AI gut-imaging software takes on the US with FDA clearance and national hospital partnership
AI gut-imaging software takes on the US with FDA clearance and national hospital partnership
- Motilent’s clinically-validated AI software has received 510k clearance from the US FDA
- Currently, 62 million people in the US are diagnosed with a digestive disorder annually, causing an ever-growing burden on healthcare services globally
- Almost $136BN is spent on GI therapies annually but some drugs, e.g. those used in Inflammatory Bowel Disease, have a 60% failure rate within 1 year. It can take months or years to confirm if a therapy is no longer working for a patient.
- New collaboration with AI-powered solutions provider Nuance Communications will allow US healthcare clinics using innovative GIQuant software to accurately measure intestinal motility and treatment response using AI medical image analysis
LONDON, UK. 23/11/21: Today, Motilent, the first company to specialise in the assessment of digestive diseases using AI medical image analysis, announces FDA 510K clearance in the USA. The rollout of this technology will be in partnership with Nuance AI solutions.
Launched in 2013 by King’s College London and University College London (UCL) alumnus Dr. Alex Menys, Motilent was created to support the 62 million people1 affected by digestive diseases in the US, and ultimately help get patients on the right treatment more quickly.
The post-processing software, GIQuant, already used in UK institutions including Great Ormond Street Hospital, works alongside standard magnetic resonance imaging (MRI) scans to measure and track movement of the intestine. This measure of intestinal movement, known as ‘motility’, is often affected by gastrointestinal (GI) disease activity, and thus provides insights into disease progression.
Spotting treatment failure in Crohn’s Disease: With an initial focus on Crohn’s disease, GIQuant aids physicians in advanced image assessment: providing data led insights to monitor therapeutic response and allow for more informed clinical treatment decisions. This extra layer of objective data – collected non-invasively – can help physicians take patients off ineffective therapies faster, and speeds up patient treatment journeys.
The new FDA 510k clearance [search K211356] gives Motilent the greenlight to deploy GIQuant across healthcare providers in the US. Supporting the move into the US healthcare market, the company has also announced a new partnership with AI patient-care software provider Nuance.
Used by 90% of hospitals, 10,000 healthcare organisations worldwide, and 80% of US radiologists, Nuance’s AI‑powered solutions capture 300 million patient journeys each year and apply real-time intelligence to support clinical decision-making. Collaborating with Nuance, GIQuant will equip clinicians, radiologists and care teams with new motility data and a suite of actionable insights to help monitor, understand, and ultimately improve clinical quality and patient safety.
Motilent CEO Alex Menys comments: “For me, the digestive tract has always been an enigmatic but crucial system that influences how we feel, what we think and often how we act. Across a range of diseases, symptoms like abdominal pain, constipation and nausea cause a huge amount of distress and impact on quality of life. To date, our options for analysing the gut have been limited – hindering basic research, drug development and ultimately effective patient treatment. With FDA clearance, our first product GIQuant can be used in combination with routine MRI to easily evaluate gastrointestinal function. I’m hugely proud of the Motilent team and excited by the potential this technology has to improve the management of digestive disease.”
Peter Ellis, Chairman of Motilent says: “FDA clearance is an important step for Motilent as we move to the US market. Through our partnership with Nuance, and via our own direct sales capabilities, we will have extensive market access, ensuring more US patients have access to Motilent’s technology. This is an incredibly exciting milestone for us on our mission to get every patient with digestive disease on the right treatment, at the right time.”
To mark their launch in the US, Motilent will be exhibiting for the first time at RSNA 2021, the Radiological Society of North America’s annual conference, taking place 28th November-1st December 2021. The team will showcase their technologies (booth 5158) and discuss GIQuant in real world settings, including initial experiences and findings from a year’s use at Frimley Park Hospital NHS Foundation Trust.
To find out more about Motilent, please visit: https://www.motilent.co.uk/
– ENDS –
Notes to editors:
Motilent will be exhibiting at RSNA 2021 (28th November-1st December), at booth 5158.
Please arrange a meeting, or one-to-one demo, with the team using this link: https://calendly.com/motilent/1-to-1-demo-at-rsna-2021?month=2021-11
For further information, please contact:
Belle Taylor | [email protected]
- Alex Menys, Motilent CEO, is available for comment. Please email Belle Taylor (above) to arrange.
Motilent is a technology startup on a mission to change the way we see the gut. Specialising in the assessment of digestive diseases using medical image analysis, their main focus areas include Crohn’s Disease, Irritable Bowel Syndrome (IBS) and Gastroparesis. Motilent’s first product GIQuant aims to help clinicians to identify earlier when patients stop responding to immunotherapy.
