Mercia EIS Funds’ portfolio company, Sense Biodetection Limited (Sense) has announced the appointment of Heiner Dreismann as non-executive Chairman. Heiner was previously the President and CEO of Roche Molecular Systems, the world leader in molecular diagnostics.

During his tenure at Roche Molecular Systems, Heiner oversaw the substantial growth of the PCR business with revenues doubling in five years. In his earlier career at Roche, Heiner led the integration office of the successful acquisition of Boehringer Mannheim into Roche Diagnostics and went on to become Head of Global Business Development with responsibility for the entire diagnostics business.

Commenting on his appointment Heiner said:
“I am delighted to join Sense at this exciting stage in its development and to be in a position to help the company achieve its ambitious plans. Sense has a compelling proposition and a significant opportunity to transform the IVD field with a new class of molecular diagnostic product.”

Sense CEO Harry Lamble commented:
“I am very pleased to welcome Heiner to Sense. I regard Heiner as a pioneer of the molecular diagnostics industry and the whole team is thrilled to have the endorsement of such a global leader in the field. His market insight and wealth of experience will bring great value to the company as we realise our vision of developing the next generation of truly point-of-care molecular tests.”

Heiner has over 35 years experience in the leadership of high growth businesses on a global basis. Since leaving Roche he has served on the board of a number of private and public biotech and healthcare companies.

Richard di Benedetto, the current President of Aetna International; one of the world’s largest health benefits businesses has been appointed as a director and non-executive chairman of the Braintrain2020 board.

UK-based Braintrain2020 is the organisation behind SleepCogni – a first-in-class patented medical device providing a combined diagnostic and treatment system to help clinicians identify and treat sleep disorders.

di Benedetto’s appointment, along with his pledge of a personal six-figure investment, strategically coincides with the commencement of a £4.8million Series A fundraise for the commercialisation of SleepCogni. Ahead of that process, SleepCogni’s main investors, led by investment firm Mercia Fund Managers, have also committed to providing follow-on funding in the next investment round. This continued support sends a strong message to future investors, regarding the strength and potential of the SleepCogni offering.

di Benedetto brings a wealth of experience and knowledge to his new role having spent over 20 years leading healthcare companies. Alongside this new appointment, he will continue in his role at Aetna International where he will soon be part of a new executive team when the $69billion trade sale of Aetna to CVS Health is complete. Prior to joining Aetna International, Richard served as CEO at Euromedic International – one of Europe’s largest private equity owned providers of diagnostic services, labs and cancer treatments. He also spent 15 years with GE Healthcare, most recently as President and CEO of their Eastern and African growth markets.

Richard di Benedetto said: “As chairman of Braintrain2020, and also as a personal investor in SleepCogni, I see an enormous growth opportunity ahead of us with the potential to help many people live healthier lives.

“Demand for healthcare across the world has never been so great. Populations are increasing and ageing, people are better informed, technology continues to develop at pace, and there is an unprecedented increase in the prevalence of lifestyle-related diseases. Innovative approaches are required to meet these evolving demands and I passionately believe that we need to shift our focus from treatment to prevention.

“For this reason, I am very excited about SleepCogni. There is overwhelming clinical evidence which shows that disrupted sleep is a major factor in many physical and mental illnesses. If we can help people to rebuild healthy sleep patterns, we can improve their overall health and ultimately their quality of life.”

Richard Mills, Braintrain2020 founder and CEO, said: “Attracting such an experienced leader in the healthcare industry to the role of chairman is testament to our achievements to date and how far we have come in such a short period of time. We are delighted to have Richard’s backing and shared vision in place as we commence our fundraise and we have no doubt that his experience and knowledge will be instrumental in guiding and strengthening the management team as we look to commercialise SleepCogni into the US sleep clinic market in 2020.”

