Talisman needle-free CGM demonstrates strong correlation to blood glucose in clinical studies and moves towards large volume manufacturing
17 Junio 2024 - 1:00AM
Talisman needle-free CGM demonstrates
strong correlation to blood glucose in clinical studies and moves
towards large volume manufacturing
- Data from Clinical Performance Study
of Talisman shows strong correlation with blood glucose values
- GlucoModicum is partnering with
world-class manufacturers to build large-volume production lines
for Talisman devices and sensors
- Recent completion of a funding round
to enable the progression of manufacturing, clinical and regulatory
approvals
Helsinki, Finland, 17 June 2024
– GlucoModicum, a company transforming glucose monitoring with
proprietary needle-free magnetohydrodynamic (MHD) technology, today
provides an update on the clinical performance, product development
and commercialization pathway of Talisman, the Company’s
needle-free continuous glucose monitor (CGM).
Talisman is a wearable CGM that uses MHD
technology to extract interstitial fluid (ISF) from the skin
without the use of needles. By integrating ultra-sensitive and
low-cost biosensors, Talisman enables continuous, painless, and
accurate monitoring of glucose levels.
Clinical Performance and
manufacturing
Data from an ongoing Clinical Performance Study
(FIMEA-K485) of Talisman, recently presented at the World Congress
of Diabetes Technology and Therapeutics in Kochi, India, confirms a
strong correlation to blood glucose values (currently, N>100
individual tests). The study, which commenced in 2023, will recruit
up to 500 participants including patients with Type 2 diabetes and
healthy volunteers and is authorized and monitored by the Finnish
Medicines Agency (FIMEA) under EU regulation.
CLINICAL PERFORMANCE STUDY (FIMEA-K485)ANALYSIS
CORRELATION
- Talisman yields strong correlation to reference blood glucose
measurements in clinical performance studies.
- The study involves 100+ adult participants including persons
with type 2 diabetes.
- The correlation and data obtained
from the study serve to confer Talisman with the required
accuracy.
Talisman, as being used in the CPS, is
manufacturable in large volumes with low COGS. The device and
sensor are nearing a “design-freeze”, enabling GlucoModicum to make
progress in the manufacturing proof of principles and finalizing
the design of automated high-volume manufacturing lines. The
company will own the manufacturing lines and associated IPR and has
received several offers for contract manufacturing from large
world-class operators. The first automation line is designed to
produce 21 million sensors annually which can be duplicated
cost-efficiently with a 10-month lead time. For the device, the
initial ramp-up volume will be 100 thousand devices annually, but
the company has finalized the blueprints to be able to manufacture
up to a million devices annually. The Company plans to enter a mass
manufacturing service agreement (MSA) during 2024, anticipating
device pilot production towards the end of 2024 and sensor pilot
production in 2025. GlucoModicum remains compliant with the ISO
13485 standard in quality management, an important element in
R&D and manufacturing partners’ operations.
Funding and progression towards launch
GlucoModicum recently completed a funding round
backed by a consortium of international investors and family
offices. In addition to private funding, GM has received a
substantial amount of public (non-dilutive) funding with the option
of receiving further public funding for manufacturing investments.
Using this funding, the Company continues to make progress towards
CE marking and FDA submission as it prepares for product launch,
continuing its work with global key opinion leaders to evaluate and
validate the Talisman, target patient segments, and develop use
cases. GlucoModicum is in the process of designing pivotal clinical
studies to be conducted in recognized research centers testing
Talisman devices and sensors manufactured in the actual
manufacturing lines as required by the regulations.
Alejandro García Pérez, Chief Technology
Officer at GlucoModicum said: “We are thrilled by the
positive results from the study, which highlight the significant
advancements we have made in the development of Talisman as we
approach its launch. GlucoModicum continues to progress across all
the critical areas including manufacturing, R&D, and regulatory
approval and we look forward to the accelerated path towards
commercialization.”
Jokke Mäki, Managing Director of
GlucoModicum, commented: “GlucoModicum is well funded to
deliver its objectives and is supported by high-quality investors
who share our vision of delivering a needle-free alternative to CGM
for all. This represents a strong validation of our technology, and
we look forward to accelerating our progress towards
commercialisation while maintaining our strong track record.”
- END -Contacts
ICR ConsiliumChris Welsh / Evi Useh Email:
glucomodicum@consilium-comms.com
About GlucoModicumGlucoModicum
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. 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.
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.https://doi.org/10.1038/s41598-021-86931-7https://doi.org/10.1038/s41598-022-21424-9https://doi.org/10.1016/j.bios.2022.114123