Bergen, Norway, 3rd April 2024: Lifecare AS (LIFE), a clinical stage medical sensor company developing the next generation Continuous Glucose Monitor (CGM), has successfully reached the target for pilot production of the Sencell sensor. Reports show a breakthrough, and this will pave the way for the automated production by end of Q2 as scheduled.
Reference is made to Lifecare’s list of trigger events, as presented at the Q4 report of February 27th, 2024. Finalizing pilot production in Q1 and the launch of an automated production line by end of Q2 2024 are set as major milestones.
Commercialization is anticipated for Lifecare in the near future as the company now continues the processes of setting up automated production by the end of the second quarter.
– This milestone is in many ways more important to us than regulatory approval. This confirms that we can mass-produce our sensor that can measure glucose levels in humans and animals. The milestone means that we are a significant step closer to the goal of bringing this ground-breaking innovation from Norway to the global diabetes technology market. It will also strengthen our expectations of taking a position as a significant international manufacturer of continuous glucose monitors, says CEO Joacim Holter.
– We must admit that we have faced very complex technical challenges over time. We have been aggressive, but realistic regarding the plan for trigger events. I am therefore incredibly happy that we have kept what we promised the shareholders, says Holter.
Lifecare has gone from production by hand to pilot production with machines. This will naturally make the company far more efficient and increase the production quality of the sensors.
IMPORTANT STEPS DUE TO PRODUCTION ARE SOLVED
Our team in Reutlingen, Germany, used a Scanning Electron Microscope (SEM) with customized software to produce the Sencell – Lifecare’s unique sensor for Continuous Glucose Monitoring applying osmotic pressure as the sensing principle.
Sophisticated 3D-printing processes carried out in a SEM enables Lifecare to obtain the precision necessary to apply pressure sensing elements of a size as small as 40 nanometers (one nanometer corresponding to a millionth of a millimeter).
An essential part of the production preparations has been the programming of the software. The steps of comprehensive coding and customization went according to plan. Hence the software program was able to successfully handle the part of the pilot production used by the SEM. This part of the production is considered as step one.
Step two of the pilot production is also considered as finalized. This part of the production is the automated process of filling Lifecare’s proprietary and patented glucose-reactive chemical solution in the nanosized chambers of the sensors. This will also apply the nano-porous membranes to seal the chambers after filling. To solve this part of the production we use automated production components; a BioScaffolder (“BS 3.3) and a customized Nano-Plotter (“NP 2.1”) from the German supplier GeSiM mbH.
OUTLOOK
– In theory, we can start automated serial production tomorrow. It does, however, remain important details to finally prepare for volume production. Based on the pilot production, we are confident about the further process. This is definitely a major breakthrough for the company, but not least for a product in a global market. We will launch the sensor for the veterinary market first, says Joacim Holter.