Business, Company, Devices, Equipment, Feature, Products, Report

Australian-made HP-OCT to hit the market

Cylite HP-OCT

Melbourne company Cylite is putting the final touches on its Hyperparallel-OCT (HP-OCT) ahead of its official launch next month. The company discusses its journey up until this point and the sophistication that sets its technology apart.

A major feat in Australian engineering is set to take place next month when the first official iteration of the homegrown Cylite HP-OCT is presented to the local market.

It’s an unlikely story. A team of physicists and engineers – armed with their own expertise and money before additional backing – toiling for eight years to design and build an OCT system from scratch in Australia.

An instrument sporting the ‘Australian Made’ mark, which works to overcome the shortcomings in existing models while combining capabilities not often seen in a single OCT, is more remarkable when you consider the company is operating in one of the most competitive ophthalmic segments. The OCT market is worth around AU$775 million, and largely dominated by big-budget multinationals from the US, Germany and Japan.

At the time of writing, Cylite was planning the HP-OCT’s first official public showing to take place at the Orthokeratology Society of Oceania on the Gold Coast on 1 October. Then, COVID permitting, was hoping to head north to Noosa from 20-23 October when local ophthalmologists can get their first glimpse at Australasian Society of Cataract and Refractive Surgeons (AUSCRS) Conference.

The fact Cylite has chosen these events to launch hints as to where its creators initially expect the system to have the biggest impact.

OCT has mostly been perceived as a retinal imaging system. While the Cylite HP-OCT has this capability, its greatest initial strength is in the front of eye where the company says it creates true volumetric, or 3D, images of intricate anterior segment structures in a single snapshot. Scans are acquired at industry-leading rates of more than 300,000 A-scans per second. This means it can capture a full biometry scan in seconds, enabling accurate, motion- artefact-free measurements of all ocular surfaces.

Keratoconus patient – 1. True dense 3D volume image. 2. B-scan slice (corresponds with horizontal yellow line in 4). 3. B-scan slide in Z axis or enface axis (corresponds with yellow line in 5) shows the thinning/distorted posterior cornea. 6. A vertical B-scan along the vertical dotted line in image 4.

The company expects the highly precise measurements to be a mouth- watering prospect for practitioners involved in myopia management and scleral contact lens fitting, as well as cataract and refractive surgeons.

With the launch now imminent, CEO and co-founder Dr Steve Frisken says the company has been keen to shift the focus from the hardware that makes the system so unique, to educating the market about the advantages in the clinic and research lab.

For a while now, the HP-OCT has been in the hands of several institutions testing its capabilities to measure and monitor conditions such as keratoconus, closed-angle glaucoma, presbyopia, cataracts, corneal infections and biomechanics, to name a few. One of those universities, UNSW in Sydney, acquired the device after OCT co-inventor, Dr David Huang, praised it to a senior lecturer at an international conference in 2018.

“The value proposition is built around the fact we get this full 3D visualisation of the eye, but it’s not only having that capability of seeing the volume, we can provide really accurate measurements of the different ocular surfaces that are meaningful for many diseases,” Frisken explains.

“Given the unique dense snapshot capture of the technology, we can take a B-scan slice of the eye in any direction, X, Y or Z (enface) axis; we haven’t seen any competitor try to do this at the front of the eye, so we think we have a really strong advantage in this space for a while to come.”

The company also has projects under way looking at OCT-angiography to measure vascular flow at the front of the eye. It also expects further developments on the retina, among a host of other applications. But it isn’t getting ahead of itself.

“When you move into this type of medical space and are developing a technology from the ground up, you’re talking about a long-term bet, and we are now seeing a financial model that can work for us on the first release of product,” Frisken says.

“There is a whole roadmap of ideas where we think this basic building block will continue to deliver in many other areas, but we have to walk before we run, so we are putting the roadmap thinking in the background, and focusing on the first release product, and working hard to define what it can do.”

Start-up to fully fledged firm 

Cylite was founded in 2013 in Melbourne with the backing of four prominent Australian scientists drawn from the fields of photonics, optics, instrumentation, and software development.

