Dear , 

Age-related Macular Degeneration is the leading cause of incurable blindness in the Western world, with global estimates of 196 million suffers by 2020. AMD results in loss of central vision, leaving sufferers unable to read, drive or perform simple hand-eye coordinated tasks.

AMD results from the build-up of waste products, which form plaques at the back of the eye called Drusen. Over time this leads to a breakdown of the retina and death of the rods and cones (geographic atrophy) and eventually central vision loss (dry AMD: leading form). Early identification of those susceptible to AMD is key to prevention.

At present, due to the costs associated with testing and the lack of methods or devices suitable for mass screening, most people at risk are not being detected until it is too late and they are already showing signs of disease onset. Using IP developed by the University of Bristol, Azul Optics intends to develop an affordable, effective and widely available method of assessing people’s risk.

The Technology

The company is developing a novel, easy to use, affordable ophthalmic instrument for rapidly screening individuals for low macular pigment density.  The product harnesses the human ability to see polarised light to measure the density of macular pigments in the eye. The product generates an image (Haidinger’s Brushes) and the ability of an individual to continue to see this image as the percent of light that is polarized decreases depends on the level of their macular pigments. 

Two breadboard devices (a benchtop system and a handheld device) have demonstrated the core technology and the principle for measuring macular pigments. The benchtop version has been used in limited human trials to demonstrate a correlation with instruments available on the market.

Development Milestones

Funding will enable the company to

• Establish a beta prototype to allow expansion of the data set, referencing performance of the Azul Optics product with industry standard instruments.
• Identify design improvements, particularly surrounding the interaction of the patient with the instrument, to optimise and standardise the user experience and data output.
• Design, build and validate a production ready instrument that is CE certified as a Class 1 medical instrument.
• Establish the manufacturing for the ophthalmic instrument to meet early demand (approx. 10 units per month).
• Establishing the company with ISO 9001 certification.
• Build a sales network suitable for supporting the sales of the instrument to early adopters.

Intellectual Property

A material piece of Intellectual Property, the basis of the UK patent application 1602068.7, is owned by the University of Bristol, which the Company has an exclusive licence dated 24 January 2017 to utilise and exploit. This patent is not limited to using the technology for screening for low MP density and the technology could have other ophthalmic applications. No Freedom To Operate (FTO) issues were identified during a comprehensive FTO search undertaken during the patenting process.

Azul Optics will seek to build a portfolio of IP in addition to the core technology, as well as a strong ‘portfolio’ of non-patented IP and know-how. The design of all devices will be protected through design registration.

The Opportunity

AMD generally develops in the over 50s and is a form of blindness, it is more common in women and is linked to blue eyes. AMD also has a familial connection. The incidence of AMD in both the UK and the US is reported to be around 2.0% of the adult population, and the socio-economic impact is high. AMD cannot be cured.

Early assessment of macular pigment density can help identify individuals at risk and the incidence of AMD can be reduced by simple, preventative measures (e.g. sunglasses, diet, dietary supplements).

The market for the Azul Optics technology is potentially broad ranging from high-end ophthalmic products to home use devices.

Azul Optic’s ophthalmic instrument is targeted at a market with the potential of approximately 400,000 sales in the western world. The market offers early adopter sales opportunities to eye care practices already offering macular pigment assessment.

Azul Optics has been working with a potential distributor to cover Canada and the US with a specific interest in tools for identifying individuals at risk from AMD.  Their assessment is that there is an immediate demand for the Azul Optics product and they forecast sales of 100 units in the first year.

The Team

Dr Joseph Cefai - CEO

Joseph has founded and managed several start-ups with the latest two being medical device companies focussed on diabetes care. Cellnovo has a product on the market and is listed on Euronext Paris. ViCentra has released its patch pump product into the European market. Joseph enjoys and specialises in start-up development.

Dr Shelby Temple - CTO

Inventor and founder with 16-years’ international experience in vision research.  Shelby is highly creative, resourceful and has a strong entrepreneurial spirit.

Matt Evans - COO

Strong organisational and project management skills with 20-years’ experience as manager of small and large IT development teams, in both large companies and start-ups.

The Outlook

The company is undoubtedly at a very early stage of its commercial development.  The team, however, is experienced and has a strong mix of relevant skills we believe will enable it to exploit a powerful IP position.  The market opportunity is huge and the prospects exciting.

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