Deltex Medical Regulatory News (DEMG)

13 May 2008 11:50



Deltex Medical Group plc

Results of Annual General Meeting and Trading Update 

13 May 2008 - Deltex Medical Group plc ("Deltex Medical" or "the Company"), the UK's leading haemodynamic monitoring company, today held its Annual General Meeting. All resolutions put to shareholders at the meeting were passed. The following is the text of a statement made at the meeting by the Company's chairman, Nigel Keen.

"Deltex Medical's CardioQ-ODM™ oesophageal Doppler provides doctors caring for patients having major surgery with a unique and proven means to reduce complications, improve outcomes and reduce lengths of hospital stay.

The evidence-base for the CardioQ-ODM includes multiple randomised controlled trials, independent trial reviews and government-sponsored technology assessments. This evidence is built on the CardioQ-ODM's unique ability to measure and detect small changes in central blood flows. These changes are a very common consequence of surgery and can provoke severe and even life-threatening complications if not dealt with quickly.

The body's ability to maintain blood pressure in the face of serious and potentially life-threatening reductions in circulating blood volume means that monitoring systems that rely upon changes in blood pressure simply cannot be used to follow the proven treatment approach employed by users of the CardioQ-ODM.

In the year to date we have seen continued strengthening demand for our products in each of our key markets.

April was another record month in the UK for sales of our disposable probes with continued strong growth in use in operating theatres. The UK government, through the Centre for Evidence-based Purchasing recently published a highly positive review of the impact of oesophageal Doppler monitoring that included detailed models of cost-benefit. The report noted the significant potential for oesophageal Doppler monitoring and that even in the lowest case it was possible to achieve savings of at least £3 for every £1 spent on the technology.

In Europe we have established a direct sales operation in Germany and have secured additional funds to support accelerating uptake in this key market. In Spain, our other direct market in Europe, work on the audit of the use of the CardioQ-ODM in colorectal surgery has started well and a report on its outcomes is expected later in the year. The audit is being led by the head of the Spanish society of surgeons and is similar to the work done at key centres in the UK. In France, our longest established distributed market, the strong growth seen in 2007 has continued into 2008 and we are working in partnership with our distributor to implement new sales programmes based on those used in the UK.

In the United States, there are early indications of the impact of physician reimbursement on usage in those hospitals that were first to submit claims. In one of our flagship hospitals in southern California reimbursement levels have settled at the upper-end of expectations and the largest private insurer in the region is reimbursing all claims submitted. Private patients account for between sixty-five to seventy percent of all patients treated at this hospital and we have seen usage of our technology grow by fifty percent since reimbursement began.

Similarly, doctors at the first hospital to submit for reimbursement in New England have reported having all claims to date paid by its largest regional insurance group.

The Company continues to work with users across the United States to support the claims process and expects to see public sector reimbursement in due course.

As previously reported, we have secured further dedicated funds to support our near-term expansion plans in the USA as we continue the controlled rollout of our technology in key hospitals.

In April we released the CardioQ-ODM, an upgraded version of the CardioQ™ that provides users with an improved and more flexible software interface and greater data management capabilities.

The board looks forward to continued progress throughout the remainder of 2008 and beyond".

End

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  Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODM™ monitor, which uses disposable ultra-sound probes inserted into the oesophagus to determine the amount of blood being pumped around the body - 'circulating blood volume'. Reduced circulating blood volume is known as hypovolaemia, which leads to insufficient oxygen being delivered to the organs. This causes medical complications including peripheral and major organ failure which can lead to death. Hypovolaemia, which is akin to severe dehydration, affects virtually every patient having surgery because of the combined effects of pre-operative starvation, the impact of the anaesthetic agents and trauma from the surgery itself. Using fluids and drugs, guided by the CardioQ-ODM, to optimise the amount of circulating blood significantly reduces post-operative complications allowing patients to make a faster, more complete recovery and return home earlier.

The CardioQ-ODM incorporates the Company's proprietary software and a small diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is used for transmitting and receiving an ultra-sound signal. By using this technology, the CardioQ-ODM provides clinicians with the ability to haemodynamically optimise critically ill patients and those undergoing routine moderate to major surgery through the controlled administration of fluid and drugs. Haemodynamic optimisation has been scientifically proven to improve the speed and quality of patient recovery and reduce hospital stay.

There are already over 1,500 CardioQ-ODMs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries. In addition, there are currently more than 100 clinical publications on the use of the CardioQ-ODM which have repeatedly:-

Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works

Proved that the CardioQ-ODM works in a wide range of surgical procedures

Demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients.

The SupraQ™ is an entirely non-invasive device which uses an ultrasound probe held at the base of the patient's neck to track the flow of blood in the aorta; it presents the same data as the CardioQ-ODM in a similar format and is used for taking snapshots or monitoring over short periods.