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Oxford Optronix Ltd announces MHRA regulatory permission to commence clinical trials of its WellBeing™ System.
Oxford Optronix Ltd. today proudly announces that we have received permission from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the Research Ethics Committee (REC) for its Clinical Trial Application for the WellBeing System. The approval provides permission for Oxford Optronix Ltd to initiate a study of tissue oxygen monitoring for detecting impending shock states in the critically ill patient and those patients undergoing high risk surgery.
This first-in-man (observational) study in 315 patients will be undertaken at the University College London Hospital (UCLH) under the auspices of Professor Mervyn Singer¹
Dr Andy Obeid², CEO, commented, “Receiving regulatory approval to advance our first medical device from bench into the clinic is a significant step in Oxford Optronix’ journey. Our bladder tissue oxygen monitoring platform offers an exciting means of monitoring the adequacy of tissue oxygenation, using the bladder wall as a surrogate for other organs. The simplicity of our approach is that the bladder wall can be readily accessed via a simple urinary drainage catheter routinely inserted into patients having major surgery or requiring critical care. Early detection of sub-optimal oxygen perfusion in the bladder should allow earlier intervention/resuscitation in patients and prevention of downstream complications.”
¹Mervyn Singer (Chief Investigator) MB, BSc, MD, FRCP(Lon), FRCP(Edin), FFICM is Professor of Intensive Care Medicine at University College London, an NIHR Senior Investigator and Chair of the International Sepsis Forum.
²Andrew Obeid BSc, MSc, PhD is CEO of Oxford Optronix Ltd.
WellBeing™ clinical trials commence
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