Brothers Steve and Grant Frisken were the masterminds. Steve Frisken has 25 years’ experience in photonics, having previously founded Photonic Technologies (acquired by Nortel) and Engana (acquired by Finisar). He is also a prolific inventor, with 45 US patents in optics and the inventor of the Dynamic Wavelength Processor that has generated more than $AU1.3 billion in cumulative revenue.

Mr Grant Frisken is the chief technology officer with more than 20 years’ medical and real time software experience. He designed the Medmont E300 software, considered the gold standard in corneal topography.

Grant Frisken understood the limitations of current technologies, so he urged his brother to build a team that could harness the accuracy of OCT for metrology of all eye surfaces.

Cylite founders HP-OCT
Cylite founders (from left) Steve Frisken, Trevor Anderson, Grant Frisken and Simon Poole.

Dr Simon Poole, vice-president of business development, is also a founding member. He has 40 years’ experience in photonics in both academia and industry. And chief scientist Mr Trevor Anderson has 25 years’ experience in industrial R&D, government research labs and start-ups, with expertise in optical communications and signal processing.

In recent times, the company added Ms Kylee Hall as its vice-president of commercial and clinical. She was previously responsible for Zeiss’ Australian and New Zealand medical business group.

Cylite received its CE mark for the European market in late 2020, paving the way for Australian registration earlier this year. After the Australian launch the company will work towards the European and the UK markets, with the US slated for further down the track.

The HP-OCT’s first official showing in Queensland is being met with anticipation. It’s already received major plaudits, including Engineer Australia’s highest honour – The Sir William Hudson award – in 2020. This year Cobalt Design, Cylite’s industrial design partner, and Cylite itself received the Victorian Premier’s Design Award.

Hall, who is leading the commercial launch, says the company has also been inundated with institutions locally and globally wanting to use the system on loan. This is in addition to numerous calls from overseas distributors wanting to know when they can access the technology.

Such pent-up excitement is humbling; however it comes with the weight of expectation.

That’s why Cylite has been narrowing its focus on its production capabilities and software development. Part of that has been expanding its staff count to around 50 people and leasing a second building near its headquarters within the Monash Technology Precinct in Melbourne.

The company is also well financed heading into the next phase with backing from Main Sequence Ventures, which manages the CSIRO Innovation Fund.

“We have been working particularly hard on our user interface,” Hall explains.

Cylite is producing the instrument locally in Melbourne.
Cylite is producing the instrument locally in Melbourne.

“It has taken seven to eight years to fine-tune the hardware and micro-optics that make it so unique, but the user interface is what people will ultimately judge the product on. Its ease of use, how it displays the information when a scan is captured, and what you’re able to do with that information.”

Cylite’s software, Focus, has been engineered from scratch locally as well. Hall says there’s no legacy system here; the review component has been built on the latest web-based software and utilises advanced knowledge from the gaming space to ensure images can be displayed and manipulated easily.

“We are developing it with the future in mind, so it can interact with technology developments within the AI space, for example,” she says.

“We’re also passionate about enabling researchers access to the raw data they need to advance research in the ophthalmic and optical space. Too many products cut the data down and lock it up.”

Cylite OCT system
Cylite says its HP-OCT offers volumetric imaging for both anterior segment and retina at industry-leading scan rates.

Medical device design of this calibre is an anomaly in Australia, but it’s even rarer for companies to conduct their production locally. During the past 18 months, Cylite has tripled its Melbourne production team.

Frisken says the company sources its specialised optical components from suppliers both locally and internationally. Cylite has a clean room for assembling the optical components, and performs the complicated optical alignment process in-house.

“To do production in this environment, you need to have a really good quality control system, which we have built from the ground up; we have been successful in gaining our ISO:13485 and subsequent CE mark on that basis,” he says.

“At the end there is a whole calibration process; there’s a separate group focused on ensuring the instrument provides exact measurements, that’s the algorithmic side of things and the software development to do that. It has all been done out of our facilities in Melbourne.”