Locate Therapeutics to lead regenerative medicine revolution following first equity investment by the Midlands Engine Investment Fund

  • Nottingham-based Locate Therapeutics Ltd is the first firm to receive equity finance from the Midlands Engine Investment Fund (MEIF)
  • MEIF is providing £400k as part of a £2million investment that will help the firm to deliver an innovative targeted drugs and stem cells delivery system to market
  • The capital will also enable the company to add six more experts to its team and open the doors to international trade

Pioneering specialist in regenerative medicine, Locate Therapeutics, has received the first equity investment from the MEIF Proof of Concept & Early Stage Fund.

Part of a £2million finance package, underwritten by Mercia Fund Managers, including MEIF POC and Mercia EIS funds, this cash injection will help the firm fast-track its medical inventions to market, as well as make six more expert hires.

Headquartered within MediCity in Nottingham – an incubator space for companies specialising in medical technology – Locate Therapeutics, a spinout from the University of Nottingham, is leading the way in the development of a targeted drug and stem cells delivery system. This system enables doctors to administer treatments to delicate parts of the body where greater levels of precision are required, with the added investment bolstering Locate Therapeutics’ business development capacity as it trademarks its inventions and begins to market it to medical providers all over the world.

The Life Sciences sector has been marked by the government in its recent Industrial Strategy as being one of the UK’s main growth sectors over the next 20 years, boasting a current national turnover of £64 billion – a figure that is set to increase significantly.

Explaining the implications of this investment, Dr Ian Wilding, Chairman of Locate Therapeutics, said:

“We are extremely excited about the potential of our drug delivery technologies to be ‘game changers’ in the field of regenerative medicine, opening up new products to change the lives of patients with severe illnesses.

“Our company has successfully transitioned from the research to development phase in the last three years and we welcome the backing of Mercia Fund Managers as our investment partner in our journey to commercialisation.”

Ken Cooper, MD at the British Business Bank, commented:

“Locate Therapeutics has a real opportunity to make improvements in patient care – factors that without this equity investment would not be able to take place. Helping deals such as this go through is a big part of what the Midlands Engine Investment Fund was set-up to do, as it continues to support small innovative companies to grow and to address the regional funding imbalances across the UK.”

Commenting on the deal completion, Julian Dennard, Investment Director at Mercia, said:

“To be able to support innovative firms such as Locate Therapeutics is a key driver for Mercia Fund Managers. This is a great example of how finance available through the MEIF can be leveraged with private money to bring needed capital to a potentially high growth life sciences’ business.

“We look forward to working with Locate Therapeutics and its partners to drive the business forward, allowing patients to benefit from new treatments by building an exciting next generation drug delivery business.”

Peter Richardson, Chair D2N2 LEP, said:

“The Midlands Engine Investment Fund is designed to make the Midlands an engine for growth. By increasing the amount of finance available to companies across our area and working together as councils, businesses and local enterprise partnerships – we are helping businesses like Locate Therapeutics to grow, access new markets, export and flourish, both nationally and internationally.”

The Midlands Engine Investment Fund project is supported financially by the European Union using funding from the European Regional Development Fund (ERDF) as part of the European Structural and Investment Funds Growth Programme 2014-2020 and the European Investment Bank.

A Midlands-based life sciences company which develops synthetic alternatives to antibodies has closed a £1.5m Series A funding round supported by Mercia Fund Managers and a number of private investors.

The investment will allow MIP Diagnostics to expand its team, set up new production facilities and develop its own products to sell under licence. The business – a spin-out from the University of Leicester – develops ‘nanostructured molecularly imprinted polymers’ (nanoMIPs), which can be used to replace antibodies in a wide range of applications, from vaccines, medical research and diagnostics to oil and gas, food and environmental testing.

New antibodies can take months to make and the process can be unreliable, as it involves ‘challenging’ cells with an antigen or foreign molecule in the hope that it will produce the right antibodies. By contrast MIPs are synthesized in a laboratory and can be created in days. They are also more cost-effective and much more stable than antibodies, with a longer shelf-life and can be used in conditions where antibodies will not function.

MIP Diagnostics is skilled at rapid development and manufacturing and has patent applications to protect its technology. Mercia first invested in the business in 2015 and since then the company has continued to grow. MIP Diagnostics provides a service to develop MIPs on behalf of partners ranging from small biotech businesses to global pharmaceutical companies.

