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21 December 2015
Oval Medical adrenaline auto-injector wins praise from
allergy sufferers and healthcare professionals
Oval Medical Technologies Limited ('Oval'), a UK developer of medical devices and technologies, has won praise from allergy sufferers and medical professionals for its progress in its planned delivery of a compact, portable, easy-to-use adrenaline auto-injector.
In an independent study commissioned by the Cambridge company, all 21 allergy sufferers taking part used the device successfully without training, demonstrating that simple, clever design and clear labelling could benefit patients.
Seventeen participants said Oval's compact size was a major advantage, while 19 preferred it to three other auto-injectors available in the market. Portability was a major factor. Many patients preferred Oval as, being much smaller than the market leader, it could fit it in their bag or pocket.
All 10 participants in a companion study of medical professionals preferred Oval's device to the others. Further, all believed allergy sufferers would carry the device more readily than the other marketed devices.
At 93mm x 29.75mm x 16mm, the slimline Oval device is less than half the size of the current market leader.
Millions in the UK suffer from allergy, with the number of those affected increasing by 5% a year - half of them children. NHS hospitals in England dealt with 20,320 admissions for allergies in the 12 months to February 2014, a 7.7% increase from 18,860 for the previous 12 months. Admissions for allergies were highest in those aged 0 to 4.
Some 62% (12,560) of admissions due to allergic reactions were emergencies, a 6.2% increase (730) on the previous year (11,830), according to the Government's Health & Social Care Information Centre. Nearly one in five (4,070) of admissions were for anaphylactic reactions, an increase of 9.9% (370) from the previous period.
Yet many young people won't carry the potentially life-saving kit used to treat a severe reaction.
Auto-injectors treat early symptoms of an anaphylactic reaction - often caused by a wasp sting or foods such as peanuts. They contain epinephrine (adrenaline) solution to relieve swollen throat and mouth, breathing difficulty and loss of consciousness.
Symptoms such as restricted breathing and falling blood pressure can worsen quickly so those at risk should carry an injector and be able to use it quickly to stave off anaphylaxis.
Health experts are concerned that the size and bulk of injectors - first developed in the 1960s to protect soldiers from biological weapons - can deter young people especially from carrying them. They are also concerned that some people struggle to use them properly in a real-life emergency.
In one UK study involving children with severe food allergies, more than half their mothers could not use an injector effectively six weeks after undergoing thorough training. Crucially, the tests took place in a 'simulated anaphylaxis scenario', designed to mimic a genuine attack.
A separate, US study found that only 16 per cent of patients used an epinephrine auto-injector properly. In June 2015 the European Medicines Agency (EMA) directed suppliers to provide more effective educational material for use with their products.
Barbara Lead, Chief Executive Officer of Oval Medical Technologies, said: "Patients don't always carry auto-injectors because they're too big, and they often don't know how to use them should an emergency occur - parents too.
"Teenagers often won't carry them at all - but they are more likely to carry a compact device that fits in their pocket. As our report makes clear, size and usability are two crucial factors in persuading patients to carry auto-injectors and ensuring they're well prepared for an emergency.
"This market research confirms that Oval's approach to auto-injector design and our progress to date are addressing a vital global healthcare need affecting young people especially. We are now focused on addressing regulatory trials followed by a product launch in about 2019."
The charity Anaphylaxis Campaign urges all injector users to carry two at all times in case of device failure, making compact size an even more compelling concern.
Lynne Regent, CEO of Anaphylaxis Campaign, said: "In our survey of young people living with severe allergy, only 66% of respondents reported always carrying their epinephrine auto-injectors and we know that one of the reasons is that the devices currently available are too bulky.
"Following the death of an 18-year-old, his parents said he did not carry his allergy injection because it ruined the outline of his skinny jeans. We welcome any new device that would encourage more allergic individuals to carry and to use this life-saving medication."
Oval Medical Technologies Limited
+44 (0)1223 437 140
+44 (0)20 3137 2500
About Oval Medical Technologies
Oval Medical Technologies is a cutting-edge parenteral-technology company based in Cambridge, UK. Oval was founded by Matthew Young in 2009 with the following key aims:
· To design an auto-injector that is safe and easy to use in all patient populations,
· To significantly improve the quality and reliability of auto-injectors and
· To provide a less contaminating environment for the storage of all drugs including fragile biologics.
Working together, Oval's team of world-leading experts has achieved a number of important milestones in delivering these technologies. The company has established a quality management system that complies with the requirements of BS EN 13485:2012, and works with the guidelines and principles from FDA 21 CFR Pt 820, Medical Device Directive 93/42/EEC and ANSI/AAMI HE75.
Oval is currently undertaking an equity funding round to support regulatory trials of its epinephrine auto-injector.
For further information please visit www.ovalmedical.com.
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