Prominent ears are an inherited problem affecting 5-10% of the UK population. It may be unilateral or bilateral and arises as a result of lack (or malformation) of cartilage during primitive ear development in intrauterine life. Although the condition poses no health issues it can be a distressing and demoralising affliction – it can lead to a reduced quality of life, reduced self-esteem, social avoidance behaviour and poor performance in school.
There is a growing demand for prominent ear repair with a potential addressable market of £191 million per annum. Current treatment is by surgery (otoplasty). The procedure is usually available on the NHS to children; however most adults have to go privately unless the person can be shown to be in extreme psychological distress. Furthermore, there are complications associated with otoplasty including development of scars, numbness of the ear(s), asymmetry between the ears, haematoma, recurrence, dehiscence and infection.
A new approach to treating prominent ears - EarFold™ - was developed by Dr Norbert Kang at West Hertfordshire NHS Foundation Trust using an implant manufactured from a high technology memory metal which can be inserted subcutaneously under the skin of the ear. This quick and effective procedure performed under local anaesthetic has fewer side effects than conventional otoplasty surgery and is less invasive.
Using EarFold™, the procedure takes 20 minutes under local anaesthetic as an outpatient, compared to the traditional two hours in general surgery. Overall patient outcomes are improved with reduced risk of keloid scaring and cartilage damage, less chance of infection, faster recovery times and improved symmetry when both ears are being corrected.
HEE supported Dr Kang by investing over the initial funding to prove the concept, secure patents internationally, undertake detailed market research and define a product development plan. HEE also helped to form the new company Northwood Medical Innovation Ltd which received external investment from a high net worth individual based in the US.
With the benefit of HEE’s ongoing support, EarFold™ received a CE mark in April 2015, and has been made available to trained and accredited surgeons in the UK, Spain, Portugal, South Africa and Croatia. Northwood Medical Innovation was subsequently acquired by Allergan plc (NYSE: AGN) in October 2015.
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