It now plans to develop products of its own to provide it with ongoing revenues from licensing, with the first two being a nanoMIP for use in blood tests to diagnose heart attacks, and another for use in bioprocessing. The latest funding round, which is supported by a number of private investors including Andrew Fisher and David Evans, will allow the business to move out of the university complex into a new facility in Colworth Park, Bedfordshire and double its current five-strong team with four additional laboratory staff and a business development manager.

CEO of MIP Diagnostics, Dr Adrian Kinkaid, said:

“We are delighted continue to enjoy the support of Mercia and to add that of our new investors. Our technology has proven to be highly effective in a range of applications and with diverse targets from small molecules to viruses. This investment enables us to respond to the growing demand by increasing headcount and moving to new laboratories. I am particularly pleased that we can now start to develop our own high-performance MIPs to meet the needs of recognized high-value markets. These assets will be licensed to our partners in due course.”

Dr Nicola Broughton, Investment Director and Head of Universities at Mercia Fund Managers, said:

“Recent research has highlighted the benefits of MIPs and blue-chip companies are starting to recognise their potential, in particular in applications where antibodies cannot be used. This funding will allow MIP Diagnostics to make a step change in the business, by moving into its own premises and developing its own products to take advantage of the huge global market.”

Mills and Reeve provided legal advice to Mercia on the investment.

A spinout company whose technology could save the lives of thousands of dialysis patients has secured £500,000 from Mercia Fund Managers, in the first investment deal since Mercia’s partnership with the University of Edinburgh was announced in November 2017.

Invizius stems from years of research by biologist Dr Andy Herbert and his team, who believe they have found a way to reduce the risk of cardiovascular disease among patients undergoing long-term dialysis. The investment will allow the company to build its team and take the product to the next stage of development in preparation for clinical trials.

Despite improvements in dialysis therapy, cardiovascular disease remains the leading cause of death for dialysis patients. Today, almost half of all dialysis patients die from cardiovascular complications, and life expectancy on dialysis is just one-third of that for the general population. The patient’s immune system sees the dialysis filter as a foreign body, creating inflammation that damages the cardiovascular system over time.

Invizius’s H-Guard™ product is a powerful anti-inflammatory used as a ‘primer’ to coat the filter surface which, when mixed with the patient’s blood, makes the surface seem less foreign to the patient’s immune system. Unlike some other proposed solutions, H-Guard does not shut down the immune system but instead effectively ‘hides’ the device from it to prevent an immune response.

While the first product is aimed at kidney dialysis, there is also potential to use the technology with other devices or procedures such as catheters, stents, organ transplants and vascular grafts.

Invizius is led by CEO Richard Boyd, who previously founded VueKlar Cardiovascular, with Dr Herbert as CTO. The team has spent six years developing the technology with support from world-leading dialysis manufacturers, Kidney Research UK, and £600,000 from Scottish Enterprise’s High Growth Spin Out Programme.

Edinburgh Innovations, which manages industry engagement for the University of Edinburgh, has supported the researchers throughout the commercialisation process, which started with their novel scientific findings and included the recent launch of the spinout company.

Richard Boyd said: “We are very pleased to welcome Mercia as an investor. Their ability to back and help develop life science businesses from the point of spinout through to commercialisation makes them an ideal partner for Invizius.”

Dr Nicola Broughton, Head of Universities at Mercia, said: “Invizius builds on the world-class research carried out at the University of Edinburgh and is an excellent choice for our first investment under our partnership with the University. This technology could revolutionise kidney dialysis and, with 3 million patients worldwide, has the potential to save countless lives. The funding will take the company one step closer to bringing it to market.”

Dr George Baxter, Chief Executive of Edinburgh Innovations, said: “I’m delighted to see this substantial investment in a University spinout company, whose work holds such promise for many patients. It’s a perfect example of how partnerships can enhance the University’s impact, and Edinburgh Innovations looks forward to working with Mercia and our researchers to identify and support further such opportunities.”

