The Electrospinning Company manufactures the electrospun component at the core of Nurami Medical’s ArtiFascia® dural repair graft. This case study describes how TECL successfully scaled manufacturing using an advanced electrospinning platform, increasing production capacity while maintaining the quality, consistency and reproducibility required for a regulated medical device.

Challenge

The Electrospinning Company supplies electrospun sheets to Nurami Medical as a critical component of its ArtiFascia® dural repair graft.
Nurami achieved FDA 510(k) clearance and launched the product in the USA in 2024 and has been building traction across leading neurosurgical centres since. Increasing commercial demand created the challenge of scaling manufacturing capacity while maintaining the quality, consistency, and reproducibility required for a regulated medical device.
As the product had already achieved FDA clearance, the scale-up programme was completed while maintaining regulatory and quality requirements.
Although the electrospinning process had been successfully established and manufactured at modest scale for several years, larger production volumes required a carefully controlled scale-up strategy. Any increase in throughput needed to to maintain product quality and manufacturing consistency while supporting future commercial growth.

Solution

The Electrospinning Company led the scale-up programme, combining its electrospinning manufacturing expertise with an advanced electrospinning platform. A structured scale-up plan was developed with Nurami Medical, defining the manufacturing strategy required to increase production while maintaining the validated process and quality requirements of an FDA-regulated medical device.
The team then applied its expertise in electrospinning science, materials behaviour and quality requirements to optimise process conditions for large-scale production and execute the agreed manufacturing strategy. The scale-up programme was conducted in accordance with medical device quality requirements, with process changes evaluated through established quality management practices while maintaining product quality.
Structured manufacturing workflows and validated standard operating procedures formed a core part of the implementation plan, minimising operator variability and ensuring repeatable execution across teams as production capacity increased.
Drawing on lean manufacturing and Six Sigma principles, TECL implemented validated standard operating procedures and standardised production practices to deliver a manufacturing process capable of supporting ongoing production within the regulatory constraints of an FDA-cleared medical device. These structured workflows ensured consistent execution across operators and production campaigns while maintaining the traceability, process control and documentation required for commercial manufacture. Following implementation, the scaled manufacturing process was successfully validated, providing a robust and scalable manufacturing platform for continued commercial production.

“One of the most rewarding aspects of this project was seeing different areas of expertise come together to solve a complex manufacturing challenge. The Fluidnatek LE100 platform provided the process control we needed, while our team’s experience in electrospinning and regulated manufacturing allowed us to optimise and scale the process with confidence. Working closely with Nurami Medical throughout the project meant we could respond to challenges together and successfully deliver a manufacturing process ready to support commercial growth.” — Giulia Creed, Product Development Engineering Manager, The Electrospinning Company.

Results

By combining advanced electrospinning equipment, structured change management and manufacturing expertise, TECL successfully increased the production capacity while maintaining the validated manufacturing process and avoiding significant process changes requiring regulatory notification.
Key outcomes included:
• Maintained industry-standard process capability metrics through structured manufacturing workflows.
• Successfully implemented a controlled scale-up programme while maintaining product quality and manufacturing consistency.
• Maintained the quality, consistency and repeatability required for regulated medical device manufacture while increasing production capacity.

The Electrospinning Company has supported Nurami Medical in the development and manufacture of the electrospun component of the ArtiFascia® dural repair graft from the initial partnership in 2018, through clinical supply, FDA 510(k) clearance and commercial scale-up. Throughout the programme, the electrospinning platform has provided the manufacturing capability required to support each stage of product development and commercial growth.

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In this case study, we explore how the team at RenovoDerm is developing next-generation electrospun wound care technologies designed to improve tissue regeneration, reduce scar formation, and promote durable wound closure for acute and chronic wounds.

Challenge

Chronic and difficult-to-heal wounds remain a significant clinical challenge, especially when the wound environment does not support effective tissue regeneration. Traditional wound care approaches may not fully address the biological complexity of acute wounds, chronic wounds, and burns, where inflammation, poor tissue remodeling, and delayed closure can slow recovery.

Solution

RenovoDerm developed Phoenix Wound Matrix®, a bioresorbable, electrospun wound care scaffold designed to create a temporary regenerative microenvironment that supports the body’s own healing response. Its biomimetic, ECM-inspired structure is intended to support cell infiltration, tissue integration, and regenerative healing across a range of wound types.
Using Fluidnatek electrospinning technology, RenovoDerm can produce reproducible electrospun sheets with the process control needed to support both R&D and manufacturing. That level of control is especially valuable when working with large-format wound care scaffolds that require consistent morphology and reliable output.

