Periodic Reporting for period 1 - Nurami (Medical nanofiber technology to prevent cerebrospinal leakage in neurosurgeries)
Okres sprawozdawczy: 2024-12-01 do 2025-08-31
The Dura Mater is the fibrous membrane that protects the brain and spinal cord while retaining cerebrospinal fluid (CSF). Dural repair is routinely required after head or spinal trauma, neurosurgical procedures, or tumour removal. A common complication is post-surgical CSF leakage, occurring in 4–32% of neurosurgeries depending on surgical site. Such leaks can lead to extended hospitalisation, reoperations, and infection, with associated costs ~ €11,000 per patient. Beyond the economic burden, these complications cause significant physical and emotional distress for patients.
Current dural repair solutions are limited: they are expensive, require time-consuming suturing, and fail to both ensure watertight sealing and promote regeneration. As a result, leak rates remain high and the risk of post-op complications persists.
Nurami’s ArtiFix: An Innovative Solution
ArtiFix will be the first 3-in-1 nanofiber-based adhesive patch for dural repair, combining:
1. Watertight sealing of wet tissue, preventing CSF leaks.
2. Strong adhesion to the surgical site without the need for sutures.
3. Natural healing promotion, via a porous nanofiber matrix that cues cell regeneration.
The adhesive nanofiber technology uniquely allows in-situ activation of functional groups, enabling application to wet tissue surfaces — a key advantage.
Project Pathway
The project aims to reduce CSF leakage rates from up to 32% to below 1%, while lowering procedural and overall healthcare costs. By eliminating the need for separate sealants and suturing, ArtiFix will reduce direct procedural costs by approximately €280 per surgery (~30%). For a mid-sized medical centre performing 2,000 neurosurgeries annually, savings are projected at €2.56M per year.
The initial commercial pathway involves a soft launch in Centres of Excellence (CoEs) across the EU and US, leveraging key opinion leaders (KOLs) and clinical case studies to accelerate adoption. Data generated will support broader market penetration through a hybrid in-house and distributor sales model. The product initially targets high-leakage and hard-to-suture cases — spinal, infratentorial cranial, and trauma supratentorial repair — with potential expansion to the €12.5B soft tissue repair market
Projected Impact
The clinical and economic impact is substantial:
• Clinical: Improved patient safety, fewer complications, faster recovery, and reduced need to reoperate.
• Economic: Significant direct and indirect healthcare savings for hospitals and systems.
• Market: First-mover advantage in a global dural repair segment with unmet needs, enabling rapid scale-up.
Healthcare systems in the EU and US are under increasing pressure to reduce hospital stays and improve surgical outcomes while controlling costs. This aligns with policy and procurement trends favouring innovative solutions that combine improved clinical efficacy with cost savings. ArtiFix supports these goals, offering an evidence-based, surgeon-friendly product that can be rapidly integrated into standard neurosurgical practice.
Current dural repair solutions are limited: they are expensive, require time-consuming suturing, and fail to both ensure watertight sealing and promote regeneration. As a result, leak rates remain high and the risk of post-op complications persists.
Nurami’s ArtiFix: An Innovative Solution
ArtiFix will be the first 3-in-1 nanofiber-based adhesive patch for dural repair, combining:
1. Watertight sealing of wet tissue, preventing CSF leaks.
2. Strong adhesion to the surgical site without the need for sutures.
3. Natural healing promotion, via a porous nanofiber matrix that cues cell regeneration.
The adhesive nanofiber technology uniquely allows in-situ activation of functional groups, enabling application to wet tissue surfaces — a key advantage.
Project Pathway
The project aims to reduce CSF leakage rates from up to 32% to below 1%, while lowering procedural and overall healthcare costs. By eliminating the need for separate sealants and suturing, ArtiFix will reduce direct procedural costs by approximately €280 per surgery (~30%). For a mid-sized medical centre performing 2,000 neurosurgeries annually, savings are projected at €2.56M per year.
The initial commercial pathway involves a soft launch in Centres of Excellence (CoEs) across the EU and US, leveraging key opinion leaders (KOLs) and clinical case studies to accelerate adoption. Data generated will support broader market penetration through a hybrid in-house and distributor sales model. The product initially targets high-leakage and hard-to-suture cases — spinal, infratentorial cranial, and trauma supratentorial repair — with potential expansion to the €12.5B soft tissue repair market
Projected Impact
The clinical and economic impact is substantial:
• Clinical: Improved patient safety, fewer complications, faster recovery, and reduced need to reoperate.
• Economic: Significant direct and indirect healthcare savings for hospitals and systems.
• Market: First-mover advantage in a global dural repair segment with unmet needs, enabling rapid scale-up.
Healthcare systems in the EU and US are under increasing pressure to reduce hospital stays and improve surgical outcomes while controlling costs. This aligns with policy and procurement trends favouring innovative solutions that combine improved clinical efficacy with cost savings. ArtiFix supports these goals, offering an evidence-based, surgeon-friendly product that can be rapidly integrated into standard neurosurgical practice.
In addition to administrative and organizational management of the product, Nurami has advanced in its R&D efforts, in QA system improvement, has managed related project risks and continued IP management and strategic planning. Below the research and development work performed in this phase and the main achievements of these efforts:
Nurami has completed key preclinical studies demonstrating the safety and effectiveness of ArtiFix in duraplasty models, benchmarked against DuraGen Plus.
