Coloplast expands its Luja™ portfolio with next generation catheter for women

The female intermittent catheter enables complete bladder emptying in one free flow¹, aiming to reduce the risk of urinary tract infections².

Following the successful launch of Luja with Micro-hole Zone Technology, a next generation intermittent catheter for men, Coloplast is now launching Luja for women.

"So far, we have received great feedback on Luja for men in our product evaluations. Nearly all healthcare professionals would recommend the male catheter to their patients³, and seven out of ten users feel confident that it empties their bladder completely without needing to reposition the catheter⁴,” says Nicolai Buhl, Executive Vice President of Innovation.

Urinary tract infections remain a major concern and challenge for men and women using catheters⁵. Flow stops and blockage of conventional catheter eyelets during catheterisation increase the risk of leaving residual urine behind in the bladder, which raises the risk of bacteria growth and is a well-known UTI risk factor².

"I am excited that the Micro-hole Zone Technology will now be available for female catheter users. The new female catheter has 50+ micro-holes*, enabling complete bladder emptying in one free flow¹, and I believe this technology will set a completely new standard in the market,” says Nicolai Buhl.

Luja with Micro-hole Zone Technology for female users will launch across all Coloplast’s key markets over the next 12 months, starting in Denmark and Italy in May 2024**.

Clinical studies: No need for repositioning and no discomfort
The performance of Luja for women is supported by two clinical studies. The studies found that the catheter enables complete bladder emptying in one free flow without having to reposition the catheter¹. The studies also found that women reported no discomfort when using Luja and that the catheter was gentle to use⁶.

Reduced environmental footprint
Luja Female is designed with the user and environment in mind. The catheter is made with 28% less plastic than Coloplast’s SpeediCath® Compact Eve and has a 22% lower carbon footprint⁷. The Luja Female product container material is recyclable⁸.

Contacts
Peter Mønster
Sr. Media Relations Manager
+45 4911 2623
dkpete@coloplast.com

Aleksandra Dimovska
Sr. Director of Investor Relations
+45 4911 2458
dkadim@coloplast.com

References
¹Luja female ensured zero flow stops in 87% of catheterisations & <10 mL residual urine at first flow stop in 83% of catheterisations (RCTs, post-hoc, NCT05841004, n=73, & NCT05814211, n=82). Coloplast Data-on-File, 01/2024. Individual
results may vary.

²UTI risk factors defined by Kennelly M, Thiruchelvam N, Averbeck MA et al. Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections, Adv Urol., 2019; 2:2019:2757862

³Vaabengaard R, Islamoska S, Zeeberg R, Jacobsen L. Healthcare professionals feel confident and less worried about bladder emptying and urinary tract infections when patients use the micro-hole zone catheter Luja™. BAUN Annual Conference, AAC, Liverpool, UK 2023. PM-28201, n = 62.?

⁴Vaabengaard R, Islamoska S, Zeeberg R, Jacobsen L. Users of intermittent catheters feel more confidence and less worries of bladder emptying and urinary tract infections when using the micro-hole zone catheter Luja™. BAUN Annual Conference, AAC, Liverpool, UK 2023. PM-28203, n = 816.

⁵Averbeck MA, Kennelly M, Thiruchelvam N et al. Risk factors for urinary tract infections associated with lower quality of life among intermittent catheter users. British Journal of Nursing, 2023, Vol 32, No 18 (Urology Supplement).

⁶Coloplast Data-on-File, RCT, NCT05814211, 03/2024, n=82

⁷Compared to SpeediCath® Compact Eve. Based on externally reviewed carbon footprint according to ISO14067.

⁸Product design, use and local waste management specifics may limit recyclability.

*minimum of 50 micro-holes on Luja female CH10-16.

**Luja for female users is a medical device for which the CE-mark has been affixed. Product availability is subject to the regulatory process of individual countries and is not guaranteed. The product is currently not available in the US.

Attachment

• Luja Female