IRISS Medical

Idea

Introduction

An innovative, patent protected medical device that performs automatic eye tests aimed at the early detection and prevention of lazy eye in children. Lazy eye is the impairment of vision in one eye and is the leading cause of preventable blindness in people under 40.

Even in the 21st century, eye specialists and doctors rely on manual techniques to conduct examinations for the diagnosis of conditions such as squint, for fitting contact lenses and for assessing eyes prior to lid surgery. Some of the techniques still in use today were developed over a century ago. They require considerable skill and experience in order to achieve the best outcome. The result is that 3% of children suffer from lazy eye which had been missed, and 16% of contact lens wearers drop out due to poor fitting.

IRISS Medical has developed a device that automatically provides accurate eye measurements. It is the digital version of those techniques and aims to address these problems. The device was launched in late 2014

Intended impact

Lazy eye (amblyopia) affects approximately 3% of the child population. Its chief cause, squint, is a complex condition which is missed in many children and, as a result, they may grow up to develop a permanent vision impairment in one eye. Early identification and treatment of squint is essential for successful treatment, but a significant proportion of squint cases in children are undetected and go untreated.

Contact lenses is an area in which most of the available products are aimed at patients whose eye parameters fall within a certain "norm" both in terms of the physical fit of the lens and the optics that are required. The result is that many patients suffer from poor fitting or simply drop out from wearing contact lenses.

The IRISS device hopes to revolutionise the way in which conditions such as squint are detected; the way contact lenses are fitted and the way other measurements of the eyes are carried out.

Instead of using millimeter rulers and other manual techniques, the IRISS device automatically provides accurate measurements of the eyes. This will enable doctors, optometrists and health screeners to:

- Identify and treat a much larger proportion of the 3% of children
worldwide who develop squint and lazy eye;

- Better fit contact lenses for the 27% of the population whose
eye parameters fall outside the norm and to drastically reduce the
16% of contact lens wearers who drop out.

- Significantly enhance the accuracy in measuring key eye features such as pupils and lids as part of routine or surgical work;

The IRISS device has the potential to become the new Gold Standard for external eye measurements and to be widely used by clinicians throughout the world.

Substantial accomplishments to date

IRISS is no longer a pre-revenue company, and has recently launched its product on the market. Founded in June 2011, to date IRISS Medical has -

- Developed, commercialised and launched the device, branded as
Volk Eye Check.

- Achieved early revenue by beginning to sell devices as of late 2014.

- Partnered with US based Volk Optical Inc., global leader in
ophthalmic diagnostic lenses, for the marketing and distribution of
the device.

- Been granted two international patents with a third patent pending.

- Received regulatory clearance from the US FDA and the CE Mark
for the European Union, clearing the way to selling in the US and in
Europe.

- Been awarded ISO 13485 accreditation - the international quality standard for medical device companies.

- Published 3 scientific posters at international medical conferences.

Monetisation strategy

IRISS aims to sell the Volk Eye Check device to optometrists and eye doctors as well as to GPs and screening programmes.

The business model consists of two parts:

1. Selling the device into the market, via its partnership with Volk Optical. This involves distribution channels into the optometric market. This part of the business model has already begun, with IRISS achieving early revenue as of late 2014.

2. For contact lens specialists, IRISS aims to receive revenue on a pay- per-use basis. This is because the device can provide on-going recommendations as to the best fit lens. Therefore IRISS will look to provide both a device and a service to contact lens specialists.

Use of proceeds

Following the commercialisation of the Volk Eye Check device, IRISS now needs to support the launch of the device and accelerate its acceptance in the marketplace.

Proceeds will be used to scale up and support the sales and marketing efforts by:
- Creating the necessary sales resources to support its partners across the world;
- Conducting trials and studies for further validation and market recognition;
- Establishing presence in key trade shows in the US and Europe.