Enlighten Imaging - Advanced Hyperspectral Retinal Imaging To Transform The Diagnosis Of Eye And Central Nervous System Diseases : MTPConnect

19 Oct 2023
/ Case Study

Pictured: Enlighten Imaging’s state-of-the-art hyperspectral retinal imaging camera.

Vision impairment and blindness are major public health issues in Australia, with over 13 million people experiencing at least one long-term vision disorder in 2017–18¹. Older people are particularly at risk; about 444,400 people aged 55 or older (almost 10 per cent of that age group) are visually impaired. By 2050, the prevalence of vision loss in people aged greater than 50 is forecast to exceed one million². By 2050, vision loss will impact 7.5 per cent of the entire population.

The major causes of visual impairment are age-related macular degeneration (AMD), cataract, glaucoma, and diabetic retinopathy, and together with uncorrected refractive error, they contribute to over 90 per cent of visual impairment among older Australians. Early detection of these and other eye and central nervous system diseases remain a challenge, as patients often have no symptoms.

Imaging the retina, the inner layer of the eye, presents two diagnostic opportunities, firstly the diagnosis of a range of ocular conditions, as well as the identification of biomarkers of neurological conditions, including Alzheimer’s disease. Early detection of retinal and central nervous system diseases is important to enable treatment before irreversible impairment occurs.

Hyperspectral imaging, imaging across many discrete wavelengths simultaneously in every pixel, is opening new windows into the diagnosis of both vision and central nervous system conditions.

Developing a novel eye imaging method inspired by NASA technology

Enlighten Imaging – a medical technology company spun-out of the Centre for Eye Research Australia – has developed a novel eye imaging method inspired by NASA satellite technology. Instead of imaging the eye with a single white flash of light, the company has developed a camera capable of rapidly capturing many images of the eye with different colours (wavelengths) of light. The resulting ‘cube’ of image data is interrogated with machine learning algorithms to detect signs of disease that cannot be seen using other imaging methods. This ‘hyperspectral’ imaging platform is poised to transform the detection of a wide range of retinal and brain diseases including diabetic retinopathy, age-related macular degeneration, glaucoma, and Alzheimer's disease.

With the support of BioMedTech Horizons (BMTH) program funding, Enlighten Imaging set out to transform its prototype hyperspectral retinal camera into a regulated medical device for advanced retinal imaging. While there is one other hyperspectral retinal imaging camera on the market, its substantial size and cost, coupled with the requirement for pupil dilating eye drops mean that application and benefitto patients is likely to be limited. The Enlighten Imaging platform overcomes these limitations and has potential to become the new standard in optical imaging.

The team partnered with a leading Australian product development company, Ingenuity Design Group, whose expertise, and quality management systems were instrumental in developing the device. Additional support was provided by experienced regulatory consultancy Blue Curve, as well as Entech Electronics, an Australian electronic board manufacturer.

Significant achievement - design & assembly of hyperspectral retinal imaging camera

During the project, the team designed and fully assembled a state-of-the-art hyperspectral retinal imaging camera under ISO 13485 – a significant achievement, particularly given that there was a global shortage of electronic components at the time. These cameras are critical for the next phase of clinical studies and are to be used by clinical trial centres globally.

Pictured: from left, Enlighten Imaging Co-founders, CEO Associate Professor Peter van Wijngaarden and Chief Technical Officer Dr Xavier Hadoux at the company’s Melbourne-based facilities.

While some of the project’s planned clinical activities were impacted by COVID-19, preliminary biomarker findings for the detection of diabetic retinopathy and glaucoma have been validated, including contrast-free retinal angiography to detect areas of the retina that are not receiving sufficient blood (ischemia) and estimating the thickness of the retinal nerve fibre layer in glaucoma.

Throughout the project, all aspects of product development were addressed, from specification to risk assessment, user needs evaluation and extensive verification and validation processes, explained Enlighten Imaging’s Lead Software Engineer, Maxime Jannaud.

“Building the software to control all aspects of the camera, while keeping user and patient needs at the forefront, has made this a challenging and rewarding experience,” he said.

The first patent has now progressed from Patent Cooperation Treaty (PCT) stage to national phase in 10 jurisdictions, which is integral to the commercial value of the device. A patent application related to the camera design has also been submitted, which will soon enter national phase in 10 jurisdictions, having received favourable review on patentability.

In a strong position for next stage of product commercialisation

As part of the BMTH project, Enlighten Imaging held a positive pre-submission meeting with the US Food and Drug Administration (FDA), gaining valuable clarification on the data needed for regulatory approval of the camera. Technical development and validation through the BMTH project have placed the company in a strong position for eventual marketing approval by the FDA and has primed the team to seek external investments for the next stage of its commercialisation journey.

The team is now actively engaged in fundraising to gain FDA clearance of its camera, develop a cloud analytical platform, advance a pipeline of novel imaging biomarkers for clinical validation and scale device manufacture.

Enlighten Imaging is developing an end-to-end imaging and analytics platform that utilises advanced artificial intelligence (AI) methods. This could lead to substantially improved AI-based decision support in retinal imaging, with the potential to transform clinical workflows and facilitate more accurate and earlier diagnosis of diseases.

As the team’s Product Development Lead, Dr Francis Labrecque, explained, participation in the BMTH program has enabled Enlighten Imaging to transform a promising research project into a state-of-the-art medical device.

“It has been quite a journey over the past two years, and it has involved a lot of learning,” he said. “We have come a long way and the device has exceeded our expectations.”

Enlighten Imaging - national & international objectives & vision

Enlighten Imaging is now at a pivotal point for investment and partnership opportunities. Over time, the company hopes to make its technology available to people around the world in eye clinics, optometry practices and hospitals. Realising these objectives will involve national capacity development, as well as local and international partnerships.

According to Enlighten Imaging’s CEO and Co-Founder, Associate Professor Peter van Wijngaarden, this innovative technology is set to disrupt the provision of primary eyecare and may prove transformational in the early-stage diagnosis of neurological conditions such as Alzheimer’s disease.

“I am tremendously proud of what our team has managed to achieve with support from MTPConnect, funding from the MRFF through the BMTH program and expert assistance from leading Australian product development, IP and regulatory specialists,” he said. “In this process we have evolved as a company and are excited to take the next steps to bring this remarkable technology to the clinic for the advancement of human health.”