GO-Pen and the EIC Accelerator: An Approved Insulin Pen
About 13 million people with diabetes still inject insulin with syringes, according to GO-Pen's EIC project, because branded insulin pens cost more. GO-Pen, founded in 2019 at the DTU Science Park in Kongens Lyngby, Denmark, designed a pen that users fill themselves from a standard insulin vial, compatible with any insulin, with the aim of costing no more than syringes while dosing more accurately.
The European Innovation Council granted €2,499,999 towards a €4.6 million project from March 2023 to August 2025. The final report says the team "completed a cost-neutral design compatible with fast-acting insulin", ran a clinical evaluation with 100 patients confirming safety and usability, obtained ISO 13485 certification and commissioned a lifecycle analysis from the Technical University of Denmark. The FDA cleared the pen on 24 April 2025, according to its 510(k) database, and in November 2025 GO-Pen announced a Class IIb CE Mark, with rollout expected in 2026.
Company file
- Legal entity
- GO-PEN ApS, CVR 40134131, Kongens Lyngby
- Founded
- 2019
- CEO
- Ole Kjerkegaard Nielsen
- Product
- User-fillable, reusable insulin pen
- Manufacturer
- SP-Meditec, Helsingør
- Approvals
- FDA 510(k) K250262, April 2025; CE Class IIb, November 2025
- EIC project
- GO-Pen, 1 Mar 2023 to 31 Aug 2025
Where GO-Pen Stands Now
The CE announcement named SP-Meditec in Helsingør as the manufacturer and said commercialisation would run in parallel in Europe, the US and emerging markets with many syringe users. It gave no price. We found no announcement of the first sales by September 2026. GO-Pen's 2025 accounts on Proff show a loss of DKK 1.84 million and equity of DKK 27.5 million, with seven employees.
The record
An insulin pen meant to be cheap, cleared; no first sales found
GO-Pen won FDA clearance and CE marking during and after its EIC project. It planned to start selling in 2026.
- 2019Company foundedDTU Science Park, Kongens Lyngby
- Jun 2022EIC Accelerator cut-offThe first universal, price-neutral insulin pengrant first
- Mar 2023EIC project startsDesign, clinical usability, production scale-up€2.50M grant
- 2023ADA Innovation ChallengeWon by the UNIPEN design
- Apr 2025FDA 510(k)K250262 cleared
- Aug 2025EIC project ends100-patient usability study; lifecycle analysis by DTU
- Nov 2025CE MarkClass IIb under the MDR
- 2026Planned rolloutEurope, US and emerging markets
CORDIS, FDA 510(k) database and GO-Pen.
"The CE approval confirms that our user-fillable insulin pen meets the highest European standards for safety and performance."
Ole Kjerkegaard Nielsen, CEO, GO-Pen, November 2025The Technology: A Pen You Fill Yourself
According to CORDIS, the pen is refilled by the user and is designed to be compatible with any type of insulin. The pen won the American Diabetes Association's Innovation Challenge in 2023. Anne Peters, a professor at the Keck School of Medicine, called it "the most innovative concept I have ever seen towards the needs of patients who take insulin using syringes".
The market
The people the pen is meant for
Millions of people, as cited by the EIC project and report.
CORDIS project 190178477.
What the EIC Project Promised, and What CORDIS Shows
The EIC project
The EU paid 54% of a €4.6M project
The GO-Pen project ran from March 2023 to August 2025.
CORDIS project 190178477. Values in € millions.
The project promised the first affordable, safe and sustainable insulin system for the world's most resource-constrained patients, with production scaled up by the end of the project. The design, clinical evaluation and approvals were delivered; the report describes the device as "ready for international scale-up", which means scale-up had not yet happened.
- Cost-neutral designDeliveredPer final report.
- Clinical usabilityShown100 patients.
- Regulatory approvalDeliveredFDA and CE, 2025.
- Production at scaleNot yetRollout in 2026.
The Money
GO-Pen's gross profit was minus DKK 1.24 million in 2025. Its balance sheet totalled DKK 54.5 million, half of it equity. It has not disclosed its private investors or the size of its funding rounds.
The accounts
The balance sheet in 2025
DKK thousands, 2025 annual report. Gross profit was minus DKK 1.24M.
Proff, GO-PEN ApS (CVR 40134131).
What Cannot Be Checked
Questions for the EIC
The pen's price, whether it has reached patients in low-income countries, how many units SP-Meditec can make, and who funds the rollout are not public.
Why Europe Should Care
GO-Pen is an EIC-funded device aimed at people who cannot afford branded pens. It has done the hard regulatory work in both the EU and the US. The test of the EIC's money is whether the pen now reaches those patients at syringe prices.
What the project promised
An affordable, safe, sustainable insulin pen for resource-constrained patients, produced at scale.
What the record shows
A tested and approved pen, a Danish manufacturer, and a rollout planned for 2026 with no price disclosed.
The Verdict
Approved and ready, not yet in hands
GO-Pen did the development, testing and approvals the EIC paid for. Its social promise, a pen at syringe prices for poorer patients, depends on a launch that had not been reported by September 2026.
GO-Pen and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Industry
HealthMedical devices
- Focus
- Diabetes devices
- Technologies
- Drug delivery systems
- Keywords
- Insulin pens
- Diabetes
- Global health
- Affordable care