With the completion of the InDx FTI project, the InDx CMC Implant is well on its way to becoming an innovative, disruptive entrant into the orthopaedic extremities marketplace, offering a safe and effective treatment to the millions of patients worldwide suffering from the debilitating effects of thumb-base arthritis.
Over the course of the the InDx project, the consortium has achieved significant progress in the development, testing, validation, regulatory approval, IP protection and dissemination of the InDx CMC Implant. All of this been achieved against a background of severely challenging working conditions due to the worldwide restrictions imposed to combat the COVID-19 pandemic.
A series of Wear, Fatigue and Biocompatibility testing has been successfully completed in accordance with established validation and verification protocols and regulatory requirements. A QMS has been put in place to ensure all Design History File documentation is appropriately tracked and recorded. Following a request by the FDA, a rigorous and comprehensive series of additional performance and biocompatibility testing were conducted. These tests will be a key part of the FDA regulatory submission.
The consortium has received approvals from the relevant bodies in the proposed location of the First in Human Clinical Investigation, which started with first patient enrolment in 2021. Initial results of the study are positive and indicate the potential for real impact and benefit to patients. The clinical data will also be used to advance regulatory submission to an EU Notified Body for CE marking and regulatory clearance.
A secure Data Management System has been put in place to ensure all patient data gathered during the Clinical Investigation is appropriately and securely handled in compliance all relevant regulations. A Data Protection Officer has been appointed to oversee data protection strategy and ensure implementation of, and compliance with GDPR requirements as well as the ethics requirements laid down in the project guidelines. A full build of clinical prototypes has been successfully completed, packaged and sterilised, and has been shipped to the site of the clinical trial.
A Final 5-year business plan has been developed which details the commercialising strategy for the InDx implant including the sales & marketing plan, regulatory strategy, financial projections and the commercial management of a focussed campaign to target markets in European, U.S. and Asian markets.
Dissemination and communication of activities have been conducted throughout the InDx project to meet the main objective to raise awareness of the InDx implant to key commercialisation stakeholders and ensure wide-spread dissemination of the overall project results to relevant parties at both an EU and international level.
The InDx Project website has been updated with publications, presentations, awards and conference attendances. In addition, updates have been posted on social media though the InDx Project LinkedIn and Twitter accounts on key milestone events of the participant companies, as well as any relevant research and industry trends.
Loci Orthopaedics has participated in key Orthopaedic and MedTech conferences both on an EU and global stage. Even though the scheduling and format of international conferences have been greatly affected by COVID-19 related travel restrictions, Loci Orthopaedics continued to attend key conferences such as as the American Society for Surgery of the Hand (ASSH) conference in San Francisco in September 2021.
