BioMedical Enterprises, Inc. is proposing to develop methods and systems for Selective Laser Sintering (SLS) of calcium carbonate powders to form complex three-dimensional bone structures for use as a degradable or permanent osseous scaffold. The Phase I objectives are to evaluate the biomaterials aspect of technology that can take a computer aided tomographic (CAT) image of a bony structure and duplicate it out of porous and structurally strong calcium carbonate based material. We will fabricate test materials for chemical, microstructure and porosity characterization, strength testing and biocompatibility evaluation. Phase II and commercialization activities will involve the development of a modified SLS system that can form a custom Class III medical device. The instrumentation and method will allow CAT scan images to be input to the SLS system to form the part and post-processing to cure and sterilize the synthetic bone structure. Strength, porosity and degradation kinetics can be controlled for each patients indication, as well as a custom fit implant to exactly conform to the bony defect.Proposed commercial application:The U.S. Department of Health and Human Services reported that 50% of the 2.4 million maxillofacial and musculoskeletal surgical procedures performed in the United States in 1990 involved surgical manipulation of bone. Reconstruction of osseous defects could benefit from an implant that matched the shape of the patients original anatomy. Market data show a disparity between the 1.2 million per year in need and the 400,000 who are being treated. Treatment of the additional 800,000 patients in need per year would provide a tremendous healthcare benefit and nearly triple the potential U.S. market to $300 million per year.National Institute of Dental Research (NIDR)
