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News & Milestones

Follow the progress of OstomySecure AS as the TIES implant advances through clinical evaluation, regulatory milestones, and key partnerships toward commercial availability.

MedTech Malta Awards 2025, Best Patient Impact of the Year
10 Jan 2026 Event

MedTech Malta Awards 2025: Best Patient Impact of the Year

OstomySecure AS received recognition in the most important category at the MedTech Malta Awards 2025: Best Patient Impact of the Year. This achievement reflects the intensive efforts throughout the past year to advance the TIES implant toward patients who need it most.

Over the past year, the OstomySecure team worked to bring its vision to life. What the public often does not see is the determination, motivation, and teamwork behind closed doors that made this achievement possible.

The entire OstomySecure team pushed forward relentlessly, always prioritizing the mission and the lives the company aims to improve. The goal has always been clear: to give people a chance for a better, more comfortable life with a significantly improved quality of care.

OstomySecure expressed gratitude to the full team including Graeme L. Smith, Professor Manish Chand, Dr. Steven Wexner, Stig Jarle Pettersen, and all the companies and shareholders who collaborated throughout the journey.

We did this together. And this is only the beginning.
OstomySecure patient recruitment milestone
17 Jan 2023 Clinical

OstomySecure completes important patient recruitment milestone

The pivotal clinical trial achieved a significant recruitment goal: 20 patients have been implanted with the TIES device across multiple countries.

The implanted patients are located in participating hospitals across the United Kingdom, Sweden, Poland, Austria, and India. These patients will undergo monitoring for an additional six months to evaluate the safety and performance characteristics of the technology.

The clinical data collected from these 20 patients will be included in regulatory submissions seeking CE Mark approval under the European Union Medical Device Regulation (MDR). Patient recruitment will continue during the regulatory review process to accumulate additional clinical evidence.

Implanting the TIES device has been very straightforward. There has been very little innovation in stoma therapy for many years. — Professor Manish Chand, University College Hospital London

OstomySecure CEO stated the milestone represents a crucial step in bringing this novel device closer to regulatory clearance and introducing it to a large patient population urgently in need of solutions to improve their quality of life.

OstomySecure clinical trial across five countries
20 Sep 2022 Clinical

OstomySecure continues clinical trial to fully evaluate the TIES implant

OstomySecure AS initiated a clinical trial for the TIES implant at hospitals across five countries: the United Kingdom, Sweden, Poland, Austria, and India.

The company aims to transform the lives of people with ileostomies by enabling them to regain control over their daily activities through this medical device technology.

The clinical investigation will establish critical safety and performance data necessary for obtaining regulatory approval of the device.

The safety and performance data from the trial will enable us to secure regulatory approval. This is a crucial milestone for the development of the technology. — Dr. Johan Jarte, CEO
Prof. Manish Chand
30 Jun 2022 Clinical

Professor Manish Chand joins the OstomySecure clinical study

Professor Manish Chand, Consultant Colorectal Surgeon and Professor of Surgery at University College London, joined the clinical evaluation of the TIES implant technology.

The prospect of a stoma bag can have a big impact on the lives of many patients both practically and in terms of their mental health. I am keen to see how OstomySecure's TIES implant can improve quality of life measures and be a great option for certain patients. — Professor Manish Chand

Professor Chand is a highly experienced specialist surgeon and global key opinion leader in colorectal surgery, colorectal cancer treatment, and robotic surgery techniques. He is at the forefront of medical innovation.

OstomySecure expressed optimism about welcoming patients to the London-based study, anticipating positive impacts on participants' lives.

Update on the TIES platform
28 May 2020 Corporate

Latest update on The TIES Solution

The interest in the TIES solution for permanent ileostomy patients is experiencing global growth. A clinical study designed to establish safety and efficacy was progressing well.

OstomySecure expanded its clinical research strategy by increasing participating sites from 2 locations in 1 country (United Kingdom) to negotiations with 18 sites across 4 countries: Austria, Poland, Sweden, and the United Kingdom, with additional sites under consideration.

Conventional stoma options have changed very little in the last 30 years and our goal is to provide additional options for permanent ileostomy patients. We are committed to do whatever it takes to bring the lifestyle changing TIES ileostomy lid solution to as many people as possible. — Graeme Smith, CEO

Upon receiving clearance to resume clinical studies in Europe, OstomySecure committed to supporting EU sites in participating in the clinical trial.

OstomySecure office at Karolinska Campus, Stockholm
14 May 2020 Corporate

New Stockholm office at Karolinska Campus

OstomySecure AS moved its Stockholm operations from Kista to the Karolinska Campus area in Solna, in the heart of the Stockholm life science scene.

The relocation positions OstomySecure in closer proximity to leading research institutions and clinical partners in Sweden. The Karolinska Campus in Solna is one of Europe's most prominent life science clusters, home to Karolinska Institutet and a growing ecosystem of medtech companies.