About Caristo Diagnostics
Caristo is a spinout from the University of Oxford Department of Cardiovascular Medicine that has developed a proprietary vascular imaging technology platform that predicts risk of major cardiometabolic diseases. The first product is based on the prediction of heart attack risk from analysis of routine CT heart scans using our proprietary AI algorithms. The technology is already being used as an endpoint in clinical trials being run by leading pharmaceutical and biotechnology companies that involve over 1000 patients and 12 countries. Caristo was recently named by Nature, the leading science journal in the world, as one of the top-4 global spinouts across all scientific sectors. An article about Caristo was recently published in the Sunday Times.
Clinical Problem and Commercial Opportunity
Every year, over 100,000 people die from a heart attack or related stroke in the UK alone, and heart disease and stroke remain the two biggest overall causes of death worldwide. Heart attacks are often caused by inflamed plaques dislodging from the coronary artery and blocking blood getting to the heart. Yet there is no method that allows for early detection of a potentially fatal build-up of plaque that could trigger a heart attack. Caristo's technology, which has been developed as part of a research collaboration led by Oxford University academics, has highlighted the biological importance of the layer of fat tissue that surrounds the coronary arteries, known as perivascular adipose tissue (PVAT). In short, we can detect changes in the texture and composition of PVAT using our proprietary AI algorithms that are highly predictive of future cardiac death and heart attacks. Caristo's bold claims are backed up by a solid scientific foundation, with a string of high-profile publications in top-tier scientific journals such as Circulation, Diabetes, Science Translational Medicine, European Heart Journal and The Lancet. The technology has been called "game-changing" by the European Society of Cardiology and the British Heart Foundation.
Caristo and Commercial Objectives
Caristo received a CE mark for its first product, CaRi-HEART™, in February 2021. Initial US approval is already in place, with further US approvals expected in 2022. Caristo has a strong pipeline of future products, which include products to predict stroke and diabetes risk. We have been awarded prestigious research grants from organisations such as the British Heart Foundation, the UK National Institute of Health Research and the EU (Horizon 2020). The Company has already signed commercial contracts with biotech and pharma worth >£1 million and has raised over £10 million from leading Investors.
Caristo has achieved the required quality standards (ISO 9001, ISO 13485, ISO 27001). The technology is offered on a Software-as-a-Service basis utilizing cloud-based technology. Importantly, Caristo's technology is hardware agnostic, meaning it can be deployed into hospitals without any changes to hospital infrastructure.
- Manage a team of approximately 15 staff comprising project and project quality management, product management, software, DevOps and test engineers;
- Own the technical strategy, product development, maintenance and release activities, software quality, test automation and manual testing activities
- Oversee the software application architecture, coding standards and practices, source code management system, hardware, and software infrastructure as part of medical device development
- Take responsibility for design and implementation of information security aspects of the product and development processes in relation to Caristo's implementation of ISO 27001 certification including managing penetration testing
- Own the software development processes in conformance with medical device regulations and the quality management system, in particular ISO-IEC 62304 and ISO 13485 including the maintenance and configuration of the eQMS and Application Lifecycle Management software (HelixALM)
- Own the commercially oriented product strategy and roadmap, aligned with the regulatory roadmap
- Oversee product management, backlog management and prioritisation from release to release, maintaining regular release cadence multiple times per year, managing inputs from multiple stakeholders
- Lead the development of partnerships and software integrations with 3rd party software vendors and scanner OEMs
- Manage translation and verification of user interface and end-user documentation, human factors engineering (UX Design) and usability testing in conformance with medical device regulations
- Communicate engineering strategy to stakeholders and the board
- Oversee the cloud infrastructure (AWS) in support of development, testing and production live systems, continuous integration and deployment of products and services.
- Competitive salary with share options
- Private medical insurance and life assurance
- Working with a knowledgeable, high-performing and experienced team
- The chance to be part of a growing start-up and a leader in building a global business that will have material impact on the health and wellbeing of millions of people.