Author Archives: Alex

Aparito is delighted to announce that we are joining the fight against COVID-19. Using our flagship platform Atom5TM, Aparito will support remote patient monitoring of up to 1,200 cancer patients under the care of Betsi Cadwaladr University Health Board, helping vulnerable patients to stay at home and still receive care and support from their clinicians. #mHealth #wearables #cancer #oncology #Garmin

Aparito is a digital health company with a technology platform (Atom5TM) that supports remote patient monitoring globally. Using patient-generated data in the form of videos, data from Garmin wearable devices, photos and text, data is captured and transferred via the patient’s own smartphone/tablet and made available to clinicians and researchers in real-time. The system is deployed under a Quality Management System for ISO 13485, has Cyber Essential Plus (CE+) in place and operates within the GDPR regulations.

The COVID-19 crisis means that bed capacity in all hospitals is vastly overstretched. All efforts are now focused on both increasing this capacity and reducing the need for patients to be admitted (e.g. through cancelling clinical appointments and day care admissions).

For the oncology population, this is a particularly worrying time. During this COVID pandemic, febrile (feverish) patients have to be assumed as potential virus-positive individuals and kept in isolation. This is because of the risk that if the patient does have COVID-19 they risk contaminating all immunosuppressed patients they may come into contact with during hospital visits.

Thus, such patients should be monitored at home where possible so that low-risk neutropenic patients can more easily and safely be sent home via their Doctor on oral antibiotics with the Aparito digital surveillance solution in place.

At the same time, keeping all patients in hospital which can result in an escalation of care to critical and/or intensive care is not always the right care option for the patient. This means that they may be better supported in their own home with the help of their own family member and the community team. Based on the clinical assessment, physicians may discharge patients with Oxygen therapy and Aparito’s digitally enabled remote patient monitoring solution via our Atom5TM platform and a Garmin wearable device. Garmin wearable devices are not designed or intended to be used as medical devices but can provide health data, including resting heart rate, activity levels and blood oxygen saturation that can be useful in tracking a patient’s health.

We are proud to collaborate with the experienced team at Aparito to help them provide insights for patients facing a higher risk of COVID-19.

Jörn Watzke, Senior Director, Garmin Health BD

Cancer patients – especially those who are immunosuppressed, are feeling particularly vulnerable to serious complications of infection and of side effects of chemotherapy. Our efforts to supply appropriate surveillance at home with minimal impact of patient’s routine will mean that our triage team, led by myself and Dr Nicholas Wreglesworth will be able to provide the best advice and minimise unplanned clinical visits to those really required. This digital solution could moreover pave the path to a more proactive, precise and home-based approach to management of patients receiving anticancer treatment.

Dr Pasquale Innominato, Consultant Oncologist at Ysbyty Gwynedd:

The recent spread of COVID-19 has caused unprecedented demand to our National Health Service (NHS). Providing acute care to COVID-19 without negatively impacting on the care of other conditions will be a major challenge. Over the last five years at Aparito we have deployed our Atom5TMplatform for supporting patient enrolment in clinical trials and research. The solution naturally lends itself to supporting routine clinical care and we are pleased that we can offer this to support Dr Innominato and his colleagues in north Wales.

Dr Elin Haf Davies, Aparito CEO and Founder

Collaboration is key in the fight against COVID-19 which is why Aparito welcomes the opportunity to partner in this endeavour to support remote patient monitoring.

Aparito, a company transforming healthcare by unlocking real-world patient data through mobile apps and wearable devices, and Pulse Infoframe, a leading cloud-based healthcare data insights company delivering a holistic solution to foster collaboration and answer complex research, statistical and economical questions have announced a strategic partnership in rare disease.

The integrated approach will provide an extended offering to users and clients and enable greater insight into the disease burden of patients living with rare diseases. With end-to-end capabilities that link patient-generated data captured remotely via mobile apps and wearables with clinical data, the insight-rich analytics that result will be an invaluable new resource for the life science ecosystem and medicinal products life cycle. 

Our partnership with Pulse Infoframe is an exciting development in our steadfast commitment to deliver unparalleled value to patients and partners. This partnership extends our combined global footprint, which is especially relevant when developing new paths forward for those living with rare diseases. We look forward to growing from strength to strength.

Dr. Elin Haf Davies, Aparito Founder and CEO.

The partnership is addressing high unmet needs in rare disease where significant work remains to be done to increase knowledge of this community. By combining Aparito’s remote data collection approach with Pulse Infoframe’s rich data ecosystem, the solution will generate high quality real‐world evidence while maximizing the efficiency of development programmes. 

