Patient specific biomimetic materials for bone regeneration

Project Information

Bone3Dmatch

Grant agreement ID: 858886

DOI

10.3030/858886

Project closed

EC signature date 24 April 2019

Start date 1 May 2019

End date 30 September 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 136 914,00

EU contribution

€ 795 839,80

Coordinated by

MIMETIS BIOMATERIALS SL
Spain

Periodic Reporting for period 3 - Bone3Dmatch (Patient specific biomimetic materials for bone regeneration)

Reporting period: 2021-07-01 to 2022-09-30

Summary of the context and overall objectives of the project

Bone3Dmatch is Mimetis’ latest innovation: it combines the latest advances in biomaterials with 3D-printing technology. This unique product is osteo-regenerative and personalized to each patient using through 3D printing technology. This disruptive innovation is three-fold:
1) Materials science: Using the proprietary biomimetic technology, the biomaterial mimics the bone creation conditions (aqueous composition and low-temperature processing), so that bone cells recognise the implant as natural, original bone. This accelerates the bone regeneration and shortens the patient’s recovery.
2) Manufacturing process: The design and production of bone graft substitutes are fully adapted to the patient's anatomy using 3D-printing technologies.
3) Value chain: The innovation allows offering patient-specific bone grafts under 72h after the approval of design by the surgeon.

Bone grafts substitutes from natural sources (human or animal) are clinically efficient but raise major concerns about ethics, risk of disease transmission, morbidity and cost. Bone graft substitutes from synthetic sources solve these issues but lack clinical efficacy. Patient specific solutions are made of foreign materials to the body, causing infection and failure. Our solution to this problem is biomimicry: bone graft substitutes that mimic the mineral phase of the bone and are included in the physiological remodelling of the bone.

The project will position Europe at the forefront of bone regeneration medicine. It will also bring substantial benefits to the lives of millions of people worldwide who suffer from bone defects (2.2M bone grafting procedures each year) due to illness, trauma and especially ageing. In the mid term, the ambition of the company is to offer a cost-efficient patient-specific bone regeneration solution in combination with surgical guides which opens the potential for significant cost reduction focused especially on hospitals and the national health services.

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

On the first period of the project Mimetis was focused on obtaining the license for manufacturing patient specific devices, developing all the documentation required for the clinical trial for the patient specific solution and setting up the strategy for the launch of Bone3Dmatch commercially
Mimetis held meetings with several KOL and renown hospital in the CMF and orthopedic field in order to present the solutions and its advantages.
On the second period the focus was on starting the clinical trial, obtaining certification as a class III medical device for both product and migration to new medical device regulation.
The validation of the new packaging for orthopedics is in the final stages.

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)

Over 2 million bone grafting procedures are performed annually worldwide nearly half of them in the EU, being the 2nd most transplanted tissue after blood. Bone defects caused by trauma, osteoporotic fractures, infection, tumour or cyst resection pose a great clinical and socio-economic problem. The project will helps with this by offering a innovative solution that is easy to use, that offers synchronization between bone formation and graft resorption, that allows to have a vascularized and stable in volume bone formation and that has no side effect by being synthetic.
By the end of the project, and with the end of the clinical trial, we expect to have a fully validated patient specific solution that is efficient, safe has good performance and can be offered with a reasonable price.
In the long term, our ambition is to deploy a decentralised model where hospitals around the world are able to print their own patient-specific implants. This opens the potential for cost reductions benefiting hospitals, their patients and the national health services

Steps that show the patient specific scaffold