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Non-invasive screening of the status of the vascular system

Final Report Summary - NISTAS (Non-invasive screening of the status of the vascular system)

Executive Summary:
The NISTAS project prototyped a novel medical instrument, named VascuLight, for fast and contactless screening of the status of the vascular system of human patients. As such, NISTAS responded to the need for fast, reproducible, and widely available measurement of the arterial stiffness that is a recognized predictor of cardiovascular risk and mortality, and a potential marker for monitoring the beneficial effects of medical treatments for arterial diseases.
The Pulse Wave Velocity (PWV) is the speed of travel of pressure waves in the aorta and other arteries and is a demonstrated and accessible indicator of arterial stiffness. Today, the PWV is measured by contact techniques, but the VascuLight system is capable of performing PWV measurements via a contactless technique at a local (carotid, arm and leg arteries) and regional level (combined carotid-arm/leg measurements). The displacement measurement instrument consists of a light source and a sensor coupled to a control unit, where fast processing allows a prompt diagnosis.
In NISTAS, three SMEs exploited their expertise for the common goal of realizing the VascuLight instrument, transferring photonic and electronic technologies, so far deployed in other industrial fields, to life science and medical areas. Research and Technological Development (RTD) partners with clinical expertise guided the consortium towards clinical tests, with the goal of validating the effectiveness of the proposed method for vascular disease and risk diagnosis. NISTAS also initiated a path towards CE certification of the instrument, in order to allow a quick market exploitation of the project results when series of production and manufacturing of the marketable VascuLight devices will be operated.
The NISTAS system is aimed to be deployed as a new medical instrument at European hospitals and other points-of-care. The project obtained results are specific and verifiable and can be summarised as follows:
- elaboration of a LED-Based Line Projection system with linewidth <1 mm at a range > 100 mm,
- modelling, design and construction of a dual-line projection system with a LED source,
- development of the electronic and software modules that are required to rapidly extract accurate PWV information from the NISTAS used sensor data,
- prototyping, testing and deployment of the VascuLight modules with clinic level performance,
- performance evaluation and validation of the prototyped system.
The NISTAS project results will have an impact on the domain of contactless vascular screening that is intended for medical diagnostics. It introduces innovations in the area of photonic/optic technology and data fusion algorithms that are related to the PWV data exploitation.

The NISTAS system patenting is currently under investigation by the consortium SMEs, namely ECLEXYS and JULIGHT who are envisaging a joint market exploitation for it in a timeframe of one year after obtaining its CE marking.

Project Context and Objectives:
NISTAS developed new 2D (two dimension) laser triangulation systems. The concept novelty is represented by the projection and detection of two parallel light lines for the simultaneous measurement of the deformation/displacement of the patient’s skin in two different points along a superficial artery. It also investigated new signal-processing algorithms that can extract the required displacement information from the two dynamic light images (in the form of a sort of “wobbling line”) that is detected by a two-dimensional optical detector (a CCD or CMOS sensor). Each laser triangulation system must be of the 2D type, meaning that it is capable of measuring the profile of the “object under test” along a line (length of the line: 15-30mm). The “object under test” is a sample of the patient’s skin just above one superficial artery (e.g. carotid). The transversal profile of the skin is measured by aligning the laser line at approximately 90° with respect to the artery axis. The apparatus can have a stand-off distance of 150-400mm.
The objectives of NISTAS are of different nature and required different action schemes for their achievement and exploitation. The Project’s main objectives can be grouped by area of application/exploitation as follows:

1. SCIENTIFIC / MEDICAL
- Objective 1.1 - Demonstration of contactless repeatable optical PWV measurement.
- Objective 1.2 - Demonstration of VascuLight as a screening method for prevention of vascular diseases – Validation and testing on a population of normal and diseases subjects to assess prevention capabilities.
- Objective 1.3 - Demonstration of VascuLight as a diagnostic and monitoring tool.
- Objective 1.4 - Data collection with the goal of defining referral values of local pulse wave velocity in normal population, classified by age, gender, height, weight, ethnical groups
- Objective 1.5 - Generate practical guidelines for translation of the use of VascuLight in any out-patient setting – Including out-patient monitoring by family doctors in the Pavia area (Italy), in collaboration with the local agency for health (ASL, Azienda Sanitaria Locale, Pavia, Italy). Proper dissemination/training events/instruments were organized to train end users on the performance and operation of the VL system.