Alex Menys on The Health-tech Podcast
Motilent’s CEO and Founder, Alex Menys speaks with Dr James Somauroo on The Health-Tech podcast.
In the show Alex and James talk about the challenges of getting a product to market in the Med-Tech space as well as the the role of regulations, evidence and relationship building with the clinical community. There’s also a good chunk of back story to Motilent too. James has had some fantastic guests on the show and Motilent’s honored to have been featured.
Motilent & Partners Receive Prestigious UKRI Funding
- Crohn’s Disease is a chronic inflammatory condition of the intestine affecting people of all ages.
- There is an urgent need for technology to guide the use of powerful and expensive anti-inflammatory medications.
- Motilent has been awarded a prestigious UKRI grant to tackle this challenge.
About the project
Motilent has been awarded a UKRI grant to improve the way Crohn’s Disease is managed in adults and children.
A total of seven projects led by many of the UK’s leading institutions were funded as part of the £16 million call designed to enable the development of disruptive technologies to improve outcomes in chronic and challenging disease areas.
Working with Great Ormond Street Hospital, University College London (UCL), University of Nottingham (UoN) and IBDrelief, Motilent will develop an improved method of assessing medical imaging data from MRIs of Crohn’s disease patients, while incorporating a range of time and cost saving advances for a routine MRI test.
Approximately 180,000 people live with Crohn’s disease in the UK and there is no cure. Flare ups are managed with powerful but expensive immunosuppressive medications, which have a high failure rate. This project will help ensure the right patients are receiving the right medications at the right time for them.
This image shows three types of MRI scan of the same patient with severe Crohn’s Disease. The blue box represents the area of disease (thickened bowel on the left, low motility in the middle and bright inflamed bowel on the right). The blue circle shows normal bowel. These images are currently interpreted subjectively by Radiologists. The goal of the project is to quantitatively assess the data produced by MRI so smaller changes can be detected to fine tune patient treatment.
What the project partners say
Alex Menys, CEO Motilent: “This project has been a long time in the works and brings together a fantastic and dedicated team with the ability to deliver this exciting programme of work. We’re going to be developing a tool for the radiologist to generate an objective score for Crohn’s Disease activity based on well validated parameters that are currently too time consuming to perform clinically.”
Professor Stuart Taylor, Consultant Radiologist, UCL: “MRI plays an very important role in diagnosing Crohn’s disease as well as treatment planning and monitoring. Interpretation is relatively subjective and time consuming. The software developed in this project will increase both the accuracy and speed of MRI interpretation which will be a significant advance.”
Dr Tom Watson, Consultant Paediatric Radiologist, GOSH: “I am routinely asked to image children as young as 4 with Crohn’s Disease. Imaging the bowel in children can be extremely challenging. An MRI scanner is an intimidating place for an adult let alone a child and on top of that, children need to be still for upwards of 30 minutes using conventional scanning protocols. These protocols often require injection of drugs to highlight areas of inflammation. This requires needles which increases the anxiety for our children with Crohn’s. For me, high quality, high speed imaging without the need for injections would be a huge leap forward. At GOSH we’ll be taking the latest advances in adult imaging and analysis and ensuring they’re relevant to our paediatric population.”
Dr. Gordon Moran, Consultant Gastroenterologist, UoN: “This project is going to help me get a quantitative score for Crohn’s Disease activity which especially in the small bowel is hugely important for assessing treatment response with powerful expensive medications. We’re also going to be able to tie our existing work in fibrosis imaging at UoN into a new protocol expanding the clinical utility of the technique.”
Seb Tucknott, CEO of IBDrelief, said: “This project is really exciting and could have some big benefits for patients with Crohn’s disease in the small bowel, helping them to receive more targeted treatments in a more timely fashion. At IBDrelief we are passionate about ensuring that patients are involved in every stage of research and development to achieve the best outcomes possible, so we are delighted to be working with Motilent and partners to make sure this project helps make a big difference to patients as well as clinical teams.”
What happens next?
- MRI or Magnetic Resonance Imaging is a safe, non-invasive and powerful test to look at a persons insides.
- It’s especially good for looking at soft tissue like muscle and organs like the brain, liver and digestive system.
- Motilent generates a lot of content around MRI and the intestine and this is a quick recap for those that haven’t spent years in the medical setting!