Eleanor Mitchell, Director Enterprise Growth, Grant Appraisal & Management, said: “We are delighted that Invizius has secured this important seed investment. Our initial support helped to engage a strong commercially experienced management team early in the process to ensure the technology development was focused on the market application. Scottish Enterprise looks forward to a continued relationship with this innovative company on a high growth trajectory with a product that will make a huge difference to patients on long-term kidney dialysis.”

Morton Fraser provided legal advice to Mercia on the investment while MBM advised the company.

A Nottingham regenerative medicine company which has developed a groundbreaking therapy that can help prevent sight loss has completed a £500,000 funding round backed by Mercia Fund Managers, angel investors and the University of Nottingham.

The investment will allow NuVision Biotherapies to further develop its product range, strengthen its management team and increase sales in the UK and internationally.

NuVision was set up in 2015 with funding from Mercia to commercialise research work carried out at the University of Nottingham by Dr Andy Hopkinson, who is now the company’s CEO. Its innovative wound healing therapy harnesses the regenerative properties of amniotic tissue, which is found in the sac surrounding babies in the womb and is normally discarded at birth.

NuVision’s first product Omnigen® is designed for use in eye surgery and provides a ‘biological bandage’ for the treatment and surgical reconstruction of wounds. More than 2,400 treatments have been distributed since the product was approved for human and veterinary use in April 2016.

NuVisions’ latest innovation OmniLenz®, a bespoke contact lens, allows the simple delivery of Omnigen regeneration without the need for complex and costly surgery. Applied in the clinic treatment room, many more patients will benefit from treating wounds more quickly.

NuVision is also exploring other wound care applications and has funded a clinical study due to start in May using it to treat diabetic foot ulcers, which is a major clinical problem worldwide. The company has signed agreements with distribution partners in Ireland and Finland and is in talks with distributors in other countries.

Peter Dines, Investment Director and Head of Life Sciences & Biosciences at Mercia Fund Managers, said: “NuVision’s cutting-edge therapies offer a highly effective and affordable wound treatment. While its initial products have focused on eye trauma, there is potential for patients with many other common conditions to benefit from this therapy. The funding will allow the company to build its sales and marketing operation, strengthen the management team and develop a wider range of products.”

Mills and Reeve provided legal advice to Mercia while 3Volution advised the company.

Manchester Imaging, a dental diagnostic software company, today announced that it has raised a £600,000 investment from NPIF – Mercia Equity Finance, which is managed by Mercia Fund Managers, part of the Northern Powerhouse Investment Fund and the GM&C Life Sciences Fund, managed by Catapult Ventures.

The investment will support the development and commercial launch of the company’s first suite of software products that use machine learning and computer vision processes to automatically detect the very early signs of tooth decay, which can go unseen by dentists.

Manchester Imaging, a spin-out of The University of Manchester by its agent for IP commercialisation, UMI3 Ltd, is based on more than a decade of academic collaboration between Professor Hugh Devlin, Professor of Restorative Dentistry, and Dr Jim Graham, Honorary Reader in the Centre for Imaging Science.

Tony Travers, CEO of Manchester Imaging, said: “I’m very pleased to be working with Catapult Ventures and Mercia Fund Managers, and to have secured the funding to enable Manchester Imaging to commercially launch CARIESDENT for the detection of early stage tooth decay. I look forward to supporting dentists and their patients to identify tooth decay earlier, thereby enabling the use of preventative treatments or earlier intervention to avoid the need for fillings.”

Dr Mark Wyatt, Investment Director at Mercia Fund Managers, commented: “We’ve been very impressed with the progress made by the company and the well-rounded, highly experienced and commercially focused leadership team. Having previously backed the company through Mercia’s EIS Funds, we are delighted to continue supporting Tony and his team with growing Manchester Imaging as a leader in dental diagnostic imaging software.”