This is about excellence and service delivery to the rare disease community. The Aparito/Pulse partnership creates a new, convenient, and seamless pathway to capturing valuable data, from multiple data sources to create a comprehensive view of the impact of medical conditions, in the real-world. The combination of both companies’ expertise can transform the way clinical trials are conducted, leverage the true value of real-world data to accelerate research and collectively can propel science forward and improve the lives of patients and their families. Together, with Aparito, we are eager to serve this important community and address these unmet needs.

Dr. Femida Gwadry-Sridhar, Pulse Infoframe Founder and CEO

About Aparito

Aparito is a global health tech company that brings clinical trials to patients and unlocks real-world data through mobile apps, video assessments & wearable devices. They provide innovative patient-centric clinical trials solutions that integrate specialist medical & regulatory expertise to capture patient data and develop digital endpoints for hybrid and decentralised clinical trials. 

About Pulse Infoframe

Deployed globally and focused on cancer, rare disease, and chronic conditions,  Pulse’s transformative solution healthie™ is a technology platform designed to extract, curate, analyze and disseminate Real-World Data for the purpose of

• Accelerating scientific research and advancing the delivery of new products to market
• Optimizing the quality of patient care, while increasing operational efficiencies through workflow management
• Establishing reimbursement, cost of therapy, and pricing strategies

healthie™ is a platform that encompasses a patient registry and health visualization solution. This GDPR and HIPAA-compliant platform can be described as a collaborative ecosystem that enables the gathering and sharing of information with many partners. Our healthie ecosystem enables patient advocacy, clinicians, patients and researcher partners to increase operational efficiencies by providing insights into complex data that are analyzed and rendered into an easy-to-understand visual display. This intuitive display, provided through a web interface, supports real-time data capture and thus simplifies workflow for building Patient, Natural History and Clinical registries. Pulse Infoframe’s mission is to deliver a holistic solution that answers complex research, statistical and economic questions.

Aparito Limited, a med-tech company developing innovative digital endpoints to support remote patient data capture has worked extensively with the wider Gaucher community to develop disease specific digital endpoints to support patients. 

Gaucher disease is a lysosomal storage disorder caused by mutations in both copies of the GBA1 gene, which can have a wide range of effects on organs throughout the body. Gaucher disease has three subtypes, which vary by the presence or absence of neurological symptoms, severity of symptoms, age of onset and age at death.

Conveying disease impact and disease-specific hallmarks in young children with devastating rare diseases, such as neuronopathic Gaucher disease, can be challenging. Innovative technology now allows patients and parents to capture outcomes that are important to them with minimal burden and effort. This is an important move towards designing clinical trials that are patient-centric and reducing time spent on hospital visits. 

This innovative technology approach was utilized in one of Aparito’s first studies to evaluate the disease activity of Type 1 and Type 3 Gaucher patients using wearable technology and a disease-specific mobile phone app. The study, which was supported by Sanofi Genzyme and Shire Pharmaceuticals, illustrated that a rich dataset is obtainable and useful for proactive clinical care and for clinical trial outcomes.

Aparito also coordinated the phase one development of a global patient registry for neuronopathic Gaucher disease on behalf of the International Gaucher Alliance in order to increase disease knowledge and understanding, as well as develop new outcome measures and support emerging drugs/ treatments in the pipeline. 

As part of this work, Aparito’s CEO Dr Elin Haf Davies was instrumental in the development of a disease-specific Patient-Reported Outcomes and Caregiver Reported Outcome, which will be undergoing construct validity assessments in the coming months as part of the registry development, presented at the 2020 European Working Group on Gaucher Disease. 

More recently, Aparito, working with Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, created a mobile app solution to be used in Prevail’s PROVIDE trial. PROVIDE is an open-label, Phase 1/2, multicenter study to evaluate the safety and efficacy of single-dose PR001 in infants diagnosed with Type 2 Gaucher disease. PR001 is being developed as a potential disease-modifying, single-dose gene therapy for Type 2 Gaucher disease and Parkinson’s disease with GBA1 mutations.

Type 2 Gaucher disease, the most severe form of Gaucher disease, affects infants and toddlers. It causes rapid and irreversible brain damage beginning in the first six months of life; patients typically die by age two. 

The mobile app developed for PROVIDE will capture both clinician and parent-reported assessments of Type 2 Gaucher disease, including feeding and the attainment of developmental milestones. Parents will also use the app to report any seizures that the child may experience. 

