
Other matters
Coloplast US has agreed to purchase the
outstanding shares of Uromedica
Coloplast US has signed a definitive
merger agreement with Uromedica, a
privately held medical technology
company specialising in the treatment of
stress urinary incontinence whereby
Uromedica will become a wholly owned
subsidiary of Coloplast US. The
Uromedica Board of Directors has
recommended shareholders vote in favor
of the transaction. The transaction is
expected to close in February 2025/26,
subject to customary closing conditions
and requisite Uromedica shareholder
approval.
Uromedica is a commercial stage
company with a unique minimally
invasive solution for stress urinary
incontinence. The solution is highly
complementary to Coloplast’s existing
Men’s Health business in Interventional
Urology and supports Coloplast’s
ambition to innovate and expand our
presence in Men’s Health through a
combination of organic innovation and
bolt-on acquisitions.
The transaction consists of an upfront
cash payment and a contingent
milestone-based structure under which
the majority of the potential
consideration is tied to future regulatory
and commercial achievements. Deal
terms will remain undisclosed, and the
transaction will be financed through
existing credit facilities.
The transaction is expected to have an
immaterial impact on Group financial
performance in 2025/26 and is expected
to be accretive to Interventional Urology’s
financial metrics in the second half of the
Impact4 strategic period.
Changes to Medicare reimbursement in
the skin substitutes out-patient setting
Effective January 1, 2026, CMS has
implemented a fixed reimbursement rate
of $127/cm2 for skin substitutes in the
Medicare outpatient setting, while the
final Local Coverage Determination
1
(LCD) expected to take effect on the same
date was withdrawn December 24, 2025.
Around 20% of Kerecis total sales comes
from the Medicare outpatient setting,
and this new payment model directly
affects Kerecis’ two product brands,
MariGen® and Shield®. Because Shield is
priced above the fixed rate, it will be
phased out of the Medicare market and
replaced by a renewed MariGen portfolio,
which is competitively positioned under
the new pricing. This shift will create a
negative mix effect as MariGen volumes
scale.
Although ultimately cancelled, the LCD
had identified only 18 products out of
more than 300, clearly distinguishing the
technologies with the strongest clinical
evidence. The inclusion of both MariGen
and Shield on this list provides robust
external validation of the clinical potency
and differentiation of Kerecis’ fish-skin
platform.
Long-term, CMS’ decision to adopt a flat
national rate reinforces Kerecis’
competitive position as a high-quality
wound-care partner with a sustainable
business model built on the patented,
clinically potent fish-skin technology and
a uniquely cost-efficient production
setup.
To align with the new Medicare
requirements, Kerecis has already
adapted its go-to-market model in the
first quarter and will launch a series of
targeted products throughout the year to
support the updated commercial
approach and sharpen sales priorities.
Taken together, these regulatory
developments and strategic actions
position Kerecis well to compete and win
in an evolving US skin substitutes market.
Changes to Executive Leadership Team
On December 18, 2025 Coloplast
announced changes to the Executive
Leadership Team
2
. Executive Vice
President of People & Culture, Dorthe
Rønnau, has decided to leave Coloplast to
pursue the next chapter in her career and
will have her last day at Coloplast at the
end of February. An external search for
her successor has been initiated. In
Interventional Urology, Tommy Johns,
Executive Vice President of Interventional
Urology has decided to retire. Kevin
Hardage joins Coloplast on February 9th
and will step into the role of new
Executive Vice President of Interventional
Urology. He brings extensive experience
from the global MedTech industry,
including senior leadership experience
from Teleflex in the urology space.
CMS final rule on DMEPOS Competitive
Bidding Program
On November 28, 2025, the CMS in the
US announced a final rule
3
with an
update on the Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding
Program (CBP).
The final rule confirms that ostomy and
urological supplies, including catheters
and related items, will be included in the
next round of Medicare CBP.
Tracheostomy supplies, originally
included in the final rule, has since been
excluded in an update published
December 8, 2025
4
. According to CMS,
contracts under the Medicare CBP will
take effect no later than January 1, 2028.
Chronic Care in the US accounted for
around 12% of Group sales in FY
2024/25, with an estimated 50% related
to Medicare.
Announcement no. 1/2026 | 6 February 2026
10
1 Coloplast notes CMS decision to withdraw the final LCD
2 Coloplast announces changes to executive leadership team
3 Reaction to CMS final rule on DMEPOS Competitive Bidding Program
4 DMEPOS Competitive Bidding Program – Updates and Important Information