SBIR-STTR Award

In collaboration with The University of Texas Health Science Center at San Antonio and University of Texas at Austin, BioMedical Enterprises, Inc. is proposing to develop methods and systems for Selective Laser Sintering (SLS) of calcium and phosphate powder mixtures to form complex three-dimensional bone structures for use as a degradable or permanent osseous scaffold. Calcium phosphate compositions can be formed into implants to repair skeletal abnormalities and trauma. Phase I objectives will evaluate the biomaterials aspect of a technology that utilizes computer aided tomographic (CAT) image of a bony structure and duplicate it out of porous and structurally strong calcium phosphate based material. We will fabricate test materials for chemical, microstructure and porosity characterization, strength testing and biocompatibility evaluation when used to restore an atrophic alveolar ridge. Phase II and commercialization activities will involve the development of a modified SLS system that uses commercially available calcium phosphate powders to form custom class III medical devices. The instrumentation and method will allow CAT scan images to be input to the SLS system. Post-processing to cure and sterilize the synthetic bone material will be modulated to control strength, porosity and degradation kinetics and customized for each patient's indication.

Keywords:
Bone, Laser Sintering, Calcium Phosphate, Oral Reconstruction, Biocompatibility

In collaboration with The University of Texas Health Science Center at San Antonio and University of Texas at Austin, BioMedical Enterprises, Inc. is proposing to develop methods and systems for Selective Laser Sintering (SLS) of calcium and phosphate powder mixtures to form complex three-dimensional bone structures for use as a degradable or permanent osseous scaffold. Calcium phosphate compositions can be formed into implants to repair skeletal abnormalities and trauma. Phase I objectives demonstrated biocompatibility, computer aided tomographic (CAT) image acquisition and formation of anatomical bony structures from porous and structurally strong calcium phosphate. Test materials were chemically, microstructurally and structually characterized. Implants were evaluated in vivo to restore an atrophic alveolar ridge. Phase II activities will involve the development of a pilot scale SLS bone manufacturing system consistent with medical device manufacturing practices. The instrumentation and methods will be established to allow CAT scan images to be input to the SLS system. Post-processing to cure and sterilize the synthetic bone material will be implemented to supply animal and human studies. FDA approvals will be sought and human clinical trials will be established.

Keywords:
Calcium Phosphate Laser Sintering Biocompatibility Bone Oral Reconstruction