IntelliCap, the unique personalised oral drug delivery and monitoring system pioneered by biotech innovator Medimetrics, has gained CE approval for its use in a clinical setting.
This follows the successful completion of rigorous clinical testing and validation to confirm its effectiveness and safety.
The IntelliCap capsule is given orally. It passes through the digestive tract as a result of natural gut movement (peristalsis, for example).
It is unique in the way it controls the release of a drug, giving precisely the right dosage at the right place and time within the gastro-intestinal tract.
During its travel, the IntelliCap is able to measure pH levels and temperature, and communicate via a wireless link.
“CE approval is a significant milestone in the development of the company,” said Medimetrics chief executive officer, Dr Olaf Weiner.
“It not only certifies that IntelliCap has been independently assessed as safe, but is judged effective and appropriate for clinical use. This opens the door for its use in clinical investigations, enabling it to become an even more powerful tool in drug development.
“We already work with leading pharmaceutical customers and the drive to expand has come from their confidence in the IntelliCap – and its unique way of providing a fast and personalised, oral drug delivery system.”
Prof Clive Wilson, Professor of Pharmaceutics at Strathclyde University, added: “IntelliCap offers novel solutions for drug candidate screening, profiling and rapid formulation prototyping.
“This could see new formulations launched earlier, reduce the risk of attrition in drug development and help create new, targeted therapies.”