Inossia, a Swedish company, has invented the Inossia Cement Softener, an additive that makes the standard PMMA bone cement used to repair broken vertebrae less stiff, so that it better matches brittle osteoporotic bone. The company's final report says current cements are "too hard and stiff for the osteoporotic, brittle bone, causing new fractures in up to 40% of the already treated patients". Inossia was selected in the EIC Accelerator's January 2023 cut-off for blended finance and received an EU grant of €2.30 million for SMART-SOFT, a €3.28 million project that ran from August 2023 to July 2025, according to CORDIS.
The project is closed. Its final report states that all nine clinics in four countries were activated by September 2023, that 196 patients were recruited by April 2024, that one-year follow-up data was collected from most of them by April 2025, and that the technical documentation for CE certification and FDA approval was prepared "as far as possible before the clinical results are available", according to the CORDIS reporting page. The pivotal study reached primary completion on 20 October 2025, but no results have been posted, according to ClinicalTrials.gov.
Company file
- Legal entity
- Inossia AB, 556923-9097, Stockholm
- Product
- Inossia Cement Softener (investigational)
- Pivotal study
- NCT05676320, 203 patients
- US pathway
- Breakthrough designation; planned 510(k)
- Quality system
- ISO 13485, recertified 2024
- Staff
- 4 in 2025
- EIC funding
- Blended finance; €2.30M grant
Where Inossia Stands Now
In April 2025 Inossia closed a rights issue at SEK 10.3 million, double its SEK 5 million target, partly "to finalize the clinical report from Inossia's pivotal clinical study, which will serve as the foundation for regulatory applications in both the US and EU", according to its announcement. In June 2025 the FDA granted the softener Breakthrough Device Designation, supporting a planned 510(k) submission. The company's news page has no update since July 2025.
"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."
Inossia, final report to the EIC, 2025The Technology: Making Cement Match Bone
Broken vertebrae are often treated by injecting bone cement to stabilise them. Inossia's additive works with existing PMMA cements to lower their stiffness and strength so they behave more like the surrounding bone. The pivotal study compares patients treated with ordinary cement against those whose cement included the softener, with the aim of showing fewer new fractures.
What the EIC Award Promised, and What the Record Shows
The award centred on the clinical study to prove safety and efficacy, plus production scale-up and regulatory preparation. The operational work was delivered on time, the company says, and it filed four new patents. The result that matters, whether the softener reduces new fractures, is not public almost a year after the study's primary completion.
- Trial recruitmentDelivered196 by April 2024.
- Production validationDeliveredProcess and sterilisation.
- Proof of efficacyUnverifiedResults not published.
- Market approvalNot yetCE and 510(k) pending.
The Money
Inossia's accounts show a net loss of SEK 3.7 million in 2025 on revenue of SEK 12.6 million, and equity of SEK 15.3 million, according to hitta.se. The free data does not show how much of that revenue is grant income; the company has four employees and no approved product. Whether the EIC Fund invested is not public.
What Cannot Be Checked
Questions for the EIC
What the pivotal trial showed, why results are not yet public, when CE and FDA submissions will be made, and whether the EIC Fund invested are not public.
Why Europe Should Care
The final report cites 27.5 million people with osteoporosis in Europe and says one in three women and one in five men over 50 will suffer a spinal fracture. A cement that prevents follow-on fractures would matter to many of them. The EIC funded the final stages of the trial that should answer the question; the answer has not been shared.
What the award promised
A clinical study proving that softer cement reduces new spinal fractures, leading to market approval.
What the record shows
A completed 203-patient trial, FDA Breakthrough status, and no published results or approval.
The Verdict
Waiting on the answer
Inossia ran the trial the EIC funded. Until it publishes the results, nobody outside the company knows whether the softener works.
Inossia and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
