Sphere Medical floated on AIM
22 November 2011
Cambridge, UK. Sphere Medical Holding plc (AIM:SPHR.L) has announced that admission and trading of 18,943,843 additional Ordinary Shares commenced on 18 November on the AIM market of the London Stock Exchange. The First Admission of 17,861,801 Ordinary Shares took place on 17 November 2011. The Company’s enlarged issued share capital totals 36,805,644 ordinary shares.
Sphere’s Business Sphere is a UK based medical device company completing the development of a range of in vitro diagnostic products designed to provide significant improvements in patient management in a number of hospital specialities.
Chief Executive Officer, Dr Stuart Hendry, said: "Sphere
Medical's successful admission to AIM is an important further
milestone in its
Sphere’s products are expected to allow near real time measurement of blood gases, various electrolytes and drug levels with laboratory accuracy, at the patient’s bedside. This information can be used in a wide range of medical applications and is intended to enable faster clinical decision making and consequently to improve the management of patients.
Sphere’s two most advanced products, based on its proprietary microanalyser platform technology, are a disposable patient-attached arterial blood analyser for use in the Intensive Care Unit and Operating Room (Proxima) and a device for continuous blood monitoring in the bypass circuit in patients undergoing cardiopulmonary bypass surgery (CPB device).
Sphere has also developed a device (Pelorus 1000) that can measure blood levels of the intravenously administered anaesthetic drug, propofol and in October 2011 Sphere completed its first commercial sale of a Pelorus 1000. In each case, these products will ultimately target patients requiring close monitoring and frequent levels of blood testing.
Proxima Generation 1 has received CE Marking and 510(k) clearance as an IVD laboratory research instrument. CE Marking for Proxima Generation 2, Sphere's first IVD patientattached device, is anticipated in December 2011, at the same time the 510(k) application will be submitted for Proxima Generation 2. CE Marking clearance for Sphere's CPB device is expected in Q2 2012 and 510(k) clearance is expected in Q4 2012. Pelorus 1000 has achieved CE Marking for use as a research instrument. CE Marking and 510(k) clearances for the Pelorus 1500 IVD device are expected in Q2 and Q4 2012, respectively.
Sphere has recently completed a clinical trial at the University Hospitals Birmingham (one of the largest ICU centres in Europe) and at the West Suffolk Hospital. This 17 patient open, non-randomised, clinical trial compared readings from the Proxima Generation 2 device with those obtained from a commercial blood analyser used in the trial hospital and also the Abbott i-STAT handheld POC device.
Clinical data from this trial together with the supportive laboratory data will form the basis for CE Marking clearance in December 2011 and for the submission of 510(k) clearance for the Proxima Generation 2 device.
Admission of the share capital of the Company and the first tranche of placing shares to trading on AIM is expected to occur on 17 November 2011 and admission of the second tranche of placing shares is expected to occur on 18 November 2011
Sphere employs 43 staff in the areas of research and development,
product development, sales and marketing and management and
operations at its premises at Harston, Cambridge,