Copenhagen, Denmark-based Go-Pen ApS says that, despite advances in diabetes technology, approximately one-third of insulin users worldwide (more than 20 million people) rely on traditional vials and syringes due to cost and access limitations.
According to a news release, more than 3 million insulin users in the U.S. alone depend on syringes for daily insulin administration.
The company said its Go-Pen addresses this gap by allowing users to refill the device from standard insulin vials. This reduces the cost per dose compared to traditional disposable pens. Its design enables individuals in low-resource settings to manage their diabetes with improved ease and precision.
Go-Pen ApS says it put the device through rigorous physical, chemical and human factors studies to ensure safety and effectiveness in diverse environments. The company reports positive user feedback, indicating the device’s global potential.
Next steps for the insulin pen include converting existing letters of intent into formal launch contracts. As the company takes the device commercial, it wants to work with partners to ensure broad access to the pen. It also plans to raise about $5.6 million (€5 million) in equity to support manufacturing scale-up and meet demand.
“Our mission has always been to democratize access to essential diabetes care,” said Ole Kjerkegaard Nielsen, CEO and co-founder of GO-Pen ApS. “Receiving FDA clearance is a significant step toward realizing our vision of making high-quality insulin delivery accessible to all, regardless of geographic or economic barriers.”
