“The support East Midlands AHSN has provided has been invaluable. The advice and guidance has been extremely useful, particularly when looking at developing our products for new markets and working on strengthening our evidence base. We know our innovations can make a huge difference to the lives of patients, as evidenced during the current pandemic, therefore working towards solidifying adoption across the UK healthcare system to benefit patients is our ultimate goal.”
Dr Andrew Hopkinson, CSO NuVision
Overview

NuVision’s innovative Tereo® processed human amniotic membrane (membrane from placentas) is a ground-breaking platform technology that provides tissue-healing solutions across multiple clinical specialities including ophthalmology and wound care. The technology is unique, as the material is dry-preserved making it easy to store and access in hospitals, and it allows development of treatment strategies to treat patients within an out-patient setting without the need for surgery.

NuVision’s current innovative eye treatment (Omnigen®, Tereo processed amniotic membrane) offers an alternative to conventional eye surgery by using the product to treat damaged corneas and promote natural and faster healing in a routine out-patient setting. The company is in process of expanding the use of its Tereo process amniotic membrane into new markets including dry eye disease, and to facilitate the treatment of chronic wounds, such as diabetic foot ulcers (DFUs).

East Midlands Academic Health Science Network (EMAHSN) has been instrumental in supporting the company to commercialise this revolutionary procedure – with the support of the AHSN the company has experienced a significant increase in sales, has leveraged additional funding and has created new jobs.

The AHSN has worked with NuVision since 2017 and this is an example of the AHSNs’ key roles in generating a pipeline of innovation – the company was spun out of research carried out over 15 years at University of Nottingham. The company is based in Nottingham and the product is currently used over 130 NHS sites in the UK including, Moorfields, East Grinstead, Portsmouth, Bristol, Nottingham and King’s College with other new sites and private hospitals in the pipeline.

Initially EMAHSN invited NuVision to attend an extended innovation surgery – an element of the AHSN’s Innovation Exchange process – which focused on market scoping and advice around business direction and growth.

They also attended several one-one support sessions with EMAHSN experts, including a workshop on developing an NHS business case.

After this initial guidance, EMAHSN signposted and supported NuVision in their application for a MedTech grant provided by Medilink and part funded by EMAHSN and the European Regional Development Fund (ERDF). This was instrumental in helping secure a £100,000 grant to cover a patient and assessor blind randomised controlled pilot study to provide an evidence base for using the product for the treatment of DFUs, paper published 2021. The company has also received support to develop and expand their network of contacts.

NuVision has also recently secured an additional £50,000 MedTech innovation support grant to build on previously generated proof-of-concept clinical data and generate a prospective and multicentre case series at Queen Victoria Hospital, Maidstone and Tunbridge Wells NHS Trust and Bristol Royal Infirmary to support the ground-breaking management of ocular surface disease in a surgery-free outpatient setting, and it is expected to be complete 2023.

With the support of the EMAHSN:

  • Over 5,500 treatments have been distributed for the management for ocular surface disease, UK and internationally.
  • Successfully completed and published outcomes of the randomised controlled study in DFUs and are planning further and more substantial studies.
  • Anticipating to double company turnover in 2022-23 with a major clinical and international expansion plan.
  • Secured a further £2 million investment and are embarking on a further Series A funding round within the next financial year.
  • Expanded its senior management team to enhance the business through its next stage of growth.
  • Expanded its product range for ophthalmology and expect to launch its new wound care product range within the next 9 months.
  • Expanded its clinical program in ophthalmology to include dry eye and EMAHSN-funded early treatment of ocular surface disease.
Challenge / problem identified

There are many corneal conditions that can cause eye wounds, which in many cases are not able to be successfully treated without eventual surgical intervention – the worst cases can be the loss of vision. NuVision has developed innovative ways of effectively applying their product without the need for surgery. They have developed a special bandage contact lens called OmniLenz which is uniquely designed to allow amniotic membrane to be loaded, applied, and retained at the surface of the eye without the need for sutures or surgery. For the first time, this has allowed patients to be treated in a routine outpatient setting meaning more patients can be considered and earlier in the treatment pathway.

In 2017/18 over 120,000 episodes were recorded in England involving corneal injuries*. There is evidence that NuVision’s product Omnigen can heal persistent epithelial defects. In a recent published study of persistent eye wounds of 81 patients (90 defects) treated in an outpatient setting using Omnigen, 86% of defects demonstrated complete (63%) or partial healing, with an average of 1.2 treatments over an average of 22 days.

NuVision’s Omnigen / OmniLenz has the potential to:

  • Reduce the need for costly theatre resources
  • Enable more patients to be treated in an outpatient setting and much earlier in the care pathway
  • Improve outcomes and quality of life for patients
  • Reduce Trust workloads decreasing treatment pathway and process
  • Provide a solution to treating patients during a pandemic and helping to reduce the post-pandemic burden on waiting lists

*Based on the ICD10 codes 2017/2018 data.

