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Product Development ICU/OR


A Clinical Guidance Tool
Product Development

Neomedix Systems (NMS), had prior to 1997, been associated through the supply of equipment, with an Australian tertiary hospital Intensive Care Unit which has been developing a numeric control approach to the management of the patients circulation.

Stabilising the newly admitted ICU patient and the subsequent circulatory volume management is frequently a complex activity and absorbs 40% of the intensive care staffs attention. There is currently no unified or universally accepted method of managing the circulation although many attempts have been made to provide this.

The ICU involved uses a servo control technique, which utilises volume as the control target to successfully manage the difficult task of circulation control in these critically ill patients. Of particular difficulty is the control of the volume state when patients are undergoing bedside renal dialysis. This unique management process was initially applied where the patients clinical status called for an alternative to the conventional approaches to circulatory management. It has however now become the routinely adopted method of managing the circulation. Clinical papers utilising this process have been published including that of a critically ill patient group of ICU patients also undergoing bedside CVVHD haemofiltration.

The increasing shortages of trained clinical ICU staff, is causing the bedside monitoring manufacturer to consider provision of devices which not only monitor, but also provide advisory guidance to the clinician with respect to the undertaking of related interventional therapy.

With this background, the decision was made by Neomedix Systems in 1998 to undertake R&D with respect to the equipment required to facilitate numeric control of the blood volume and to then commercialise the product (Sextant).

Commencing in 1999 as a $2.0 million AUD R&D project, with support from an Australian Federal Government R&D Start grant, the R&D Project was undertaken and successfully concluded with two series of pig trials during late 2002. These animal trials were carried out by Amtec (a Biomedical Research unit) located in the dept of Medicine at Sydney University, managed by Prof. Colin Sullivan (the inventor of the commercially successful CPAP product now produced by Resmed Inc). These 'proof of concept' experiments using Sextant prototypes proved the ability of the technique to provide predictable numerically controlled management of the circulation in the face of deliberate gross alterations to the animals blood volume.

Sextant will provide unique bedside information pertaining to the circulation via an innovative process utilising four commonly recorded vital sign parameters derived from an existing bedside monitor and also the output from three additional (unique) Sextant measurement devices, for which no commercial product is currently available. The clinician is then provided with two currently 'missing' physiological parameters, crucial to predictable numeric control of the circulatory volume. The initial release product will be a circulation specific status display used by the physician as an advisory/guidance tool. It is intended to later provide a version for closed loop circulation control, which is anticipated to by then be viewed in much the same way that an autopilot is expected for the complex control requirements on modern aircraft.

Partnering Opportunities

NMS is a privately owned Biotechnology SME and is interested in forming on-going, strategic relationships complementary to the opportunities presented by development of these products for the Intensive (or Critical) Care Unit and, perhaps separately, for its activity in the pre and post operative Urogynaecology markets.

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