2. TECHNICAL
- Objective 2.1 - Demonstration of dual-line light projection system – A novel LED-based compact system capable of projecting two parallel, thin light lines of length 20-40mm, at a working distance of 100-200mm.
- Objective 2.2 - Demonstration of multiple-line light projection system – A novel LED-based compact system capable of projecting >4 parallel, thin light lines of length 20-40mm, at a working distance of 200-400mm.
- Objective 2.3 - Demonstration of 2D triangulation sensor for displacement measurement with dual- and multiple-line measuring points – The 2D triangulation sensors have a displacement resolution of 2-10 μm and a relative temporal resolution of a few tens of microseconds (i.e. to allow for the measurement of transit time of the pressure wave with accuracy of few tens of microseconds).
- Objective 2.4 - Development of signal processing algorithms for the extraction of PWV data from 2D triangulation sensor with dual- and multiple-line measuring points – that ensures the measurement of the local PWV with 2.5% accuracy.
- Objective 2.5 - Demonstration of VascuLight instrument with full functionality – This objective included the development of the main unit (CVL-Main) and the optical head CVL-OH200.

3. SOCIETAL
- Objective 3.1 - Definition of the contactless PWV measurement approach as a new diagnostic mean – allowing for a greater number of individuals to have access to periodic screening of the health of their cardiovascular system at a much-reduced cost for National Health Systems.

4. COMMERCIAL / BUSINESS
- Objective 4.1 – Initiation of CE marking of VascuLight instrument – in order to rapidly enter into the market.
- Objective 4.2 - Business plan for the series production and marketing of VascuLight instrument – A credible Business Plan was elaborated, with the goal of optimizing the investment and effort of the participating SMEs that will jointly manufacture the VascuLight instrument.

Project Results:
The S&T work that was performed in the NISTAS project was articulated around six Work Packages (WPs), that are:
- WP1 “Project management”
- WP2 “Optical Sub-Systems”
- WP3 “Electronics & Signal Processing”
- WP4 “Assembly and Demonstration of the VascuLight Instrument”
- WP5 “Clinical Study”
- WP6 “Exploitation and Dissemination”.

The WP1 controlled the project during each phase of the VascuLight development, taking care of technical and administrative coordination, communication, document management as well as timing and progress monitoring. The WP2 was related to the optical subsystem prototyping. Its outcome included the specifications of the signal processing algorithm (that were exploited in WP3) and the implementation of single line and multiline LED contactless sensor that was used in the implementation of the VascuLight prototype. The WP3 represented the first engineering step of the VascuLight prototype in the NISTAS project. The development process for WP3 was related to three main interconnected streams, that converged to the prototyping of an initial version of the product VascuLight. The WP3 implemented:
- the User Interface for the VascuLight device;
- the data analysis system;
- the VascuLight electronic board and the related firmware development.

These development streams were driven by the system specifications that were defined in WP2 and by the signal processing algorithm that was optimised from a hardware and software co-design point of view. The outcome of WP3 was an initial prototype of the VascuLight product that needed to pass through a second engineering and integration step in WP4 to become a more advanced product.
The last stage of development involved WP5 with a pre-clinical test phase based on volunteering with the purpose of setting up the guidelines for the optimal measure configuration. To improve the effectiveness of the test phase, a user-friendly web-based system, to assist the people involved into the test and to continuously monitor the results and the possible faults or improvement hints, was implemented.
The NISTAS obtained results were disseminated according to the WP6 activities focusing on the increase of awareness about the VascuLight system and its future impact to shape the screening of the status of the vascular system of human patients.

At the level of WPs, from a spent effort point of view, the use of resources by the consortium partners for each WP respected what was planned originally by the NISTAS Description of Work (DoW). The WPs specific main S&T results/foregrounds can be described as follows.

