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EarWay: a simple, safe and efficient medical device for earwax removal

Periodic Reporting for period 1 - EarWay (EarWay: a simple, safe and efficient medical device for earwax removal)

Reporting period: 2019-05-01 to 2019-08-31

Cerumen impaction is a very common phenomenon. 1.12 billion people are suffering from ear wax impaction with 49.5 million earwax removal procedures each year in Europe. It is common in people with hearing aids, or in people with ear canal anatomically abnormal. Cotton-tipped swabs are the most common method used for ear care hygiene. However, its use has been condemned by otolaryngologists worldwide as cotton-tipped swabs push the wax towards the eardrum resulting in uncountable complications (i.e. trauma, tympanic perforation, infection…). To relief people suffering from earwax, we have developed EarWay®: an innovative ear wax removal tool to clean ears safely at home. EarWay® is a silicone tip designed with a flexible helical head with an open profile that can be rotated inward into the ear canal to collect the cerumen, and extract it as a single cluster. The open profile ensures that the cerumen is not pushed back. Designed with a handling system for home use, EarWay® provides an easy to use safe device and in addition offers the possibility to examine the ear canal with an integrated camera. This option paves the way for the definition of a totally innovative digital tool to treat ear wax impaction and enable diagnosis of tympanic membrane. After confirming its technical and commercial feasibility in phase 1, EarWay® will reach the market by a phase 2 project for: 1) Develop and integrate the handling system that will anchor the EarWay helical heads; 2) Perform safety testing by measuring the ear canal depth of several populations; 3) integrate into the device a camera to take pictures of the ear canal and tympanic membrane to enable diagnosis of ear drum inflammation; 4) certification and materials preparation to meet privacy protection; 5) commercialization by a comprehensive dissemination-communication plan. EarWay® will first target Europe and then US by a B2B2C strategy starting with audiology dispensaries and pharmacies. Market launch is expected for 2022, with €25.07M revenue accumulated by 2024 while contributing to improving the wellbeing of millions of people in need of innovative, clinically proven, accessible ear-care solutions.
During the last four months (May-August 2019) EarWays Medical staff have worked hard to perform a comprehensive feasibility study supporting:
a. The technical feasibility of EarWay®, a homecare solution for safe, simple self-removal and management of earwax accumulation and impaction. According to this technical feasibility study, it is possible to implement several improvements to our EarWay® prototype to:
1.) Develop and integrate the handling system that will anchor EarWay helical heads and integrate to the device a camera that will give users the possibility to take pictures of their ear canal and check for ear drum inflammation either through sending pictures to a data server containing an eardrum inflammation detection algorithm or directly send the pictures to a healthcare professional. Both can be guaranteed as long as we set a strong data protection management we will develop in the project.
b. The economic feasibility of EarWay® with foreseen sales of 732,291 units and a 0.2% market uptake (conservative scenario). Overall this would translate into €5.6 million net profit accumulated by our company in the 3 years post-market launch (2022-2024) and a payback period of 1 year post-commercialisation (by 2023).
c. The commercial feasibility of EarWay®, provides a clear roadmap to follow for a successful commercialization, communication and dissemination during the project and beyond. Phase 1 has allowed identifying key mitigation contingency procedure to the EarWay® regulation and has allow to draw a preliminary strategy for communication and dissemination. Furthermore, we have identified key partners that would foster our commercial development including several distributors in Europe and a global strategic partner.
Phase 1 has also allowed to: a) confirm by a FTO assessment that no patents block EarWay® commercial development; b) plan the intellectual property strategy and; c) identify the dissemination and distribution channel instruments to deliver EarWay® to target public for a successful commercialization of our product in EU and US.
When excessive cerumen causes pain, hearing loss or other symptoms, it must be removed. However, in the past 30 years, there has been little to no innovation in the field of earwax removal. While 1.2 billion people suffer from earwax impaction worldwide, cotton-tipped swabs which are the most common method used in our daily lives are condemned in Europe (by the British Society of Audiology) and in US (American Academy of Otolaryngology) as well as banned by the FDA for use in the Ear Canal. Cotton swabs and are planned to be banned in Europe by the end of 2019. There is a need for simple yet safe methods and a requirement to provide an alternative to the widely extended wrong use of cotton buds for earwax removal.
Since the creation of the company, EarWays Medical has been closely working with ENT specialists on the development of EarWay®. EarWay® is innovative: it is based on a unique patented- technology providing the only earwax removal method that uses a flexible helical open-profile to wrap the earwax instead of pushing it. EarWay® is efficient: the flexible neck allows for manoeuvring in three-dimensional space of the ear canal towards the earwax achieving an efficient (usually 100%) collection of the earwax at once. And EarWay® is safe: EarWay technology ensures safe and effective cerumen extraction, without harming the ear canal or eardrum.
According to the market study developed during phase 1, EarWay® is clearly superior to competing alternatives in term of safety but also easy to use. EarWay will mainly target the European and US markets, where, assuming a conservative 0.2% market uptake, EARWAYS Medical estimates sales of 732,291 units and €25.07 million revenues in the 3 years post-market launch (2022-2024). Beyond becoming an essential asset for the company´s growth and job creation (i.e. around 26 jobs created in 5 years), EarWay® will benefit the European and US societies offering the only safe and reliable solution to million people in need of accessible ear-care solutions.
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