EIC-backed projects on World Diabetes Day 2025: technology, claims and remaining hurdles

World Diabetes Day on 14 November 2025 carried the World Health Organization theme 'Diabetes across life stages', which stresses integrated care, prevention and equitable access for people living with diabetes. Two projects supported by European Innovation Council instruments were highlighted as examples of technologies aiming to address access and complications: GO-Pen ApS from Denmark with a reusable user-filled insulin pen and Sweden's Ilya Pharma AB with ILP100, a topical live biotherapeutic for difficult wounds. Both projects present promising technical milestones but also illustrate the gap between clinical proof of concept and broad, affordable patient access.

GO-Pen ApS: a reusable, user-filled insulin pen that aims to reduce cost barriers

GO-Pen is a Denmark-based medical device company whose stated vision is to make modern insulin pen delivery affordable for people who currently use vials and syringes because of cost. The company developed the UNIPEN system, a reusable pen with a user-fillable reservoir designed to accept insulin drawn from standard vials. GO-Pen positions the product as delivering pen-level dosing precision while retaining the unit cost advantages of vial insulin. The firm says one pen lasts three years and that manufacturing at scale will make the device widely available.

Regulatory milestones reported by GO-Pen include FDA 510(k) clearance announced in May 2025 and a CE class IIb mark reported on the company website in November 2025. The company has said it is preparing for market entry in the United States and converting letters of intent into launch contracts with partners. GO-Pen has publicly signalled plans to raise about €5 million in equity to scale up manufacturing after the summer of 2025.

The company and its supporters frame GO-PEN as a solution for more than 20 million people worldwide who still use syringes for insulin injections. GO-Pen cites data from the International Diabetes Federation stating there were 589 million adults with diabetes in 2024, with more than $1 trillion spent globally on diabetes care that year. The product has attracted endorsements from clinicians and humanitarian practitioners who see potential to improve dosing safety and adherence in lower resource settings.

Independent perspective and unresolved questions. The product's promise depends on several factors outside a device clearance. Price per dose and reimbursement arrangements will determine whether the pen is genuinely cost comparable to syringes in public procurement or out-of-pocket markets. Manufacturing scale-up for a device intended to last three years requires consistent quality control and supply chains for parts and cartridges. The refill-from-vial approach raises operational questions about compatibility with a wide range of insulin formulations, user training to avoid dosing or mixing errors, sterility and safe handling, and whether global cold-chain and pharmacy distribution models will support uptake. Environmental benefits from reusability are plausible but need lifecycle analysis to quantify.

Ilya Pharma AB: ILP100 and a bacteria-based approach to chronic and difficult wounds

Ilya Pharma is a Swedish biotech that developed ILP100, a topical investigational therapy using genetically modified lactic acid bacteria engineered to deliver the human chemokine CXCL12 at the wound site. The company argues the approach can accelerate healing and reduce reliance on dressings and antibiotics for chronic diabetic wounds, which affect an estimated 18 percent of people with diabetes and represent a heavy clinical and economic burden in Europe and worldwide.

Key clinical and commercial milestones. The EIC-supported WHILYAS project aimed to accelerate ILP100 through preclinical toxicity work and first in human testing. An adaptive, randomised, double-blind, placebo-controlled first in human trial enrolled 36 healthy volunteers who each had four or eight standardized 6 mm punch biopsy wounds created. ILP100 was administered topically in single and multidose regimens. Results released in 2021 reported accelerated healing: across multiple quantitative assessments ILP100-treated wounds healed on average three days faster than controls, and the highest dose showed a six day average improvement in some analyses and an 11 day difference for time to first recorded healed wound with the top dose in the study. At day 32 blinded evaluators rated 86 percent of ILP100-treated wounds healed versus 71 percent of controls. Multidose ILP100 also reduced scar volume by about 30 percent at six weeks in the analysed cohorts. Safety endpoints were reportedly met and no systemic exposure or skin colonisation was detected in the trial.

Funding and corporate developments. After a period in which the company pivoted toward commercial activities, Ilya Pharma announced the close of a €5 million funding round in August 2024. The round had participation from existing shareholders and the EIC Fund and brought in six new investors. The company says the funding will support development across a portfolio of three first‑in‑class local immunotherapies for skin, gastro, and lung indications.

Independent perspective and limitations of the data. The first in human trial used an acute wound model in healthy volunteers with punch biopsy wounds. That model is useful to show biological activity and safety but does not replicate the complex pathophysiology of chronic diabetic ulcers which involve poor perfusion, neuropathy, biofilm formation and comorbidities. Acceleration of healing in healthy subjects is encouraging but is not definitive proof of benefit in diabetic chronic wounds. The trial was small and not powered to show clinical outcomes that matter to patients such as amputation avoidance or long term recurrence. Wider development will require Phase II and III trials in relevant patient populations, scalable manufacturing for a live biotherapeutic, regulatory engagement on product classification and microbiological safety, and health economic studies to substantiate claims about cost efficiency compared to current standard of care.

Milestones, funding and next steps compared

Context: why these solutions matter and what remains to be done

Both projects respond to well documented gaps in diabetes care. Global figures cited by the International Diabetes Federation and used in company materials show hundreds of millions living with diabetes, millions undiagnosed, and substantial health system expenditure. WHO messaging for World Diabetes Day 2025 emphasises that prevention and integrated care must span the life course and lists global targets for 2030 such as 80 percent diagnosis coverage and 100 percent access to affordable insulin and self-monitoring for people with type 1 diabetes.

From an EU innovation policy perspective the two cases illustrate the EIC role in taking risky, early stage projects to regulatory milestones and investor interest. The EIC Accelerator Blended Finance model and the EIC Fund can help de-risk projects and attract follow-on capital. Yet moving from device clearance or small FIH trials to population impact requires sustained investment, clinical validation in target patient groups, reimbursement pathways, manufacturing capacity, and distribution strategies especially for low and middle income countries.

For clinicians and health systems the decisive questions will be whether GO-PEN and ILP100 deliver reliable clinical benefits at lower overall cost when compared to existing care, and whether they can be integrated safely into routine practice. For donors and global health actors the questions are whether pricing and supply models will reach those still dependent on syringes and whether live bacterial therapies can be manufactured and regulated to meet safety expectations for broad use.

Where to find more information

Company websites and project entries on the EU research databases contain project descriptions and claimed milestones. GO-Pen has public press releases about its FDA 510(k) clearance and a CE mark. Ilya Pharma has published clinical trial results and press statements about its funding round. WHO and IDF resources provide context on the scale of diabetes and global targets for care coverage.

Disclaimer: This article synthesises public statements, company communications and published trial results to clarify milestones and open questions. It is not an evaluation by regulators or health technology assessors and should not be taken as medical or investment advice.

Key quotes and endorsements reported

Ole Kjerkegaard Nielsen, CEO and co-founder of GO-Pen ApS said receiving FDA clearance was an important step toward 'democratising access to essential diabetes care'. Clinicians and advocates quoted on GO-Pen materials include Professor Anne Peters from Keck School of Medicine and practitioners from Médecins Sans Frontières who emphasised potential benefits for underserved populations. Ilya Pharma executives described the ILP100 data as supporting continued clinical development and as positioning the therapy to be superior to limited existing pharmaceutical options for wound healing.