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  • Press release
17 Apr 2019

Coloplast responds to FDA’s decision to remove Surgical Transvaginal Mesh as Treatment Option for Pelvic Organ Prolapse

Coloplast was informed yesterday by the FDA that the PMA for Restorelle DirectFix Anterior is not approved and the company must cease marketing and distribution immediately.

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As a result, FDA regulations require that all anterior transvaginal synthetic mesh products, including Coloplast’s Restorelle DirectFix Anterior device, can no longer be commercialized in the U.S., effective immediately. Coloplast will work with the FDA and other relevant authorities to ensure the orderly removal of these devices from customer inventories.

 

In accordance with the FDA guidance, Coloplast recommends that women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. However, any patient with questions or concerns should speak to her healthcare provider. Please refer to the full statement on the  FDA website.

 

Coloplast is disappointed by the FDA decision to remove surgical transvaginal mesh as a treatment option for women suffering from pelvic organ prolapse. Coloplast has been committed to working with the FDA on the 522 clinical studies to document the long-term efficacy and safety of the products.

“Our mission at Coloplast is making life easier for people with intimate healthcare needs. Pelvic organ prolapses (POP) can be a painful, embarrassing, and a debilitating issue for the women who suffer from it. While mesh sales to treat POP in women account for approximately 0.2% of our global revenue, we firmly believe that patients and their physicians should have a choice of therapies. We are disappointed with the FDA’s decision because it reduces the treatment options for women with POP. We remain committed to providing alternative therapies.” says CEO Kristian Villumsen, Coloplast.

 

Coloplast has alternative solutions for the same type of products including tissue products as well as alternative procedures for pelvic organ prolapse. The FDA’s decision is limited to mesh for the transvaginal repair of pelvic organ prolapse and does not extend to mesh used to treat stress urinary incontinence.

 

 


CONTACTS
Lina Danstrup

Senior Media Relations Manager, Corporate Communications

+45 49 11 26 07

dklina@coloplast.com

 

Ellen Bjurgert

Vice President, Investor Relations

+45 49 11 33 76

dkebj@coloplast.com


  • Press release
5 Feb 2019

Coloplast delivers solid start to the year with 8% organic growth

Coloplast delivered 8% organic growth and EBIT increased by 8% to DKK 1,297m, corresponding to an EBIT margin of 30%, in the first quarter of the 2018/19 financial year. The company maintains its financial guidance for 2018/19.

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Coloplast delivered 8% organic revenue growth in the first three months of the 2018/19 financial year, while reported growth in Danish kroner was up by 9% to DKK 4,321m. Currency developments reduced revenue by less than 1%, and revenue from acquisitions contributed 1%.

 

Organic growth rates by business area were 8% in Ostomy Care, 8% in Continence Care, 9% in Interventional Urology, and 11% in Wound & Skin Care.

 

Looking at sales by geography, the European markets contributed with 6% growth, Other developed markets delivered 10% revenue growth, while Emerging Markets provided a 14% increase.

 

“We maintain solid growth rates across all geographical regions and business areas. I would like to highlight our strong performance in Europe driven by new product launches and our Wound Care business delivering 10% organic growth driven by the Biatain® Silicone portfolio in UK and France. Our organic revenue growth is twice the market growth, and we maintain our guidance for 2018/19. In short, we are off to a good start to the financial year,” says newly appointed Coloplast CEO Kristian Villumsen. 

 

Investments in further growth
Coloplast continued its incremental investments in growth of up to 2% of revenue during the first quarter. Investments were made in innovation as well as sales and marketing initiatives across multiple markets and business areas.

In addition, Coloplast is expanding its SpeediCath® portfolio with the launch of SpeediCath® Navi. SpeediCath® Navi is a hydrophilic catheter designed specifically for Emerging Markets and it will be launched during 2019 and 2020.    

 

-        “As part of our investments in Emerging Markets, we’re proud to be able to offer a product developed specifically for catheter users in this region. Our aim is to raise the standard of care and to accommodate markets with lower reimbursement.  I’m confident that SpeediCath® Navi will make a big difference to our users, while giving Coloplast a strong competitive edge,” says Mr Villumsen.

 

Financial guidance for 2018/19
Coloplast continues to expect organic revenue growth of ~8% at constant exchange rates and a reported growth in DKK of 8-9%.

 

Coloplast continues to expect an EBIT margin of 30%-31% at constant exchange rates and a reported EBIT margin of ~31% in DKK.

 

 

 


CONTACTS
Lina Danstrup

Senior Media Relations Manager, Corporate Communications

+45 49 11 26 07

dklina@coloplast.com

 

Ellen Bjurgert

Vice President, Investor Relations

+45 49 11 33 76

dkebj@coloplast.com


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