We are excited to partner with Aparito and use their technology to broaden how we evaluate the effects of PR001. Type 2 Gaucher disease is the severe, progressive neuronopathic form of Gaucher disease for which there are no approved treatments, and the use of a digital biomarker endpoint in our study will provide a supportive measure of disease burden and severity.

Dr. Eriene Wasef, Medical Director

It’s been a real honour to collaborate with the team at Prevail on this innovative initiative. I have worked with the Gaucher community for over 18 years, and this study brings much needed hope. Knowing the disease so well has helped us to co-develop a digital endpoint that can convey a meaningful and objective measurement without being a burden to patients and families. 

Dr Elin Haf Davies, CEO at Aparito

About Aparito 

Aparito is a global health tech company that brings clinical trials to patients and unlocks real-world data through mobile apps, video assessments & wearable devices.

We provide innovative patient-centric clinical trials solutions that integrate specialist medical & regulatory expertise to capture patient data and develop digital endpoints for hybrid and decentralised clinical trials. 

We do all this through Atom5™, our iOS & Android-compatible web and mobile app platform. Atom5™ captures multiple, high-frequency data points from video, voice, wearables, and electronic Patient Reported Outcomes, then analyses the results in conjunction with our team of data scientists to provide rich, real-time insights to clinical teams. 

Through the presentations, we invited our speakers to illustrate how we could capture real word data in different formats such as video, text, photos, and audio and develop novel digital biomarkers.

Our first speaker, Tanya Collin-Histed, CEO of the International Gaucher Alliance, opened the event with the perspective of a patient advocate and parent, reminding the audience of ‘Aunty Elin’ at Great Ormond Street where the inspiration for Aparito originated.  She recalled a difficult time historically when a clinical trial for Gaucher was halted with inconclusive results, reinforcing the toll it takes on families and the opportunity cost in terms of time and the appetite for future participation. 

Fast forward to the present day and an IGA powered solution that has been worked on in collaboration with Aparito which advocates for global, federated, patient-led disease registries that support a better understanding of the disease. The aim of combining a global registry with technology is to be able to empower patients and support recruitment for studies, validate new endpoints – clinical and PROs, but also encourage and support the education of health professionals. The model is made sustainable via pharma investment. 

Dr. Aimee Donald from the Royal Manchester University Children’s Hospital spoke next and took up the topic of generating meaningful data in her research presentation, titled ‘Measuring disease activity and patient outcomes in Gaucher disease with wearable tech and mobile phone apps.’She noted three major challenges in the research: The scientific challenges of the disease itself; the fact that it is a rare disease and what that means for patient recruitment and the implications for clinical trial design. She spoke about the practical considerations of hospital-based trials for families, often having to undertake extensive travel and the impact on children’s motivation in particular, of multiple tests, in a short time period and their resulting fatigue.

She contrasted that with the results of an Aparito assisted app-based trial using wearables which yielded a rich and meaningful data set. Her conclusions pointed to the importance of patient engagement and motivation and the support she observed for the technology. With these two factors in place, it is possible to both expand data collection and focus on specific areas with enhanced patient feedback.

We next had the privilege to hear from Maddie Collin, a Gaucher Patient and Patient advocate about the experience of participating in clinical trials as a child in conversation with Dr. Aimee Donald. Now in her twenties, Maddie and her mother Tanya have a long experience to draw on which can be illuminating for companies designing trials. Listening to Maddie explaining her burden and attitude to different invasive procedures necessary for clinical practice and clinical trials it was clear that a patient-centric approach is important for success in patient recruitment and engagement. 

It is key for Aparito to support access to healthcare in every region of the world, therefore Dr. Karen Fieggen, Head of Medical Genetics at Groote Schuur and Red Cross Children’s War Memorial Hospitals in Cape Town, SA spoke about our collaboration and research into ‘Precision medicine in South African children with refractory epilepsy’, based on the hypothesis that home technology-based monitoring has the potential to improve the management of children with epilepsy in South Africa.Working with the Aparito Atom5 platform she summarised the inherent challenges of working with trial participants living in the townships and rural areas that they needed to overcome, such as the high cost of cellular data and limited cellular access in rural areas. Despite the limitations, she concluded that the technology opens up areas that were previously not accessible. 