Past, Present and Future – a long journey living with Crohn’s Disease: Part 1
A patients perspective on living with Crohn’s Disease, by Nigel Horwood
- Crohn’s is a chronic, inflammatory disease affecting the digestive tract and the incidence is on the increase
- Treatment options have come a long way but as yet there is no cure so attaining remission is the primary goal
- As we make real progress treating the disease we must continue to work hard to improve support, acceptance and address the mental health aspects of Living with Crohn’s
The Past - Conventional Drugs
When I was diagnosed with Crohn’s Disease, in the late 1970s, treatment options were simple. There was – salazopyrine (a disease-modifying anti-rheumatic drug), prednisolone (a corticosteroid) and codeine phosphate (an opioid analgesic). With no internet, the only sources of information about both the condition and treatment were your consultants or medical books. The disease was not widely known about by the public or GPs, and the concept of being an “informed patient” was unheard of.
If you were lucky, and I was lucky – mostly, the drugs would kick in, the inflammation in the gut would be reduced. You might even go into remission. I did have a temporary blip when my bowel perforated and I had the chance to experience the alternative treatment option – surgery.
With the advent of the internet, patients were able to be much better informed. At this point I had been taking steroids continuously for over 20 years. I read about their potential side effects and asked my gastroenterologist if there was an alternative. A barium meal x-ray showed that I had a stricture near my terminal ileum that had reduced the lumen down to the size of my little finger. The choices were stark. Either go for surgery or try, as a “final resort”, azathioprine – a chemo drug, an immunosuppressive therapy from the world of transplants. There would be the inherent risk of side effects but I was adamant I wanted to avoid surgery so opted for the drug.
The treatment worked well and brought with it 9 years of virtual remission, then a routine blood test showed that my platelet count had dramatically fallen. I had succumbed to one of the known side effects – bone marrow suppression – and the drug was stopped. A CT scan showed that the stricture was as bad as ever but now there were internal fistulas interconnecting loops of the bowel. The gastroenterologist said “it looks like you’ve got an octopus in there”.
(CT scans are now being widely replaced with MRI scans which can provide the ‘cross-section’ anatomical detail but without the ionizing radiation of the former.)
Magnetic Resonance Imaging of the small intestine showing the bowel moving. A stricture can be seen in the middle of the screen, above the bladder.
I was now resigned to surgery so was surprised to be offered a final “final” resort in the form of Infliximab (Remicade), a monoclonal antibody. I had not heard of this new class of drugs that work to reduce inflammation by targeting proteins in the immune system. This particular one, introduced in 1998, had been identified as good at healing fistulas. In all honesty I think my condition was too far advanced to be treated by any drug and after the initial “Infliximab high” I was getting progressively worse. The drug, delivered by infusion, was stopped after the third dose. In late 2010 I went into the operating theatre, for the second time in my life, to finally have the stricture removed. I had been warned that a temporary stoma was a possibility in order to give my gut a chance to recover. When I woke up post-operation I now had a “bag” which remained in place until July 2011.
Following surgery it is common to be given a maintenance dose of Azathioprine. In my case it was not an option but as the follow-up colonoscopies showed no sign of inflammation I took no Crohn’s drugs at all.
Rise of the Monoclonal Antibodies (MAbs)
When I encountered monoclonal antibodies in 2009 they had already been in use for a decade. In the following years there has been a great deal of research work ongoing for their use in multiple areas of medicine and many have subsequently been licenced to treat Crohn’s. However they are neither cheap to develop or manufacture and each dose is expensive when compared to more traditional medicines.
A number of the original MAbs, Remicade for instance, are now out of patent which has led to a range of “biosimilars” being produced. Whilst the cost of development, approvals and manufacture is still high the NHS can make considerable savings over the original drugs. Some patients have voiced their concern about switching over from their regular prescription to the corresponding biosimilar.
Once treatment commences there is a finite period before its effectiveness can be gauged. The clearest indication will be the patient finding that their symptoms are improving but the situation is more complicated for those that are asymptomatic. A formal monitoring regime may consist of regular faecal calprotectin test (FCP) tests three months after the start followed by a colonoscopy and MRI at twelve months. (The timings will vary depending upon the treatment being used). These two procedures are complementary. The colonoscopy enables the consultant to assess the internal surface of the gut wall and take biopsies as required; the MRI scan can see any extramural disease or thickenings.
My own encounter with MAbs did not end with Remicade. In 2016 a routine FCP showed an elevated level. This indicates that there is active inflammation somewhere in the gut. It was a surprise as I was feeling no symptoms. My gastroenterologist decided to investigate with the combination of a colonoscopy and a small bowel MRI scan.
Neither test showed anything untoward. I was happy to continue drug free and accepted that the raised FCP level must be an anomaly.
Further, regular FCP tests showed an upward trend continuing but I still felt very well with a good QOL. In late 2018 I thought we really should do some further investigation and asked to have the one procedure that I had never experienced – a capsule endoscopy. When the results came back it showed moderate inflammation in the small bowel. After discussion with my gastroenterologist we decided that I should start Entyvio as it was the most suited to my particular circumstances.
