CASS system has been proven in the Phase I study. The specific aim of the Phase II proposal will be to develop a user-friendly software package that will allow surgeons to plan complex cranio-maxillofacial surgeries from beginning to end. In addition, this newly developed software will be validated following the FDA? rules and regulations. Finally, we will continue to investigate the clinical feasibility of the investigators? CASS. The ultimate goal of this project (Phase III) is to take this product to the market. The field of cranio-maxillofacial (CMF) surgery involves the correction of congenital and acquired deformities of the skull and face. These include dentofacial deformities, congenital deformities, and defects after tumor ablation, post-traumatic defects, and deformities of the temporomandibular joint (TMJ). In the United States each year, a significant number of patients undergo reconstructive surgery for these types of defects and deformities.

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

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