Periodic Reporting for period 2 - RePace (Rebuilding Joint Surface to Prevent Pain and Immobility)
Período documentado: 2023-01-01 hasta 2024-06-30
The knee joint is an organ, and when organs fail, difficulties begin. Joint failure does not kill you, but it controls your life. Joint pain and loss of function significantly lower your quality of life and prevent you from doing the things you love. Healthy cartilage is a vital part of a healthy joint. Over time, cartilage defects progress to joint degeneration and osteoarthritis (OA), which today is the leading cause of disability among adults.
Joint preservation is the future of orthopedics. Over 650 million people suffer from knee joint degradation globally. The key drivers for this growth are an aging population, escalating obesity, and the desire for more active years in life. In addition, sports and related trauma drive cartilage destruction, increasing the need for early interventions that enable a quick return to sports and long-term maintenance of the results.
Early interventions to preserve joint structures and stop degradation are of paramount need. Askel’s COPLA® solution has been designed to address the key unmet needs of surgical cartilage repair:
- Science-based solution: The product is based on patented technology created by multidisciplinary academic research.
- Universal product: An affordable and available product that can be used for various lesion sizes by any orthopedic surgeon.
- Surgical simplicity: Implanted in a single surgery with an easy-to-adapt technique using existing instruments.
- Affordability: An off-the-shelf product with favorable production economics guarantees affordable pricing.
- Patient benefits: The exclusive promise of immediate full weight-bearing of the operated leg after surgery allows patients to begin early rehabilitation with fast pain relief and functional recovery.
- Joint preservation: Early intervention can preserve the damaged joint surface and postpone or even eliminate the need for total knee replacement surgery. The health economic benefits are evidently extensive.
The market for surgical knee cartilage repair is large and growing. For example, in the US alone, approximately one million cartilage repair surgeries are performed annually. Of these, 600,000 are estimated to be treatable with COPLA®. Askel can serve this market with its proprietary and industrially scalable in-house production capability.
We aim to become the gold standard of early surgical cartilage repair, and the RePace project has been a crucial component in reaching this goal.
Joint preservation is the future of orthopedics. Over 650 million people suffer from knee joint degradation globally. The key drivers for this growth are an aging population, escalating obesity, and the desire for more active years in life. In addition, sports and related trauma drive cartilage destruction, increasing the need for early interventions that enable a quick return to sports and long-term maintenance of the results.
Early interventions to preserve joint structures and stop degradation are of paramount need. Askel’s COPLA® solution has been designed to address the key unmet needs of surgical cartilage repair:
- Science-based solution: The product is based on patented technology created by multidisciplinary academic research.
- Universal product: An affordable and available product that can be used for various lesion sizes by any orthopedic surgeon.
- Surgical simplicity: Implanted in a single surgery with an easy-to-adapt technique using existing instruments.
- Affordability: An off-the-shelf product with favorable production economics guarantees affordable pricing.
- Patient benefits: The exclusive promise of immediate full weight-bearing of the operated leg after surgery allows patients to begin early rehabilitation with fast pain relief and functional recovery.
- Joint preservation: Early intervention can preserve the damaged joint surface and postpone or even eliminate the need for total knee replacement surgery. The health economic benefits are evidently extensive.
The market for surgical knee cartilage repair is large and growing. For example, in the US alone, approximately one million cartilage repair surgeries are performed annually. Of these, 600,000 are estimated to be treatable with COPLA®. Askel can serve this market with its proprietary and industrially scalable in-house production capability.
We aim to become the gold standard of early surgical cartilage repair, and the RePace project has been a crucial component in reaching this goal.
All the key project goals were reached by the end of the project. The main goal was to set up and run the first-in-human trial to prove the safety of COPLA® in human patients. This goal was met, and the safety of COPLA® was demonstrated.
Key achievements during the project include:
- Clinical Development Strategy: Established to provide a comprehensive road map from the first-in-human trial to the commercial use of COPLA®.
- In-house COPLA® Production: Further developed and its capacity strengthened.
- Quality Management System (QMS): Set up and deployed as a company-wide management system to ensure the quality of all operations.
- Pivotal Trial Preparations: Progressing well, with patient recruitment set to start in 2025.
- Conferences Attendance: Key conferences in the field attended to build awareness among orthopedic surgeons and other stakeholders.
- Partnership Dialogues: Initiated with top-tier partner candidates for future collaboration.
The impact of the project has been tremendous for the company. The successful completion of the project objectives has mitigated major risks and positioned the company better for future financing, bringing us multiple steps closer to market entry.
Key achievements during the project include:
- Clinical Development Strategy: Established to provide a comprehensive road map from the first-in-human trial to the commercial use of COPLA®.
- In-house COPLA® Production: Further developed and its capacity strengthened.
- Quality Management System (QMS): Set up and deployed as a company-wide management system to ensure the quality of all operations.
- Pivotal Trial Preparations: Progressing well, with patient recruitment set to start in 2025.
- Conferences Attendance: Key conferences in the field attended to build awareness among orthopedic surgeons and other stakeholders.
- Partnership Dialogues: Initiated with top-tier partner candidates for future collaboration.
The impact of the project has been tremendous for the company. The successful completion of the project objectives has mitigated major risks and positioned the company better for future financing, bringing us multiple steps closer to market entry.
The main impact of the RePace project is based on the results of the Pilot Trial, specifically the demonstration of the safety of COPLA® in human patients. These results will serve as the cornerstone for building the Pivotal Trial, which aims to establish the clinical, health economic, and commercial impact of COPLA®.
To achieve the company’s vision, several actions must be taken in the coming years, including:
- Securing funding for the Pivotal Trial and early commercialization
- Strengthening intellectual property rights (IPR)
- Conducting the Pivotal Trial successfully
- Gaining marketing authorization in Europe and the US
- Executing a successful launch in the selected initial markets to demonstrate COPLA®'s commercial potential
These actions will require extensive support from various stakeholders to ensure success.
To achieve the company’s vision, several actions must be taken in the coming years, including:
- Securing funding for the Pivotal Trial and early commercialization
- Strengthening intellectual property rights (IPR)
- Conducting the Pivotal Trial successfully
- Gaining marketing authorization in Europe and the US
- Executing a successful launch in the selected initial markets to demonstrate COPLA®'s commercial potential
These actions will require extensive support from various stakeholders to ensure success.