Validation in relevant environment of customized photobiomodulation therapy stability

Abstract

Tergos Pesquisa e Ensino (Bright Photomedicine) emerged in 2014, from a desire to undertake and transform the results that Marcelo Sousa obtained in his doctorate. Before that, the treatment with photobiomodulation therapy (PBMT) did not consider the individual characteristics of the patients and the lack of predictability of its results was due to the lack of customization of light dosimetry used in therapeutic procedures. In this way, Bright aims to develop a customized photobiomodulation therapy (PBMTc) for the treatment of patients with chronic musculoskeletal pain. Widespread use of this technique could lead to simple, effective and cost-effective treatment for millions of people, resulting in billions of savings for the healthcare ecosystem. Therefore, the problem to be solved, and which will now have its solution validated, is the technology that allows customizing the dosimetry used in PBMT, making its results predictable and allowing it to be more disseminated in healthcare. Currently, Bright offers a service that makes PBMTc available for the treatment of chronic pain for various musculoskeletal pathologies. This service includes medical prescription, dose calculation, application to the patient and monitoring the therapy's evolution. The delivery of the PBMTc is done through Light Aid Pro (Anvisa Registration: 80745679003), a lighting device developed by us for the delivery of doses. This version and the various applications were revisited and launched on the market in the last 12 months, with its proper certification and clinical trial at the Hospital das Clínicas da Faculdade de Medicina da USP-SP. Bright has extensive experience in technology validation with several partners. The current project involves the coordination, deployment, monitoring and analysis of stability test data in relevant/operational environments. These tasks involve the interaction between Bright and Care Club with IDOR, in addition to internal technicians for the development of all proposed activities. The coordination and implementation activities will be carried out by Bright with IDOR. Within Bright, analysis and monitoring activities will be carried out, which refer to the specific requirements of the study; and data monitoring activities. This plan is designed in accordance with the study protocol, based on good clinical practice and applicable regulatory requirements. As a scope of work, some monitoring activities are necessary to maintain the study data. Therefore, Bright designs the study and hires the execution of IDOR. The Care Club, in the person of its research physician, Dr. Marcelo Bonadio, together with Bright's Materia Medica team, constantly evaluates the execution of the study carried out by IDOR and its professionals. Bright together with the Care Club and IDOR will refer patients for the research. Scientists from the three institutions will monitor the results and write papers for publication and validation of the clinical research and its commercial trial. (AU)