News and press releases

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.

“As part of our 2025 strategy, Strive25, we set an ambition to significantly raise the standard of care for our users and bring new products to market at a higher pace. I am excited to see that our Innovation unit continues to deliver on this commitment, latest with these three new products in Ostomy Care,” says Executive Vice President of Innovation, Nicolai Buhl.

Introducing Heylo

For many people living with a stoma, leakage is a significant physical and mental challenge in their daily life. Heylo is designed to detect potential leakages under the ostomy baseplate, and by notifying users at an early stage it enables them to take action and prevent the leakage from progressing. The product consists of a sensor layer that is attached to the baseplate, a transmitter that is attached to the sensor layer and connects to the user’s smartphone via Bluetooth®, and an app that notifies the user at the first sign of leakage and if it continues to spread.

“Heylo is the world’s first digital leakage notification system and a big step forward in providing more personalised care for our users. I believe Heylo will help users feel more in control, bring peace of mind, reduce their fear of leakage, and ultimately improve quality of life,” says Nicolai Buhl.

The first market to launch Heylo will be the UK, where national reimbursement has been granted as of 1 July 2024*.

Introducing SenSura® Mio in black and SenSura Mio Convex Soft with Flex coupling

Coloplast is also expanding its SenSura Mio range with two new products. The company is launching SenSura Mio in black, aiming to provide more product choice for people with a stoma.

“We know that having more product choice matters to people adapting to life after stoma surgery and may even help people in accepting their condition. Black is neutral, discreet, and timeless – and our hope is that this new bag will empower users and give them confidence to live life on their terms,” says Nicolai Buhl.

The first variants of the SenSura Mio in black will be introduced in key markets over the next six months, starting with Italy, France, Denmark, Norway, and the Netherlands in May 2024*.

Coloplast is also launching SenSura Mio Convex Soft with Flex coupling to reach more users that need convexity and 2-piece solutions. This product will be introduced in key markets over the next nine months, starting in Italy and France in May 2024*.

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

*Heylo, SenSura Mio in black, and SenSura Mio Convex Soft with Flex coupling are medical devices for which CE-mark has been affixed. Product availability is subject to the regulatory process of individual countries and is not guaranteed. These products are currently not available in the US.

It is estimated that 10-15% of the world’s population are affected by chronic constipation¹ and that 6% struggle with faecal incontinence², both of which can cause physical discomfort and mental distress³. Although transanal irrigation treatment can help, the journey to treatment is often challenging with many patients left untreated. For some patients, symptoms are not considered severe enough, while others can feel intimidated by the existing treatments and product offerings, often leading to social isolation⁴.

“Transanal irrigation is a well-documented and effective treatment, but there are still many barriers that prevent people from getting the right care. With Peristeen Light we aim to help break down those barriers, enabling more people to access the treatment and improve their quality of life,” says Nicolai Buhl, Executive Vice President of Innovation.

Peristeen Light is designed to bring relief. It is a hand-held, low-volume transanal irrigation device that instils water into the rectum, thereby evacuating the stool from the lower bowel. Peristeen Light is developed based on 20 years of insights from Coloplast’s high-volume transanal irrigation device, Peristeen Plus. Peristeen Light is designed to be intuitive and easy to use, assembled in just two steps, and enables a smooth insertion into the rectum with a soft and flexible catheter.

The launch of Peristeen Light begins in February 2024 and the device is expected to be available in European markets over the next 12 months⁵.

Transanal irrigation treatment

Transanal irrigation is a procedure to manage bowel disorders by instilling water through a catheter to promote evacuation. The procedure helps regulate bowel movements and is often employed for symptoms like faecal incontinence and/or chronic constipation.

A growth driver in Bowel Care

Peristeen Light is a new transanal irrigation device within Coloplast’s Bowel Care segment. The addressable market for bowel care, comprised of transanal irrigation treatment, is estimated at around DKK 1 billion, growing at a high-single digit rate. Peristeen Light is expected to contribute to Coloplast’s growth trajectory for Bowel Care and help solidify the company’s global market leader position within transanal irrigation. 

Contacts

Peter Mønster

Sr. Media Relations Manager, Global Communications

+45 4911 2623

dkpete@coloplast.com

Aleksandra Dimovska

Sr. Director, Investor Relations

+45 4911 2458 

dkadim@coloplast.com

¹ Barberio B, Judge C, Savarino EV, et al. Global prevalence of functional constipation according to the Rome criteria: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology. 2021;6(8):638-48.

2 Sharma A, Yuan L, Marshall RJ, et al. Systematic review of the prevalence of faecal incontinence. The British journal of surgery. 2016;103(12):1589-97.

3 Coloplast, Market Study, The impact of bowel dysfunction of patients and HCPs, 2017, Data-on-file

4 Coloplast, Market Study, The impact of bowel dysfunction of patients and HCPs, 2017, Data-on-file

5 Note that Peristeen Light is a CE-marked medical device. Availability is dependent on the individual country's regulatory process. Not available in the US.

“We are now introducing new innovation to the US market, aiming to grow our presence within the foam dressings segment. We have a great product in our hands, and we have invested significantly in our sales organization to reach the full potential of this launch. I am really excited to get started,” says Kimberly Ditter, Vice President of Wound & Skin Care, North America.

Changing demographics and an aging population are leading to a higher demand for healthcare services, putting significant strain on healthcare systems. In the US, chronic wounds are reported to affect 10.5 million patients annually¹, while 2.5 million patients develop a pressure injury in acute care facilities each year². Therefore, it is critical for healthcare providers to choose products that simplify their workflows and deliver the best possible care for their patients.

“Choosing the right dressing for wound treatment or pressure injury prevention should be simple and easy and give the patient a soft, secure and comfortable fit. Biatain Silicone Fit offers exactly that. It fits to the body, and it fits to the wound,” says Kimberly Ditter.

Fits to the body and fits to the wound

Biatain Silicone Fit with 3DFit Technology is designed for both pressure injury prevention and wound management. It stays securely in place during patient movement, fitting to body creases and allowing easy skin inspection as part of pressure injury prevention protocols³. It also matches the shape and depth of the wound bed up to 2 cm deep⁴, lowering the risk of infection and maceration for optimal wound healing conditions.

Biatain Silicone Fit comes in 12 different sizes and shapes to suit the facility’s needs. All sizes and shapes are developed and indicated for both pressure injury prevention and wound treatment to accommodate multiple purposes and a reduced number of SKUs.

Biatain Silicone Fit is available in the US as of January 2024.

Expanding Wound Care in the US

The global advanced wound dressings market is estimated at DKK 26-28 billion, with an annual estimated growth rate of 2-4%. Around 25-30% of the market is derived from the US, where products are typically used in the hospital setting.

1)     Sen CK. Human Wound and Its Burden: Updated 2022 Compendium of Estimates. Adv Wound Care (New Rochelle). 2023 Dec;12(12):657-670. (LINK)

2)     Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019 Jun;16(3):634-640. (LINK)

3)     Coloplast data on file, 2022. Based on simulated use.

4)     Coloplast data on file 2023. Fit to the wound bed may vary across product design.

Contacts

Peter Mønster
Sr. Media Relations Manager, Global Communications
+45 4911 2623
dkpete@coloplast.com

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