Indigo Diabetes

Indigo Diabetes N.V. is a Belgian medical device company developing a continuous multi-metabolite monitoring (CMM) system for people with chronic diseases, with an initial focus on diabetes. Founded in 2016 by Dr. Danaë Delbeke and her team as a spin-off from Ghent University and imec, a leading research center in nanoelectronics, the company is headquartered in Ghent, Belgium, with a US subsidiary, Indigo Medical US Inc., in Boston.

The founder and CTO, Danaë Delbeke, has a PhD in Applied Sciences from Ghent University and a background in both photonics engineering and economics. Her work in photonics and a desire to make a tangible impact on quality of life led to the creation of Indigo. Delbeke is a serial entrepreneur, having founded or co-founded seven high-tech photonics companies. The management team includes CEO Peter J. Devlin, who has extensive experience at companies like Abbott Laboratories and Insulet Corporation.

The company's core product is a subcutaneously implanted CMM sensor designed to be invisible after insertion. This sensor utilizes proprietary nanophotonics technology, effectively a miniaturized spectrometer-on-a-chip, to measure the absorption of light in interstitial fluid. This allows for the simultaneous, continuous, and real-time monitoring of multiple metabolites like glucose, ketones, and lactate without using enzymes or fluorophores. The data is transmitted wirelessly via Bluetooth to a mobile app, providing users and their caregivers with actionable insights to manage their condition. The implantable sensor is designed to have a lifespan of up to two years.

Indigo's business model centers on the development and eventual commercialization of this medical device for the chronic disease management market. The company has raised significant capital to fund its research, development, and clinical trials. In 2016, it secured a €7 million Series A round. This was followed by a €38 million Series B round in 2020, led by Fund+, to prepare for and initiate clinical studies in Europe and the US. The company has successfully completed its first-in-human (GLOW) and longer-term stability (SHINE) clinical trials and has received ISO 13485:2016 certification for its quality management system. While the initial market is diabetes management, Indigo plans to explore applications for its CMM sensor in other chronic conditions such as kidney disease, oncology, and cardiovascular disease.

Keywords: continuous metabolite monitoring, implantable sensor, nanophotonics, diabetes management, medical devices, glucose monitoring, ketone monitoring, silicon photonics, medtech, chronic disease