Investor Presentaiton
Comprehensive clinical program behind
Luja™ to demonstrate the clinical
relevance and difference
Pre-clinical studies
In-vivo and in-vitro animal
models used to optimize
technology features and
document the effect.
Pilot studies
8 studies comparing Luja vs.
conventional catheters¹
involving 160+ users,
demonstrating
number of flow-stops and
residual volumes at first flow
stop significantly lower with
micro-hole zone catheters as
compared to conventional
catheters
Pivotal studies
2 multinational pivotal studies²
involving 110+ users
demonstrating the impact on
the key risk factors of UTIs
Multicenter, randomised cross
over trials comparing Luja™
vs standard of care
•
Endpoints: Residual volume,
Flow stops, Blood in urine, QoL
The first pivotal study³ showed
significant improvement in bladder
emptying with Coloplast's Luja™
compared to competitor catheter
The second pivotal study confirmed
the improved performance of Luja
seen in the first study
1 Clinicaltrials.gov references: NCT03337048, NCT04633291, NCT04231149, NCT04250987, NCT04445051, NCT04543136, NCT04557787, NCT05224544.
2 Clinicaltrials.gov references: NCT05485935, NCT05485922
3 Study shows significant improvement in bladder emptying with Coloplast Luja™ compared to competitor catheter
4 The data set from the second pivotal study and other relevant clinical data on Luja is available via this link
37
ColoplastView entire presentation