Taking into consideration the necessary valid tools to develop regulatory and clinical purposes, Dr. Marcus Grobe-Einsler from the German Centre for Neurodegenerative Diseases (DZNE) at University Hospital in Bonn spoke about SARAhome a new patient related outcome measure for ataxia. Using the Aparito platform patients can video themselves performing a series of tests that would normally take place in clinic. The images are downloaded and assessed by experts remotely. In the future, AI based assessment could be used to automate this process further. The use of technology will reduce patient hospital visits and with the help of AI in interpreting the data, medical doctors will have more time for patient evaluation.

Also looking to the future, Dr. Alberto E. Tozzi, Chief Innovation Officer at Bambino Gesu hospital in Rome spoke about the eHealth Hub initiative to identify new technololgy based innovations. From forty innovations, Aparito was the idea that was selected to support a project in children with shunts in cases of hydrocephalus. Dr. Andrea Carai from the Oncological Neurosurgery Unit presented the issues of monitoring these children which he characterized as: 

• Inappropriate ER referrals; Avoidable diagnostic tests; 
• Delayed referrals; Clinical risk
• Costs: Financial, Biological and Human

Aparito is joining forces with Bambino Gesu hospital to develop a platform for better monitoring and quicker interventions addressing the unmet needs of patients and health care professionals in cases of hydrocephalus.

Aparito also invests in research: Grace Bailey from Cardiff University presented her PhD research on Use of technological platforms to enhance phenotypic understanding in dystonia. Working with Aparito as a research partner, Grace is currently recruiting patients nationwide for her study. She is focusing on sleep as one of the areas where remote wearables can help remove the difficulties of subjective patient description. She pointed out that sleep is not normally included in symptomatic clinical review and there is now the opportunity to objectively assess sleep quality in “real-life” environments.

The last word was given over to finance, specifically Aparito’s first investor, the impact investment firm Bethnal Green Ventures. Managing Partner, Melanie Hayes spoke about scale, and their mission to back ambitious entrepreneurs using technology to tackle big issues with the potential of radically improving millions of lives. Melanie pointed out that impact investors proactively seek out diverse management teams (which includes female founders) because they have been proven to lead to better impact and superior returns.

That’s one thesis we’re taking at face value.

Innovation Point is an international innovation partner providing services to help businesses develop new and disruptive technology ideas that help them grow. At this year’s festival for the first time The Top Women in Welsh Technology were announced and Dr Elin Haf Davies, CEO, aparito was names as one of the ten. The Top Women in Welsh Technology are the females driving the digital industry in Wales. Only 15% of the people working in STEM roles across the UK are female. Only 5% of leadership positions in the tech industry held by women. Innovation Point believes sharing the stories of female’s leading the way can inspire others to follow. Following a public nomination process, judges chose 10 women from across Wales and across sectors including females who’ve founded companies working worldwide, saving lives, creating careers, innovating and boosting the economy. The headline speakers at the event were David Rowan (founding editor, WIRED); Jackson Hull (GoCompare); Keith Teare (Silicon Valley Investor); Ken Skates AM. 2000 delegates attended the festival and this was the sixth annual event. Digital Festival is organised by Innovation Point in partnership with Welsh Government.

Aparito is proposing a platform that provides wearable devices and disease-specific mobile apps to provide remote patient monitoring outside of the hospital environment. This continued monitoring provides real-time data for clinicians to capture subtle differences in ambulation and sleeping patterns, which can’t be conveyed during short, snapshot clinic visits, in a way that actively supports and enhances diagnosis, treatment and drug development. Aparito is also developing a tool that can measure differences in speech patterns.

Elin said following her success:

It’s a real achievement for us and we are so proud of the innovative team who have been working so hard to develop the technology”. Aparito are going from strength to strength with a number of projects in development and a study taking place over the next few weeks in South Africa.

Dr Elin Haf Davies, CEO of Aparito

This week’s awards success caps off a remarkable 18 months for the Wrexham Technology business park start up. In December Aparito won the title of ‘Best Startup’ at the Mediwales Innovation Awards 2017. Elin spent much of her time as a paediatric nurse caring for children with rare diseases. She conducted redundant, time-consuming, and often painful tests in order to monitor each patient’s health. After feeling this method was inefficient Elin came up with the idea of remote patient realtime monitoring. With the help of a team of diverse backgrounds, Aparito was born. Together we share the goal of improving the lives of individuals with rare diseases.

In this study matched funding comes from the South African Medical Research Council and is led by Principal Investigator Dr Karen Fieggen, University of Cape Town and Clinical Co-Investigator Prof Jo Wilmshurst, of Red Cross Children’s War Memorial Hospital.

