The InDx CMC Implant. A new treatment for thumb base joint arthritis.

Project Information

InDx CMC Implant

Grant agreement ID: 190131605

DOI

10.3030/190131605

Project closed

EC signature date 16 November 2022

Start date 1 November 2022

End date 30 April 2024

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 658 337,50

EU contribution

€ 2 500 000,00

Coordinated by

LOCI ORTHOPAEDICS LIMITED
Ireland

Periodic Reporting for period 2 - InDx CMC Implant (The InDx CMC Implant. A new treatment for thumb base joint arthritis.)

Reporting period: 2023-08-01 to 2024-04-30

Summary of the context and overall objectives of the project

Thumb base joint arthritis causes pain and significant restrictions of hand use.
Approximately 5% of the population of the EU are affected with this condition to the extent that they seek medical intervention.
The pain caused by this condition causes a decreased power of the hand, difficulties with activities of daily living, and significant impact on patient reported quality of life.
Loci Orthopaedics have developed the first implant for this condition that is evidence-based and mimics the natural biomechanics of the hand, to not only reduce pain, but also to fully restore the natural motions of the joint, thereby restoring hand power and function.
This implant is the InDx Implant.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Over the course of this project, Loci Orthopaedics has run a clinical investigation to demonstrate the positive clinical outcomes of the implant.
The clinical outcome shave been very positive with the implant out-preforming implant and non-implant competitors across key domains of pain reduction, hand function and quality of life improvement.
The company will use this data to advance regulatory clearance in the EU as well as the US.
In parallel, the company has finalized its reimbursement strategy to facilitate commercialisation post-regulatory approval.
In addition, the company has added to its existing intellectual property portfolio and Health Economics dossier.
Planning for EU and US commercialisation will be initiated, and additional private equity funding added.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The clinical trial has demonstrated the positive clinical outcomes of the device.
These clinical outcomes can be analyzed against clinical outcomes for other relevant implants and surgical interventions.
Preliminary analysis has shown that the InDx Implant has performed excellently in comparison to all other surgical intervention options.
This data will also help formulate additional clinical data planning which is currently in advanced stages.
EU and US Regulatory clearances will facilitate the commercialisation of the product, with reimbursement, Health Economic, and commercialisation planning during the project facilitating this overall strategy.