focused on preventable blindness

Business Summary

A Personal Statement from the FounderThe retina can tell you a great deal about a person, not just about their health but also their well-being and lifestyle. It tellsstories about high blood pressure, cholesterol, diabetes, pregnancy, neurological disorders and many other factors. In fact it isthe only place in the body where you can see nerve tissue, a part of the brain, and the vasculature directly. Clearly, such arich source of information can be of very high clinical value and although devices to see it have been around since 1847, I cantell you from years of experience that they are fiendishly difficult to build.More than 160 years later there are a number of general purpose retinal cameras out there and some of them providequalitatively excellent images. Most of them are expensive though, for much of the World prohibitively so. The price you pay has more to do with marketing than engineering. If you are a company primarily selling into the USmarket, where healthcare sales are worth around $3-4 trillion, then you must price your product high because the perceivedvalue is then higher. This feeds back into the engineering and ends in a product with more and more features, some of whichare of questionable clinical utility. If your company trades primarily in the US market then you just can't reduce the price inthe rest of the World without eviscerating your US sales. This all makes the Worldwide health market an inequitable place foralmost all Developing World customers – they end up with US specification equipment at US market prices

At lower cost, what is required is maximum clinical utility for the price. We believe that the way to achieve that is to buildbest quality devices from the ground up. The epiCam family are our first entry into this market, consisting of a deviceprimarily for imaging vasculature and pathology associated with DR, a device for general purpose white-light imaging and adevice for veterinary use. All three devices use best quality optics, bespoke electronics and very well thought-out software.They are unique because they are designed to entirely fulfil customer requirements.

We are constantly talking to clinicians and potential customers. They understand very quickly why we are doingwhat we are doing and immediately become enthused and excited. Not only have we made a lot of friends this way but theyhave been instrumental in helping advise where we can do a better job and how we can reach out into the market. Theyunderstand that we aren't just putting a device into a new marketplace to optimize our bottom line, we will be changing howthat market works. We are more open than other manufacturers both with our design and our processing methodology. Thatkind of co-operation is the way to build real scale.

Dr. Craig RobertsonFounder and Managing DirectorEpipole Limited

December 2017

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Business Summary

Part 1: The Business

Epipole Limited is a limited company registered in Scotland as SC391348 and registered for VAT no. 155159210. Thecompany was incorporated in January 2011 to develop intellectual property in the area of medical imaging and machinevision. Our epiCam family of devices are designed to image the retina and find pathology. They are in manufacture and readyfor sale with epiCam M, C and V all formally launched by Q4/2016.

RegulatoryEpipole is registered with the MHRA in the UK as a developer, producer and supplier ofretinal fundus cameras and associated software. Epipole is also certified to ISO 13485 asa designer, producer and seller of retinal fundus cameras and associated software forimage display and storage.Epipole recently extended their ISO 13485 certificate by adding an ISO 62304component to cover diagnostic algorithms and other associated software components.

EpiCam has been declared to be conformant with the regulatory framework for CE, themandatory regulations applicable in Europe and several other territories Worldwide and as such bears the CE label as shown.Some diagnostic software we have produced is certified as Class 2a and has received the corresponding CE examination andcertification.

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Business Summary

Part 2: Product Overview – The epiCam Family

We have developed a family of medical devices to take images andvideo of the retinal tissue at the back of the eye. The retina provides arich source of information about health as blood vessels and nervetissue can be seen clearly. This allows easy access to many differenttypes of diagnostic information of, for example, systemic diseases likehypertension and diabetes. Unlike other retinal cameras, whilst it takesISO 10940 compliant images, epiCam is also both easily portable andhand held. Using it, the clinician can make a permanent digital recordof the patient's retina which can be saved, processed or forwarded to aremote specialist screening centre or for automated processing.

epiCam MBecause retinal blood and vessels can be seen clearly we have tunedepiCam M to take advantage of this in order to image the signs ofdiseases like diabetic retinopathy. Diabetes is a condition affectingproper blood circulation and sufferers are at high risk of developing avariety of eye diseases including cataract, glaucoma and diabeticretinopathy (DR). The WHO has estimated that it is currentlyresponsible for two million cases of preventable blindness throughoutthe World and is easily the largest preventable cause of blindness.DR is caused by damage to the small blood vessels in the patient'sretina which split and leak blood between retinal layers. Early detectionand treatment is key to preventing vision loss, making it crucial fordiabetic patients to have regular retinal images taken. In populationswhere healthcare provision is difficult it can also possible to firstdiscover diabetes as a result of a retinal screening. In many differentscenarios, clinicians are faced with the problem of travelling to examine

patients, often to remote areas or with populations that are hard to bring to clinics. For these clinicians, low cost portabletools like epiCam are crucial but in very short supply.

