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2 May, 2017 - 12:37 By Tony Quested

Sphere Medical monitor gains European traction

Sphere Medical Proxima

Advanced monitoring technology from Cambridge-based Sphere Medical Holding is gaining further commercial momentum across Europe.

A trading update from the UK business reports that a large number of hospitals across Europe are evaluating the Proxima 4 platform and trials are starting to convert to firm orders.

Proxima 4 was launched into the European market in December and a positive reaction has been received with forward visibility of an expanding sales pipeline.

More than 40 hospital departments have now engaged with Sphere Medical on Proxima 4 and have requested evaluations, of which more than 30 have undergone a product demonstration. 

Evaluations, in which the system is connected to patients, have been conducted at 14 hospital departments and to date six of these across three countries have placed orders for Proxima 4. This more than doubles the key metrics over the two months from the announcement of Sphere Medical’s full year results at the end of February. Follow-up discussions are underway with the other hospitals which have conducted evaluations.

The company says that one of the advantages of Proxima 4 over the previously available product, Proxima 3, is the paediatric application, where a patient’s blood conservation during procedures is typically even more critical than in adults.

Since the launch of Proxima 4, the system has been connected to children for the first time and the Royal Manchester Children’s Hospital has already placed an order, becoming the first paediatric unit to purchase Proxima.

In continental Europe, the list of product distributors continues to expand and now includes Eumedics Medizintechnik GmbH in Austria. Training, marketing and monitoring of patients in hospitals are now underway via Burke and Burke in Italy and Prhoinsa is on track to commence marketing in Spain imminently.

Production processes have now been fully converted to Proxima 4 from the earlier product iteration and the establishment of Sphere’s manufacturing facility in Wales has continued to progress according to plan. As is normal in the ramp up of wafer based technologies, a key focus remains on increasing product yield.

Sphere Medical says it has been experiencing occasional limitations on the supply of Proxima 4 sensors. However, whilst supply is currently low, the board is confident that yields will improve and there will be sufficient supply in place to meet the sales targets for the current full year and beyond.

CEO Wolfgang Rencken said: “We are very pleased with the market reaction to Proxima 4 and encouraged by the early response from customers. We look forward to building on this through 2017.”

In other local BioMedTech news, Atlantic Healthcare plc a pharma company with a core focus on gastrointestinal disorders, has initiated the rolling submission of its New Drug Application (NDA) with the US Food and Drug Administration (FDA), and filed its nonclinical package for alicaforsen to treat pouchitis – a rare and serious form of inflammatory bowel disease for which there are limited treatment options. 

Alicaforsen enema has been granted Orphan Drug designation by the FDA and European Medicines Agency and FDA Fast-Track designation in recognition of the unmet medical need for this disease. Alicaforsen enema is currently being evaluated in a pivotal Phase 3 trial in pouchitis.

Toby Wilson Waterworth, CEO at Atlantic Healthcare, said: “The filing of the nonclinical data package initiates the regulatory process for obtaining marketing approval for alicaforsen in the treatment of pouchitis. This is a significant milestone in our corporate development.

“As an antisense therapy, alicaforsen enema has the potential to be first to market in a new class of drugs for the treatment of IBD. Alicaforsen also has the potential to treat multiple inflammatory diseases of the GI tract and elsewhere.

“Atlantic Healthcare is currently exploring additional formulations to extend the use of alicaforsen into other IBD indications.”

Fellow Cambridge company, Avacta Group plc, the developer of Affimer® biotherapeutics and research reagents, says its chief executive Alastair Smith will be presenting at BioTrinity 2017 – said to be Europe’s leading Biopartnering and Investment Conference – on May 9 and 10 in London.

Kiss Communications

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