I have now completed the first three “loading” doses. Is it working? The simple answer is – I don’t know. I feel no different from after my reversal operation. The monitoring plan for FCP and, after one year, another colonoscopy and MRI scan. Meanwhile I get a trip to London every two months for the infusion which is followed by a virtual clinic reviewing my progress.
The IBD market, as a whole, has been identified as a growing commercial opportunity so expect to see a wide range of new or improved treatments being rolled out by pharmaceutical companies. Ultimately the goal is to find a “cure” but in the meantime the focus is on developing treatments more targeted to specific areas of the gut thereby reducing the side effects caused by generalised anti-inflammatory drugs. Other areas are also being explored, including stem cell therapies. Two currently undergoing trials are :
Cx601 – specifically aimed at healing perianal fistulas, a very distressing condition that may result in patients undergoing extremely serious and life changing surgery. Cx601 is administered as a single injection given by a colorectal surgeon.
Stem Cell Transplant – currently trialing with a small number of Crohn’s patients. They undergo chemotherapy and hormone treatment to mobilise their stem cells, which are then harvested from their blood. A further round of chemotherapy then wipes out their faulty immune system. When the stem cells are re-introduced back into the body, they develop into new cells which give the patient a fresh immune system that will no longer react adversely to the patient’s own gut.
Advances in treatment are being mirrored by improvements in test procedures. Conventional scopes are unable to travel far into the small intestine and are therefore unsuitable for observing small bowel Crohn’s. The capsule endoscopy enables images of the whole of the digestive tract to be recorded. First approved in USA in 2011, it consists of a swallowable capsule containing a camera and a wireless transmitter. Images are recorded on a unit worn by the patient and the results then interpreted by a gastroenterologist. This latter process is time consuming as there are hundreds of frames to assess.
A boom in medical imaging software means that the analysis of images from tests like MRI and capsule endoscopies are becoming quicker using machine learning/AI techniques. Crucially, the software can provide quantitative analysis with the promise of rapid, objective indicators of when treatment is working.
An example of this software is GIQuant, developed by Motilent for use with standard MRI scanners, it quantifies the motility of the gut and gives results in virtually real time. It has the additional benefits of shorter scan times, reduced prep solution and no need for gadolinium-based contrast dye. In many instances it will also replace the need for a colonoscopy.
What direction may future developments take? There is no definitive answer to what causes Crohn’s Disease. A number of factors, such as heredity, a malfunctioning immune system and environmental conditions are thought to play a role in its development. In each patient the mix of these factors will vary. The logical next step will be to produce test that can identify this mix and tailor therapies to the individual patient’s circumstances.
This article has only touched on physical symptoms. Part Two will look at what it is like to live with Crohn’s Disease day-to-day, the potential effects on one’s mental health and some of the therapies being researched to help patients cope.
Motilent appoints Laurence Bourn as Chief Technical Officer
We are delighted to announce that Laurence Bourn has joined the Motilent team as Chief Technical Officer. Laurence started working with Motilent in August 2019 and will lead the growth of the Company’s technical operations as it enters the clinic.
Laurence has 20 years of commercial experience within the medical device industry. He began as a software engineer in the early days of Voxar in Edinburgh, playing a key role in the core technology team. After working at Medis BV in Leiden,Holland he became software architect at 3mensio BV. On return to the UK, Laurence joined Biotronics3D where he lead the development of their cloud PACS: 3dmetmedical, taking the technology from inception to daily clinical use in over 150 institutions across the EU. He then worked with the InnerEye team at Microsoft Research in Cambridge, bringing his expertise to clinical integration of their AI technologies. Laurence has a wealth of experience leading the transition from research of novel applications into the healthcare domain, delivered to the highest standards required by current regulatory frameworks.
Alex Menys, CEO, said: “I’m incredibly excited to have Laurence onboard and especially at this important transition point for the company where we’re getting ready to take our technology into the clinic. I think we’re both going to learn a lot!”
Laurence Bourn, CTO, said: “The Motilent team have worked extremely hard to develop the technology and crucially the evidence base for MRI in digestive disease. An incredibly important but under served area of need in healthcare. It’s great to join the team at this exciting time as we broaden our clinical portfolio and bring our products to an international audience.”
G.I. Know – The Health Data Research Hub for Inflammatory Bowel Disease
Great news for patients and researchers working in Inflammatory Bowel disease.
Read more here: https://www.hdruk.ac.uk/infrastructure/the-hubs/g-i-know/
DigitalHealth.London Cohort 4
Motilent’s delighted to be on the DigitalHealth.London Accelerator along with 20 other exciting Health/MedTech companies.
Find out more here: https://lnkd.in/dQrawsA