Europe Editor

PARIS — Sphere Medical (Cambridge, UK) marks a milestone this week as it rolls out the European launch for its lead product, the Proxima blood gas analyzer, at the International Symposium on Intensive Care and Emergency Medicine (ISICEM), Brussels.

Bringing the device to the market also marks a high point for Wolfgang Rencken, who in the year since being named the company's CEO has restructured a company better known for research and development than for commercializing products, advanced Proxima to a CE Mark, announced strong clinical evidence, brought on board heavyweight key opinion leaders, and won the first sale of the platform in the UK.

"There is a difference between building prototypes and marketing a medical device," he told Medical Device Daily. "You can spend a lot of time dwelling in prototype land, and some tough decisions need to be taken to get over that chasm. In the end it is not about adding more technologies to a product but making a product that can bring make a change in the way we can treat patients."

The promise of Proxima is that for the first time blood gas results, a crucial measure for managing patients in the intensive care unit (ICU), can be delivered like blood pressure results at the patient bedside. Currently this test is typically performed by a central hospital lab after a blood draw.

As a point-of-care test (POCT), Proxima is potentially disruptive not only for streamlining workflow, but by providing frequent readings of a critically ill patient's condition that could impact patient management and improve outcomes.

Readings can be consulted every hour or even every 30 minutes instead of every four hours without additional cost, said Rencken.

"This is why it becomes a game changer," he said. "The frequency of the data is what will make a change. Once clinicians see how easy it is to get additional measurements, that they can afford to have additional measurements, they will be able to see more frequently how a patient's physiology changes and perhaps adapt the therapy. We expect improvements to patient management will come with this additional data."

The miniature Proxima sensor, containing a range of biological sensors, is attached directly to the patient through an arterial line with the blood pressure transducer.

When a reading is required, blood is withdrawn from the patient into the device and a panel of anlaytes is measured with the results displayed on a dedicated monitor with a touch screen interface. All blood is returned to the patient, promoting blood conservation and reducing the possibility of hospital acquired anemia and subsequent transfusions. The disposable sensor can be used for monitoring blood gases and electrolytes over a 72-hour period as many times as required

Commenting on the clinical importance of Proxima, "Rapid return of data and swift response to changing blood gases is as essential in patient care as the continual measurement of blood pressure. Fast feedback and response could have a real impact on efficiently stabilizing patients or weaning them from mechanical ventilation," said Tom Clutton-Brock, from the University Hospital Birmingham.

A member of the medical advisory board for Sphere Medical who led the first clinical study comparing Proxima outputs to laboratory analyzer accuracy, Clutton-Brock will present findings from the 20-patient comparative trial at ISICEM.

Patients with a range of clinical conditions, including trauma, head injury, post-surgical recovery and sepsis were connected to the Proxima system for up to three days. Concurrently a blood sample was drawn and tested using the hospital's standard bench top blood gas analyzer. Collectively the trial generated 300 comparative data points with each analyte showing "excellent agreement" with the reference, according to Clutton-Brock.

Rencken said the company is not planning an expanded clinical trial, focusing its efforts instead on winning early adopters at reference medical centers and advancing development of a next-generation platform, the Proxima 4.

The current clinical evidence is sufficiently powered to demonstrate accuracy, he said.

"Clinicians will believe the study data to a certain point, but then their focus becomes specific to their operation, to assessing their process for taking patient measurements and the number of patients and whether it makes sense to get the Proxima system. Doing one study with simple comparators is difficult because every customer pays different costs for lab testing, in consumables, for the amount of time spent, for the cost of people and equipment," he said.

"Once we move beyond the clinical evaluation phase, we need to work closely with each customer on a very dedicated investment case, helping them collect the data points that will be important for that case. It all boils down to economics in the end. The clinician can be keyed up, the nurses may like the technology, but if the finance guys say 'No,' then it all becomes very difficult. At the moment it is a complex clinical sale, and we started in the UK where preparing business cases is a slow process," said Rencken.

The first steps in Europe will be tightly focused on Germany and the Benelux countries, he said.

"We have chosen a targeted approach to Europe where we have a small dedicated sales force in countries that are known to be early adopters of technology. It is important for us to be close to the customer for this initial roll-out phase to maximize the experience of customers," he said.

After getting sales traction, Rencken said the next inflection point for the company will come with CE mark approval for Proxima 4, which is expected in the first half of 2016.

Proxima 4 extends the capabilities of the platform with the addition of glucose and sodium monitoring, which will expand the indications for patients in critical care. The platform also will feature extended connectivity with HL7 protocols.

Ortho-Clinical Diagnostics (Raritan, New Jersey) holds an option to negotiate worldwide distribution rights on Proxima 4, which will be triggered with market approval.

"Clearly they are in the pole position," said Rencken. "But the agreement is not constructed in such a way that they have the only option. We could see a better deal, and we may opt to work with somebody else. We just want to be sure we choose the best partner in the end." //

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