In addition to the investment, Kevin D’Silva, a Venture Partner with Catapult Ventures, will join the board of Manchester Imaging as non-executive Chairman. Kevin has held a number of non-executive and Chairman positions, including Monica Healthcare (acquired by GE Healthcare), Crystallon (acquired by Judges Scientific), and Imorphics (acquired by Stryker Corporation). He is also a Director and former Chairman of both Surface Transforms plc (AIM listed) and Hallmarq Veterinary Imaging Ltd. Kevin was a founding director of Ferraris Group plc (FTSE: listed) and created Salusinvest in 2006 to invest in a number of EU and US life science businesses.

Kevin D’Silva commented: “I’m delighted to be joining Manchester Imaging as a director and investor at an important time when the company is poised to launch CARIESDENT. I believe that its patent-protected technology and early partnership with a leading multinational dental supplier provides a good route to market and positions Manchester Imaging extremely well for commercial success.”

The Northern Powerhouse Investment Fund project is supported financially by the European Union using funding from the European Regional Development Fund (ERDF) as part of the European Structural and Investment Funds Growth Programme 2014-2020 and the European Investment Bank.

A Nottingham business which is developing new software to help pharmaceutical companies to manage clinical trials more effectively has secured a £500,000 equity investment from Mercia Fund Managers and angel investors.

PHARMASEAL International was established in 2016 by Daljit Cheema and Sara Rutner, who both have extensive experience in the pharmaceutical industry and previously held senior roles at pharma IT specialists ClinPhone Group and PAREXEL.

The two founders have already developed a prototype product. The funding will allow them to roll out their first module – a trial management platform that allows clinical trial operators to manage and monitor their clinical trials in accordance with good clinical practice (GCP) regulatory standards.

The deal also reunites the founders with their former boss Dr Neil Rotherham, the founder and ex-CEO of ClinPhone which was sold to PAREXEL in 2008. He has now joined PHARMASEAL as its Chairman.

PHARMASEAL’s cloud software is designed for the global pharmaceutical SME market, unlike the current software solutions on the market which are complex, costly and aimed at multinationals. The team also plan to release two further modules – a patient safety tool to identify any adverse outcomes during clinical trials, and a license and regulatory management tool allowing pharma companies to submit audit data to regulatory authorities. While Daljit is based at the company’s headquarters in Nottingham, co-founder Sara leads its office in New Jersey which is targeting the US market.

Daljit, PHARMASEAL’s Chief Executive Officer, said:

“This investment is important in allowing PHARMASEAL to complete product development and endorses the innovation in developing a unified control and governance platform for clinical trials”

Dr Ash Patel, Investment Manager with Mercia Fund Managers, said:

“There is a growing number of smaller pharmaceutical companies developing innovative products but they often have difficulty in gaining regulatory approval because of the weaknesses in their audit systems. Pharmaseal’s software will help them manage the process more effectively, from clinical trials to building a clear audit trail and submitting the right data to regulators. It will help SME firms to bring new drugs and devices to market more quickly and at lower cost.”

As early and growth-stage investors we are obsessed with understanding where value creation will lie in the future. For Mercia’s Life Sciences & Biosciences team, this means focusing on the areas of healthcare where we can have the maximum impact on improving patient outcomes and reducing healthcare system costs. In this article, Dr Ash Patel explores the macroeconomic trends that we believe will drive value creation in healthcare for the next generation of businesses.

Increased life expectancy and the aging population

Let’s start with a big one. This is probably the single greatest challenge facing our societies at present. Modern science (and with it modern medicine) has been an overwhelming success in the human story. The average life expectancy of an individual living in a developed economy has grown consistently since World War 2, resulting in a female child being born in the UK today expecting to live to 82.8 years on average compared to 71.5 years for the same child being born in 1951. This is as a result of improved childhood survival due to vaccines, the massive reduction in infectious diseases over this period, and the increasing availability of treatments for chronic illnesses such as hypertension and heart disease.

