Periodic Reporting for period 5 - InDx (InDx - an innovative implant that restores natural motion to patients with thumb base joint arthritis)
Periodo di rendicontazione: 2021-07-01 al 2021-12-31
The thumb base joint is one of the most remarkably complex but elegant joints in the body. In patients suffering from thumb arthritis, the cartilage inside the joint breaks down over time, causing bone to rub against bone, which in turn leads to increasingly severe pain. Thumb arthritis can become crippling, partly because the thumb is needed so often each day, with the thumb providing about 40% of hand function. Daily tasks such as writing, turning door keys, using a phone, or getting dressed become painful and difficult.
Thumb base joint arthritis is a highly prevalent, disabling disease, with a large individual and socioeconomic burden. The population most affected by symptomatic thumb base arthritis are those aged over 65. Globally, the number of people over 65 years old is forecast to increase to almost a billion by 2030. The number of individuals whose activities are limited by arthritis is expected to rise from 2.8% to 3.6% in the same period. Owing to the increasing growth in this segment of our population, its burden on EU health care resources will increase significantly in the future.
Due to the COVID-19 pandemic, many people suffering from thumb base arthritis have particularly struggled. As people have been forced to live alone, and have decreased support from friends and family, any loss of hand function due to this condition has significantly worsened their situation. People with this condition find it difficult to open medication containers, put on face masks, and use mobile technology for communication. The InDx Project consortium are working tirelessly to bring a much-needed solution to a common and disabling condition to an already vulnerable population.
The primary objective of the InDx project is to launch the world's first implant designed to mimic the biomechanics of the thumb base joint and offer a treatment for the millions of sufferers of thumb arthritis. The commercialisation process will be linked with the regulatory pathway for market entry into the intended markets. The consortium intends to build and strengthen the clinical evidence that will drive market adoption of the system.
The InDx project consortium is a group of innovative and complementary companies. Loci Orthopaedics, the company that designed the InDx implant, is a multi-award winning medical device company specialising in the development of orthopaedic technologies to meet unmet clinical needs in the orthopaedic extremities space. EndoLab is a world leader in the provision of technical services in the context of medical device development and approval. NAMSA is a Medical Research Organisation (MRO), accelerating product development through integrated clinical and consulting services. MedVie has a strong expertise in medical device design, project management and commercialisation.
Thumb base joint arthritis is a highly prevalent, disabling disease, with a large individual and socioeconomic burden. The population most affected by symptomatic thumb base arthritis are those aged over 65. Globally, the number of people over 65 years old is forecast to increase to almost a billion by 2030. The number of individuals whose activities are limited by arthritis is expected to rise from 2.8% to 3.6% in the same period. Owing to the increasing growth in this segment of our population, its burden on EU health care resources will increase significantly in the future.
Due to the COVID-19 pandemic, many people suffering from thumb base arthritis have particularly struggled. As people have been forced to live alone, and have decreased support from friends and family, any loss of hand function due to this condition has significantly worsened their situation. People with this condition find it difficult to open medication containers, put on face masks, and use mobile technology for communication. The InDx Project consortium are working tirelessly to bring a much-needed solution to a common and disabling condition to an already vulnerable population.
The primary objective of the InDx project is to launch the world's first implant designed to mimic the biomechanics of the thumb base joint and offer a treatment for the millions of sufferers of thumb arthritis. The commercialisation process will be linked with the regulatory pathway for market entry into the intended markets. The consortium intends to build and strengthen the clinical evidence that will drive market adoption of the system.
The InDx project consortium is a group of innovative and complementary companies. Loci Orthopaedics, the company that designed the InDx implant, is a multi-award winning medical device company specialising in the development of orthopaedic technologies to meet unmet clinical needs in the orthopaedic extremities space. EndoLab is a world leader in the provision of technical services in the context of medical device development and approval. NAMSA is a Medical Research Organisation (MRO), accelerating product development through integrated clinical and consulting services. MedVie has a strong expertise in medical device design, project management and commercialisation.
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.
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.
The activities conducted, tasks accomplished and milestones realised during the project will establish the InDx CMC Implant as the gold standard for the treatment of thumb-base arthritis into the future.
As thumb base joint arthritis has a significant psychological impact on patients, the modification and amelioration of symptoms will have a positive impact on a patient’s ability to live and function independently. The current treatment options for this condition result in a significant loss of hand function as well as a recovery time of up to six months. The InDx implant has the potential to fully restore hand function with a recovery time estimated at eight weeks and become the gold standard technology for the treatment of thumb base joint arthritis. At this time, when it is more important than ever for people to be able to live independently and at times in isolation from others, the InDx Implant is a product that will relieve pain, increase hand function, and support patient independence.
As thumb base joint arthritis has a significant psychological impact on patients, the modification and amelioration of symptoms will have a positive impact on a patient’s ability to live and function independently. The current treatment options for this condition result in a significant loss of hand function as well as a recovery time of up to six months. The InDx implant has the potential to fully restore hand function with a recovery time estimated at eight weeks and become the gold standard technology for the treatment of thumb base joint arthritis. At this time, when it is more important than ever for people to be able to live independently and at times in isolation from others, the InDx Implant is a product that will relieve pain, increase hand function, and support patient independence.