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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - InDx (InDx - an innovative implant that restores natural motion to patients with thumb base joint arthritis)

Teaser

Summary

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.

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.

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.

Work performed

The project officially launched in July 2019 with a kick-off meeting of consortium partners held in Dublin.
Activity in the first six-month period of the project has focused on finalisation of the product development and performance testing of materials and biomechanics. The results of this activity will lead to approval for a First in Human Clinical Study that will commence in 2020. Dissemination and communication of the project activity is ongoing with the creation of a project website and representation of the project at orthopaedic and medtech conferences, both on an EU and global stage such as the American Society for Surgery of the Hand (ASSH) Annual meeting in Las Vegas in September 2019 and Med in Ireland Conference in Dublin October 2019.

The InDx Implant is intended to be provided as a sterile device to the surgeon for clinical use. A significant element of the product development at this stage of the project involved the creation of appropriate and compatible packaging and sterilisation and labelling specifications bearing in mind regulatory and standards requirements for each of these elements. The labeling for the implant was successfully finalised in line with specific regulatory requirements.

It is a requirement of regulatory authorities that the materials from which the InDx device is fabricated are suitable to the application and that the material demonstrates sufficient robustness to survive implantation over the predicted lifetime of the device. To this end, a batch of pre-clinical investigation units were produced to allow the performance testing of materials and biomechanics. The test methodologies and protocols for the relevant test regimes were developed in order to complete a suite of wear, fatigue, and biocompatibility testing that are a requirement for relevant regulatory clearance, as well as for ethics approval for the Clinical Investigation that will take place in 2020.

Monthly project meetings have been held since the Kick-off Meeting in order to report internally on progress towards the objectives for each task, identify and mitigate against any anticipated risks, promote good and timely communication between partners and to ensure integrated progress throughout each work package. Internal project resources have been created to share documents, facilitate communication between partners and track progress of tasks, deliverables, reporting and administration as well as any relevant project dissemination and communication activities.

A unique visual identity has been created for the project. This identity can be used across all project reports, presentations and deliverables to give consistency and professionalism to project outputs. The InDx Project website is now live containing information about the project, consortium partners and ongoing activity. A blog facility allows updating of the site with relevant dissemination activity that has taken place across the project. LinkedIn and Twitter accounts have also been created for the InDx Project to assist in the dissemination and communication of the project.

Final results

The InDx implant is the closest any implant has ever come to fully reproducing the motion of the normal thumb base joint. All other implants constrain the joint in one plane or another and this restriction of motion over time leads to an unacceptably high failure rate of current implant designs.

Loci Orthopaedics has conducted an extensive clinical literature review and deep dive on competitive product analysis, as well as extensive interviews with international key opinion leader hand surgeons. This led the team to design the first evidence-based implant around the natural biomechanics of the joint to avoid all the failure mechanisms of previous offerings. The unique features of the InDx implant maintain most of the natural motions of the joint and will provide excellent clinical outcomes while significantly decreasing the risk of implant failure.

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 patientâ€™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.