“Our wound care scaffolds can be as large as 10 x 20cm. If there is any defect present such as spits or drips, we must scrap that piece. The Fluidnatek LE-500 system allows us to consistently produce these large electrospun sheets without defects, saving us time and money. We use the Fluidnatek LE-500 system in the R&D and manufacturing of most of our products. I have over 10 years of electrospinning experience, and I am very pleased with the ease of use, consistency of product, and the manufacturing output of the Fluidnatek LE-500 system. It has been the backbone of our production since we began developing this product in 2015, supporting V&V sample builds, pilot production, and validated manufacturing of commercial medical devices.” — Jason Chakroff, Lead Engineer at RenovoDerm.

Results

Phoenix Wound Matrix® supports RenovoDerm’s mission to advance wound healing solutions for acute and chronic wounds, as well as burns. The platform is designed to help create a wound-friendly environment that supports tissue remodeling and regenerative repair while gradually resorbing over time.
The result is a scalable wound care technology built around a synthetic, electrospun scaffold architecture that aligns with modern regenerative wound care development. Fluidnatek’s process control and reproducibility have helped RenovoDerm move from development toward translational application with greater consistency.

Evolution of a full-thickness dermal wound. Left to right: Results using Phoenix Wound Matrix at days 0, 14, 21, and 31. Far right (Day 31 histology): Microscopic view confirming complete re-epithelialization, matured granulation tissue, and a significantly reduced inflammatory response.

The Phoenix Wound Matrix is engineered to trigger functional tissue regeneration, moving beyond the limitations of chronic inflammation and fibrosis. In this case, the wound’s severity initially led to a recommendation for euthanasia. However, at the owner’s request, Phoenix Wound Matrix was applied instead. Thanks to this breakthrough technology, the horse achieved a full recovery.

Want to develop advanced biomaterials with Fluidnatek? Let’s talk!

contact@fluidnatek.com +34 674071303

In this case study, we examine how Atreon Orthopedics leveraged electrospinning technology to develop ROTIUM® Bioresorbable Wick — an advanced synthetic scaffold engineered to improve tendon-to-bone healing and support biologic tissue remodeling in orthopedic repair procedures.

Challenge

Rotator cuff repair remains challenging because the tendon-bone interface often does not provide an optimal biologic environment for healing. Atreon Orthopedics set out to address that gap with a solution that could support the healing cascade while integrating easily into standard surgical workflows.

Solution

Atreon Orthopedics developed ROTIUM® Bioresorbable Wick, an interpositional scaffold placed at the tendon-bone interface. The product is 100% synthetic and built with PGA and PLCL, and it is designed to supercharge the biologic environment, support tissue remodeling, and improve long-term outcomes after rotator cuff repair.
Using Fluidnatek electrospinning technology, Atreon can produce reproducible synthetic nanofiber scaffolds with the process control needed for development and manufacturing.

“We use the Fluidnatek LE-500 system in the R&D and manufacturing of most of our products. I have over 20 years of electrospinning experience and am very pleased with the ease of use, consistency of product, and the manufacturing output of the Fluidnatek LE-500 system. The high voltage and multiple voltage sources play a critical part in our manufacturing process. Our electrospun scaffolds have been used in over 20,000 surgeries to date and our fantastic outcomes for our patients are powered by the Fluidnatek systems.” — Jed Johnson, CTO of Atreon Orthopedics.

Results

ROTIUM has been used in more than 10,000 rotator cuff repair surgeries, and Atreon later received FDA 510(k) clearance to expand the indications to tendon repair surgeries.
Atreon reports that the scaffold supports repair at the critical tendon-bone interface and integrates seamlessly into standard surgical technique without adding surgical time.
The result is a clinically adopted bioresorbable scaffold platform that has helped Atreon broaden its regenerative orthopedic offering.

Want to develop advanced biomaterials with Fluidnatek? Let’s talk!
contact@fluidnatek.com +34 674071303

In this case study, we explore how MARILYS Blanchy, Expert in Materials for Medical Devices at APPLUS/RESCOLL, addressed the challenges of developing advanced biomimetic scaffolds for bone regeneration using our electrospinning technology.

Challenge

“In our quest to create advanced biomimetic scaffolds, we faced a significant challenge: reproducing fully functional and vascularized tissue. These scaffolds serve as templates, enabling endogenous tissue to reconstruct or regenerate effectively.”

Solution

To address these needs, APPLUS/RESCOLL developed a multi-material, multiscale approach that combines a 3D scaffold for mechanical support with an electrospun membrane designed as a drug reservoir and cell-interactive interface. They used a Fluidnatek LE-100 electrospinning system to fine-tune fiber morphology, scaffold architecture and release behavior.

Marilys Blanchy: “With Fluidnatek LE-100 we can control the environment (temperature and relative humidity), we have two sources of high voltage, different geometries of collectors (rotating or flat), and we can fine-tune the flow rate and the line displacement of the nozzle during the manufacturing process.”

