The problem
Standard clinical practice in hospitals for patients with arthritic conditions is to make use of self-reported questionnaires and goniometers to measure individual joint angles in hospitals. These are resource-intensive scoring systems, affected by high variability and can take up to an hour or more per patient per appointment once or twice a year. This can result in patients not receiving appointments with the advised frequency while their condition worsens severely.
Arthritis affects over 54 million Americans, and these patients use up to 30% of GP appointments for the continual pain suffered. Studies conducted in 2017 in the USA found the following from 2013: $157 billion was spent on arthritis‐attributable medical expenditures. $326 billion was lost between medical expenditures and earning losses. 1.9% of GDP for that year was therefore lost to arthritic pain. Effective pain management and early detection could save individuals a lifetime of pain and suffering and then also could save billions to their respective economies.
The solution
The Arthronica platform takes between 5 and 15 minutes to gather required assessments, questionnaires, images and analytics from a patient remotely from the comfort of their home. Our platform then provides this information to a patient’s clinician with an objective disease activity score, created using our bespoke machine learning algorithms that measure all a patient’s joint ranges of motion and we relate this to their historical ranges we’ve logged and benchmarking thresholds.
Clinicians save hours every day in assessment time helping them to focus more on individual treatment, triaging and patient care and not on taking subjective assessments and diagnosis that blocks them from helping patients.
Patients provide their doctors with their monthly disease activity scores from the comfort of their home, better allowing effective triaging. Patients can also keep track of their flares better informing their clinician of their need for early intervention and drug adherence.
Where did the idea originate?
Our team is building on Letizia Gionfrida’s world-leading research from the bioengineering lab of Imperial to provide a unique and state of the art remote-monitoring solution for people living with arthritis. Letizia created Arthronica’s initial machine-learning model versions that analyse range-of-movement and areas affected through noticing the lack of technical assistance in Arthritic care leading to poor patient outcomes.
Letizia Gionfrida is an Italian/Brazilian bioengineer. She obtained a B.Eng. in Italy and received a scholarship from the European Union to do an M.Eng. at the New York University Langone Health, where she also worked on the use of computer vision in image processing. She then moved to Singapore, where she worked for the Nanyang Technological University of Singapore in collaboration with Procter and Gamble and the National Skin Centre in Collaboration, a subsidiary of the National Healthcare Group of the Singaporean Government. In Singapore, she worked as a software engineer implementing a mobile application that was using neural networks to perform assessment and quantification of skin related disease.
She moved to London in 2016 to do a PhD at Imperial College London in Bioengineering investigating the application of computer vision in the field of biomechanics. From the start of her PhD, she secured and managed over £1M in European funding, under Horizon 2020 bid and other awards. Funded by the British government on a research England bid she founded Arthronica in fall 2018. She secured over £350,000 in grants and won the support of a major corporation for Arthronica. She received €500,000 in January 2020 from private capital investment to support clinical validation and commercialisation and to grow the team from three to eight full-time employees. She was recently appointed as Non-Exec Director on the board of the Imperial Enterprise, Imperial Venture Mentoring Service and supports small VC firms as the Creator Funds on their investments pipeline.
Was your business inspired by a major global challenge/industry need that you were exposed to because of your education/research at Imperial?
I began my entrepreneurial journey as a participant in the MedTech SuperConnector (MTSC), an Imperial-led accelerator programme that gives postdocs and postgraduate students training, financial support and access to a supportive community to launch medical technology ventures based on ideas arising from their research. Beyond the commercialisation of technology, MTSC aims to help individuals develop and build institutional capacity in partner institutions. Through the knowledge exchange programme, it empowers its entrepreneurs to inspire and aid future entrepreneurs.
How did your team meet?
Letizia met Nick Hughes via a doctor at a medical start-up and he joined as a Co-Founder at the beginning of 2020 drawing on 10+ years of experience with similar systems, Nick has designed the architecture of the platform that will run these services using AWS—assisted by Shaun Taylor-Morgan a PhD physicist optimising this system along with an incredible frontend-developer and an amazing senior designer Nick has previously worked with. All the Arthronica staff have experience from within healthcare tech start-ups, and this knowledge has helped us massively with our approach. We have just recruited a new PhD Research Scientist to further our ML models and research efforts. The Arthronica team have been working together for over a year now.
Do you have any advisers?
Dr James Galloway is a clinical lecturer at King’s College London and an honorary consultant in rheumatology at King’s College Hospital. He runs the biologics assessment service for the rheumatology department. His research background has been in the study of biologic therapy safety. James heard about us via communications with King College NHS trust about starting a trial and joined as an advisor in 2020.
What stage is the business at and what are your plans moving forward?
The Arthronica platform is currently at a TRL-7 with a small scale cross-sectional diagnostic investigation currently waiting to start at King’s College in London, UK. With this proposal, Arthronica aims to gather the resources necessary to validate the platform in a multi-site longitudinal clinical trial, to demonstrate the sensitivity to change and assess the reliability of the platform and acceptability by the patients, which will enable the platform to achieve TRL-8.
