Demonstration of a fixation device for connective tissue

Project Information

WASHER-CAP

Grant agreement ID: 827965

DOI

10.3030/827965

Project closed

EC signature date 2 August 2018

Start date 1 September 2018

End date 28 February 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ABANZA TECNOMED SL
Spain

Periodic Reporting for period 1 - WASHER-CAP (Demonstration of a fixation device for connective tissue)

Reporting period: 2018-09-01 to 2019-02-28

Summary of the context and overall objectives of the project

In the field of traumatology, one of the most common lesions is the injury of the ligaments of the bone joints, and amongst them, the most frequent is the partial or complete tear of the Anterior Cruciate Ligament (ACL) of the knee. Historically ACL reconstructions were performed using a patellar tendon graft with bone blocks at the ends of the graft, fixed with interference screws (Bone-Tendon-Bone (BTB) technique). Currently about 70% of interventions, and experiencing rapid growth, are performed by using the soft tissue graft technique, which was introduced to eliminate the extraction of healthy bone and to extract the tissue from a less invasive area. The lack of a specific device for fixing the soft graft to the bone has led to continue using the interference screws, which causes possible damage to the soft graft, retention problems and loss of tension, osteolysis and osseointegration complications. Current solutions do not guarantee a good recovery of the functional capacity of the patient’s joint after the surgical intervention. Moreover, more than 50% of patients undergoing surgery for ACL restoration develop osteoarthritis and up to 30% require a second surgical intervention.

To solve these problems ABANZA TecnoMed has developed and patented a specific fixation solution, WasherCap(TM), for the soft graft technique, specifically designed so as to: Preserve the soft tissue graft not invading the area of the osteointegration; Be placed in the hard outer layer of the bone (the cortical bone), which is compact, in contrast to the porous trabecular bone; Improve the level of fixation of the graft ; Control the level of tension applied to the graft in the intervention and maintain the tension in the long-term, allowing proper functionality of the joint; . Hence, our proposed solution improves the quality of life of the patient after the intervention, favouring the return to the level of activity prior to the lesion.

The objective of this action was to analyse the feasibility of the innovation project, identify most attractive market segments, make agreements with surgeons to integrate them into the validation process and determine the business model to adopt in order to guarantee the profitability of the investment in the identified markets and future scenarios.

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

During the Phase 1 project we have analyse the market features and its segmentation, the market regulation, the competition and the differentiation of WasherCap with competitors’ devices, the IP protection strategy, the value chain of the business and our business model, the activities performed by ABANZA TecnoMed and the subcontracted activities, the partners for externalized activities, the cost structure and revenue model, the risks for introducing the solution into the market, the time to market and commercialization plan, the sales projections and the funding scheme. As a result of this study, the following activities has been identified as necessary for the Phase 2 project.

Although WasherCap is an implantable non-active device and it does not require clinical investigations to demonstrate compliance with the general safety and performance requirements of the Medical Devices Legislation (compliance can be based on technical, biological and clinical equivalence to other already certificated devices), we will carry out clinical studies in different hospitals across Europe and in USA to introduce the solution into the market.
We will also test and validate a device for femoral fixation based on the same concept of the tibial system, which has been requested by surgeons after verifying the successful performance of the WasherCap tibial device in pre-clinical tests with animals and scorps.
In addition, the current manufacturing process will be optimized, moving from a machining process to an injection process for reducing costs.

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)

Regarding technical feasibility, WasherCap has registered resistance of 200N higher than the interference screws (Gold Standard) in traction tests, which implies in some cases, up to 50% more resistance, with a average standard deviation of 8% with respect to its average load, compared to the 14-28% deviation presented by the interference screws. In addition, the WasherCap device has not migrated in traction tests with loads over 1.000N. The interference screws, in contrast, may migrate from 5mm to 7mm once implanted due to the loads to which they are subjected, causing a loss of tension in the graft and therefore affecting the stability of the joint.

WasherCap is an innovative solution with clear advantages for patients, doctors and health systems:

• Patients: the fixation of the new graft is the main factor that conditions the mechanical properties of the knee and the correct stability of the joint in the earliest postoperative period. With the WasherCap fixation, patients will be able to begin rehabilitation earlier, which is essential to minimize the loss of strength and muscle mass, and recover the level of activity prior to injury in a shorter period of time. In addition, patients have a device specifically designed for soft tissue fixation, without the need to remove the patellar tendon (Bone-Tendon-Bone), which results in higher morbidity for the patient and presents post-operative problems such as anterior knee pain.
• Doctors will have an adequate and reliable fixing device for ligaments reconstruction with soft grafts, together with specific surgical tools for the implantation of the fixing device. With WasherCap, doctors can use a specific device for soft tissue fixation, without having to use devices that were developed in the 1980s for the fixation of other types of implants.
• Health systems will save costs and increase the availability of resources by reducing second interventions associated with fixation complications (loss of tension, device migrations, reactions to foreign bodies), and by improving rehabilitation processes.

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