All posts by Rebecca Anderson

Creavo begins 60 patient Brugada syndrome study at St George’s, University of London

Creavo Medical Technologies (Creavo) is pleased to announce the start of a new study at St George’s, University of London, led by Dr Elijah Behr.

The study will assess if Creavo’s magnetocardiography (MCG) device can identify Brugada syndrome (BrS) in patients, then use this information to classify a group at risk of sudden cardiac death (SCD).

Approximately 60 patients will be enrolled throughout the study, which is scheduled to be completed in the October timeframe.

Dr Behr, who is a Reader in Cardiovascular Medicine at St George’s University of London and consultant cardiologist at London’s St George’s Hospital, is a renowned specialist in the field of arrhythmias and SCD. He said: “This trial is one of the first to assess the potential use of MCG to identify patients at greater risk of sudden cardiac death. Only by exploring new technologies can we work to improve outcomes for patients, and we are very pleased to be undertaking this project.”

Steve Parker, Chief Executive Officer at Creavo said: “There is extensive research into the use of MCG to accurately rule out acute coronary syndrome in chest pain patients in an A&E setting, but this new study will help assess the potential for the device to be used as a screening tool outside of emergency care. This is an important step in our journey, and we thank the team at St George’s University for their involvement and support.”

St George’s is also involved in a separate multi-site study that is being conducted in the emergency department of several major UK hospitals located in Sheffield, Nottingham, Bristol and Leicester.  That study will assess the effectiveness of Creavo’s device in aiding physicians identify patients at low risk of ischaemic heart disease.

There have been a number of notable achievements for Creavo in the last two years. The device received EC certification for CE marking in Europe in November 2016 and secured 510(k) clearance from the U.S. Food and Drug Administration in October 2017. Following initial funding for its MCG device, the company raised an additional £13.4m ($17m) in July 2017 from private equity investors. The round was oversubscribed and exceeded Creavo’s target, reflecting strong investor support and endorsement of the company’s strategy and team.

Creavo enrolls final patient in largest magnetocardiography (MCG) trial of its kind

Trial tests the viability of Creavo’s MCG device at five major emergency departments across the UK.

Creavo Medical Technologies (Creavo), the UK-based medical device company, has completed patient enrollment in its multi-centre study.   Involving 750 patients across five of the UK’s largest emergency departments — Sheffield, Nottingham, Bristol, Leicester and London’s St George’s — the study has been conducted to assess the accuracy of Creavo’s  magnetocardiography (MCG) device in identifying those at low risk of ischaemic heart disease.

Lead investigator Prof Steve Goodacre commented,” The study is entering an exciting phase, in which we will analyse the data to determine the accuracy of the MCG device for aiding the diagnosing of ischaemic heart disease”

The device, which performs a non-invasive scan within minutes at the patient’s bedside, has been designed to aid clinicians meet a clinical need, to quickly rule out ischaemia related heart problems at the point of admission to emergency departments. Identifying these patients early can potentially reduce patient anxiety and can save the hospitals valuable time, resources and bed space. Financially, the device has the potential to save the UK healthcare system up to £200 million a year.

Steve Parker, Chief Executive Officer at Creavo said: “Finalising this important study is a major milestone for Creavo as we work towards our goal of offering rapid diagnostic solutions that improve patient outcomes and meet the needs of healthcare professionals. This study will give us important information and I’d like to thank the experienced healthcare professionals and patients who have supported and participated to make this trial possible.  Feedback from the users has been positive and we’re looking forward to releasing the results in due course.”

There have been a number of notable achievements for Creavo in the last two years.  The device received CE mark registration in Europe in November 2016 and secured 510(k) clearance from the U.S. Food and Drug Administration in October 2017.   Following initial funding, the company raised £13.4m ($17m) in additional private equity funding in July 2017 for its MCG device. The round was oversubscribed and exceeded Creavo’s funding target, reflecting strong investor support and endorsement of the company’s strategy and team.

 

Creavo appoints distinguished medical technology Chiefs to its Board

Chris Meredith and Pierre Chauvineau bring a wealth of experience to the growing business

 Creavo Medical Technologies (Creavo), the UK-based medical device company has appointed senior medical technology industry leaders Chris Meredith and Pierre Chauvineau as non-executive directors.

The new members of the company’s expanded board will provide ongoing guidance and governance as Creavo continues to work towards full commercialisation of its portable magnetocardiography (MCG) device.

Chris Meredith is currently Group Chief Executive Officer of Advanced Medical Solutions Group plc and has previously held senior sales and marketing roles at Smiths Industries – now Smiths Group plc, Cardinal Health, Banner Pharmacaps, and Aster Cephac. His experience covers contract manufacturing, product development, clinical research and branded product sales, all within the medical device, pharmaceutical or consumer healthcare markets.

Pierre Chauvineau has over 25 years’ international business leadership experience in corporate and start-up companies within the medical technology industry. He recently held the role of Vice President and General Manager Rhythm Management Europe at medical device manufacturer Boston Scientific. He was also Vice President and General Manager International for Cameron Health, a medical technology business – later acquired by Boston Scientific – which developed a novel cardiac defibrillator. He has also held a variety of senior roles in the cardiac rhythm management division of medical technology firm Medtronic.

Robert Barr, Chairman of Creavo commented “We are delighted to welcome both Chris and Pierre to the board at this important time as we move towards full commercialisation. Their complementary skills and experience in developing world class medical device businesses and launching disruptive technologies in the cardiology space will add significant value as we move into the next phase of Creavo’s evolution.”

