The positive financial development in Q4 2020 is mainly caused by two factors:
- In January 2020, the company established a collaboration as co-owner of the German company Digital Diagnostics AG (Digid). In return for granting Digid a non-exclusive license for commercial exploitation of Lifecare's patents and IP, Digid has undertaken to finance the remaining development of Lifecare's sensor technology for Continuous Glucose Monitoring (CGM), Sencell.
- In October 2020 Lifecare, in collaboration with academic institutions in Italy, Germany and France, launched a project which received grant support of just over NOK 43M from the EU Research and Innovation Funding program HORIZON 2020. The project named “FORGETDIABETES” aims to develop a miniaturized closed-loop artificial pancreas device, which is planned to be implanted in the abdominal cavity. As a so called “close-loop system”, the device will deliver the correct amount of insulin based on continuous glucose readings delivered by an integrated Sencell glucose sensor. Lifecare's stake of the total funding is approx. NOK 6.3M, partly credited in Q4 2020. The project is planned to run until end of Q3 2025.
Sencell Development status
The technical development of Sencell was subdued in Q2 and Q3 2020 by emergencies induced by the COVID19 pandemic, leading to the opportunity for Lifecare's development partner Digid to bring a novel 5-minute antigen rapid test for SARS-CoV-2 to a mature and market ready stage.
On a positive side, necessary development steps required for both device developments were prioritized as compared to the original Sencell development plan and are now applicable also for the further CGM development.
In Q4 2020, Lifecare re-established the main focus on technical development of Sencell for use in CGM and the project FORGETDIABETES. In November 2020, Lifecare presented a method for using Sencell as the core component in a long-lasting needle glucose sensor at the Diabetes Technology Meeting in San Francisco. This method may lead to wired needle sensors with substantially longer usage time than currently existing wired CGM solutions and even involves opportunities for commercialization of the Sencell technology at an earlier stage than originally expected.
Cantisense development status
The technical development of Digid's Cantisense SARS-CoV-2-Test progressed as expected in Q3 and early Q4 2020, facing challenges related to the manufacturing process, which occurred in the first half of October 2020. However, Digid meanwhile addressed these issues with intensified efforts and has conducted important further testing in Q4 2020. In addition, Digid is in the final process to prepare for ISO 13485 certification,a quality system enabling the company to market certified (CE mark) medical devices in the European Union and associated countries.
The overall development at Digid is good, although the timeline for bringing the Cantisense SARS-CoV-2-Test to a market ready stage has turned out longer than originally expected based on reports from Digid. In parts of 2020 Digid was indirectly exposed due to activities by associates to, and representative of, its previous majority owner. Despite the fact that these activities were outside Digits control and otherwise without relevance for the activities at Digid, the circumstances had an impact on the Digid operations and progress. The circumstances lead to a change in the Digid Board as the former chairman of the company was dismissed by unanimous vote at an Extraordinary Shareholders Meeting in Q4 2020.
Forward looking statement
In 2021, Lifecare expects substantial development progress for the Sencell Osmotic Sensor technology. A first-in-human Clinical Study Protocol has already been approved by the responsible Institutional Review Board, and Lifecare expects final approval by the responsible German regulatory authorities (BfArM) and the subsequent initiation of clinical pilot trials In Q1 2021. Additional clinical trials are planned for 2H 2021.
The overall goal for 2021 is to initiate the CE mark approval process for the Sencell technology. Areas of use for the Sencell technology besides glucose measurement are considered on an ongoing basis and are expected to be further intensified in 2021. The FORGETDIABETES project is still in early stage but will nevertheless constitute a key focus area for Lifecare in 2021 and the years to come.
Digid informs that the development of the Cantisense SARS-CoV-2-Test will continue unabated in 2021. Digid indicates furthermore that the CE marking and start of commercialization can be expected in Q2 2021. The application of the technology for other diagnostic tests is possible and will be further explored.
The information contained in this statement has not been audited and maybe subject to change.
For more information, please contact:
Joacim Holter, CEO
Phone: +4740 05 90 40