GlucoModicumpublishes first-in-human data assessing the safety and effectiveness ofits MHD technologyfor accurate needle-free glucose monitoring
- Human data shows high correlation between concentration of glucose in samples extracted with MHD technology against capillary blood glucose samples with MARD of 12.9%
- Subsequent improvements post-trial have resulted in MARD of <9%
- Results further validate MHD for accurate needle-free continuous glucose monitoring
- Significant progress made in product development of Talisman with Philips-Medisize, a world leader in MedTech design and development
Helsinki, Finland, 09November 2022 - GlucoModicum, a company transforming glucose monitoring with precise, needle-free magnetohydrodynamic (MHD) technology, announces that peer-reviewed data from the first-in-human study assessing the safety and effectiveness of its proprietary MHD technology for needle-free measuring of glucose levels has been published in Scientific Reports, part of the Nature Research portfolio.
Data drawn from glucose tolerance tests on healthy volunteers obtained a strong correlation between the concentration of glucose in interstitial fluid (ISF) samples extracted with GlucoModicum's MHD technology against capillary blood glucose (CBG) samples.
The data obtained with MHD technology demonstrate a 12.9% MARD (Mean Absolute Relative Difference), a measure of the agreement between a glucose sensor reading and a reference blood glucose reading. This value lies within the range of 10-15% typically reported by commercially available CGM devices. Furthermore, no evidence of long-lasting effects on the skin were observed.
The results further validate data published in the journal Biosensors and Bioelectronics in April this year, which demonstrated that MHD integrated with a biosensor is a highly effective method for accurate determination of glucose concentrations. Additionally, GlucoModicum published data in Scientific Reports in 2021 showing that MHD extracts ISF from the skin 13x more effectively than other needle-free approaches. Taken in combination, these datasets validate the key building blocks of GlucoModicum's technology offering: efficient extraction of ISF, strong correlation to blood glucose levels, and the integration of MHD with a biosensor in a small device. This provides a strong evidence base supporting the development of a non-invasive glucose monitor using GlucoModicum's MHD platform technology.
Alejandro García, Chief Technology Officer of GlucoModicum, commented: "The benefits of continuous glucose monitoring in diabetes management are well documented, but broader adoption of CGM systems is limited by their cost and invasiveness.These results, the first from research conducted inhumans, highlight the efficacy of our proprietary MHD technology in extracting interstitial fluid through the skin,along withdemonstrating the accuracy of our approach. Recent improvements in our technology have enabled us to obtainMARD values of <9%, demonstrating an accuracy beyond many commercial, invasive CGMs."
GlucoModicum is pleased to provide an update on the product development of the Talisman, the Company's proprietary non-invasive CGM which uses MHD technology. In close collaboration with Philips-Medisize, GlucoModicum's design and development partner, the Talisman continues to be developed to ensure usability and manufacturability of the final prototype.
The publication is available online on Scientific Reports here: https://www.nature.com/articles/s41598-022-21424-9
Image: Prototype of the Talisman, a non-invasive continuous glucose monitor
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About GlucoModicum
GlucoModicum is transforming glucose monitoring with precise, needle-free magnetohydrodynamic technology. Its proprietary platform has the potential to radically change how people monitor their health, creating solutions that are precise, accessible and needle-free, empowering people to live healthier lives. The company's first product is a non-invasive, wearable glucose monitor for patients suffering from diabetes. GlucoModicum was founded in 2018 as a spinout of the University of Helsinki and combines an experienced, multi-disciplinary in-house team with world-class partners to deliver groundbreaking solutions for personal biomarker monitoring. www.glucomodicum.com
About Talisman
GlucoModicum's magnetohydrodynamic (MHD) technology is currently being productized as the Talisman, the first new, truly non-invasive CGM technology in 25 years. The Talisman uses MHD to extract interstitial fluid (ISF) from the skin without the use of needles, enabling rapid, painless and accurate readings of glucose levels. Talisman addresses the needs of the ~500 million diabetics and ~500 million pre-diabetics globally, and serves as a tool to promote better health among the +2 billion people at risk of developing diabetes.
GlucoModicum is undertaking an ongoing device programme with Phillips-Medisize, a global leader in design and high-volume manufacturing of FDA approved diabetes care devices. The effectiveness and accuracy of GlucoModicum's technology has been demonstrated in peer-reviewed studies assessing the efficiency of ISF extraction, biosensor compatibility and correlation of readings to blood glucose levels. Talisman will enter clinical studies in 2023.
