Periodic Reporting for period 1 - GRIP (reGeneRative bone Implant for the treatment of hip dysPlasia)
Okres sprawozdawczy: 2022-08-01 do 2024-01-31
Hip dysplasia is a common anomaly and an estimated 3,3% of the human population has a dysplasia of the hip joint, whereas incidences in the canine population are even higher (5-15%). Patients suffer from a reduced load-bearing area, often leading to osteoarthritis (OA) at a young age. The two most commonly used surgical methods to modify the effects of hip dysplasia in humans are the re-alignment of the hip socket (osteotomy) or the extension of the socket by insertion of a bone graft (shelf arthroplasty). Both are technically demanding invasive procedures either with a relatively long rehabilitation period and are not suitable for younger (paediatric) patients. Building on our previous outputs and expertise, GRIP delivers a regenerative three-dimensionally (3D)-printed bone implant that functions as a durable treatment for hip-dysplasia, obviating the need for complex and invasive surgeries and preventing the development of OA at a relatively young age.
To explore the pathway from research to innovation we will assess and validate the effectiveness of the project’s outcomes GRIP will combine technical WPs with market assessment and commercialisation activities:
1. Confirm the mechanical integrity of the GRIP implants (WP1 and WP2)
2. Evaluation in a canine animal model (WP3)
3. Perform Market assessment and commercialisation activities (WP4)
To explore the pathway from research to innovation we will assess and validate the effectiveness of the project’s outcomes GRIP will combine technical WPs with market assessment and commercialisation activities:
1. Confirm the mechanical integrity of the GRIP implants (WP1 and WP2)
2. Evaluation in a canine animal model (WP3)
3. Perform Market assessment and commercialisation activities (WP4)
1. Confirm the mechanical integrity of the GRIP implants (WP1 and WP2)
A. Design of the architecture of implant for optimal mechanical stability.
To ensure and evaluate long-term mechanical integrity and ultimate durable integration of the GRIP implants in the host, a design iteration process was carried out. This yielded a hybrid design that includes a regenerative bone part, as well as a titanium support structure.
B. Development the automated scaffold production approach of complex architectures
In the GRIP project, a new production approach has been developed that implements a personalized static support, which is made prior to the fabrication of the GRIP implant.
C. Quantify the hip dislocation potential
The implants with the hybrid designs did out-perform the ceramic-only implants. Ddislocation forces observed for the hybrid implants were within acceptable ranges justifying the start of the in vivo experiment.
2. Evaluation in a canine animal model (WP3)
To ensure the market potential of GRIP implants, regulatory bodies were consulted to determine translational regulatory requirements. A material risk assessment and toxicity evaluations were conducted according to ISO10993 guidelines, revealing toxic compounds still present in the implants after washing. This poses significant translational challenges and therefore, Therefore, we have explored an alternative (commercial) hyperelastic bone formulation.
3. Perform Market assessment and commercialisation activities (WP4)
Intellectual property rights evaluation: The process of filing a patent was initiated and other potential protection methods are considered to support this, for which scientific communication has been delayed avoiding any conflicts with the patent filing.
Market Analysis: A comprehensive market analysis was performed, and the price comparison evaluation revealed a large variation in regional prices and an increase linked with the complexity of the treatment.
Commercialisation strategy: A strategic partnership with a commercial party is now further explored, as the hybrid GRIP implant would fit well in their current product portfolio and enhances the overall combined business value.
A. Design of the architecture of implant for optimal mechanical stability.
To ensure and evaluate long-term mechanical integrity and ultimate durable integration of the GRIP implants in the host, a design iteration process was carried out. This yielded a hybrid design that includes a regenerative bone part, as well as a titanium support structure.
B. Development the automated scaffold production approach of complex architectures
In the GRIP project, a new production approach has been developed that implements a personalized static support, which is made prior to the fabrication of the GRIP implant.
C. Quantify the hip dislocation potential
The implants with the hybrid designs did out-perform the ceramic-only implants. Ddislocation forces observed for the hybrid implants were within acceptable ranges justifying the start of the in vivo experiment.
2. Evaluation in a canine animal model (WP3)
To ensure the market potential of GRIP implants, regulatory bodies were consulted to determine translational regulatory requirements. A material risk assessment and toxicity evaluations were conducted according to ISO10993 guidelines, revealing toxic compounds still present in the implants after washing. This poses significant translational challenges and therefore, Therefore, we have explored an alternative (commercial) hyperelastic bone formulation.
3. Perform Market assessment and commercialisation activities (WP4)
Intellectual property rights evaluation: The process of filing a patent was initiated and other potential protection methods are considered to support this, for which scientific communication has been delayed avoiding any conflicts with the patent filing.
Market Analysis: A comprehensive market analysis was performed, and the price comparison evaluation revealed a large variation in regional prices and an increase linked with the complexity of the treatment.
Commercialisation strategy: A strategic partnership with a commercial party is now further explored, as the hybrid GRIP implant would fit well in their current product portfolio and enhances the overall combined business value.
1. Hybrid implant
A novel implant design has been developed and tested ex vivo, for which we are exploring the patentability. The final output of the mechanical testing demonstrate that these implants have significant mechanical stability to now move forward to the in vivo evaluation.
2. Implementation of a personalized static support
The conventional additive manufacturing process is limited by its layer-by-layer fabrication technique, presenting challenges such as the need for sacrificial support structures and costly post-processing procedures to create clinically suitable shapes for medical implants. However, in the GRIP project, a novel method that incorporates a customized static support system was developed. This innovative approach brings about several benefits, including enhanced surface quality, reduced fabrication time, all the while preserving the flexibility in orientation inherent to additive manufacturing techniques. In close collaboration with our local TTO we are now explore the patentability.
3. Integrating commercially available biomaterials
As the evaluated hyperelastic bone formulation in its current form poses significant toxicological translational challenges, we have integrated an alternative hyperelastic bone formulation. We have initiated a non-inferiority study regarding our initial biomaterial for which we have performed mechanical evaluation and are currently executing an in vivo study.
A novel implant design has been developed and tested ex vivo, for which we are exploring the patentability. The final output of the mechanical testing demonstrate that these implants have significant mechanical stability to now move forward to the in vivo evaluation.
2. Implementation of a personalized static support
The conventional additive manufacturing process is limited by its layer-by-layer fabrication technique, presenting challenges such as the need for sacrificial support structures and costly post-processing procedures to create clinically suitable shapes for medical implants. However, in the GRIP project, a novel method that incorporates a customized static support system was developed. This innovative approach brings about several benefits, including enhanced surface quality, reduced fabrication time, all the while preserving the flexibility in orientation inherent to additive manufacturing techniques. In close collaboration with our local TTO we are now explore the patentability.
3. Integrating commercially available biomaterials
As the evaluated hyperelastic bone formulation in its current form poses significant toxicological translational challenges, we have integrated an alternative hyperelastic bone formulation. We have initiated a non-inferiority study regarding our initial biomaterial for which we have performed mechanical evaluation and are currently executing an in vivo study.