CORDIS - EU research results

Towards the Wider uptake of Arterial Stiffness As a BIomarker for cardiovascular diseases

Periodic Reporting for period 1 - WASABI (Towards the Wider uptake of Arterial Stiffness As a BIomarker for cardiovascular diseases)

Reporting period: 2015-12-01 to 2016-05-31

Aortic stiffness is a recognized vascular biomarker (ESC position paper, Vlachopoulos et al., Arthero-sclerosis 2015) and measurement of aortic pulse wave velocity (PWV) is the gold standard methodol-ogy to assess large artery stiffening. Elevated aortic PWV has been shown to predict cardiovascular, and in some cases all causes mortality in individuals with end-stage renal failure, hypertension, diabe-tes mellitus, as well as in the general population. However, at present, PWV is little used in everyday practice mainly because PWV measurement is not reimbursed in any of the European states and be-cause devices on the market (ALAM Medical Complior, SphygmoCor, Mobil-O-Graph, PulsePen, BPLab Vasotens, or Arteriograph) are either complicate to use, time consuming to get the measure and relatively expensive, or only provide low-cost estimations of arterial stiffness whose clinical value is questionable.
ALAM Medical, specialized in arterial stiffness and central pressure, has initiated the WASABI project to scale up the clinical use of PWV as a biomarker, notably by investigating alternative sensors in or-der to offer an easier to use and more affordable device measuring gold standard aortic stiffness and local carotid stiffness. By providing a medical device with such characteristics, as well as by under-taking appropriate market awareness actions, we intend to transform our existing niche market, main-ly composed of clinical researchers, into a large-scale market composed of clinical practitioners, car-diologists or physicians: arterial stiffness measurements have the potential to move from research to standard medical practice, on the model of blood pressure measurements.
During project Phase 1, ALAM Medical has investigated several sensor technologies to measure ca-rotid-femoral PWV, the gold standard methodology for arterial stiffness. The evaluation results of the sensors evaluation led ALAM MEDICAL to re-orientate the WASABI project toward another solution to assess arterial stiffness. ALAM Medical performed in-depth market survey, started a R&D collabora-tion project with another company and elaborated a business plan to work with them.
At the begining, the business idea was to find easy-to-use sensors for gold standard carotid-femoral pulse wave velocity. However the project has evolved. We could not identified sensors technologies which combines ease of use and acceptable accuracy. In the process, we foresee that wider clinical use of arterial stiffness is unlikely to happen through its present gold standard method. Key opinion leaders are shifting their opinion and are more and more ready to accept pulse wave velocity measured on a larger pathway, brachial ankle PWV for example. What is more, arterial stiffness need to be offered with other tools of cardio-vascular diagnostics to be successful on the market. For this reason we teamed up with MESI Medi-cal d.o.o. a Slovenian company, developing and distributing a device assessing an index to diagnose peripheral arteriopathy. Their main target is primary care and prevention centers.
We have started to add central pressure measurement to their device and are about to add brachial-ankle PWV. We already show the new product at a international medical congress. For future commercialisation, we will take advantage of their existing distribution network which includes most European countries, USA and Canada as well as most active emerging countries active in health management. We will also take advantage of their existing customers and offer a specific package to update their equipment to also have central pressure and arterial stiffness functionalities.
Cardiovascular risk and more specifically arterial Health is divided in several arterial territory. Being able to measure large artery health (by arterial stiffness and central pressure) with lower limb arterial health (with ankl-brahcial Index) is a novelty for the market. What is more the tehcnology is easy to use and ready for large routine clinical use. The only obstacle to overcome before large scale adoption is education of the market. However, prevention of cardiovascular events is crucial so physicians are interested in measurements such as ours. We are expecting than in 5-10 years the majority of cardiologist and primary care specialist will be equipped with devices measuring arterial health.