**Maqsood, S. et al. (2021) ‘Management of Persistent Corneal Epithelial Defects with Human Amniotic Membrane-derived Dry Matrix’, Clinical Ophthalmology, 15, pp. 2238–2231. doi: 10.2147/OPTH.S299141.

DFUs are one of the most significant and devastating complications of diabetes, affecting approximately 10-15% of all people with diabetes. DFUs present a major source of disability, distress, and cost, and can have a significant impact on a patient’s health. Healing is often delayed and both major and minor amputations are common outcomes.

Currently, there is variation in practice in the management of diabetic foot problems. There is a strong clinical need to develop an effective method of accelerating the healing of DFUs to improve patient outcomes and costs to the NHS.

NuVision’s Tereo processed amnion has been used as part of a multi-centre, prospective, patient- and observer-blind, randomised, controlled pilot trial in collaboration with the University Hospitals of Derby and Burton NHS Foundation Trust. The objective was to investigate whether 2 weekly applications of Omnigen compared to standard of care versus standard of care alone increased the proportion of healed participants’ index foot ulcers within 12 weeks. Thirty-one people were randomised and within 12 weeks, healing occurred in 27% patients who received Omnigen versus 1% of usual care group. The pilot study results show that Omnigen is safe and a promising treatment, and results from the pilot trial will be utilised to design a statistically powered, larger study*.

*Game, F. et al. (2021) ‘The effectiveness of a new dried human amnion derived membrane in addition to standard of care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study’, International Wound Journal, 18, pp.692-700. doi: 10.1111/iwj.13571.

How is the AHSN involved?

EMAHSN have offered a range of support to further NuVision’s business and new product development. They have received in-depth advice and expert guidance on developing a business case commercialisation, diversifying their product, market research/scoping and gathering supporting evidence.

EMAHSN signposted to a MedTech trials grant scheme for the development of their product for the treatment of chronic wounds will allow the company to diversify and enter new markets. They were successful with their application and received a £100,000 grant for a pilot clinical study with the University Hospital of Derby and Burton NHS Foundation Trust. Data from the trial is enabling NuVision to apply for additional funding to further their work in the wound care arena.

More recently NuVision has been awarded a further £50,000 and EMAHSN support through a MedTech trial innovation support grant to support the management of ocular surface disease in a surgery-free outpatient setting.

Impacts / outcomes of AHSN involvement to date 

NuVision have seen year-on-year commercial growth over the last several years, especially during the recent pandemic when NuVision’s innovative surgery-free products have provided the NHS with an important solution to continue treating patients with eye disease. By developing their product to cover wider ophthalmic specialities including dry eye disease and drive adoption in the treatment of chronic wounds, they have the potential to see further significant growth.

EMAHSN have used their unique position between industry and the health and care system to provide expert advice on the market, brokering connections and opportunities to develop a further evidence base. NuVision have used this advice and expertise to better understand their audience to improve sales and to appeal to a wider market.

Learning to date

Barriers and challenges to the adoption and spread of NuVision’s current products are:

  • That there is an established treatment pathway for eye wounds and this treatment would require a revaluation of the existing pathway
  • Expansion of evidence is needed to create a robust case to encourage adoption and NICE approval
  • There is the procurement barrier and the need to secure a supplier listing
Plans / timescales for adoption and spread

NuVision’s platform technology is applicable for use in a variety of clinical settings. Their current focus is ophthalmology, but they are now expanding their out-patient treatment strategy into dry eye disease, as well as the wider wound care markets to facilitate the treatment of chronic wounds, such as DFUs.

NuVision has an ongoing clinical study in dry eye disease at Aston University, and ocular surface disease at Queen Victoria Hospital, Maidstone and Tunbridge Wells NHS Trust and Bristol Royal Infirmary, but they are planning a further randomised control trial in DFUs with University Hospital of Derby and Burton NHS Foundation Trust in the near future.

Opportunities to get involved

NuVision is working to increase the adoption and grow the depth of use of their existing products and platform technology. They are interested in rolling out the product to other NHS and private trusts, specifically wider teaching hospitals, and to undertake further clinical trials within different ophthalmic specialities and wider wound care markets.

NuVision are supporting UK centres in setting up HTA satellite licences that will allow Omnigen to be accessible in emergency and non-elective settings.

Develop a resource driven approach to drive deeper adoption including digital marketing and online support to customers.

Start and end dates

2017 – ongoing

Contacts

Media enquiries:

Julie Warren, Communications Manager, East Midlands AHSN
E: julie.warren@nottingham.ac.uk
T: 07929 750930