O.N. DIAGNOSTICS, LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): With over 400,000 patients undergoing spine fusion s

O.N. DIAGNOSTICS, LLC — SBIR Phase I award from Department of Health and Human Services.

Amount
$225,000
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
SBIR · Phase I
Solicitation
PA13-234
NAICS
Place of performance
CA
Period

Description

DESCRIPTION (provided by applicant): With over 400,000 patients undergoing spine fusion surgery each year, many of whom have low bone density because of their advanced age, it is now clear that failure of the bone after a fusion procedure is a serious andincreasingly common problem. This negative outcome of the primary fusion surgery requires the patient have a second surgery, and arises because the patient's vertebral bone is too weak to sustain the loads applied to it after the primary fusion surgery. The bone can fail in different ways, the most common modes of bone failure being: 1) fracture of the adjacent-level vertebra; 2) loosening of a pedicle screw due to local failure of the supporting bone; and 3) subsidence or fracture of the vertebral endplates. These failure modes have been difficult to avoid because, although spine surgeons have a variety of both surgical and non-surgical approaches to reduce the risk of bone failure, these risk-mitigating measures add complexity and expense to the sur