Bespoke design 

Much of the marketing around the Cylite HP-OCT has centred on it being “the 4th generation of OCT”. This is because it follows in the footsteps of Time-Domain OCT, the original commercial device introduced by Zeiss in 1996, Spectral-Domain OCT (SD-OCT), still the incumbent technology, and Swept-Source OCT, which hasn’t reached the same heights due to its higher price tag.

Cylite’s HP-OCT most closely resembles SD-OCT, but the system has fundamental technological differences that place it in a new category.

Firstly, it is based on a bespoke micro-optics design (or free space optics), as opposed to fibre optics used in many other systems.

A key element within the micro-optics system is the microlens array which creates a grid on the eye of 1,008 beamlets enabling simultaneous A-scans to be captured with an acquisition time of about one millisecond. The acquisition time is short enough to freeze any eye movement, allowing highly accurate measurements of the topography of each optical surface within the anterior segment (anterior cornea, posterior cornea, anterior lens and posterior lens).

The micro-optics within the HP-OCT then ‘dithers’ the grid of 1,008 beams over the eye and snapshots are acquired, capturing highly detailed volume images all registered to one another, ensuring accuracy.

According to the company, this differs significantly from existing systems that effectively scan a single spot over the eye in a raster style scanning pattern.

“Motion artifacts are a common issue for existing OCTs to overcome. Traditional OCTs build volumes from B-scans stitched together, whereas the HP-OCT acquires these volumes at the initial capture,” Hall explains.

“True volume with the Cylite HP-OCT means that post-capture, the user can slice the volume in any direction they want, X, Y or Z axis and they won’t have any gaps, holes or B-scan stitching artifacts to deal with.”

Early adopters 

Dr Maitreyee Roy, a senior lecturer within the School of Optometry and Vision Science and director of the Optics and Radiometry Lab at UNSW, is among early adopters of the Cylite system globally.

As mentioned earlier, she first became aware of the technology by Huang, the OCT co-inventor, who told her he was impressed with the technology at the ARVO 2018 meeting in Hawaii.

She successfully applied for a UNSW infrastructure grant, with the university set to use it for five potential research areas: advanced contact lens research and anterior eye, myopia research, corneal biomechanics, diagnostic and ocular disease including closed-angle glaucoma and keratoconus, and vision-related projects like presbyopia and quantifying lens accommodation and bionic eye.

“I was impressed with their measurement techniques because they have developed a unique ability to capture volumetric images,” she says.

“Because HP-OCT can provide accurate metrology measurements of the anterior chamber, it is useful for several diagnostic and clinical applications, including accurate corneal topography and corneal thickness measurement – desirable for fitting contact lenses.

“It’s also good for screening disease like keratoconus, and monitoring induced corneal changes for things like orthokeratology, and improving quantitative ocular models to predict refractive outcome for corneal or cataract surgery. For myopia progression, it could be helpful because it can continuously measure the on and off-axis and align the model of optical properties of that eye.”

For future upgrades, Roy believes it will be important to improve its posterior imaging analysis, create a normative database, and use one software platform – because she says it currently uses different software for image acquisition and then image analysis. (Roy is currently using the research software).

Another researcher, Dr Edmund Tsui, is an Assistant Professor of Ophthalmology at the Stein Eye Institute within the University of California, Los Angeles (UCLA). He’s been using the Cylite system on dense cataracts and seeing how it compares with FDA approved biometers (it’s too early to provide results) and has been imaging patients from his uveitis clinic.

Dr Edmund Tsui.

At a recent ARVO Imaging in the Eye 2021 Conference, he presented his findings on using the HP-OCT to image herpes zoster stromal keratitis.

Because it captures a single widefield volume image that’s 16.8 by 9.6mm, he says it is ideal for patient education because he can show a complete 3D image of how the scars can impact vision, while also demonstrating how their condition improved over time with treatment.

“I can then scroll through the corresponding B-scans and see where any scars remain. The benefit of the HP-OCT being able to capture entire cornea all at once, without having to perform multiple scans on the cornea, is two-fold: it is easier for the operator to obtain images and the rapid acquisition time allows imaging across a wide area of the anterior segment without motion artifacts.”

More reading

Cylite takes out Engineering Australia’s highest honour

Cylite’s HP-OCT secures ‘Australian Made’ status