Significant Achievement for OstomyCure AS and TIES®Solution

Oslo, Norway (ots/PRNewswire) -

Approval for multicenter study "TIES-C03" in major university
hospitals in Leeds, UK & Umeå, Sweden.

OstomyCure AS has achieved an important milestone on the way to
making the revolutionary TIES® Solution available to ileostomy
patients, a patient population that has not experienced any major
improvements in "standard of care" in the last 30-40 years. The study
aims to gather more and longer term clinical data regarding safety,
performance and Quality of Life.

The study has started at Norrland University Hospital, Umeå,
Sweden with Associate Professor Karin Strigård and Prof. Ulf
Gunnarsson and at St. James Hospital, Leeds with Professor David
Jayne as the main investigators. OstomyCure plans to commit
additional clinical centers to participate in the "TIES-C03" study.

The TIES® Solution is a "no skin touch" solution which uses a
titanium ring implanted at the stoma site, creating an external
attachment point for lids or drainage bags. The indwelling part of
the device is a porous mesh that allows the intestinal and
surrounding skin tissues to grow through, creating a tight seal and a
safe and stable junction between intestinal and dermal tissues and
implant. The device extends a few millimetres above the skin,
allowing it to be sealed with a fitted plastic lid with a hatch and a
bag attachment system that allows patients to drain the intestine
easily and at their convenience, with no direct contact with the
skin. The TIES® aims to provide a tested alternative to the current
standard of external stoma pouches glued to the skin that overcomes
the problems of skin infection/irritation and fungi that afflict
almost all ostomates today. With a tightly sealed stoma and no
constant need for external bags, patients can now control waste
discharge directly, and are free to bathe, swim, and engage in other
activities that are restricted or impossible with the traditional
solutions, none of which offer a continent seal.

OstomyCure's system is expected to largely eliminate the painful
skin issues associated with stoma care today, and greatly reduce the
inconvenience and cumbersomeness of current systems. The TIES® device
- leak-free, sanitary and odourless - gives patients greater
independence and control and significantly improves their quality of
life. The product is already CE-marked in Europe, but OstomyCure, in
consultation with its regulators, is undertaking the current trial to
increase the base of safety and efficacy data available before a full
commercial launch.

Dr. Ben Broennimann, M.D., CEO of OstomyCure, saluted his team.
"Our team at OstomyCure has worked incredibly hard and tenaciously at
establishing this study on schedule. The outstanding collaboration
between all internal and external stakeholders has been a great
contributor to the success in achieving the initiation of the study
according to plan. This is a significant milestone for our company,
and brings the TIES® Solution closer for the many thousands of ostomy
patients who have waited so long for innovative products to improve
their lives."

"We are pleased to see the high interest and commitment of a
number of highly renowned clinical centers and opinion leaders, as
well as of the patient community for the TIES® Solution clinical
study," added Dr. Ben Broennimann.

OstomyCure AS is a privately-owned Norwegian medical technology
company developing a revolutionary technology called the
Transcutaneous Implant Evacuation System (TIES®), addressing a market
estimated to be worth $2bn annually. For more information, please
visit http://www.ostomycure.no. The stoma market today is dominated
by Coloplast, Convatec & Dansac/Hollister but other players such as
B. Braun, Medtronic, Johnson & Johnson/Ethicon, Baxter, Salts
Healthcare, Welland and Fresenius Kabi also participate.

Investor Relations:

Dr Ben Broennimann, CEO

info@ostomycure.com

+41 793 016 272

ots Originaltext: OstomyCure AS
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