Tag: ITM News

A company working with experts from the University of Birmingham and King’s College London has been awarded funding by Innovate UK to produce custom-fitted, reusable, medical grade facemasks that will fit all people regardless of age, sex or ethnicity.

MyMaskFit will focus on producing masks at FFP3 standard, which filter 99% of aerosols.  The FFP3 standard is recommended in healthcare settings where there is a risk of COVID-19 transmission.

The masks will be the first fully custom-fitted, reusable, filtering face piece (FFP) masks made to this standard in the UK.

The issue of mask fit is critically important in healthcare settings, where an adequate seal is required between the mask and the face.  Yet the wide variations in mask design and the inevitable variation in the shape of human faces mean that this fit can be difficult to achieve, and when healthcare staff find a mask that fits, it may not be available at the next round of supply.

Scientists from the University of Birmingham and King’s College London recognised these issues at the outset of the UK lockdown, and started a collaboration that brought together expertise in facial imaging, skin interfacing devices and 3D printing.

Starting in April, this intensive project involved Professor Liam Grover, Director of the Healthcare Technologies Institute based at the ITM, Dr Sophie Cox, Senior Lecturer in Healthcare Technologies, University of Birmingham, and Professor Owen Addison, Chair of Oral Rehabilitation, and Dr Trevor Coward, Reader in Maxillofacial & Craniofacial Rehabilitation, at King’s College London.

Supported by the EPSRC as part of the UKRI COVID-19 response, the combined team rapidly produced a promising prototype for a customised mask seal to reduce exposure risk and fitting time, while also improving comfort for professionals who need to wear FFP masks all day, every day.  Both universities filed patent applications during the course of the project, and the rights to these patents are being licensed to MyMaskFit.

MyMaskFit will now take the product through regulatory approval and bring it to market to meet the growing demand for FFP3 masks.  The first masks will be manufactured in Swansea, Wales.

Paul Perera of MyMaskFit, who conceptualised the project, commented:  “MyMaskFit is bringing clinical knowledge, chemistry and manufacturing engineering expertise.  The company is working with technology partners in the spirit of the UK’s Ventilator Challenge to accelerate the pace of innovation and development so we can supply the NHS and care homes with masks that fit their workers, who will be able to use a mobile device to scan their face, and receive a mask within 24 hours.”

MyMaskFit plans to make technology behind the mask available to developing countries.  It will be assisted in this by the Emergent Alliance, a not-for profit collaboration consisting of large corporates, individuals, NGOs and Governments that aims to build economic resilience in the post-COVID world.

Dr James Wilkie, CEO University of Birmingham Enterprise, which filed the Birmingham patents, said: “This is a fantastic example of bringing university research ideas to market quickly so they can improve people’s lives as soon as possible.”

Professor Owen Addison said: “Both UKRI’s rapid support of COVID-19 responsive projects and outstanding collegial working environment between universities, industry and policy makers during this difficult time is enabling the early translation of this work which can deliver real benefit to the point of greatest need.”

A nasal spray that can provide effective protection against the COVID-19 virus has been developed by researchers at the University of Birmingham based here in the ITM, using materials already cleared for use in humans.

A team in the ITM’s Healthcare Technologies Institute formulated the spray using compounds already widely approved by regulatory bodies in the UK, Europe and the US. The materials are already widely used in medical devices, medicines and even food products.

This means that the normal complex procedures to take a new product to market are greatly simplified, so the spray could be commercially available very quickly.

A pre-print (not yet peer-reviewed) study describes cell culture experiments designed to test the ability of the solution to inhibit infection. They found cell-virus cultures inhibited  the infection up to 48 hours after being treated with the solution and when diluted many times.

The spray is composed of two polysaccharide polymers. The first, an antiviral agent called carrageenan, is commonly used in foods as a thickening agent, while the second a solution  called gellan, was selected for its ability to stick to cells inside the nose.

The gellan, is an important component because it has the ability to be sprayed into fine droplets inside the nasal cavity, where it can cover the surface evenly, and stay at the delivery site, rather than sliding downwards and out of the nose.

Lead author on the paper, Dr Richard Moakes, said: “This spray is made from readily available products that are already being used in food products and medicines and we purposely built these conditions into our design process. It means that, with the right partners, we could start mass production within  weeks.”

The spray works in two primary ways. Firstly, it catches and coats the virus inside the nose, from where it can be eliminated via the usual routes – either nose-blowing or swallowing. Secondly, because the virus is encapsulated in the spray’s viscous coating, it is prevented from being uptaken by the body. That means it will reduce the viral load in the body, but also even if virus particles are passed on to another person via a sneeze or cough, that person is less likely to be infected by active virus particles.

