World Patient Safety Day 2025: How two EIC-backed firms aim to change respiratory and paediatric cardiac care
- ›On World Patient Safety Day the EIC highlights HBOX Therapies and Biomodics as beneficiaries developing devices to reduce harm in respiratory failure and congenital heart disease.
- ›HBOX Therapies is developing MiRA a miniaturised extracorporeal gas exchange system intended to oxygenate blood and remove carbon dioxide without conventional mechanical ventilation.
- ›Biomodics is developing StealthStent a fully absorbable paediatric stent intended to accommodate vessel growth and reduce repeat procedures for children with congenital heart disease.
- ›Both projects are EIC-backed but remain at premarket stages and face regulatory, clinical trial, manufacturing, and adoption challenges before they can deliver on safety claims.
World Patient Safety Day 2025 and two EIC-backed device projects
The World Health Organization designates 17 September as World Patient Safety Day to focus attention on measures that reduce harm in health care. Against the 2025 theme on newborn safety the European Innovation Council community has highlighted two European innovators who are developing device-based alternatives to high-risk standard therapies. HBOX Therapies from Germany is advancing a miniaturised extracorporeal gas exchange device intended to reduce dependence on invasive mechanical ventilation. Biomodics from Denmark is working on a fully absorbable stent tailored for children with congenital heart disease. Both firms receive EIC support and present technically ambitious approaches to important clinical problems but the road from innovation to safer routine care is complex and uncertain.
HBOX Therapies and MiRA: a compact extracorporeal gas exchange system
HBOX was founded in 2021 and is an EIC Accelerator Blended Finance beneficiary. The company also won first place at the Third BIOINC Pitch Competition in Mansfield Massachusetts in July 2025 where MiRA was judged the top pitch among an international field. Those wins provide validation and visibility but they do not substitute for peer reviewed clinical data or regulatory approval.
Biomodics and StealthStent: a paediatric absorbable stent
Biomodics frames the device as a paediatric innovation that may also benefit certain adult patients by reducing repeat interventions. The concept of an absorbable paediatric stent is compelling but presents materials science, mechanical performance, and safety challenges that must be resolved in rigorous preclinical models and clinical trials.
What EIC backing means and what it does not
The European Innovation Council provides several types of support including the EIC Accelerator Blended Finance instrument and the EIC Transition grant. Accelerator Blended Finance combines grant support with equity financing to help scale deep tech and medtech firms. EIC Transition grants fund the maturation and scaling of technologies coming out of research projects. EIC awards bring financial resources, coaching, and visibility which can accelerate development. They do not guarantee regulatory approval market adoption or reimbursement.
Clinical, regulatory and market hurdles to watch
| Company | Clinical target | Reported stage or milestone | Key near term technical goal | Regulatory or clinical hurdle |
| HBOX Therapies | Acute respiratory failure patients who would otherwise require invasive mechanical ventilation | EIC Accelerator Blended Finance beneficiary, BIOINC pitch first place July 2025 | Validate MiRA gas exchange and blood compatibility in relevant preclinical and early clinical studies | Safety and efficacy data versus mechanical ventilation and ECMO, device blood compatibility and anticoagulation strategy, ICU adoption and reimbursement |
| Biomodics | Children with congenital heart disease who need stent treatment | EIC Transition project StealthStent started April 2025. GrownValve implantation milestone June 2025 | Optimize radial force, complete in vitro and in vivo tests to reach TRL 5 | Material bioresorption safety, mechanical performance during growth, long term follow up in paediatric clinical trials, paediatric device regulatory pathways |
Several recurring themes affect both projects. First there is the challenge of translating promising benchtop or early preclinical results into consistent performance in patients. Second paediatric devices face specific regulatory requirements and smaller market sizes which can complicate investment cases despite clear clinical need. Third extracorporeal and blood-contacting devices must demonstrate low thrombogenicity and acceptable anticoagulation strategies because clotting risks can negate intended safety gains. Finally procurement and reimbursement rules in EU health systems favour evidence of clinical benefit and cost effectiveness which take years to assemble.
How these innovations relate to patient safety priorities
The WHO World Patient Safety Day theme for 2025 emphasized safe care for newborns and children. Both projects address high-burden areas where device design could reduce avoidable harm from repeated invasive procedures or from complications of life support. If proven safe and effective these technologies could reduce morbidity and mortality and ease health system burdens. That potential is important but remains hypothetical until independent clinical data are available.
Takeaways and next steps to watch
HBOX Therapies and Biomodics exemplify the kind of deep technical innovation the EIC seeks to support. Their technologies target legitimate safety problems in respiratory and paediatric cardiac care. The immediate milestones to monitor are peer reviewed preclinical results regulatory filings and early clinical trial data. Observers should also watch manufacturing scale up and health technology assessment processes because those determine whether innovations reach patients and improve outcomes at scale. Until clinical and regulatory milestones are met claims about reduced mortality or broad system impact should be treated as early stage and contingent.
This article draws on material published by the EIC Community the companies involved and public sources. The original EIC Community story included a disclaimer that the information presented is for knowledge sharing and should not be interpreted as the European Commission's official view.
Company profiles and public information sources
HBOX Therapies is a Germany based medical device company founded in 2021 that focuses on miniaturised extracorporeal gas exchange systems. Biomodics is a Denmark based company developing absorbable biomaterials and devices with a focus on vulnerable groups including newborns. Both companies are listed in Horizon Europe project databases and maintain company websites with additional technical and corporate information.
Readers seeking to follow progress should look for clinical trial registrations peer reviewed publications and regulatory submissions in the EU and other jurisdictions as primary evidence of safety and effectiveness.