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
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.
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.
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.
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.
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.
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.