FibGel^™: A Next-Generation Hydrogel for Medical Devices

The growing demand for biocompatible, animal-free materials in the medical device sector is driving rapid innovation in biomaterials. One such recent innovation is FibGel™ — a novel hydrogel designed for use as a component in various medical devices. Unlike other hydrogels, FibGel is manufactured from nanofibrillar wood cellulose and ultrapure water, maximizing biocompatibility and safety for medical use.

Evaluated according to ISO 10993 for human use, FibGel’s patented technology is a game-changing advancement for e.g. wound care and mucosal indications. With its injectable and sprayable properties and ability to provide long-term stability, FibGel offers medical device manufacturers a valuable solution that addresses the limitations of traditional hydrogels.

Challenges with Conventional Hydrogels  

Hydrogels are widely used in the medical field, but existing technologies often fail to meet the stringent standards required for their use in medical devices with injectable or implantable applications. The major hurdles faced by conventional hydrogel materials include uncontrolled degradation, lack of tunability, and poor biocompatibility. Many of these issues stem from using synthetic plastics and animal-derived raw materials in medical devices.

Complications with Animal-Derived Products   

Animal-derived products in particular, as well as other foreign materials, often cause some level of negative immune response ¹. Patients may experience immune hypersensitivity or rejection, or may require immunosuppressants or even removal surgery. This limits the approved applications of animal-derived hydrogels as more extensive biosafety studies are required. While animal-derived gelatin and collagen are used extensively in pharmaceuticals and therapeutics, many challenges remain for their use in human applications such as wound healing ². Collagen and gelatin must be specifically processed so as not to cause an immune response or allergic reaction. Unless modified, they quickly degrade in the body which makes them unsuitable for long-term implants—and such modifications can cause delayed inflammatory reactions themselves³. Additionally, the methods used to extract gelatin cause a cytotoxic effect. Even decellularized animal-derived biomaterials can cause adverse effects. In a previous clinical trial three out of four pediatric patients implanted with decellularized porcine aortic valves died within one year as a result of complications and severe inflammation; the fourth had the valve removed ¹. This highlights the concern and need for extra testing to be carried out with animal-derived medical components.

Problems with Synthetic Plastics  

The widespread use of synthetic polymers creates complications for medical implants since their mechanical and physicochemical properties are often incompatible with surrounding tissues. Polypropylene for example, despite being considered biocompatible and nontoxic, when used in a mesh implant to treat pelvic organ prolapse was found to cause significant complications ^4,5. This led to the FDA ordering manufacturers to stop selling and distributing surgical mesh intended for pelvic organ prolapse treatment ⁶.

It is common for fibrous capsules to form around implants and medical devices that are made from non-biodegradable and non-porous materials ⁷. The silicone polymer polydimethylsiloxane (PDMS) is used in many medical devices and implants, such as breast prosthetics. These cause a foreign body reaction which leads to the formation of fibrous capsules around the implants ^7,8.

Many plastic-derived hydrogels do not provide the stability required for long-term implantable or injectable devices. Their properties, such as rigidity, may change and they can degrade over time, making them less effective in long-term applications. Using plastics sourced from fossil fuels also brings sustainability issues.

FibGel: A Sustainable, Biocompatible Solution

FibGel is the world’s first wood-based cellulose hydrogel developed as a class IIb component for medical devices. It is animal-free and biocompatible, composed of only sustainable birch wood cellulose and water. Designed to meet the needs of medical devices requiring biocompatible and injectable materials, FibGel addresses the challenges of traditional hydrogels.

FibGel is manufactured in accordance with ISO 13485 and has already been evaluated according to relevant ISO 10993 biocompatibility tests. Compared to traditional hydrogels, it has superior stability, tunability and handling properties. FibGel can be injected, even in high viscosities, through a small needle. Tests so far have shown high biocompatibility without any acute or chronic systemic toxicity. In addition, the future medical devices using FibGel will benefit from UPM’s long experience of using nanocellulose with 3D cell culture.

Safe and Biocompatible: FibGel is animal-free, non-toxic, and does not cause fibrosis, making it safe for long-term clinical use. It has been rigorously tested according to relevant ISO 10993 standards for biological safety.

Biomechanically Unique: Unlike degradable hydrogels, FibGel is stable and remains intact after a single injection, reducing the need for repeated procedures and follow-up visits. This stability is a game-changer for patient outcomes and healthcare efficiency.

• • In the future, degradation of FibGel nanocellulose into harmless glucose will be controllable with cellulase enzymes ⁹.
  • FibGel is injectable with low injection force even at high stiffness, owing to its unique shear thinning properties.
  • Temperature stability makes FibGel easy and convenient to store and work with at room temperature.
  • FibGel’s stiffness can be adjusted to meet specific clinical needs and it can also be mixed with additional components. This makes FibGel highly adaptable for a wide range of applications from soft tissue repair to orthopedic implants.

Sustainable and Natural: FibGel is composed entirely of responsibly-sourced birch wood cellulose and water. Not only is FibGel free from animal DNA, but it also aligns with sustainability goals by supporting environmentally friendly and ethical medical innovations.

