Periodic Reporting for period 2 - SMART-SOFT (Inossia Cement Softener - a new and unique additive to bone cements to revolutionise the treatment of vertebral fractures in osteoporotic patients)
Berichtszeitraum: 2024-08-01 bis 2025-07-31
Osteoporosis affects 27.5 mln people in Europe and 14 mln people in the US (2020) and is the cause of almost 9 million bone fractures each year (Johnell et al Osteoporos Int. 2006). About 1 in 3 women and 1 in 5 men over 50 years old will suffer a spinal fracture due to weakened bone (Kanis et al Osteoporos Int. 2000).
Degenerative discs affect 40% of adults over age 40, and by age 80, the number increases up to 80% (Medical Advisory Secretariat Ont Health Technol Assess Ser. 2006).
Spinal fractures are treated by injecting bone cement into the broken vertebral body. However, current bone cements are too hard and stiff for the osteoporotic, brittle bone, causing new fractures in up to 40% of the already treated patients.
Degenerative disc disease is treated by large surgery, unsuitable for elderly patients, and injections of corticoids for pain-relief to the joints next to the damaged disc. There is no bone cement approved for this indication.
Inossia AB (www.inossia.com) has invented the Inossia® Cement Softener (ICS), a smart component which works generically to soften all the traditional PMMA-based bone cements that have been in use for over 60 years.
The disruptive character of our innovation allows for its application in the treatment of spinal fractures and degenerative discs disease. ICS can be used with acrylic bone cement to modify its properties in order to make it less stiff and more suitable for osteoporotic bone.
By replacing standard bone cements with softer cements enabled by ICS, we estimate to reduce the risk of new unnecessary vertebral fractures (to be confirm in the clinical study conducted under this grant). This technology was granted Break-through Device Desigantion by the FDA in June 2025.
Our ambition is to clear Inossia® Cement Softener as the first ever bone cement softener on the market and also to develop the first soft bone cement approved for the treatment of degenerative disc disease.
ICS has thus the potential to become a true game-changer in the field of vertebral augmentation and intervertebral disc degeneration treatments.
Degenerative discs affect 40% of adults over age 40, and by age 80, the number increases up to 80% (Medical Advisory Secretariat Ont Health Technol Assess Ser. 2006).
Spinal fractures are treated by injecting bone cement into the broken vertebral body. However, current bone cements are too hard and stiff for the osteoporotic, brittle bone, causing new fractures in up to 40% of the already treated patients.
Degenerative disc disease is treated by large surgery, unsuitable for elderly patients, and injections of corticoids for pain-relief to the joints next to the damaged disc. There is no bone cement approved for this indication.
Inossia AB (www.inossia.com) has invented the Inossia® Cement Softener (ICS), a smart component which works generically to soften all the traditional PMMA-based bone cements that have been in use for over 60 years.
The disruptive character of our innovation allows for its application in the treatment of spinal fractures and degenerative discs disease. ICS can be used with acrylic bone cement to modify its properties in order to make it less stiff and more suitable for osteoporotic bone.
By replacing standard bone cements with softer cements enabled by ICS, we estimate to reduce the risk of new unnecessary vertebral fractures (to be confirm in the clinical study conducted under this grant). This technology was granted Break-through Device Desigantion by the FDA in June 2025.
Our ambition is to clear Inossia® Cement Softener as the first ever bone cement softener on the market and also to develop the first soft bone cement approved for the treatment of degenerative disc disease.
ICS has thus the potential to become a true game-changer in the field of vertebral augmentation and intervertebral disc degeneration treatments.
This project has been a success where the main part of the planned activities have been performed according to plan and delivered in time.
We have developed an IP management plan and filed 4 new patents during the course of this project.
We have also worked on our supply chain and developed a supply chain strategy.
We have put a lot of effort into the production, by improving packaging and upscaling of production capacity.
Four deliverable connected to the production were all delivered in time; updated production documentation, process validation, sterilization validation and production of sharp products were all done in time and according to plan.