Co-author Professor Liam Grover, says: “Although our noses filter 1000s of litres of air each day, there is not much protection from infection, and most airborne viruses are transmitted via the nasal passage. The spray we have formulated delivers that protection but can also prevent the virus being passed from person to person.”

The team believe the spray could be particularly useful in areas where crowding is less avoidable, such as aeroplanes or classrooms. Regular application of the spray could significantly reduce disease transmission.

“Products like these don’t replace existing measures such as mask wearing and handwashing, which will continue to be vital to preventing the spread of the virus,” adds Dr Moakes. “What this spray will do, however, is add a second layer of protection to prevent and slow virus transmission.”

A new spray for treating severely painful blisters, mouth ulceration and oral scarring in patients with a rare genetic skin condition is being developed by researchers in the Healthcare Technologies Institute, based here in the ITM.

The spray is designed for patients with Epidermolysis Bullosa (EB), a condition that causes the skin to blister and tear at the slightest touch.

Around 5,000 people in the UK are currently living with EB, which is usually diagnosed in early childhood. Symptoms include open wounds and sores where fragile skin is damaged and severe scarring where wounds heal.

EB can be particularly painful when internal linings such as inside the mouth are damaged, making eating and teeth brushing extremely difficult. Scarring inside the mouth can also affect the development of muscles and other tissue.

Researchers in the Healthcare Technologies Institute and the University of Birmingham’s Institute of Inflammation and Ageing are working alongside experts in dermatology and dentistry to formulate an oral spray designed to alleviate some of these symptoms.

Over the next two years, the team will work closely with clinicians and patient groups to design the spray so that it can be delivered directly into the cheek cavity. It will contain anti-fibrotic molecules to both treat the blisters and prevent them from scarring.

The work has been funded by DEBRA, the UK charity dedicated to finding a cure for Epidermolysis Bullosa and supporting the EB community.

Caroline Collins, Director of Research at DEBRA says: “The development of this spray could be a giant step forward in helping to alleviate the constant pain and discomfort EB sufferers experience on a daily basis. The combination of delivery and use of treatments that reduce fibrosis could mean an EB patient is able to properly eat for the first time and maintain basic dental hygiene which many of us take for granted. I am hugely grateful to the team in Birmingham for making this happen.”

Professor Liam Grover, Director of the Healthcare Technologies Institute, is leading the project. “The hydrogels that we are designing have distinctive properties that enable them to stick to the moist tissues inside the mouth,” he explains. “Our aim is to use this formulation to deliver other ‘ingredients’ that can help treat EB symptoms.”

Adrian Heagerty, Honorary Professor of Dermatology at the University of Birmingham, said: “We regularly see EB patients who are unable to eat properly because of pain and discomfort in their mouths, Even brushing their teeth can be painful and damaging, leading to extremely poor dental health. Developing an oral spray that will help patients to eat and maintain oral hygiene could be a game changer.”

As one EB patient explains: “EB will always be part of my life, but this type of treatment could make it less painful to live with. It will be particularly important for younger people, who will be able to use it to help them reduce the damage to the insides of their mouths, brush their teeth more regularly, and keep their teeth stronger for longer.”

Three formulations will be designed, each delivering a distinct anti-fibrotic molecule. The aim will be to test each of these in a comparative clinical trial once the initial research programme has been completed.

Anthony Metcalfe, Professor of Wound Healing at the University, adds: “There is no cure, yet, for EB and so our primary focus is on managing the pain and other symptoms. We’re very grateful to DEBRA for funding this important research.”

By the end of the two-year programme, the team aim to have formulated the spray, and prepared the groundwork for an early stage clinical trial.

A method for detecting traumatic brain injury at the point of care has been developed by scientists at the University of Birmingham based here at the ITM.

Using chemical biomarkers released by the brain immediately after a head injury occurs, researchers are able to pinpoint when patients need urgent medical attention. This saves time in delivering vital treatment and avoids patients undergoing unnecessary tests where no injury has occurred.

The technique was developed by multi-disciplinary team of researchers in the group of Advanced Nanomaterials, Structures and Applications (ANMSA) led by Dr Pola Goldberg Oppenheimer.

Following a proof-of-concept study, the group has now completed Innovate UK’s commercialisation programme, iCURE, to identify commercialisation routes for the technique, identifying potential partners across eight countries.

