A multidisciplinary research environment, benchtop to bedside

Advanced Medical Technology specializes in the critical transition from early exploratory non-GLP studies to formal GLP protocol execution. By developing precise experimental endpoints in the non-GLP pilot process and understanding the requirements from regulatory agencies, formal GLP studies are designed and conducted with an expected outcome — ensuring final GLP study data is comprehensive and robust.

In vivo biological modeling is performed to address both safety and efficacy, as required by regulatory agencies and study sponsors. Advanced Medical Technology brings 30 years of experience to the operating room, with specialization in complex spinal reconstruction procedures from lower to higher order vertebrate models.

Experimental study endpoints include clinical pathology, radiological, biomechanical and histological assays, which can be incorporated as needed to quantify the safety and efficacy of treatment procedures. AMT specializes in the assessment of neurotoxicity, osseointegration, new implant technologies, bone graft substitutes, and biomaterials in the axial and appendicular skeleton.

• In partnership with multiple Contract Research Organizations, AMT performs a wide variety of fully compliant Good Laboratory Practices (GLP) preclinical studies, which are outlined by the Code of Federal Regulations: Title 21, part 58 (CFR Title 21 part 58).
• Projects are closely monitored by the Institutional Animal Care and Use Committee (IACUC) and strictly adhere to all applicable stipulations of the most recent version of the USDA Animal Welfare Act.

Biological and surgical modeling

The laboratory is configured with digital plain film imaging and Faxitron microradiography for high resolution assessment of specimens and undecalcified microscopy.

• Fluoroscopic imaging of musculoskeletal structures is performed to verify implant placement and position, and is used in concert with biomechanical testing.
• The Bruker micro CT system offers methods for quantifying bone growth on a volumetric basis as well as surface area analysis of orthopaedic implant technology, with realistic 3D visualization made possible by Bruker’s 3D.Suite® microCT software.
• Dual Energy X-Ray Absorptiometry (DEXA) provides qualitative and quantitative structural analysis of musculoskeletal structures.

3D Modeling / Rendering — MicroCT

Fluoroscopy

Digital Microradiography

DEXA Scanning

Configured with state-of-the-art tissue processing equipment and working in collaboration with GLP approved histology facilities, the histology laboratory can process a wide variety of tissue samples including decalcified and undecalcified tissues (oversized), immunohistochemistry, and cytokine staining.

Histomorphometric assays provide quantitative data to assess neurotoxicity, bone formation, biomaterial resorption and histiocytic response, if needed. Histopathology is performed in accordance with ISO 10993-6, ISO 10993-11 and FDA guidance document ISO 10993-1.

Undecalcified histology

Decalcified histology

Immunohistochemistry

Staining

The six degrees of freedom (6DOF) musculoskeletal simulator was designed by mechanical engineer Jeff Gordon, MS and Bryan Cunningham, PhD. The simulator recreates the natural movement of musculoskeletal kinematics and is used to perform biomechanical assessments of reconstruction techniques in axial and appendicular skeletal structures.

• Combined with the musculoskeletal simulator, Certus optoelectronic motion tracking quantifies translations and rotations in all three orthogonal axes — X, Y and Z — and can be unconstrained or locked if required.
• Multidirectional flexibility testing is frequently combined with Tekscan pressure mapping and quantification of implant and osseous strain utilizing Vishay Micro-Measurements systems.

6DOF musculoskeletal simulator

Watch the 6DOF simulator in motion