WP1: Management
- WP1 Activity Type: MGT
- WP1 Leader: EXYS
- WP1 Total Effort: 10PM
- WP1 Starting Date: M01
- WP1 Ending Date: M24
- WP1 main S&T results/foregrounds: The NISTAS management activities can be enumerated as follows:
- organise the consortium meetings (phone conferences, physical meeting...) according to what was agreed in the project DoW,
- define and follow-up procedures for internal acceptance of deliverables, publications, etc,
- set up the NISTAS handbook for day-to-day follow-up of the project,
- elaborate, update and maintain the project website,
- maintain the measurements of success factors and risk factors,
- deliver the reports as contractual obligations,
- lead the dissemination activities for the NISTAS project.

On the technical part, EXYS has coordinated the activities needed to maintain coherence over the developments that were carried out in the project technical WPs.

WP2: Optical sub-systems
- WP2 Activity Type: RTD
- WP2 Leader: UCC
- WP2 Total Effort: 34.75PM
- WP2 Starting Date: M01
- WP2 Ending Date: M24
- WP2 main S&T results/foregrounds:

In this WP, the optical sub-system satisfying the clinical requirements of a low-cost and durability, was developed. The main obtained results in WP2 can be described as:
- elaboration of the functional specifications of:
- the NISTAS optical system (optical 2D triangulation displacement sensor),
- the signal processing algorithm (spatial/temporal resolutions and their implications on HW and SW designs) that was used for the extraction of PWV data from 2D triangulation sensor with dual- and multiple-line measuring points,
- the VascuLight system (PWV measurement method & accuracy; user interface),
- development and testing of the single line LED and multiline LED system,
- demonstration of the PWV measurement using dual laser/LED non-contact triangulation system,
- development of a prototype for the VascuLight optical heads with full functionality.

WP3: Electronics & Signal Processing
- WP3 Activity Type: RTD
- WP3 Leader: EXYS
- WP3 Total Effort: 39.05PM
- WP3 Starting Date: M01
- WP3 Ending Date: M24
- WP3 main S&T results/foregrounds:

This WP used the NISTAS system functional specifications that were elaborated in WP2 to implement the electronic and signal processing building blocks that enabled the contactless measurements of the PWV. Its main obtained results are:
- design of the PCB that is needed to implement the PWV measurement by optical triangulation,
- derivation of the sensing and signal processing algorithms (single, double and multiline displacement measurement) for the extraction of PWV data from 2D triangulation sensor with dual- and multiple-line measuring points,
- definition and implementation of Application Programmable Interface (API) for the NISTAS system users,
- analysis of strategies of the clinical data results for the extraction of patient’s cardio-vascular information.

WP4: Assembly and demonstration of the VascuLight instrument
- WP4 Activity Type: RTD
- WP4 Leader: JUL
- WP4 Total Effort: 25.20PM
- WP4 Starting Date: M12
- WP4 Ending Date: M24
- WP4 main S&T results/foregrounds:

The WP4 activities focused on the engineering and assembly of all the VascuLight sub-systems into a final integrated instrument prototype in order to be used at point-of-care and hospital premises for the screening of a large number of patients in order to validate the VascuLight functionalities. The main results that were obtained in WP4 can be summarized as:
- engineering of the electronic modules and their assembly for the VascuLight instrument prototyping for small series production,
- plan for commercial components and materials procurement,
- demonstration of the VascuLight prototype as a medical instrument to be routinely deployed and used at points-of-care and hospitals.

WP5: Clinical study
- WP5 Activity Type: RTD
- WP5 Leader: CMGCV
- WP5 Total Effort: 27.25PM
- WP5 Starting Date: M01
- WP5 Ending Date: M24
- WP5 main S&T results/foregrounds:

The WP5 was dedicated to undertaking necessary activities for the validation of the NISTAS VascuLight system through clinical trials. To reach such objective, the following activities were done:
- submission to the local Ethical Committee (EC) of the IRCCS Foundation Policlinico San Matteo in Italy the clinical study protocol as a sponsored study using the VascuLight system in its versionv2.0 with the objective to validate the PWV results in a large series of normal subjects aged 18-65 years,
- the EC evaluated the prototype in terms of safety and functioning and gave a favorable opinion on the collection of data for the pre-clinical study that needed to be submitted to the Ministry of Health for the clinical trial on a large population,
- IRCCS contacted an insurance agency to prepare documents for the stipulation that protects healthy volunteers or subjects who undergo the measures and elaborated all necessary documents to implement the NISTAS clinical trials,
- conduction of training activities about the use of the different versions of the Vasculight system.

