Indigo Diabetes NV is working to develop a next-generation continuous glucose monitor (CGM) that would be much simpler and easier to use routinely, potentially making it more useful for a much larger population.

It has just raised a €38 million ($44.5 million) series B financing to support that effort. The Ghent, Belgium-based company is developing a nanophotonics sensor implant that is expected to be undetectable, highly accurate and to last up to two years. The financing is intended to get its technology into clinical testing.

“Indigo is developing an implant that is inserted under the skin to measure glucose and other metabolites so that anyone living with diabetes no longer has to stick themselves a couple of times a day or need to wear a sensor patch on the arm continuously to know their levels,” Indigo co-founder and CEO Danaë Delbeke told BioWorld.

“We have a very small sensor that can be inserted under the skin, and where it can measure invisibly glucose and other metabolites,” she continued. “It can capture those values, and then it sends its data wirelessly to a mobile device that the user is carrying.”

Direct measurement

Delbeke has founded five photonics companies, including Indigo, in the past 10 years. She founded Indigo at the end of 2016; it now has raised more than €45 million and has about 25 employees.

The Indigo sensor technology is based on nanophotonics, essentially making it a miniaturized spectrometer that can directly measure glucose and other biomarkers or metabolites such as ketones. It also could be applied to other indications, as it could be developed to assess biomarkers such as lactate and urea, as well as other measures such as temperature. But Indigo plans to remain focused on diabetes for the foreseeable future.

“We're using a very innovative technology, namely nanophotonics, which is the sister to microelectronics,” explained Delbeke. “So, microelectronics is wafers with electrons to carry the information. With nanophotonics, it’s the photons that are carrying information. So, it's, in fact, optical systems that are just miniaturized for chips or devices, a very classic spectrometer spectrum analyzer, that measures absolute spectrum but on a chip. So, it means the big difference with all systems on the market today is that we don't use enzymes or fluid force to measure. We do a direct measurement of glucose by measuring the spectral absorption.”

The accuracy is expected to be comparable with existing CGMs although perhaps with stronger performance in the detection of hypoglycemia, which can be a problem currently.

Indigo will use this financing to further refine the implant and then start a clinical study to validate it. That would then be followed by a larger clinical trial in the U.S. and Europe. The plan is for a parallel development track in both regions, with a CE mark in hand by the end of 2023 and a nod from the U.S. FDA shortly thereafter.

The company is currently in discussions with regulators about its validation clinical study, as well as the necessary regulatory path. Delbeke declined to elaborate further on clinical trial details or whether the implant will require full FDA approval at this early juncture.

The optimal location of the implant is still being studied but could potentially be under the skin on the abdomen. The measurement of ketone is expected to enable alerts to prevent episodes of diabetic ketoacidosis that is associated with hyperglycemia. The condition is caused by insufficient insulin, which makes the body start to break down fat for energy and results in the release of ketones. It can advance rapidly with serious consequences for the patient. Existing CGMs do not measure ketones.

Two-year implant

The implant is expected to last up to two years in the body, which is much longer than a 180-day marketed implant from CGM competitor Senseonics Holdings Inc.

Indigo has not determined which segment of the diabetes population is likely to be the best fit with its implant, but it expects to have more insight on this issue once the validation trial is complete. Delbeke also declined to speculate on potential pricing for the implant, accompanying data transmission device and smartphone app system as compared to existing options.

“Our invisible sensor really aims to provide people with an improved quality of life. Our technology has been developed by people living with diabetes. Sensor patches are already a major step forward with regards to finger picking, but it remains cumbersome because you have to manage it and change it,” said Delbeke. “There's something hanging on your body that can be annoying; when it falls off when you're sweating or in the water, it can be stigmatizing. Some people also have allergies to it, so they cannot use it anymore. So, there's a group of people that are not happy with the Abbotts and the Dexcoms these days.”

The recent series B round was led by Fund+ with the participation of Ackermans & van Haaren, Imec.xpand, Capricorn Digital Growth Fund, QBICII, Titan Baratto and the series A investors. That earlier round was led by Thuja Capital Healthcare Fund II, PMV and Sensinnovat, with participation from Powergraph, Qbic Arkiv Fund, Fidimec, Manuardeo and Capricorn ICT Arkiv.

“Clinical evidence has proven that CGMs are effective tools for people with diabetes to improve glycemic control,” said Harrold van Barlingen of Thuja Capital. “We strongly believe Indigo’s invisible sensor is the next stage. Not only will it allow better monitoring and treatment of diabetes, but the psychological impact of continuously painful finger-pricking or having to live daily with visible sensors will be a thing of the past thanks to this Indigo sensor.”

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