Along with challenges posed to governments about how best to provide long-term pension incomes for a population now living for significantly longer than previous generations, a significant challenge lies in the provision of healthcare. Many of the healthcare systems we have in Europe and North America were originally designed in the period after the Second World War, when the population demographics were entirely different. As a result, a new generation of technologies are required to reduce the cost of caring for an increasingly elderly population, whilst also dealing with the physiological challenge of providing interventions for the elderly. Surgery and anaesthesia were always designed with young patients in mind, and as our population ages, we are going to have to develop better technologies that are more suitable for dealing with patients with multiple existing health issues, but still expect (and deserve) a high quality of life post-care. These technologies must work both en-masse and at scale, in order to bring down the cost of complex care which is vital for the NHS.

As a trained hospital intensive care doctor, it’s clear to me in the clinical environment that new technologies are needed to ensure older people can benefit from surgeries that both prolong and improve the quality of life. At Mercia, we believe the next generation of technologies that help this segment will be drivers of innovation and value generation. Companies like Canary Care (a Mercia Technologies PLC portfolio company) are building technologies that help older people live independently for longer, bringing dignity for users, peace of mind for carers, and reduced costs for payers like the NHS or local councils who will potentially have fewer people needing expensive residential care. We believe companies like these will form vital parts in a healthcare ecosystem geared towards an older population.

Acceleration of development in “emerging” markets

Over the last few decades, the majority of commercial interest in healthcare has been focused on Europe and North America, but the coming years will see an increase in expenditure from high-growth “emerging” markets. The BRICS countries (Brazil, Russia, India, China and South Africa) have seen pharmaceutical sales double between 2006 and 2011 – so crucially, maintaining cost-effectiveness at a scale is of paramount importance. These high growth markets consist of a blend of public and private care provision and encourage a consumer mentality towards purchasing care. Novel organisational structures are also required to meet this growing demand for single country populations that in effect, are larger than the whole of Europe.

It is anticipated that some of the most valuable healthcare companies in Europe will generate a large proportion of their sales from BRICS economies. In my opinion, key features of success in these economies will include targeting so-called diseases of plenty (obesity, hypertension and diabetes) which are becoming increasingly prevalent as societies are lifted out of poverty. For example, in China 10% of all adults are currently thought to have diabetes. This is up from 5% of all adults in 1980. In absolute terms, this represents a patient population of 110 million, with further growth in this disease expected to result in 150 million patients by 2040. This is likely to result in market demand for new products and services such as targeted therapeutics that are optimised for the genetic make-up of the Chinese population, improved diagnostic tests, and methods of delivering care to in a cost efficient manner across a population sizes that are measured in the billions.

Key challenges for new entrants to the market will be understanding rapidly changing regulatory landscapes, navigating the political risks associated with being a foreign company in economies with varying levels of restrictions, and the challenges of intellectual property protection in jurisdictions where traditionally, it has been difficult to defend a product or service from imitators. However, with the BRICS economies predicted to overtake most of those in Western Europe by the middle of the century, we believe there is a significant chance that the most valuable companies may be those that serve these markets first. We’ve backed exciting companies like Concepta, which is bringing the latest fertility technologies to China and aiming to help millions of couples start a family. These kinds of opportunities in emerging markets show that it’s entirely possible to solve problems and capture value on a greater scale outside of Europe and North America.

The 4th Industrial Revolution

Scarcely a day goes by without a tech blogger talking about the upcoming revolution in “digital health.” Whilst digital health covers a wide variety of innovations, we are particularly interested in computational health as this actually reflects what is happening – computers helping to deliver healthcare. With recent high-profile failures, including IBM Watson being “benched” by prestigious US cancer centre MD Anderson, as reported by Forbes, it’s easy to think that computers in healthcare may be over hyped.

While current technologies may struggle to accommodate for all of the complexities in healthcare, this is often because the data used to train these systems is often incomplete. Considering that Google’s DeepMind system trained itself on 10 million YouTube videos before it learnt to recognise an image of a cat – you can start to sympathise with systems that have access to only thousands of medical records which then try to do something as complex as recognise cancer.

Furthermore, 80% of all medical data is unstructured, sometimes hand written, making it hard for super computer systems to process it. This results in a serious lack of data to train with. If the systems were trained better, the performance would be better, which would lead to significant reductions in the cost of healthcare delivery at almost every point in the value chain and improved patient care – transforming healthcare as we know it. Unfortunately, this seems a distant dream at present, but the 4th industrial revolution will change that.

