Bergen, January 27th, 2021 – Lifecare AS (LIFE).
Lifecare preliminary concludes a net profit of NOK 1.46M in Q4 2020, vs. NOK
-1.2M in Q3 2020 and NOK -2,16M in 1H 2020. Lifecare expect a net profit of NOK
-2.2M for the year 2020, which is an improvement from the net profit for the
year 2019 ending at NOK -6.5M. The Tax Incentive Scheme for R&D companies
(SkatteFUNN) is expected to further improve the final net profit for the year
2020 after audit completion.
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
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
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 may be
subject to change.
For more information, please contact:
Joacim Holter, CEO
Phone: +47 40 05 90 40
Lifecare (LIFE) is a Bergen-based technology company developing a miniaturized
implantable long-term sensor for glucose measurement for people with diabetes
mellitus. Its patented technology is also used as a central component in a
current rapid SARS-CoV-2 antigen test development and in other future diagnostic