An innovative Turkish company specialized in additive manufacturing and medical 3D printing focuses on custom made implant production for craniomaxillofacial patients. Having several properties such as biodegradability, drug release mechanism etc. provides the advantages of a controlled mechanism for the custom made implants on the defect region. The company and its German institute partner are looking for a German SME partner experienced in biocompatibility tests and in vivo studies.
An innovative Turkish company founded in 2013 and operated in Ankara, focuses on additive manufacturing and 3D printing technologies as a result of its no geometry boundaries philosophy. The company aims to replace metal or polymeric implants with biodegradable alternatives that also have the ability to deliver drugs in a controlled fashion at the defect site, particularly for pediatric cases. Many patients need craniomaxillofacial implants as a consequence of work accidents, congenital deficiencies and diseases like cancer. Craniomaxillofacial bone loss cases are primarily operated with custom made implants metal or plastic material. However, none of the metal or non-biodegradable polymeric implants is recommended to be applied to under 20 years old patients due to faster-growing up period rather than an adult. These patients are currently treated either using patientsí own bone or using a highly customized implant made from metals or polymers. However, using patientsí own bone and using metal or polymer implants have two major downsides. These techniques cannot be applied to children since their pediatric development still continues and treatments with these techniques have the risk of infections. With the biodegradability property that the company offers, craniomaxillofacial surgery is made possible for children and it improves healing progress with bioactive agents that deliver through controlled release mechanisms. This alternative approach with a scale-up potential became possible with the advancements in 3D printing due to its groundbreaking properties in terms of customization capabilities and ease of logistics with the use of digital 3D models.
The company built a consortium partnership with a German Research Institute specialized in 3D printing technologies for this project. These partners are together searching for an R&D performing SME that conducts biocompatibility tests and in vivo studies. Also, in-vivo evaluation of implantís degradation and confirmation of the biocompatibility and osteoconductivity of the implant will be the main objective of this partner.
Project duration will be 104 weeks, the deadline for expression of interest is 22/01/2021 and the deadline for the call is 04/02/2021.
- Type of partner sought: The company/consortium expects to find a German SME partner or an academic group with SME network, that has experience in any of the below to share the work packages of the projects:
In-vivo Evaluation of implantís degradation and confirmation of the biocompatibility and osteoconductivity of the innovation.
Verifying and ensuring product performance via in-vivo animal tests.
Validating the applicability of the productization process and their stages.
- Specific area of activity of the partner: The company is looking for an SME partner experienced in biocompatibility and in vivo testing studies.
The task to be conducted are as below:
- Biocompatibility studies: Biochemical and morphological analysis for determining the material cytotoxicity on unit model prototypes will be carried out with 2 different (fibroblast and bone) cell lines in accordance with the standards. Cell-material interaction with the model bone cell line and mineral deposition will be digitized by morphological and biochemical analysis. These studies will serve as a reference for the appropriateness of implant-cell interactions and the execution of in vivo tests. The work package will involve the validation of the compatibility with cell (confirming cell-proliferation capability on the 3D printed implant), local and systemic body functions.
- In-vivo studies: Before proceeding to the clinical stages, subcutaneous and bone implantation will be performed in rats in order to validate the compatibility with cells, biological safety, biocompatibility and functionality of the implant; functional-physiological conditions, the local response of the living tissue at macroscopic and microscopic levels. Evaluation of implantís degradation and confirmation of biocompatibility and osteoconductivity will be performed in big animals through the biocompatibility assessment, investigation on the local response of living tissue, assessment of local acute response and the evaluation of osteoconductivity.
The specific objectives of the work package are as below:
Assessing biocompatibility (in vivo) after subcutaneous implantation of the 3D printed implant
Investigating biological safety, biocompatibility and functionality of the implant (in vivo); functional-physiological conditions, the local response of the living tissue at macroscopic and microscopic levels will be investigated
In vivo assessment of the acute local response (bone) in a big animal model.
In vivo evaluation of implantís degradation
In vivo evaluation of new bone formation (osteoconductivity)
Having a professional team that takes the 3d-printing into focus and has experience heavily on medical solutions and custom made implants.
The company offers a technology that shortens surgery duration by 70% and also decreases treatment costs by 30%.
The consortium offers the advantage of biodegradable alternatives of CMF (Cranio-Maxillofacial) implants to make surgery possible for pediatric cases and improve healing duration by delivering proper medicine via the drug release mechanism.
The faster the implant integration, the faster the healing progress. The biodegradability property will provide faster recovery of the defect with the natural bone structure of the patient. This challenging property will be a unique opportunity that cannot be provided by metal or other implants. This innovation will also prevent infection risks and accelerate the recovery periods.
Under development/lab tested
Evaluation scheme: The Eurostars programme follows a structure that guides you from the conception of your project to after its completion. This is divided into three parts: the application, the evaluation and the monitoring of successful projects.
Coordinator required: No