If we consider that the 1st industrial revolution was the advancement of steam engines in the 18th Century, the 2nd was the growth of electricity, the 3rd was the movement from analogue to digital machines and the 4th is the development of data-driven tools – then these are instruments that gather, analyse and store data on a scale that has previously never been seen before, and it is these machines that will power the computation technologies of the future. Data really is the new oil. Interestingly, electronic medical data (which is perfect for systems like IBM Watson to process) is growing at a rate of 48% per year. Put into context, by 2020, 94% of all medical data available will have been created after 2013. This fresh data is largely electronic and ready to be processed.

The opportunities for new companies to emerge in this space are significant and Mercia is working with many of these organisations already through our managed fund activity. These companies are data-capturing companies that allow us to understand healthcare problems better (sleep-focused portfolio company SleepCogni), image recognition technologies that spot problems in X-rays that clinicians may miss (Manchester Imaging – dental imaging), regulatory technologies that ensure the latest developments stay on the right side of government regulators (new portfolio company Miotify), and even tools that let clinicians understand the needs of their patients better by improving communication and tracking outcomes (Health Centrified). These businesses all solve problems that affect global populations. This isn’t just about value capture – it’s about genuine value creation. And in my opinion, computational technologies in healthcare will change the world of medicine and in doing so will generate immense value.

If you have any thoughts or comments regarding this Insight then please don’t hesitate to get in touch, email:

An entrepreneur who is developing new software to improve the quality and safety of digital health apps has secured a £350,000 investment from Mercia Fund Managers.

Sheena Macpherson’s company MIOTIFY is creating an online toolkit to help both developers and healthcare professionals to build medical apps and navigate key requirements needed for evidence in a regulatory submission. The funding follows the company’s recent success in securing a £555,000 grant from Innovate UK.

Sheena, who was previously Global Business Development Manager for Vodafone’s mobile health business, also acts as a consultant to AstraZeneca on software-as-a-medical-device projects. She launched MIOTIFY in response to the growing number of medical Internet of Things (IoT) devices, such as connected heart monitors, which provide new data to enable medics to monitor patients remotely and gather insights to inform their treatment.

However, before any such data can be used for medical purposes, the software or apps that interprets the data into meaningful information must be approved by regulators as safe for the intended use. The high cost and complex process involved in complying with the standards means that many of the current apps on the market are of poor quality and unsuitable for medical use.

MIOTIFY’s user-friendly system allows both developers and non-IT staff to create apps within a guided framework to help them build in quality from the start and auto-generate evidence to include in a submission for regulatory approval. The funding will allow MIOTIFY to complete the development of its patent pending system. MIOTIFY will be working with AstraZeneca’s Intelligent Pharmaceutical team.

Ashish Patel of Mercia Fund Managers said: “The digital revolution has the potential to transform healthcare but current products on the market are of varying quality. Due to the cost and lack of understanding of the importance of the requirements needed for gaining approvals, often those with real potential struggle to provide the right evidence to support their claims without significant investment. MIOTIFY aims to encourage more creators to start with quality and build a new generation of apps that can be trusted as safe and effective for medical use.”

MIOTIFY has assembled a team of expert advisers including Matt Bonam, global head of AstraZeneca’s Intelligent Pharmaceutical team; Sir Alastair Breckenridge, the former chair of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); barrister and physician Dr Peter Feldschreiber, a medical and healthcare law specialist; Glen Hodgson, who is Head of Healthcare at the international data standards authority GS1; Guillaume Nebout, Director of International Professional Services at Walgreens Boots Alliance; and Ian Shadforth, who is CTO at artificial intelligence (AI) diagnostic imaging company Analytics4life.

Tim Dempsey of Epiphany Capital assisted MIOTIFY with the fundraising and provided corporate finance advice.

Mills and Reeves provided legal advice to Mercia, while Turner Parkinson provided legal advice to MIOTIFY.