Coloplast A/S ((GB:0QBO)) announced an update on their ongoing clinical study.
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Coloplast A/S is conducting a Prospective Longitudinal Study of Heylo™ for People Living With a Stoma. This study aims to evaluate the long-term benefits of Heylo™, a digital leakage notification system designed to improve the quality of life for individuals with intestinal stomas by reducing leakage incidents. The study is significant as it explores the potential of digital health solutions in stoma care.
The intervention being tested is the Heylo™ system, which includes an adhesive sensor layer, a Bluetooth transmitter, and a smartphone application. This system alerts users to changes in their stoma baseplate status, aiming to prevent leakage and enhance user experience.
The study is observational with a case-control model and a prospective time perspective. It will observe participants over a one-year period to gather data on the effectiveness of the Heylo™ device.
The study began on July 2, 2024, with a primary completion date yet to be announced. The most recent update was submitted on August 27, 2025, indicating ongoing recruitment and data collection efforts.
This study update could positively impact Coloplast’s stock performance by showcasing innovation in stoma care, potentially setting the company apart from competitors in the medical device industry. Investors may view this as a strategic move to strengthen Coloplast’s market position.
The study is currently ongoing, with further details available on the ClinicalTrials portal.