WP6: Exploitation and dissemination
- WP6 Activity Type: OTHER
- WP6 Leader: JUL
- WP6 Total Effort: 19PM
- WP6 Starting Date: M01
- WP6 Ending Date: M24
- WP6 main S&T results/foregrounds:

This WP undertook activities in order to increase the awareness about the NISTAS VascuLight system and its potential to shape the medical market of screening of the status of the vascular system of human patient. The obtained results can be described as:
- dissemination of the VascuLight system among the medical scientific community and stakeholders and increasing of the awareness about the contactless technique based on light as a driver that can revolutionize the screening and prevention of vascular diseases,
- initiation of the CE marking for the VascuLight system,
- targeted exploitation opportunities with a wide number of end-users (medical institutions and individuals) and of medical instrumentation market players,
- Identification of a credible route for commercial exploitation of the VascuLight system. The market analysis revealed that the niche markets targeted by the NISTAS products are in the area of diagnostic screening markets. Therefore, the business model that is envisaged for the NISTAS product is the launching of an innovative medical diagnostic startup company, called “NISTAS”. The company’s initial flagship product, Vasculight, is a revolutionary breakthrough technology that delivers the potential for up to 90% accuracy in the detection of CVD through the use of low powered LED light and algorithm-based automated classification. The Vasculight system will be used by nurse personnel, without the need to involve directly clinicians in the screening activity.
Potential Impact:
The NISTAS project will have an impact on the medical instruments technologies intended for screening of the status of the vascular system of human patients. It responds to an unmet need for fast methods for clinical screening by bringing an innovative contactless technique into the life science/medical fields. The paradigm of this project features is the transfer of photonic and electronic technologies, that are already deployed in the industrial field to perform non-contact measurements on unanimated objects, to the diagnostic medical and veterinary fields. The need for fast, low-cost and non-invasive diagnosis methods and instruments, to be deployed at point-of-cares and to be made available to the European population, matches well with the potential offered by modern photonic and electronic technologies. The NISTAS consortium believes that a crucial point for the well-being of tomorrow’s European society is the pervasive application of smart technologies to those fields that have the largest impact on people well-being: health. As a matter of fact, the proposed NISTAS system will allow an improved quality-of-life and a parallel growth of industrial production, technology know-how and economic return.
The NISTAS system strategic impact will be in the concretisation of the pervasive applications of smart technologies to the medical field by providing comfortable instruments to monitor the health of citizens, especially for the vascular system of human patients as this field has the largest impact on people well-being.
Furthermore, the NISTAS project has also impact on the competitiveness of its consortium SMEs. The outcome of the project significantly increased the technological knowledge of each SME partner. Their competences were better matured during the project and the competitiveness of their solutions and applications in the NISTAS related market segments was highly improved.
In summary, the NISTAS elaborated system will strategically impact the future medical instruments market by:
- generating new industrial/service medical instrument opportunities in Europe,
- reinforcing European industrial leadership in the future domain of medical instruments,
- fostering the consortium SMEs roadmaps to medical instruments mass market commercialisation,
- opening the door for the consortium SMEs to new and future applications.

The dissemination activities that were performed by the NISTAS consortium partners showed a big interest of the stakeholders of the medical domain namely the one of the screening of the status of the vascular system. Such interest motivated both ECLEXYS and JULIGHT to envisage a joint patenting approach for the future exploitation of the NISTAS results through the launching of an innovative medical diagnostic startup company, called “NISTAS”, which will commercialise the NISTAS Vasculight system.
List of Websites:
- NISTAS Web site - http://nistas.eclexys.com
- Relevant contact details
- Angelo Consoli, ECLEXYS SAGL, Switzerland.
- Tel: +41 76 316 23 14
- Fax: +41 91 600 00 01
- E-mail: angelo.consoli@eclexys.com