The method works using a spectroscopic technique called surface enhanced Raman scattering, in which a beam of light is ‘fired’ at the biomarker.  The biomarker, taken from a pin prick blood sample, is prepared by being inserted into a special optofluidic chip, where the blood plasma is separated and flows over a highly specialised surface. The light causes the biomarker to vibrate or rotate and this movement can be measured, giving an accurate indication of the level of injury that has occurred.

To produce the level of accuracy required, the test needs to be extremely sensitive, rapid and specific and this is where the Biomedical Engineering expertise at the ANMSA group at the University of Birmingham comes to the fore. The key to sensitivity is in the way the biomarkers interact with the surface. The team developed a low-cost platform, made from polymer and covered with a thin film of gold. This structure is then subjected to a strong electric field, which redistributes the film into a distinctive pattern, optimised to resonate in exactly the right way with the light beam.

Dr Goldberg Oppenheimer explains: “This is a relatively straightforward and quick technique that offers a low-cost, but highly accurate way of assessing traumatic brain injury which up until now has not been possible.”

According to the charity Headway, around 1 million people each year will visit A&E following a head injury. Current methods of assessing TBI frequently rely on the Glasgow Coma Scale, in which clinicians make a subjective judgement based on the patient’s ability to open their eyes, their verbal responses and their ability to move in response to an instruction.

“The current tools we use to diagnose TBI are really quite old fashioned, and rely on the subjective judgement of the paramedic or the emergency doctors,” says Dr Oppenheimer. “There’s an urgent need for new technology in this area to enable us to offer the right treatment for the patient, and also to avoid expensive and time-consuming tests for patients where there is no TBI.”

Research demonstrating the technique was published in the journal Nature Biomedical Engineering. In the study, 48 patients were assessed using the engineered device, with 139 samples taken from patients with TBI and 82 from a control group. The study showed that in the TBI group, the levels of the biomarker were around 5 times higher than in samples taken from the control group. The team also found the levels tailed off rapidly around one hour after the injury occurred, further highlighting the need for rapid detection.

Additional funding from the Royal Academy of Engineering, has enabled a market analysis including paramedics, neurosurgeons and sports therapists which has confirmed a strong need for the technology.

The next stage for this research will be to miniaturise the device technology used to analyse the samples, so that it could be easily stored on board an ambulance for use by paramedics, used at sporting events where head injuries can be hard to detect, at local GP services or in hospitals where it could be used over time to monitor patients to see how the head injury is progressing. The team is working towards optimising and trailing a prototype technology on a larger patient cohort.

A UK trial into the effectiveness of giving blood to trauma patients before they come to hospital has recently introduced an innovation that, if proven to be successful, could be adopted across the country.

Previously, only doctors could recruit patients to the RePHILL (Resuscitation with Pre-Hospital Blood Products) trial. The RePHILL team have developed a training course to enable paramedics to recruit and give blood to patients taking part in the trial.

Mark Beasley, The Air Ambulance Service (TAAS) Critical Care Paramedic, said: “I was excited but apprehensive when I learnt that paramedics would be authorised to recruit patients.

“The comprehensive training package and support provided by the RePHILL team meant I was confident in my ability to recruit, and I was left feeling that the patient had received the best possible care.”

The trial is sponsored by the NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC), who work closely with a number of regional ambulance services, with TAAS the first to train their paramedics to recruit patients. The SRMRC is based within the ITM.

Patients either receive blood before their arrival to hospital or the current standard care, saline, with the trial assessing whether the early use of blood could help to save lives.
Hazel Smith, Research Paramedic, added: “Giving blood to patients before they arrive in hospital is a fairly recent development in the UK, with the first patient receiving pre-hospital blood in 2012. Transfusion is traditionally decided by doctors. However, non-medical authorisation is increasingly being seen as an important advanced skill not only for nurses but also for the paramedic community.

“We believe we are the first team in the UK to support rolling this out within a clinical trial setting. Having more people who can enrol patients into RePHILL will really help with our recruitment and patient care.”

Dr Heidi Doughty, Consultant Haematologist with NHS Blood and Transplant and a member of the RePHILL team, said: “Non-medical authorisation and research are both really important developments for the emergency community. The experience of these paramedics should help shape future training courses and pre-hospital transfusion trials.”

So far, two TAAS paramedics have recruited patients to RePHILL, which has recruited almost 400 patients overall.

Recruitment to the trial is currently ongoing and is expected to finish by the end of the year.