Development of bioceramic bone graft associated with bioactive plant extracts for guided bone regeneration

• Grant number: 23/00460-3
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: February 01, 2025
• End date: January 31, 2027
• Field of knowledge: Engineering - Materials and Metallurgical Engineering - Nonmetallic Materials
• Principal Investigator: Paulo Henrique Perlatti D'Alpino
• Grantee: Paulo Henrique Perlatti D'Alpino
• Company: Triplet soluções em Biotecnologia Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: Bauru
• Pesquisadores principais: Alejandra Hortencia Miranda González
• Associated research grant: 21/06152-3 - Development of bioceramic bone graft associated with bioactive plant extracts for guided bone regeneration, AP.PIPE

Abstract

The present project initially aimed in Phase 1 to evaluate the technical and scientific feasibility of a product with incremental innovation intended for bone regeneration, specifically a bone graft with sustained release of bioactive compounds. These bioactives present synergistic action when combined in composite form, demonstrating angiogenic, proliferative, and antimicrobial activities, accelerating the healing process, mitigating infections, and minimizing postoperative problems during bone regeneration. It is known that new bone formation at the graft implantation site is a long process and subject to complications. Therefore, for the development and approval for clinical use of new products aimed at human and animal health, especially long-term implantable medical devices (classes III and IV of intrinsic risk), systematic analysis of biocompatibility and bioactivity is required, which guarantees the safety and efficacy of treatment, which are essential to ensure that these products do not pose health risks. Furthermore, these analyses are essential for product registration by the National Health Surveillance Agency (ANVISA), which provides adequate certification that allows the commercial and clinical use of the product. During the PIPE Entrepreneur training, 101 professionals from different areas were interviewed to validate this value proposition. The interviews began with dental surgeons and implant dentists as their initial target, but as the interviews were carried out, it was possible to observe the breadth of segments of health professionals and the medical-dental and veterinary industry and, consequently, the markets that we could explore. It was observed that there is a much larger market, and that this solution is interesting for several customer segments. Therefore, it is clear that there is room for the launch of new products, especially innovative materials. An extensive search was also carried out for patents for similar products, demonstrating that there is no previous use of bioceramic composites associated with plant extracts similar to the one proposed here. To guarantee ownership of intellectual property protection not only for the final product but also for the mechanisms related to the different technological processes, a patent application has already been filed via PCT. Once granted, the patent will be a competitive instrument linked to the market strategy of this new company. Given the globalized, competitive market and the abundance of technological innovations, it is expected that this prototype will be produced on a large scale at a competitive cost. Given the significant results obtained in Phase 1, this project is intended to continue this study, supported by FAPESP, in Phase 2, with a view to the transition from applied research to experimental development. Based on the knowledge explored in previous TRLs, we aim to carry out systematic development analyses involving laboratory-scale tests and the development of prototypes, among others, aiming to reach TRLs of greater technological maturity. The results of Phase 2 will support the conduct of future clinical studies and the application for certification of the product's efficacy and safety for registration of medical, veterinary, and dental products. Given the technological and marketing challenges we face, we requested Phase 2 of the PIPE FAPESP program. (AU)