Finnish tech-maker GlucoModicum will be upping manufacturing efforts of its Talisman CGM device following strong clinical data.
The device combines magnetohydrodynamic (MHD) technology, advanced algorithms and ultra-sensitive biosensors while linking to a smartphone app for data collection and reporting. MHD works by sending a small amount of energy through the skin to the interstitial fluid between the cells, bringing the fluid to the surface of the skin for easy and non-invasive sample capture.
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That is in contrast to currently available CGMs, which also adhere to the arm but feature a tiny needle that stays under the skin throughout the wear period to constantly sample the blood for glucose calculations.
Data from an ongoing clinical performance study of Talisman, called FIMEA-K485, confirms a strong correlation to blood glucose values. The study will recruit up to 500 people, including type 2 diabetes patients and healthy volunteers. Additionally, a usability study showed Talisman was well received by diabetes and healthy individuals for its ease of use.
The studies are authorised and monitored by the Finnish Medicines Agency under EU regulation, said Jokke Mäki, managing director of GlucoModicum, speaking exclusively to Medical Device Network. “The data that we show is from clinical trials that have been done under the new EU medical device regulation, so it is really tightly controlled.”
GlucoModicum was founded in 2018 as a spin out of the University of Helsinki. A funding round was recently closed, backed by a consortium of international investors and family offices. This will support further optimisation, manufacturing investments and a pivotal clinical trial of the device.
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By GlobalData“That investment also enables us to make more investments to optimise the performance further, and then it enables us to move and make relevant investments to mass manufacturing. I think that is very important for us,” said Mäki.
The company will own the manufacturing lines and intellectual property, with offers from operators for contract manufacturing, according to the 17 June announcement. GlucoModicum says the first automation line is designed to produce 21 million sensors annually, duplicable in ten months.
A mass manufacturing agreement is planned for 2024, with device pilot production by year-end and sensor pilot production in 2025. Back in October 2023, GlucoModicum teamed up with Phillips-Medisize, the CDMO owned by Molex, to help build the Talisman device.
CGMs are a rapidly evolving, highly innovative segment within the diabetes care market.
According to GlobalData’s Pharma Intelligence Centre, the insulin pump and CGM market will generate $8.1bn in the US by 2033.
According to Mäki, Talisman has the potential to improve quality of life for diabetics by offering an affordable, easy-to-use alternative to existing devices.
