Discoplasty with soft bone cement
Reference number | |
Coordinator | Inossia AB |
Funding from Vinnova | SEK 2 522 503 |
Project duration | April 2022 - October 2024 |
Status | Completed |
Venture | Swelife and Medtech4Health - Collaborative Projects for Improved Health |
Call | Swelife and Medtech4Health - Collaborative projects for better health autumn 2021 |
Important results from the project
Major steps have been taken towards i) a minimally invasive surgical method (discoplasty) suitable for the elderly patients and ii) a new soft and thick cement to fill painful discs in the back. We have done all preclinical testing and created a regulatory strategy for CE/FDA, market analysis and market introduction plan. We have a new agreement with a key opinion leader for clinical trials and have initiated a new business collaboration with a prominent European company in the sector.
Expected long term effects
The long-term effects are: - to offer immediate pain relief and better quality of life for the elderly patients with severe degenerative disc disease, which primarily affects people over 65 years of age - more efficient healthcare and lower societal costs, especially important when it comes to the current patient group, which is expected to increase exponentially over the next 25 years - that Inossia becomes a world-leading company in minimally invasive surgery/implants for the aging spine
Approach and implementation
Delivered according to plan to 4/5. 1. Project management worked well and we have met online and live. 2. Preclinical evaluation and regulatory strategy for CE/FDA done according to plan. 3. Clinical pilot study in discoplasty with a new soft cement: The Swedish Medicines Agency rejected our proposal twice and the study has now been approved in Budapest. 4. Market analysis and market introduction plan have been delivered. 5. Results have been presented at two conferences and on social media