By Steve Parker, Chief Executive Officer

It’s been an incredible year for Creavo, as we move ever closer to the commercialisation of Corsens®, the world’s first deployable MCG device with the potential to revolutionise the cardiac triage process, it is more important than ever to remain focussed. Next year is set to be our most exciting yet. I wish to thank every single member of staff at Creavo for their hard work and dedication as we continue to work together towards the realisation of our ambitious vision.

I’d like to recognise the media who have supported us in raising awareness of both Corsens® and the healthcare challenges it seeks to address. Publications including Medtech Engine, Medtech Insight, Physics World, Cardiovascular News and Raconteur, to name a few, have all been hugely supportive, and we look forward to sharing our exciting journey with new publications who have interest in this field moving forward.

Before we embark on what will be a pivotal year for Creavo, I’d like to take a look back and celebrate some of our achievements over the last 12 months.

Building our team

No organisation can succeed without the right leadership and advisory teams in place. We have seen changes and growth within important functional areas this year. Headcount has expanded significantly, with new team members added across all areas of the organisation.

We were thrilled to enhance our Medical Advisory Board (MAB) with the appointment of Professor Faizel Osman, Consultant Cardiologist / Electrophysiologist and Honorary Professor of Cardiology at Warwick Medical School. Faizel joins a group of highly-experienced healthcare professionals on our MAB, chaired by leading cardiologist Dr Richard Charles.

As we approach commercialisation, the needs of the company change, and to help us address any new challenges we have appointed Chris Meredith and Pierre Chauvineau as non-executive Board members . Chris is Group Chief Executive Officer of Advanced Medical Solutions Group plc – a globally successful, UK publicly owned medical device business. Pierre has 25 years’ experience in the medical device industry and is Vice President, CRM and electrophysiology, at Boston Scientific. We have an opportunity to gain great insights from their experience and extend a warm welcome to Creavo.

Award recognition

In addition to expanding our leadership team, we were thrilled to be recognised at various industry awards this year. Our first achievement was the Institute of Physics Business Start-up Award. This was followed up by a succession of individual awards for Dr Shima Ghasemi-Rousari and Dr Richard (Theo) Grant, who were both recognised at the Institute of Engineering and Technology (IET) awards 2018 for their outstanding work at Creavo. This is a huge achievement, and we are proud to foster such award-winning talent at all levels across our team.

Building evidence for our capability

This year we made significant progress building clinical evidence through a number of studies. There are some important and exciting results expected in 2019. Our multi-centre study at five of the UK’s major emergency departments completed recruitment and patient follow up this year, with results to be published in 2019. 2018 marked the final patient enrolled in our study with the University of Warwick which explored further applications of MCG technology within cardiology. A number of additional studies and trials are either in late planning stages or underway – looking at an array of exciting new applications.

2018 also saw the launch the largest MCG study of its kind in the United States, at five major research facilities and involving over 700 patients. This will conclude in 2019 and form the basis of our US regulatory submission.

Engaging with our stakeholders

Creavo attended a number of industry congresses in 2018, including the European Society of Cardiology (ESC) and the European Society for Emergency Medicine (EUSEM), where we showcased the new Corsens® device. It received great feedback across the board and we were delighted to hear directly from cardiologists and emergency physicians that our device has the potential to meet a significant unmet need.

Attending pan-European events helped us to secure distributor partners for commercialisation in the UK, France, Ireland, Middle East, Norway and Sweden. Other territories are being finalised with an aim for full commercial support in the target markets at launch next year.

We were also delighted to sponsor two industry events, both held in London; the European Workshop on Magnetocardiography, and the conference ‘Next Steps in Transforming Urgent and Emergency Care Services.’ Corsens® was seen as a game-changer at both conferences.

Looking ahead

2019 is set to be an important year for the company, the year in which Corsens® becomes commercially available and begins to help transform the process of triaging patients presenting with potentially serious heart problems to emergency facilities.

With our commercial partnership agreements in place, and the results of our comprehensive UK study to finalised and published, we will be ready to ‘hit the go button’. We are expecting to gain CE mark approval for Corsens® in the first half of next year (with our first iteration scanner, Vitalscan, having gained a CE mark in 2016).

We have already undergone three successful investment rounds since April 2014, raising close to £20 million. This has enabled ongoing research, product development, clinical studies, and marketing activities as well as the building of infrastructure and systems to support a world-class medical device business. We thank all of our partners for their continued support and are in the process of securing further investment to continue our journey.

My concluding thought is that it has been almost 10 years since our Chairman, Robert Barr, and Professor Ben Varcoe first met at a local school PTA meeting and began discussing some of the technologies Ben was working on. The sense soon grew that a portable MCG device could potentially have a major impact on the lives of cardiac patients. A decade on, and we are confident that this breakthrough innovation in healthcare is ready to become a reality.