"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."
New therapies for treating debilitating and life-threatening disorders of the digestive tract are urgently needed. As Prof Clive Wilson, J. P. Todd Professor of Pharmaceutics at Strathclyde University and immediate past president of the European Union Federation of Pharmaceutical Sciences, explained: "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."
Constructed from carefully selected and engineered materials, the pill-shaped (11 x 26 mm) IntelliCap capsule contains a fluid reservoir and a micro-fluidic pump to deliver drug solutions or suspensions. The pump is controlled by an integrated microcomputer processor. An ultra-low power radio transceiver makes it possible to send information from and to the device, enabling two-way, real time communication between the IntelliCap and a data-monitoring/control unit. This can be worn on the outside of the body or at an IntelliCap workstation. The drug reservoir, pump, sensors, and on-board electronics system, are all packaged into an easy to swallow capsule.
However, Dr Weiner pointed out that the IntelliCap also had a significant contribution to make in food research and the development of functional food ingredients. Typical food applications could include pH and motility profiling, gastrointestinal sampling and site absorption studies. "Existing methods are either time consuming, invasive and therefore alter normal gut function, or require dedicated imaging infrastructures," he said.
IntelliCap was originally developed in 2008 as a research tool under the Philips Medimetrics brand name. The expanding market has seen the emergence of Medimetrics Personalized Drug Delivery B.V. as a fully-fledged biotech company in its own right. The new entity, in which Royal Philips Electronics N.V. has a minority interest, has won substantial backing from Germany-based Zukunftsfonds Heilbronn GmbH & Co KG.* The company's headquarters are in Heilbronn, Germany, with research labs, service centres and administrative offices in Europe (Eindhoven, The Netherlands) and the USA (New York).
* Zukunftsfonds (zfhn) indicates an investor that focuses on innovative brand leaders of the future.