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Further update on US reimbursement coverage for oesophageal Doppler

5 June 2007 - Deltex Medical Group plc (‘Deltex Medical’ or ‘Company’), the UK’s leading haemodynamic monitoring company, today announces further details of the reimbursement status of oesophageal Doppler monitoring (ODM) and its CardioQ™™ ODM products in the USA.

The Company has confirmed with the Centers for Medicare & Medicaid Services (CMS) that, with effect from 22 May 2007, any doctor treating a CMS patient is entitled to claim professional reimbursement if they use oesophageal Doppler monitoring (ODM) to guide fluid delivery:

• in patients in intensive care whose breathing is assisted by a ventilator; or
• in patients undergoing surgery who require fluid management.

CMS reached its decision because it considers using ODM on these groups of patients to be both ‘reasonable and necessary’.

The Company's clinical advisers have confirmed both that a significant proportion of patients treated in intensive care units in the USA are placed on a ventilator at some stage and that there is growing clinical consensus that all patients undergoing moderate and major surgery are exposed to the sorts of fluid shifts requiring ODM-led fluid therapy; furthermore they have indicated that there is increasing evidence that such fluid shifts are seen in all patients undergoing surgery of any kind under general, spinal or large regional anaesthetic.

Reimbursement rates have not yet been formalised: the process to do so typically takes up to 18 months. In the meantime users will individually negotiate rates.

In addition to reimbursement for the treatment of elderly and poor patients, who make up the majority of the more than 40 million people falling into the Medicare and Medicaid population, the Company expects, as is usual practice, that private insurance groups will follow CMS's lead and also agree to reimburse physicians for the use of ODM.

CMS’s Acting Administer Leslie V. Norwalk commented:
‘(This) decision reflects CMS’ commitment to using evidence-based approaches to provide Medicare beneficiaries with reasonable and necessary medical technologies as they evolve through innovation in the marketplace. As we developed this decision, we used the best available medical evidence-in the form of randomized controlled clinical trials-to re-evaluate our position on this important non-invasive method of caring for patients in intensive care situations.’

CMS’s press release on 22 May 2007 also noted that:
‘In contrast to other techniques for measuring cardiac output, the probe of the esophageal Doppler can be inserted within minutes, requires minimal technical skill, and is not associated with major complications.’

Deltex Medical’s Chief Executive, Andy Hill commented:
‘Over five million patients in the USA every year could benefit from the use of the CardioQ™. CMS’s ruling is based on overwhelming clinical evidence and clearly confirms that ODM should be the standard of care for guiding fluid delivery in these patients.

‘This decision paves the way for the USA to turn evidence-based medicine into evidence-based practice in by making use of Deltex Medical’s CardioQ™ routine for haemodynamic management.’