The NISTAS project aims at developing a novel medical instrument - VascuLight (VL) - for fast and contactless screening of the status of the vascular system of human patients.
NISTAS responds to the need for fast, reproducible, and widely available measurement of the arterial stiffness that is a recognized predictor of cardiovascular risk and mortality. Arterial stiffness is considered as well as a potential marker for monitoring the beneficial effects of medical treatments for arterial diseases.
Today, pressure in arterial blood is measured by contact techniques, while VL will perform contactless measurements at a local (carotid, arm and leg arteries) and regional level (combined carotid-arm/leg measurements). The measurement instrument will be based on optical technologies and will be coupled to a control unit, where fast processing will allow a prompt diagnosis.
In NISTAS, 4 SMEs will lend their expertise to the common goal of realizing the VL instrument, transferring photonic and electronic technologies so far deployed in other industrial fields to life science and medical areas. RTD Partners with clinical expertise will guide the consortium towards full clinical tests, with the goal of validating the effectiveness of the proposed method for vascular disease and risk diagnosis. NISTAS will also develop a complete path towards CE certification of the instrument, allowing an immediate exploitation of project results, supported by the planning of series production manufacturing by the involved SMEs.
The NISTAS Consortium aims at the deployment of the new VL instrument at European hospitals and points-of-care, and expects to introduce measurements techniques at the same level of health dissemination as blood pressure measurement.
NISTAS Main Objectives:
SCIENTIFIC / MEDICAL
- Demonstration of contactless repeatable optical measurement
- Demonstration of VascuLight as a screening method for prevention of vascular diseases
- Demonstration of VascuLight as a diagnostic and monitoring tool
- Generate practical guidelines for translation of the use of VascuLight in any out-patient setting
Test on a population hundreds of of normal and diseases subjects to assess prevention capabilities.
Monitoring effectiveness of drugs targeting specific aspects of the vascular system. This objective is subject to a partnership with a pharmaceutical/drug Company willing to collaborate in the project as external industry advisor.
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 will be devised to train end users on the performance and operation of the Vasculight.
- Demonstration and proof-of-concept of optical technology for the NISTAS intended usage
- Demonstration of triangulation methodologies and signal processing algorithms applied to the NISTAS intended usage
- Demonstration of VascuLight instrument with full functionality
- Definition of the contactless measurement approach as a new Gold Standard
This will allow 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 Nation Health Systems. This objective will be possible thanks to the quick and efficient measurement performance/procedure offered by VascuLight. [This objective will be targeted and planned during the Project, and possibly achieved in the years following the completion of the Project]
COMMERCIAL / BUSINESS
- CE marking of VascuLight instrument
- Business plan for the series production and marketing of VascuLight instrument
For rapid entry into the market, starting immediately after Project’s completion.
A credible Business Plan will be organized, with the goal of optimizing the investment and effort of the participating SMEs that will jointly manufacture the VascuLight instrument.
Objectives reached so far:
The NISTAS reached objectives during the First Project Period are the following:
- Optical sub-system: at the level of the NISTAS optical part, the performed work and obtained results during this first period reporting can be summarized as follows:
- Investigation of the NISTAS related State of The Art and derivation of technological roadmaps.
- Description of the NISTAS system specification for the optical sub-systems needed for the VascuLight optical head.
- Design of the LED-based dual-line triangulation system.
- Electronic & Signal processing: for this part, the performed work and obtained results during this first period reporting can be described as follows:
- Investigation of preliminary evaluations in order to demonstrate that the proposed VL device can successfully be used to estimate the PWV by a totally contactless method and determine the conditions to be fulfilled in order to reach this objective.
- Study of signal processing algorithms for PWV measurement, investigation of efficient techniques and methods for its calculation.
- Clinical Study: with reference to the NISTAS Clinical Study that is envisaged, the following activities were done:
- Specification of the setup configuration of the Vasculight version 1.1 prototype that will be used for clinical evaluation.
- Submission of the planning of the first part of the clinical study to the local Ethical Committee of the IRCCS Foundation Policlinico San Matteo (P3): the non-sponsored pilot study using commercially available sensors and acquisition unit. The objectives of this part of the study are:
- to test laser based measures on human subjects, identifying significant measurements for the future clinical study,
- to develop and test the data analysis algorithm.
- Preliminary business exploitation investigations: an initial market strategy for the Vasculight was investigated and is mainly centered on the market potential of fast, low-cost and contactless cardiovascular screening techniques. The advantages and strengths of Vasculight approach were highlighted in this study, as well as weaknesses and threats to a successful market development.