Learn more about our wood-based nanocellulose

Potential Applications of FibGel

FibGel has the potential to be used in a wide range of medical devices. At the time of writing, it can be used as a component in class IIb surface medical devices, such as in wound care products, but development towards class III implantable medical device is ongoing. This will enable its use in implantable applications such as soft tissue repair, orthopedics, and aesthetics. It could also be combined with an active ingredient to serve as an excipient for drug delivery and cell transplantation.

Soft Tissue Repair   

In soft tissue repair, due to its shear-thinning properties, FibGel is easy to inject and can be used as an empty implant or combined with active components. Its biocompatibility and tunability make it ideal for repairing damaged tissues in applications like reconstructive surgery or aesthetic procedures. Such soft tissue reconstructive surgeries with FibGel may include space filling after tumor removal or accidental trauma.

Orthopedics

FibGel empty implants also have the potential to be used in orthopedics ¹⁰. Knee problems and injuries are common, particularly among athletes and the elderly. With longer life expectancies and an aging population, we have more causes of osteoarthritis. Hyaluronic acid (HA) injections are a common treatment for osteoarthritis, but this disease is an increasing strain on healthcare providers. HA degrades and patients need regular injections for symptomatic relief. Frequent injections can be an uncomfortable and inconvenient experience for osteoarthritis patients. The long-lasting stability of FibGel would make it a more convenient potential treatment option. With less frequent injections needed, it could save nurses and doctors time and cut costs.

Drug Delivery and Cell Therapy

Nanocellulose has excellent emulsification properties. This prevents pharmaceutic ingredients and cells from sedimentation and therefore a homogeneous mixture can be injected. Initial studies have shown drug loading and release profiles of various drug substances ¹¹. These can be tuned by changing concentration of the materials. Moreover, in cell therapy, the survival rate of transplanted cells remains low due to inadequate protection during the injection process and the absence of long-lasting support for tissue regeneration. Nanocellulose is able to protect the cells from the mechanical stress during injections and, in this way, can improve the treatment outcome.

While clinical case studies using FibGel are still developing, UPM Biomedicals’ previous research with similar nanocellulose hydrogels demonstrates strong potential for its adoption in these critical medical fields.

Evolution of nanocellulose products at UPM

While FibGel is newly launched, it builds on UPM Biomedicals’ long history of using nanofibrillar cellulose in biomedical applications. Since 2007, UPM has been studying and collecting data for the use of nanocellulose. In 2014, the company launched its first product for research use with 3D cell culture in vitro. Through cultivating human cells in hydrogels in vitro, and extensive in vivo animal studies, UPM has shown its cellulose hydrogel is safe and highly biocompatible.

UPM Biomedicals offers a range of nanocellulose hydrogel products. These include Grow GrowDex^® hydrogels and  GrowInk™ bioinks for research use, and in 2020,FibDex^® was approved as a class IIb topical medical device for clinical use. FibDex is an approved single-application wound dressing that is used on skin graft donor sites. Hundreds of patients have been treated with FibDex ¹². While the company’s first products were intended for in vitro use, UPM has amassed a solid understanding of how nanocellulose could be used in cell therapy and in drug delivery. Some of the preclinical research is highlighted below:

Cell Therapy Development:

• A flexible, xeno-free 3D culture system for pluripotency of human pluripotent stem cells ¹³.
• A medium to support islet preservation awaiting transplantation for type 1 diabetes therapy ¹⁴.
• A platelet-rich plasma carrier for targeted wound healing with controlled scaffold degradation ⁹.
• An extracellular matrix for injectable transplant of human embryonic stem cells in the inner ear ¹⁵.

Drug Delivery Development:

• An injectable carrier for localized drug delivery in mice models ¹⁶.
• Nanofibrillar cellulose in drug delivery ¹¹.

How FibGel Supports Medical Device Manufacturers  

For medical device manufacturers, FibGel presents an opportunity to address unmet needs with a patented technology platform. UPM Biomedicals can offer a head start to speed up device development by providing pre-clinical evidence, including biological evaluation according to the ISO 10993 standard, technical documentation for FibGel™ as a component, and technology licensing. The company’s material supply options can be tailored to your needs.

Currently, UPM can support customers in pre-clinical and clinical investigation phases. The company is working towards certification for its manufacturing operations of FibGel with the ISO 13485 standard at commercial scale. FibGel’s long shelf life and temperature stability simplifies logistical challenges, ensuring consistent performance without the need for specialized storage.

By integrating FibGel, manufacturers can confidently develop more permanent innovative solutions that are both sustainable and effective, meeting the growing demand for next-generation medical devices.

Looking Forward: The Future of FibGel

As UPM Biomedicals continues to develop FibGel, its potential to revolutionize medical devices is vast. With its strong biocompatibility, tunability, and sustainability credentials, FibGel is set to address unmet needs in wound care, soft tissue repair, orthopedics, and beyond.

As the market is increasingly demanding solutions that align with environmental sustainability and ethical standards, many existing materials don’t comply. But UPM Biomedicals is committed to advancing animal-free, sustainable biomaterials. The company’s partners expect the first human clinical trials to begin in 2025. FibGel offers a promising future for both manufacturers and patients alike, paving the way for safer, more efficient medical devices.

For more information on how we can support your next medical device innovation, contact us now!

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References:

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