Sphere Medical’s Pelorus 1500 Point-of-Care Propofol Blood Measurement System EU Cleared

Sphere Medical’s Pelorus 1500 Point-of-Care Propofol Blood Measurement System EU Cleared

Cambridge, UK, 16 July 2012: Sphere Medical Holding plc (AIM: SPHR.L, the “Company”), a leading developer of innovative monitoring and diagnostic products for the critical care setting, is pleased to announce that its Pelorus 1500 has achieved CE Marking as an in-vitro diagnostic medical device. The CE mark enables Sphere Medical to place the Pelorus 1500 for sale in all Member States within the European Economic Area.

The Pelorus 1500 is the world’s first point-of-care in-vitro diagnostic medical device for the rapid measurement of the concentration of the intravenous anaesthetic propofol in blood samples and has been developed specifically for anaesthetists in the critical care setting. The Pelorus 1500 will for the first time allow anaesthetists to know the actual rather than predicted concentration of propofol, allowing the personalisation of dosing to the patient.

Propofol is one of the world’s most widely used intravenous anaesthetics, used for the induction and maintenance of general anaesthesia in the operating room (OR) and general sedation in the intensive care unit (ICU). Each year, around 12 million patients are admitted to the ICU in the developed world and around 8 million are sedated during treatment.

Monitoring of inhaled anaesthetic gases is already a standard of care, but there is no equivalent measurement used for intravenous anaesthetics such as propofol.

Sphere Medical expects the Pelorus 1500 to be used in conjunction with existing commercially available dosing pumps. Clinical studies have already shown that a single measurement carried out during general anaesthesia can significantly improve the clinicians’ understanding of propofol levels during an operation.*

Sphere Medical is working with leading anaesthetists in the UK to investigate approaches to use propofol measurements during infusion to tailor the dose to the patient. This is expected to result in the next generation of infusion control systems which would be a significant opportunity to improve patient care and consequently is a large commercial opportunity.

We have received some early indications of interest in the Pelorus 1500 from potential commercial partners with whom Sphere Medical has an ongoing dialogue.

Stuart Hendry, CEO of Sphere Medical commented: “Obtaining the CE Mark for the Pelorus 1500 was a milestone we set down at the time of the IPO and we have achieved this on time and within budget. We now intend to capitalise on the early interest being shown by a number of medical device companies and we are already working with a number of leading anaesthetists.”

About Sphere Medical

Sphere Medical (AIM: SPHR.L), is a medical device company developing a range of innovative monitoring and diagnostic devices designed to significantly improve patient care. Sphere Medical’s Proxima and Cardiopulmonary Bypass devices deliver real time analysis of blood gases, electrolytes, glucose and drug levels with laboratory accuracy, at the patient’s bedside. Globally over 240 million blood gas and electrolyte tests are carried out on patients every year in critical care and there is an unmet need for monitoring products that are small, simple to use and cost effective with improved functionality. Sphere Medical’s products can

be used in a wide range of medical applications enabling faster clinical decision making and consequently improved patient outcomes, whilst also reducing costs for healthcare payers. Sphere Medical is headquartered in Cambridge, UK and employs around 60 people. The Company has existing commercial partnerships with the leading global medical device companies.

For further information, please visit www.spheremedical.com

* Analysis within a recent paper presented to the UK Society for Intravenous Anaesthesia Annual Scientific meeting in 2011 indicated that the single point correction improved the average prediction imprecision of the dosing pump by approximately 60% (from 38.3% to 15.8%). “Use of a device to measure blood propofol levels to improve inter-patient bias of propofol target controlled infusion (TCI)” by Nick J Cowley and Thomas H Clutton-Brock, November 2011.

Sphere Medical of Cambridge, UK has received the European CE Mark for its Pelorus 1500 point-of-care system for measuring anesthetic propofol in blood samples.

The world’s first such system that avoids long turnaround time from the lab and allows actual measurements rather than predictions to be used, it was designed for clinical use in critical care environments where quick dosing decisions are particularly important.

From the announcement:

Sphere Medical expects the Pelorus 1500 to be used in conjunction with existing commercially available dosing pumps. Clinical studies have already shown that a single measurement carried out during general anaesthesia can significantly improve the clinicians’ understanding of propofol levels during an operation.

Sphere Medical is working with leading anaesthetists in the UK to investigate approaches to use propofol measurements during infusion to tailor the dose to the patient. This is expected to result in the next generation of infusion control systems which would be a significant opportunity to improve patient care and consequently is a large commercial opportunity.

Source : http://www.spheremedical.com/documents/news/Pelorus%201500%20CE%20Mark%20FINAL.pdf

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