• Canine 6-week Effectiveness Study
o Large bilateral dural defects repaired with ArtiFix or DuraGen Plus.
o No deaths, major adverse events, CSF leaks, or seromas.
o ArtiFix showed strong tissue integration: M2 macrophage/giant cell response compatible with bioabsorbable healing, neovascularization, and fibrosis covering the defect.
o Most sites demonstrated complete dural regeneration; the remainder showed partial coverage.
o Histology indicated good healing comparable to controls, with brain changes attributable to surgical trauma rather than the implant.
• Rabbit Safety Study – Interim Report (2 and 13 weeks)
o No systemic health or neurological concerns observed.
o At 13 weeks, ArtiFix sites showed better-quality dura regeneration than controls, more similar morphologically to native dura.
o Inflammation decreased over time, dominated by macrophages/giant cells, consistent with bioabsorbable material remodeling.
o Bone healing progressed in both groups; findings localized to surgical sites, not to the implant.
o Data suggest ArtiFix supports superior dura repair over time, with ongoing remodeling, warranting longer-term follow-up.
Based on the results of the preclinical trials, biocompatibility testing, stability and validation, Nurami has assembled and submitted a technical file to the ethical committees in the EU towards approval to initiate the clinical trial. In a pre-IDE meeting, the FDA has approved carrying out the FiH exclusively in Europe.
Together with its CRO (KCRI), Nurami has built a detailed safety clinical investigation plan, based on discussions with regulatory authorities. Informed consent form, investigator brochure; insurance, CRF were established. The First in Human clinical study plan was submitted to 3 European sites (1 in Czech Republic and 2 sites in Poland). Preliminary approval has been received in the Czech Republic,and all approvals are projected by Nov. 30, 2025.
Nurami has completed key preclinical studies demonstrating the safety and effectiveness of ArtiFix in duraplasty models, benchmarked against DuraGen Plus.
• Canine 6-week Effectiveness Study
o Large bilateral dural defects repaired with ArtiFix or DuraGen Plus.
o No deaths, major adverse events, CSF leaks, or seromas.
o ArtiFix showed strong tissue integration: M2 macrophage/giant cell response compatible with bioabsorbable healing, neovascularization, and fibrosis covering the defect.
o Most sites demonstrated complete dural regeneration; the remainder showed partial coverage.
o Histology indicated good healing comparable to controls, with brain changes attributable to surgical trauma rather than the implant.
• Rabbit Safety Study – Interim Report (2 and 13 weeks)
o No systemic health or neurological concerns observed.
o At 13 weeks, ArtiFix sites showed better-quality dura regeneration than controls, more similar morphologically to native dura.
o Inflammation decreased over time, dominated by macrophages/giant cells, consistent with bioabsorbable material remodeling.
o Bone healing progressed in both groups; findings localized to surgical sites, not to the implant.
o Data suggest ArtiFix supports superior dura repair over time, with ongoing remodeling, warranting longer-term follow-up.
Based on the results of the preclinical trials, biocompatibility testing, stability and validation, Nurami has assembled and submitted a technical file to the ethical committees in the EU towards approval to initiate the clinical trial. In a pre-IDE meeting, the FDA has approved carrying out the FiH exclusively in Europe.
Together with its CRO (KCRI), Nurami has built a detailed safety clinical investigation plan, based on discussions with regulatory authorities. Informed consent form, investigator brochure; insurance, CRF were established. The First in Human clinical study plan was submitted to 3 European sites (1 in Czech Republic and 2 sites in Poland). Preliminary approval has been received in the Czech Republic,and all approvals are projected by Nov. 30, 2025.
Preclinical results demonstrate that ArtiFix, a 0.3 mm electrospun fibrous dura patch, is safe, integrates with native dura, prevents CSF leakage without suturing, and supports true dural regeneration. In canine models with 7–8 mm defects (equivalent to up to 4 cm in humans), ArtiFix achieved watertight closure and healing comparable or superior to the control (DuraGen Plus). In vitro, ArtiFix withstood pressures >10× physiological intracranial levels (7.0 psi vs. 0.6–1.2 psi), confirming its robustness.
Unlike currently approved EU sealant patches (Hemopatch, Liqoseal), which are limited to ≤3 mm gaps, ArtiFix offers a sutureless, scalable solution that reduces surgical time, lowers CSF leak risk, and eliminates reliance on animal-derived products. This creates clear clinical and economic advantages by replacing the current need for two products (patch + sealant).
For broader uptake and success, next steps include:
• Further research and demonstration in long-term and human trials.
• Regulatory engagement (particularly in the US, where no sealant patches are approved).
• Market access and commercialization planning to address adoption barriers.
• IPR and internationalisation to secure Nurami’s competitive advantage.
Unlike currently approved EU sealant patches (Hemopatch, Liqoseal), which are limited to ≤3 mm gaps, ArtiFix offers a sutureless, scalable solution that reduces surgical time, lowers CSF leak risk, and eliminates reliance on animal-derived products. This creates clear clinical and economic advantages by replacing the current need for two products (patch + sealant).
For broader uptake and success, next steps include:
• Further research and demonstration in long-term and human trials.
• Regulatory engagement (particularly in the US, where no sealant patches are approved).
• Market access and commercialization planning to address adoption barriers.
• IPR and internationalisation to secure Nurami’s competitive advantage.