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SMART-SOFT · Project

Softening Additive for Bone Cements to Prevent Secondary Spinal Fractures

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Imagine filling a crack in a fragile porcelain vase with super-hard industrial glue; the glue is so stiff that it actually causes the vase to crack further. This technology is like a softener for that glue, making it flexible enough to match the surrounding bone. It stops the cement from being too rigid, which prevents new fractures from forming after surgery.

By the numbers
50-75%
reduction in cement stiffness
75%
reduction in risk of new unnecessary vertebral fractures
40%
rate of new fractures in patients treated with current cements
The business problem

What needed solving

Current bone cements are too stiff for osteoporotic bone, causing new fractures in up to 40% of treated patients. There is also a lack of approved bone cements for treating degenerative disc disease in elderly patients.

The solution

What was built

A smart additive (Inossia Cement Softener) that modifies PMMA-based bone cements to be less stiff. The project also delivered an IP management plan, 4 new patents, and a supply chain strategy.

Audience

Who needs this

Orthopedic medical device companiesSpinal surgery clinicsBone cement manufacturersHealth insurance payers
Business applications

Who can put this to work

Medical Devices
enterprise
Target: Orthopedic implant manufacturer

If you are an implant manufacturer dealing with high rates of secondary fractures in elderly patients — this project developed a cement softener that reduces the risk of new unnecessary vertebral fractures by 75%. This allows for a safer product offering in the vertebral augmentation market.

Pharmaceuticals
enterprise
Target: Specialized bone health drug developer

If you are a pharma company dealing with the limitations of osteoporosis drug treatments — this project developed a smart component that lowers cement stiffness by 50-75%. This provides a physical intervention to complement chemical treatments for spinal fractures.

Healthcare Providers
mid-size
Target: Private surgical clinic network

If you are a clinic operator dealing with high rehospitalization rates for spinal patients — this project developed a softener that adjusts cement to the bone's stiffness. This reduces the need for costly retreatment of already treated patients.

Frequently asked

Quick answers

What is the cost or pricing of the softener?

Based on available project data, specific pricing or cost per unit is not disclosed.

Is the technology ready for industrial scale production?

The project reports that they have worked on their supply chain and developed a supply chain strategy to support production.

What is the IP and licensing status?

The project has developed an IP management plan and filed 4 new patents during the project period.

What regulatory milestones have been achieved?

The technology was granted Break-through Device Designation by the FDA in June 2025.

What is the timeline for market entry?

The project period runs from August 2023 to July 2025, with the ambition to clear the first ever bone cement softener on the market.

Consortium

Who built it

The project is led by a single SME, Inossia AB from Sweden, with a 100% industry ratio. This lean structure suggests a highly focused commercial drive, as the company manages all IP, supply chain strategy, and regulatory filings internally without academic partners.

How to reach the team

Contact Inossia AB via their official website for licensing inquiries.

Next steps

Talk to the team behind this work.

Contact us to explore licensing opportunities for this FDA Break-through technology.

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