Company of the Month – NuVision Biotherapies

NuVision Biotherapies has come up with a new way of using an old discovery and, in the process, is transforming the outlook for people with injury and chronic conditions of the eye.

We spoke to CEO Andy Hill about the company’s unique method of using amniotic membrane for ocular healing, just as the company embarks on a new investment drive to support their commitment to research.

Foundations in research

NuVision has its foundations in a PhD project at the University of Nottingham. Dr. Andrew Hopkinson, with his supervisor Prof. Harminder Dua, were looking at the use of amniotic membrane (the inner layer of the foetal membrane formed during pregnancy) as a wound dressing in ophthalmology. The idea wasn’t new – the opportunity for transplanting amniotic membrane in wound healing was first discovered in 1910. But what Andrew perfected was a method for preserving the membrane which opens up possibilities for its use in a much wider range of settings and conditions.

Having completed his PhD, Andrew and Prof. Dua co-founded NuVision as a spinout company in 2015. They gained intellectual property (IP) rights for their unique manufacturing process – the Tereo process. Previous methods for processing amniotic membrane involved either deep-freezing, or freeze-drying of the tissue. Neither produced optimum results – deep-freezing means the end product needs to be stored at -80°C, and freeze drying can mean damage to the tissue’s structural integrity and loss of some of its benefits.

The Tereo process, meanwhile, uses a multi-stage process of washes and baths, culminating in the use of low temperature vacuum evaporation to dry the material. This gentle process aims to preserve all the benefits, while resulting in a flexible, easy-to-use, easy-to-store product.

Omnigen and OmniLenz

Omnigen is the core product at the end of NuVision’s special process. A thin, dried tissue material, it can be stored at room temperature, has a long shelf life, and is supplied pre-cut in a range of sizes.

The breakthrough that has really opened up access to many more patients, however, is the development of their next product – the OmniLenz. Whereas, traditionally, the membrane dressing would need to be sutured onto a patient’s eye, the OmniLenz allows the dressing to be applied without the need for surgery. A specially-designed contact lens is combined with an Omnigen patch, and can quickly be applied by a clinician with minimal training.

This opens up use to more outpatients in emergency settings, as well as to patients with lower levels of chronic conditions, who can now access non-invasive treatment at an earlier stage.

From research to commercialisation

The challenge for many spinout companies is in translating promising research into commercialisation. This is where CEO Andy Hill comes into the story. Andy has a long and varied background in medical technology, including spinning out a company from The University of Oxford, and experience in digital technologies, artificial intelligence, and patient monitoring to name a few.

Andy came onboard in January this year as CEO, as NuVision looked to scale up, with Andrew Hopkinson staying on in the Chief Scientific Officer role. Andy says:

“We estimate that the market for the use of amniotic membrane in ophthalmology essentially doubled overnight with the introduction of the OmniLenz, because you can now use it in an outpatient setting so easily. Whether it’s for trauma or a chronic inflammatory condition, instead of needing surgery under general anaesthetic, the patient can now – in a 4-6 minute procedure – have a simple contact lens put in to accelerate their healing.”

The company already sells to over 130 NHS Trusts, including Moorfields Eye Hospital NHS Foundation Trust, as well as around 30 private hospitals in the UK. Now they are in the process of expanding into overseas markets, as well as looking at new potential uses for their products.

Dry eye

One of those new potential uses is in the treatment of a condition affecting approximately 5 million people moderately to severely in the UK – dry eye disease (DED). For people affected, DED is a chronic condition that causes great physical discomfort, often having knock-on effects for mental health. The treatment options typically involve regular application of eye drops, with the most severe cases requiring hospital treatment. Current available treatments only help manage a patient’s symptoms to varying degrees, with nothing on offer to give long-term relief.

NuVision’s latest clinical trial has just been completed – working with Aston University to look at the use of the Omnigen-OmniLenz treatment in DED. Patients with moderate-to-severe DED wore the Omnigen-OmniLenz for two week-long periods (with a week-long break in between). Prof. James Wolfssohn led the trial and said:

“Whilst the patient assessment duration has yet to finish and the complete data set fully analysed, an interim analysis suggests there is a marked improvement (reduction) in a dry eye patient’s symptoms after using Omnigen and OmniLenz for ~1 week and this is sustained over at least a 6-month period. This is certainly impressive, given what we have observed from other treatments.”

As Andy points out, the potential for large numbers of patients could be huge:

“It could be transformative for so many people. In fact, a participant came to the study team and said it had changed her life. The condition has that much of a daily impact on people.”

With their foundations in research, studies like this are important to NuVision. Andy explains:

“With the way amniotic membrane is regulated, clinicians already have the freedom to prescribe the treatment to their DED patients. But, for us, it’s extremely important that we have the clinical data and the right protocol for healthcare professionals to utilise, because we’re an evidence-based company.”

With that said, based on the early analysis of their research, they hope to be in a position to release this data by the middle of next year. This would potentially open up the pool of patients that could benefit from Omnigen-OmniLenz treatment to many millions of people worldwide.

With an eye firmly on scale, the next focus includes another new research project. NuVision has been successful in applying for Innovate UK’s new Investor Partnerships Programme, which will award them funding of £700k, on the condition that they match this with new investment into the company. They’re being ambitious, and are planning to more than match the funding with a £1.1million investment drive. ‘Project Mainstream’ will include a second clinical study into DED, this time aiming to investigate the potential for a more accessible treatment application to target a wider range of patients on the DED spectrum, which would potentially take their product to a high street optician’s prescribing optometrist.

Partnership and collaboration

For this research work, and more, partnerships have been crucial to the company’s success so far. The harvesting of the raw material they rely on – the amniotic membrane – is completed thanks to a partnership with the Anthony Nolan Trust, and their research and development work takes advantage of the UK’s many experts in ophthalmology:

“Collaboration and partnerships are absolutely critical. We’re a UK business and we work very closely with the NHS. But we don’t just sell products to them. We’ve got independent clinical research happening in a number of centres, audits going on with scientists, and we’re working on interesting collaborative research in stem cell therapy. There’s a whole world of collaborative work going on inside the company, and the UK is the only territory where we see ourselves working like that. Elsewhere, we’ll work through distribution partnerships and networks. But the UK is a leader in ophthalmology. It means that we can be really close to our customers, and that our customers can move to also being research collaborators very easily.”

With that in mind, Andy is in the process of putting together a clinical advisory board of experts in mainstream ophthalmology, as well as those specialising in DED. Andy says this is a critical part of his role in ensuring that the voice of the customer is represented within the company’s research and development. They’ve also tapped into support from MedCity to help cement their links into London-based investment and collaboration opportunities:

“We’re based in Nottingham, but London and the so-called Golden Triangle is very important. It’s a centre of gravity for UK life sciences, and MedCity sitting within that, with tendrils reaching out across the wider UK – helping to foster better relationships – is a really positive thing.”

Future

NuVision has a busy roadmap planned for the next couple of years. Andy foresees their current research projects and investment drive culminating in a bigger Series A funding round early next year. And over the next 2-3 years, they plan to grow from a team of 15 to around 80, with a focus on creating manufacturing jobs in the Midlands.

Beyond that, the longer term ambition (and potential) for the company to find new uses of both their Tereo process and Omnigen product seems huge. Amniotic membrane is already used in wound healing outside of the eye. And early signs are that they may be able to use their Tereo process to preserve other problematic material, such as corneal tissue for corneal transplants. All in all, you can see why Andy describes his vision – to build a multi-million (or even multi-billion) pound UK health tech business – so clearly.

Find out more: nu-vision.co.uk