Step 1, access to clinical studies – Sales in the UK and US are enabled via key rheumatologists we are engaging with. Arthronica is targeting single key opinion leaders in rheumatology departments; KOL’s in charge of pharma studies currently ongoing in their clinic, scoping the right investigation for platform inclusion and facilitation as the door opener for existing/ approved investigations. For instance, Professor Jinoos Yazdany Chief of the Division of Rheumatology at USCF following the Pfizer investigation suggested us for: Sanofi and a Roche study in her clinic.
Step 2, reimbursement strategy in the US – A reimbursement expert in the US has already identified the following eligible codes: #99457 #99458 for remote monitoring treatment services and #G2010 for remote evaluation of recorded video and/or images submitted by an established pathway.This will be integrated with new codes and supported by Arthronica’s FDA Breakthrough-Devices Program submission (for Class II a De Novo).
Step 3, conversion of pilots into sales – Following Arthronica’s UK trials and our FDA De-Novo clearance the Arthronica platform can be a patient-administered disease monitoring device that can integrate into healthcare centres for: – those who have undergone initial assessment and investigation but have yet to achieve remission/low disease activity, as an alternative to monthly face-to-face assessment – RA patients who have achieved the remission/low disease-activity target, in order to monitor ongoing disease-stability.
Are you raising funding, what is your fundraising target and what will you use the funds for?
Arthronica is looking for a £2.5 million seed round to add 22 months of runway and cover hiring, growth, marketing, business development and sales.
Pre Funding Milestones:
- MVP Release [Q1-2021]
- King’s Hospital trial protocol accepted, passed ethics and starting [Q1-2021]
- CE Class 1 medical device [Q2-2020]
- Beta Release [Q4-2020]
- Machine-learning models added to our site [Q1-2021]
- ISO 13485:2016 Stage 1 Audit passed [Q1-2021]
- HIPAA compliance and associated documents [Q1-2021]
- FDA Granted Breakthrough Device Designation [Q1-2021]
Post Funding Milestones:
- ISO 13485:2016 Certification [Q2-2021]
- Gaining of initial paying contracts [Q2-2021]
- FDA Approval as a Class 1 Monitoring Device [Q3-2021]
What’s been your biggest success so far?
Being the founder of a team that has worked to such a high standard to create a CE marked world-class device that will help people living with arthritis worldwide receive gold standard care helping improve the standards for care. Arthronica’s machine learning models provide a high level of accuracy to within 5 degrees in gathering the angles in all finger joints. The technical team at Arthronica was even able to build a system that mitigated many of the technological risks with artificially intelligent systems by creating an automated state of the art testing suite. Our system checks the accuracy of our neural network updates to assure our accuracy only improves, and this is working now with our product.
What’s been the biggest challenge?
Most markets are highly competitive. While your business idea may sound fantastic and be well thought through, by the time you actually get started, many variables will be different. To keep up with the changing times and be successful, you must find a coherent route to market and it must be clear to all your staff. Collect the feedback from your test users and include the updates that the market is demanding. Conduct polls and surveys to better understand your target audience’s challenges and work on solving those problems. Constant innovation is the key.
What advice would you give to aspiring entrepreneurs?
As a very results-driven professional, I most unquestionably underestimated the difficulty of completing some of the ambitious milestones we set at Arthronica. We knew some goals were not going to be easy, and these were sometimes just impossible to achieve when so many aligned, requiring substantial amounts of time individually. With the global pandemic postponing our medical trials and taking most of our medical resources from us, I learnt that it is all about solving one problem at a time. Many days can be normal, others stressful, and some manic, such as filling in multiple investors requests for due diligence forms while taking meetings and setting protocols, all with impending deadlines. Often, entrepreneurs might not start or don’t even finish an MVP. They might have so many ideas that locking down on the “minimum” is impossible. It’s far more sensible to look at entrepreneurship as a problem-solving career, slowing down and take things one step at a time, which will save energy and help you stay in it for the long run.
Support from Imperial
The Imperial Venture Mentoring Service helped me by moving my idea formation to an early-stage company with pitch practice and a focus on product and market fit. There was so much time and energy given to helping me explore my idea and progress my approaches to establish a business and continue to grow it. The wealth of business knowledge provided, experience and the willingness to share it with those who are just getting started was truly inspirational.
The MedTech SuperConnector helped move our idea forward with a hotbed for knowledge exchange. Some of the people I met here have already done some amazing things and are still communicating to voice ideas with me. One of the primary thoughts and ideas that stuck with me was how I should change my perceptions of being a perfectionist. The idea of starting a business, putting in a huge amount of work and failing can be incredibly terrifying. Luckily I wasn’t, and neither should anyone else be.
Failure is quite simply a part of life and the richest resource of knowledge. Experiencing lots of little failures is simply a part of life and business. In the end, failing fast and often will make you stronger. From what I saw of the most brilliant business ideas and companies were being built on top of something learned from a previous failure. I now make sure that I aim to approach every defeat as a valuable lesson. Embrace them, learn from them, look at the bigger picture, adapt and move on from it. As strange as this will sound, allowing more iterative failures will help you succeed more. To quote one fantastic mentor, fail fast and win faster.