We have also worked very hard with our most important task: the clinical study to prove the safety and efficacy of the Inossia Cement Softener when mixed in a bone cement. The target is to show less new fractures in the group of patients with spinal fractures who are treated with bone cement including Inossia Cement Softener compared to a control group who are treated with ordinary bone cement without softener.
In the end of September 2023 we completed the activation of all required clinical sites which was also a deliverable in this project, delivered on time according to plan. Nine clinics were activated in total and spread over 4 countries.
In April 2024, we had completed the recruitment of 196 patients and in April 2025 we had collected 1-year follow-up data from most of the patients.
In June 2025, the Inossia Cement Softener was granted the Break-through Device Designation by the FDA and met the most important milestone for the company so far!
Now we are patiently waiting for the final analyses of the one-year follow-up results which will prove safety and efficacy of our product and give us market approval for our first product.
We have prepared the Technical Documentation for CE certification and FDA approval of the Inossia Cement Softener as far as possible before the clinical results are availible and we look forward to the future!
We have developed an IP management plan and filed 4 new patents during the course of this project.
We have also worked on our supply chain and developed a supply chain strategy.
We have put a lot of effort into the production, by improving packaging and upscaling of production capacity.
Four deliverable connected to the production were all delivered in time; updated production documentation, process validation, sterilization validation and production of sharp products were all done in time and according to plan.
We have also worked very hard with our most important task: the clinical study to prove the safety and efficacy of the Inossia Cement Softener when mixed in a bone cement. The target is to show less new fractures in the group of patients with spinal fractures who are treated with bone cement including Inossia Cement Softener compared to a control group who are treated with ordinary bone cement without softener.
In the end of September 2023 we completed the activation of all required clinical sites which was also a deliverable in this project, delivered on time according to plan. Nine clinics were activated in total and spread over 4 countries.
In April 2024, we had completed the recruitment of 196 patients and in April 2025 we had collected 1-year follow-up data from most of the patients.
In June 2025, the Inossia Cement Softener was granted the Break-through Device Designation by the FDA and met the most important milestone for the company so far!
Now we are patiently waiting for the final analyses of the one-year follow-up results which will prove safety and efficacy of our product and give us market approval for our first product.
We have prepared the Technical Documentation for CE certification and FDA approval of the Inossia Cement Softener as far as possible before the clinical results are availible and we look forward to the future!
Commercialisation of Inossia Cement Softener will impact the market dynamics in the following ways:
- Our innovation will increase competition in the industry. Currently, all available bone cements on the market cause severe additional complications in the treatment of osteoporotic fractures since they are too hard and too strong compared to the brittle bone in the osteoporotic spine.
There is no bone cement approved for the treatment of degenerative disc disease.
Commercialisation of the Inossia Cement Softener will revolutionise the bone cement market and the treatment quality that will trigger the competitors to expedite R&D activity
- It will strengthen Europe’s global position and enhance sovereignty of the European manufacturing on the bone cement market which is currently dominated by North America
- Currently, there is no cement additive on the market that is compatible with all the existing PMMA bone cement products
To be able to reach success and the maximum impact possible the need of excellent clinical data is crucial and Inossia is currently performing one of the largest randomized controlled trials ever done on bone cements. Funding is a key component for success as well as market approval and reimbursement strategies in key countries, such as Germany, Spain and the US.
- Our innovation will increase competition in the industry. Currently, all available bone cements on the market cause severe additional complications in the treatment of osteoporotic fractures since they are too hard and too strong compared to the brittle bone in the osteoporotic spine.
There is no bone cement approved for the treatment of degenerative disc disease.
Commercialisation of the Inossia Cement Softener will revolutionise the bone cement market and the treatment quality that will trigger the competitors to expedite R&D activity
- It will strengthen Europe’s global position and enhance sovereignty of the European manufacturing on the bone cement market which is currently dominated by North America
- Currently, there is no cement additive on the market that is compatible with all the existing PMMA bone cement products
To be able to reach success and the maximum impact possible the need of excellent clinical data is crucial and Inossia is currently performing one of the largest randomized controlled trials ever done on bone cements. Funding is a key component for success as well as market approval and reimbursement strategies in key countries, such as Germany, Spain and the US.