Northwood Medical Innovation Ltd have entered into agreement with Allergan for earFold, a medical device for the correction of prominent ears
Prominent or protruding ears are thought to affect approximately 1-2% of the population—about 100 million people worldwide. Although current treatment options are limited, with the most conventional being surgical intervention for otoplasty or pinnaplasty, the International Society of Aesthetic Plastic Surgery (ISAPS), approximately 247,518 ear surgery operations took place across the world in 2014, making it one of the most common cosmetic procedures performed. However, many affected may choose to remain untreated due to the risks associated with these procedures, which include adverse reactions to general anaesthetic, infection, the development of keloid scarring and sometimes the need for re-do operations due to asymmetric outcomes or relapse.
earFold is a small implantable medical device made from a short strip of nitinol metal alloy, which is specifically designed to retain a preset shape. Following injection of a local anaesthetic, it is carefully inserted under the skin using an introducer, and works by gripping the cartilage of the ear, enhancing or creating the shape of the anti-helical fold—thereby reducing the prominence of the ear. Including the initial consultation, the procedure takes about 15-20 minutes to complete and can be performed within an outpatient setting, reducing the risk associated with a general anaesthetic.
Given the preset nature of the nitinol strip, treatment with earFold can deliver a consistently effective outcome. By contrast, otoplasty or pinnaplasty is a complex surgical procedure that requires a visit to a fully-fitted operating suite, requires a general anaesthetic and is associated with significant down-time post treatment.
earFold has been studied in more than 400 patients with real world experience showing the benefit of providing patients with a rapid and predictable alternative to existing otoplasty techniques.
“Following a complex outcome after a standard otoplasty procedure, early in my career, I was motivated to develop an alternative approach to correcting prominent ears,” says Norbert Kang, Consultant Plastic Surgeon and creator of the earFold™. “In my clinical practice, there are a significant number of patients who are reluctant to undergo surgery and so put up with accepting the social hindrance of prominent ears. The beauty of the earFold treatment system is that it offers an evidenced-based alternative to standard otoplasty surgery that may meet the needs of a wider range of patients, by delivering immediate and predictable results, without the risks associated with general anaesthetic.”
On completion of this deal, Allergan will establish a standardised training programme for surgeons on the earFold treatment system, in order to bring this treatment option to more patients.