epiCam CepiCam C was developed as a general purpose video ophthalmoscopebut it is causing a storm among paediatric ophthalmologists due to itsability to screen premature neonates for retinopathy of prematurityand subsequently monitor the condition.The retina is unique among developing fetal tissues in that it has noblood vessels until the 16th week of gestation. The vessels grow outfrom the optic disc, only fully reaching the periphery of the eye onemonth after birth. The incompletely vascularized retina is susceptibleto oxygen damage, especially in the preterm infant.Retinopathy of prematurity (ROP) is a proliferative disorder of thisimmature retinal vasculature. It ranges from mild to severe with

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White exudates and blood clots - indicators of diabeticretinopathy, image taken with epiCam M

epiCam- portable retinal imaging device

ROP: Avasculature retinal development which leads to childhoodblindness. Taken with epiCam C

Business Summary

marked visual impairment or blindness. It is the leading cause of preventable childhood visual impairment in low and middle-income countries. There are significant long-term ocular complications of ROP, underscoring the importance of lifelongfollow-up of individuals born prematurely. In those low and middle-income countries, high rates of premature birth andincreasing resuscitation of premature infants, often with suboptimal standards of care, have resulted in a Worldwide epidemicof ROP. It develops in 16% of all premature births, the figure rising to around 60% of infants weighing less than 1500 g atbirth and 65% for infants less than 1250g. Some studies suggest that as smaller and younger babies are surviving, itsincidence is increasing with the worldwide prevalence of severe sight impairment due to ROP is now exceeding 50,000 perannum.

One of the greatest challenges in Developing World countries ishaving adequate screening done by ophthalmologists trained todiagnose ROP with indirect ophthalmoscopy. Telemedicine with theuse of digital imaging and fundus photography may also be a potentialstrategy for ROP screening in regions where there are few trainedophthalmologists who can manage ROP. Like epiCam M, epiCam Cprovides a solution that is portable and hand held. Using it, the usercan make a permanent digital record of the state of a prematureneonate's retina which can be saved or forwarded to a remotespecialist screening centre. epiCam C is already making a hugedifference in the premature neonate screening examination, takingaway the need for anaesthetic and the detrimental effects of handexam on heart and respiratory rate.

epiCam VAlthough epiCam M and C were developed as video ophthalmoscopesfor human use, we realised quite quickly that veterinary communitywere very poorly served for ophthalmic imaging.The retina in animals is a particularly difficult thing to image becausethere are a wide range of geometries and a wide range of retinalstructures appearing in different places. One example of this is thetapetum lucidum, a reflective tissue layer associated with the retina ofsome vertebrates. Due to the reflectivity of this layer, it is impossible toimage some animals (eg sheep, cats, dogs) because the light enteringthe eye from a flash-based fundus camera will simply reflect straightback into the sensor making the image useless. The Epipole team wereable to develop an illuminant and sensor that can work in very low lightlevels, making imaging of these animals not just possible but easy for thevery first time.Like epiCam M and C , epiCam V provides a solution that is portableand hand held. Using it, the user can make a permanent digital record ofthe state of a premature neonate's retina which can be saved orforwarded to a remote specialist screening centre.

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Mongrel dog retinae showing tortuous vasculature

Healthy adult single image from video stream

Business Summary

Part 3: Unique Features

• All device optics are ISO 10940 compliant, every image at least equivalent to desktop quality but at frame rate• Video – triage and store video in real time• Portable

The device can be taken directly to the patient, irrespective of their location. This has advantages for people inrural locations, the aged population, children and those in specialised facilities like prisons and care homes.

• Non-mydriatic (dilation/drop free) - work with 4-8mm pupil diameter, >5mm is optimal• Up to 52° in a single frame• Focus correction - can correct for refractive error in prescriptions of at least +/- 15D• Safe, comfortable illumination

- C at low level tuned for neonates

- Low power, easy at the eye, safe• Steerable - Ultra-wide angles can be imaged around the retina• Quantitative, measurable images

- Standard measurement techniques can be used• Easy to examine oneself• Can be used with children, elderly patients and non-compliant animals• Cost - Some of the least expensive devices in its class, a fraction of the price of the equivalent desktop systems.• Weight around 180g• Single handed operation• 1.3 Mpx [1280x1024] and up to 5Mpx [2592x1944] for the C and V• 14/15 fps continuous acquisition• Universal USB 2/3 connector• Windows 7, 8, 10, Android all fully certified• Also available to researchers: GNU/Linux, Raspberry Pi• Simple interface• Online/offline capabilities

- storage, analysis, backup• EFTP - high security encrypted image and data transport mechanism

- recognized as an original protocol by IANA and assigned port number 376011

1 http://www.iana.org/assignments/service-names-port-numbers/service-names-port-numbers.xhtml?search=37601

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epiCam M, C, and V – images taken around the optic disc from a live video stream in each device

Business Summary

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