Specifications used:

• Temperature 20 – 50° C
• Relative humidity 10 -90%
• 2 High voltage : 0 – 30 kV et -30-0 kV
• Rotating collector : 2 diameter 18mm et 100mm v=0-2000 rpm
• Flat collector ; 40*40 cm
• Max-min flow rates: 1.257-0,73 ml/h
• 2 syringues pumpes heated up to 120°C
• X motion : 0-100 mm/s

Using these capabilities, the team:

• Adjusted process and environmental parameters, such as relative humidity, to modify fiber quality, overall thickness, porosity and patch density.
• Targeted fiber diameters of approximately 1–2 micrometers and patch thicknesses in the 500 micrometer to 1 millimeter range, then verified these values experimentally.
• Characterized and improved surface wettability, starting from a highly hydrophobic matrix with a contact angle around 130°, working on surface state to obtain a more hydrophilic membrane favorable to cell attachment.
• Produced core–shell fibers using two polymer solutions, achieving cores of around 60 nanometers and shells of about 120–200 nanometers, as confirmed by transmission electron microscopy.
• Evaluated the release kinetics of a model molecule (calcine) from the electrospun fibers and showed that, although the overall release profiles were similar, the total amount released could be tuned by changing electrospinning process parameters.

Results

By combining controlled electrospinning with careful materials and process optimization, APPLUS/RESCOLL demonstrated that they could:

• Manufacture electrospun matrices with defined fiber diameter, thickness, porosity and density that are suitable for tissue engineering applications.
• Modify surface hydrophilicity to better support cell attachment and integration.
• Generate reproducible core–shell fibers capable of encapsulating active ingredients in liposomal form and enabling tunable release amounts over time.
• Work towards scalable, batch-to-batch consistent production using medical-grade materials, while studying sterilization conditions to preserve the properties of both the fibers and the incorporated actives.

“Electrospinning has proven to be a game-changer in our research, pushing the boundaries of what’s possible in tissue engineering.” Marilys Blanchy.

In this case study, we explore how the Matrihealth team is tackling the challenge of chronic wounds and scar formation by developing next-generation elastin-based nanofiber scaffolds using electrospinning.

Challenge

Chronic wounds cause immense suffering for patients and represent a growing burden for healthcare systems. Our goal was to design biomimetic materials that restore skin function by mimicking the elastin-rich extracellular matrix.

Solution

Elastin-based nanofiber materials
→ Up to 90% elastin content
→ Sourced from food industry byproducts (sustainable)
→ Biomimetic = mimics native ECM

Results

Matrihealth achieved significant results by:

Building Elastin-Rich Biomimetic Scaffolds: They isolated elastin from food-industry byproducts and incorporated it into electrospun nonwovens in high amounts (up to 90%), creating materials that closely resemble the native extracellular matrix. The scaffolds were then chemically crosslinked to optimize mechanical stability and degradation kinetics.

Tuning Mechanical Properties for Wound Healing: By varying collagen-to-elastin ratios, they precisely adjusted stiffness and porosity, obtaining highly elastic, fully degradable scaffolds ideal for advanced wound care applications.

Validating Biocompatibility and Safety: Extensive testing—including cytocompatibility, endotoxin levels, irritation potential, tensile testing and in vivo studies—demonstrated low irritative potential, excellent cell support and no adverse tissue reactions after implantation.

Enabling Industrial-Scale, Cost-Effective Production: Using an industrially scalable electrospinning process, Matrihealth built a versatile platform for producing elastin-based nonwovens at scale, opening the door to a new generation of absorbable, protein-based wound dressings and other biomedical products.

“From our perspective, the Fluidnatek LE-50 system played a key role in the development of the electrospun material. Its simple and reliable setup enabled rapid optimization of the material system, allowing us to efficiently adjust processing parameters and iterate on formulations within a short time.

In addition, the high flexibility of the system was particularly valuable. The possibility to switch between different configurations such as single- and multi-nozzle setups, as well as drum and plate collectors allowed us to tailor the process conditions to the specific requirements of the material and target structure.

Another important aspect was the ability to produce highly homogeneous fiber mats. This was largely facilitated by the Sweeping X Unit, which ensured uniform fiber deposition. Such homogeneity was essential for obtaining reproducible results and for conducting microstructural and mechanical characterization of the material.

Furthermore, the system represents an “all-in-one” solution for development work. It not only supports classical R&D activities but also provides sufficient capacity to produce material at a small pilot scale. In our case, this enabled us to generate enough material for subsequent in vivo testing, ensuring a seamless transition from development to application.” Tobias Hedtke, CTO at Matrihealth Germany.

If you’re interested in developing your own advanced wound care or biomaterials projects with Fluidnatek’s electrospinning platforms, feel free to reach out—we’re here to help you turn your concepts into patient-ready solutions.