HYDROHEAL

What do we want to develop?

HYDROHEAL aims to develop a new generation of multifunctional, injectable hydrogels to treat complex bone fractures more safely and effectively.

  • Minimally Invasive
  • Smart Delivery
  • A Sustainable Innovation

The Problem

Every year, millions of people suffer from fractures in delicate and hard-to-treat areas like the spine (vertebral fractures, VF) and jaw (alveolar fractures, AF). Current treatments often rely on synthetic bone cement or invasive bone grafting, which can cause complications, fail to support proper healing, and carry high costs for patients and health systems.


The HYDROHEAL solution is different

We are engineering a biodegradable hydrogel formulation that:

  • Can be injected minimally invasively into bone defects,
  • Adapts to the body and hardens in place,
  • Contains nano- and micro-scale carriers loaded with therapeutic agents,
  • Enables on-demand drug release triggered by external ultrasound stimulation, and
  • Gradually dissolves as the bone regenerates, leaving no toxic residue behind.

This composite material combines bone-stimulating, anti-inflammatory, and antibacterial functions in one smart platform. It is designed for high clinical impact, patient comfort, and environmental sustainability by providing scalable green manufacturing processes.


In short: HYDROHEAL is not just a material. It’s a new therapeutic strategy that merges regenerative medicine, drug delivery, and digital design to improve how we heal broken bones.

How do we want to do this?

To bring HYDROHEAL from the lab to real-life patients, we’ve designed a clear and structured 4-year work plan. Our goal is to develop and test a safe, effective, and environmentally friendly produced hydrogel that can be injected into bone fractures—then dissolve naturally as the bone heals.

Identification

We begin by identifying what patients and doctors truly need. Then, our scientists create the hydrogel using smart, bio-based materials. Tiny particles inside the gel carry medicine that can be released on demand—triggered by ultrasound from outside the body.

Testing

Next, we test these materials in the lab using human cells and bacteria to ensure they are safe and work as intended. Once we have the most promising version, we test it further in animal models that mimic real bone fractures.

Production

At the same time, we make sure the material can be produced in a way that’s scalable, affordable, and sustainable. We use artificial intelligence to help optimize the formulation and ensure it meets clinical standards.

Feedback

Of course, we work closely with patients, doctors, and regulators to prepare everything needed for future clinical trials. From lab bench to hospital bed, the HYDROHEAL project is about turning advanced science into a practical solution that can improve lives across Europe and beyond.

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Multifunctional Carriers in Bone Healing

This diagram summarises the intended functions of the therapeutic carriers under development, including anti-inflammatory action, infection prevention, bone stimulation, and support for minimally invasive delivery.


HYDROHEAL Formulation and Applications

This visual shows the injectable HYDROHEAL biomaterial under investigation, which is designed to promote vascularisation and bone repair in fractures. Potential clinical applications include vertebral and alveolar bone injuries.

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HYDROHEAL Work Packages

Coordination, Ethics & Risk Management

Goal: Keep the project running smoothly, on target and according to regulations.

Approach: Manage timelines, funding, ethical compliance, and risks—ensuring all partners collaborate effectively and follow EU research standards.


Clinical & Technical Requirements

Goal: Define what the hydrogel needs to do in real patients.

Approach: Work with doctors to understand patient needs, select drugs to be included in the gel, and set up the ultrasound system for drug release.


Hydrogel Development

Goal: Create a safe, injectable, biodegradable hydrogel.

Approach: Use natural materials (like chitosan and alginate) and mix in bioactive minerals to build a gel that can fill bone fractures and support healing.


Smart Drug Carriers

Goal: Develop tiny particles to carry medicine inside the gel.

Approach: Create nano- and microparticles coated with layers that release their contents only when activated by ultrasound, and that improve the gel’s strength.


Bone Healing Tests (Lab)

Goal: Check if the hydrogel helps bone cells grow.

Approach: Test the gel in lab dishes with human stem cells and bone cells to see if it supports healing and reduces inflammation.


Infection Prevention Tests (Lab)

Goal: Make sure the gel can stop infections.

Approach: Test the antibacterial components against harmful bacteria, including antibiotic-resistant strains, in realistic lab conditions.


Small Animal Testing

Goal: Ensure the gel is safe and works in a living system.

Approach: Use rabbits to test how well the gel heals bone fractures, and check for side effects.


Large Animal Testing

Goal: Move one step closer to human use.

Approach: Test the most promising gel versions in goats, which have bone structures closer to humans, using minimally invasive techniques.


Manufacturing

Goal: Start scaling up production.

Approach: Test how the gel can be made in larger quantities while keeping quality high and environmental impact low. Refine the process for consistent, sterile production at the 1kg scale and prepare for future industrial use.


AI-Based Prediction Tools

Goal: Use machine learning to understand how the gel behaves.

Approach: Build models that predict how different ingredients affect properties like strength, flow, and healing.


AI-Based Optimization

Goal: Find the best-performing gel recipe.

Approach: Use artificial intelligence to suggest the ideal combination of ingredients for maximum healing and safety.


Ethics, Users & Regulation – Phase 1

Goal: Involve patients, prepare the ethical framework, develop options for clinical trials.

Approach: Organize focus groups and patient surveys; set up the foundation for responsible, transparent development, engage with end users and outline the steps toward testing the gel in human patients.


Regulatory File & User Guidance

Goal: Compile everything needed to apply for clinical testing.

Approach: Prepare a technical and regulatory dossier based on all lab and animal studies, and finalize a framework based on patient needs.


Communication, Dissemination & Exploitation

Goal: Spread the word and build awareness.

Approach: Launch the website, social media channels, project videos, and create the first public materials.

Goal: Prepare for real-world use and investment.

Approach: Develop business models, assess cost savings, and define the value proposition for hospitals and industry.

Goal: Ensure HYDROHEAL succeeds beyond the project’s end.

Approach: Finalize economic models, licensing strategies, and outreach to doctors, patients, industry, and regulators.