Epilepsy is one of the most common neurological disorders worldwide with over 65 million people living with the disorder (1). Studies have shown that the prevalence of epilepsy in low to middle income countries is substantially greater than in more resourced countries – 81.7 compared with 45.0 per 100,000 and predominately affects a younger population(2). Recent estimates in 2010 suggest that epilepsy contributes to 0.7% of the global burden of disease and the Global Burden of Diseases, Injuries, and Risk Factors Study 2010 found that the burden resulting from uncontrolled epilepsy has a disability weight second only to HIV infection(3).

There is little data on quality of life for South African children with epilepsy and their families. Resources for management of epilepsy in Africa are extremely limited reinforcing the need to gather data on cause and course of the disorder and develop innovative strategies for optimising care for the individual patient (4). Such interventions must be uniquely relevant to the local setting. As such, without piloting these interventions it will not be possible to adjust them to optimal effect.

Precision medicine (PM) is a medical model that proposes the customisation of healthcare, with medical decisions, practices, or products being tailored to the individual patient. PM aims to optimise therapeutic benefit to patients or groups of patients. PM is becoming the next goal of global health care. There is a strong assumption by healthcare funders and users alike in resource limited countries like South Africa (SA) that PM is un-affordable and unsuitable for their population. This thinking needs to be challenged. The benefits from a PM approach could be cost effective in both financial and humanitarian terms (5). There is very little published on the role of PM in resource limited countries but there is increasing evidence that a PM approach is of value in epilepsy globally(6).

As next generation technologies have permitted the wide scale screening of genetic contributions to common disorders. Determining genetic aetiologies in many common disorders such as epilepsy facilitates understanding of pathophysiology with subsequent implications for management (7,8). Research has shown that many types of epilepsy have a genetic basis and diagnostic genetic testing for epilepsy is becoming more available in many parts of the world (9,10). Genetic testing has particular relevance when it directly impacts on patient response to medication – from efficacy profile achieved to side effects observed.

Mobile health (mHealth) solutions using smart phone apps also has widescale deployment possibilities. The technololgy will focus on medication adherence support, real-time reporting of seizures by parents via the app and reporting on the patients quality of life. A paired wearable device will also be deployed to explore seizure detection and events leading to a seizure which might prove to be useful in the management of these patients. Precision medicine initiatives including genetic and pharmacogenomics testing, and home technology based monitoring has the potential to improve the management of children with epilepsy in South Africa, and beyond.

Aparito CEO, Dr Elin Haf Davies reported, “We are thrilled to be leading on this exciting initiative which has the potential to have a positive impact on the management of children with epilepsy”.

REFERENCE Thurman DJ, Beghi E, Begley CE et al. Standards for epidemiologic studies and surveillance of epilepsy. Epilepsia. 2011; 52(SUPPL. 7):2–26. Ba-Diop A, Marin B, Druet-Cabanac M, Ngoungou EB, Newton CR, Preux PM. Epidemiology, causes, and treatment of epilepsy in sub-Saharan Africa. Lancet Neurol. 2014; 13(10):1029–44. Lim SS, Vos T , Flaxman AD et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012; 380(9859):2224–60. Wilmshurst JM, Kakooza-Mwesige A, Newton CR. The challenges of managing children with epilepsy in Africa. Semin Pediatr Neurol. 2014; 21(1):36–41. Dandara C Özdemir V. Precision Medicine 2.0: The Next Wave of Science. Omi A J Integr Biol. 2016; 20(10):555–6. Striano P, Vari MS, Mazzocchetti C, Verrotti A, Zara F. Management of genetic epilepsies: From empirical treatment to precision medicine. Pharmacol Res. 2016; 107:426–9. Sands TT, Choi H. Genetic Testing in Pediatric Epilepsy. Vol. 17, Current Neurology and Neuroscience Reports. 2017 May; 17(5):45 Poduri A, Sheidley BR, Shostak S, Ottman R. Genetic testing in the epilepsies —developments and dilemmas. Nat Rev Neurol. 2014 May; 10(5):293-9 Carvill GL, Heavin SB, Yendle SC et al. Targeted resequencing in epileptic encephalopathies identifies de novo mutations in CHD2 and SYNGAP1. Nat. 2013; 45(7):825–30. Thomas RH, Berkovic SF. The hidden genetics of epilepsy—a clinically important new paradigm. Nat Rev Neurol. 2014; 10(5):283–92.