 In emergency medicine, Creavo’s technology is designed to meet an urgent clinical need, to help physicians quickly rule out serious heart-related problems at the point of admission to emergency departments. Identifying these patients early reduces patient anxiety and can save the hospitals valuable time, resources and bed space. Financially, the device has the potential to save the UK healthcare system alone up to £200 million a year.

Following initial funding, the company raised £13.4m ($17m) in private equity funding in July 2017 for its MCG device. The round was oversubscribed and exceeded Creavo’s funding target, reflecting strong investor support and endorsement of the company’s strategy and team.

 

Our cardiac imaging device triumphs at IET Innovation Awards

Creavo Medical Technologies has won two awards at the Institution of Engineering and Technology (IET) Innovation Awards for its cutting-edge cardiac imaging device which could help physicians accurately rule-out ischaemic heart conditions in a matter of minutes.

The awards celebrate the very best in new innovations in science, engineering and technology, showcasing entries from around the world.

Creavo took home the awards in the Healthcare Technologies and Emerging Technology Design categories, acknowledging the technology’s potential to revolutionise emergency department triage of chest pain patients.

It has been a busy year for Creavo, having secured CE mark registration in Europe, FDA (510k) clearance in the US, initiating rigorous multi-centre clinical trials in the UK and raising a further £13.4m in an oversubscribed funding round.

Chest pain is one of the most common reasons for people to present to A&E, but as many as 75 per cent of patients are not actually suffering from ischemic heart disease. In the absence of a true rule-out test, most will still be put through a lengthy, costly and resource-intensive process of blood tests and other diagnostic testing.

Creavo’s device uses magnetocardiography (MCG) to perform a non-invasive three to five-minute scan to detect abnormal patterns in the magnetic fields of the heart which reflect loss of oxygen to the heart muscle. This can help physicians accurately rule-out ischemic heart disease meaning that patients can go on to the most appropriate care pathway for their needs.

Chief Scientific Officer Ben Varcoe said: “Historically MCG technology has been restricted to large and immovable devices and, despite its high accuracy, has been impractical for use in emergency departments and routine clinical settings.

“However, for the first time, we have harnessed the technology into a battery-powered portable device that can be deployed directly to the patient’s bedside, meaning the potential rule out of certain cardiac conditions can become a much quicker process.”

CEO Steve Parker said: “We’re delighted to have been recognised by the Institute of Engineering and Technology.

“The device continues to impress across the industry and we’re confident that it can help address the huge global challenges hospitals face when it comes to triaging chest pain patients. Ultimately, we aim to save the healthcare industry time, costs and, importantly, improve levels of patient care.”

The IET Innovation Awards took place on 15 November 2017 in London.

Click here to view recent footage of the Creavo team receiving their award

Creavo Medical Technologies secures U.S. FDA 510(k)

Technology has the potential to revolutionise emergency department triage of chest pain patients.

Developer of innovative medical diagnostic technology, Creavo Medical Technologies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The move opens the U.S. market for its portable scanning device, Vitalscan, and demonstrates an increasing industry focus on the global challenges hospitals face when it comes to triaging chest pain patients.

Rigorous clinical trials will now start in a number of centres across the U.S. in addition to the multi- centre trial already taking place at four major UK emergency departments.

Chest pain and related symptoms are the second most common cause of emergency department visits in the U.S., accounting for approximately 7 million visits in 2010[1].  75% of these patients[2] will have a non-serious cardiac condition but will still have to go through the time-consuming process currently in place which involves an electrocardiogram (ECG), blood biomarker testing and further follow up investigations.

Vitalscan uses magnetocardiography (MCG) to perform a quick, non-invasive three to five-minute scan at a patient’s bedside. This can help physicians accurately rule-out ischemic heart disease, meaning that patients can then go on to the most appropriate care pathway for their needs rather than go through the current lengthy and resource intensive process.

Steve Parker, CEO, Creavo Medical Technologies said: “This is a major development and brings us closer to realising our overriding objective – to improve patient care and save time and resources for hospitals.

“Engagement with the FDA represents yet another significant achievement in what has been a very successful period for us. In the past year we have received CE mark registration in Europe and our large-scale, multi-centre UK clinical trial is continuing to progress well. We also raised a further $17m (£13.4m) in an oversubscribed funding round, enabling us to continue to build momentum and extend our reach further.   We know that the technology has the potential to be a game changer and our ability to go from strength to strength is further evidence of this.”

ENDS

Contact: Rachael Harper – +44 (0) 7850 211 960

Notes to editors

About Creavo Medical Technologies Ltd

Creavo Medical Technologies Ltd is a UK-based, privately held medical device company that is developing innovative diagnostic techniques. The company was formed in 2014 to bring to market ground-breaking technology developed by Professor Ben Varcoe, Chair of Quantum Information Science at Leeds University. It has facilities in Leeds and Coventry, UK.

Focused on improving front line patient care in acute medical settings, Creavo’s first application of this technology is the Vitalscan – a device that meets an urgent clinical need in global cardiology to help more accurately ‘rule out’ heart-related problems at point of admission to emergency departments.

Vitalscan is a battery-powered, portable medical device that uses advanced quantum principles to measure, display and store electromagnetic fluctuations caused by heart activity. Early indications from smaller sets of clinical trials indicate that the device can help accurately and quickly rule out significant ischaemic heart disease with near 100% accuracy through a simple, non-invasive three to five-minute scan at a patient’s bedside.

For more information about Creavo, please visit: http://www.creavomedtech.com/

[1] National Ambulatory Medical Care Survey: 2010

[2] Backus et al. 2011; Rohacek et al. 2012; Six et al. 2012; Backus et al. 2013