Periodic Reporting for period 3 - InDx (InDx - an innovative implant that restores natural motion to patients with thumb base joint arthritis)
Reporting period: 2020-07-01 to 2020-12-31
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.
There are over 200,000 surgical procedures performed each year across the US and EU for this condition. However, current treatment options are sub-optimal with uncertain clinical outcomes. This leads to patients choosing to put up with the discomfort and not progressing to surgical treatment. Surgeons report having to wait until a patient's clinical symptoms are so bad, that any improvement with a surgical intervention will be seen in a positive light.
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. COVID-19 has been hard for many people, but especially those with this condition who find simple tasks as getting dressed without assistance a major struggle. 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, world-leading, and complementary companies, who can significantly accelerate the InDx implant to market to meet a huge unmet clinical need. 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 is an expert provider of strategic market access and business development services for medical device companies and has a strong expertise in medical device design, project management and global commercialisation.
Product development is now finalised, InDx Implant has reached Technical Design Freeze status, and a full build of clinical prototypes has been successfully completed, packaged and sterilised, and is ready for use in the upcoming clinical trial. A series of Wear, Fatigue and Biocompatibility testing has been successfully completed in accordance with established validation and verification protocols and regulatory requirements. A Quality Management System has been put in place to ensure all Design History File documentation is appropriately tracked and recorded.
The results of the performance tests, in combination with the outcomes of several other project tasks, enabled the preparation and submission of a significant regulatory body approval application in April 2020, three months ahead of schedule. The consortium has received National Competent Authority and Research Ethics Committee approvals from the relevant bodies in the proposed location of the First in Human Clinical Investigation. These approvals will enable the commencement of the Clinical Investigation with first patient enrolment expected in Q1 of 2021. The Investigation will provide the clinical safety and efficacy data required to promote surgical adoption of the implant and support further regulatory approval submissions.
These approvals represent an important step in enabling the commercialisation strategy for the InDx Implant which is closely linked to the regulatory pathway in key target markets.
In line with the Intellectual Property Rights strategy of the consortium, significant patents been granted protecting the core IP of the InDx Implant, associated equipment and applications. These patents ensure IP protection in relevant geographical market areas.
A secure Data Management System has been put in place to ensure the capture, processing, usage and storage of 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.
Dissemination and Communication of the project progress, key events, and outcomes to date have taken place through the project website, across a range of social media platforms, industry publications, and by representation of the project at Orthopaedic and MedTech conferences, both on an EU and global stage.
The consortium continues to build and strengthen Key Opinion Leader relationships and support the commercialisation strategy through early adopters for the InDx implant.
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.