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OsteoMark - A Navigation Aid for Orthognathic Surgical Procedures

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
Physical Sciences Inc.
20 New England Business Center Andover, MA -
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 2
Fiscal Year: 2010
Title: OsteoMark - A Navigation Aid for Orthognathic Surgical Procedures
Agency: HHS
Contract: 2R44DE019322-02
Award Amount: $1,299,880.00


DESCRIPTION (provided by applicant): Having successfully completed a Phase I program, we propose to continue the development and demonstration of OsteoMark, a tool for implementing computer-based plans for orthognathic surgery. Physical Sciences Inc., is l eading the development of the product with support from our clinical partners in the Dept of Oral and Maxillofacial Surgery at the Massachusetts General Hospital and image-guided surgery experts in the Surgical Planning Laboratory at Brigham and Women's Ho spital. The device can be used in both endoscopic and open procedures to transfer treatment plans from computer-based 3D surgical planning tools onto the bone. The system will provide for intraoperative registration of the image to the patient, with no req uirement for fiducial markers in the pre-operative images and no fixation frame attached to the head. The surgeon will mark the bone for ostotomies, screw holes, and alignment, and then complete the procedure using instruments without any tracking, using t he marks to guide the modification of bone. The proposed device will be less expensive and less complex than a system that tracks the motion of multiple surgical instruments as procedures are performed. OsteoMark is being developed to interact with the ope n-source medical imaging software Slicer/Osteoplan, though integration with an FDA-approved commercial program is planned for late in Phase II. In Phase I, we demonstrated the ability to transfer treatment plans to the mandible in endoscopic surgery on a p ig cadaver. In Phase II, we will refine the system components and algorithms, carry out several operations on cadavers, and then perform tests on live minipigs. PUBLIC HEALTH RELEVANCE: Minimally-invasive surgery is becoming more widely used in reco nstruction of bones in the face because it results in faster recovery times, less pain and discomfort, and less scarring than open procedures. Another recent advancement has been the use of computer graphics tools to plan complex reconstruction operations. We are proposing to develop a device that will enable surgeons to copy computer treatment plans to the bone even through a very small incision, allowing surgeons to perform more sophisticated procedures with less difficulty for the patient and improved ou tcomes.

Principal Investigator:

John C. Magill

Business Contact:
Small Business Information at Submission:


EIN/Tax ID: 104251709
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No