2022-11-009 - ATMOS - Wearable personal sampler to monitor exposure to atmospheric toxicants

ATMOS

2022-11-009

A disruptive wearable digital solution addressed to monitor the personal exposure to organic air pollutants in adult and paediatric patients with chronic respiratory disease

Environmental Social & Governance are taken into account in the realisation of the project. All the components of the device are reusable up to 50 times, thus assuring the environmental sustainability of the device.

Health and social impact : A recent report of the World Health Organisation estimates that almost the whole global population (99%) breathes air that exceeds the WHO air quality limits and, therefore, threatens their health. Air pollution is the fourth greatest risk factor for human health and has been linked to seven million deaths globally and an excess of 100 million disability adjusted life years annually. An estimated 5.5 million lives were lost in 2013 to diseases associated with outdoor and household air pollution. Besides, there are also social inequalities regarding air pollution exposure. People with lower educational attainment and the more deprived the social class and from low- and middle-income countries are those suffering the highest air pollution exposures and, therefore, the highest health threats. ATMOS is easy to wear and reusable, facilitating large-scale studies on vulnerable populations that will evidence air pollution threats and inequalities, helping to design corrective measures. Economic impact : A joint study of the World Bank and the Institute for Health Metrics and Evaluation (IHME) published in 2016, estimated the cost of premature deaths related to air pollution. Exposure to atmospheric pollutants represents a major global annual economic impact. The deaths associated to this exposure cost the global economy about US$225 billion in lost labour income and more than $5 trillion in welfare losses (more than the 6% of the global economic production). In Spain, the cost of atmospheric pollution to the Spanish national health system was estimated in 2010 as the 3% of the national gross product, corresponding to 20,000 lost life years as premature deaths, and more than 200,000 years adjusted by disability. A personalised surveillance of the air pollution exposure, as the one provided by ATMOS, will have a huge impact on reducing these costs. Environmental impact : ATMOS is designed as a device aimed to have a long useful life and uses reusable components, thus having a low environmental impact. Sorbent materials can be reused after each monitoring by conditioning them at high temperatures, having a life cycle of ca. 100 uses. Microsensors have even a larger durability, depending on the type and brand. During the development of this project, we will select those batteries with larger useful life and lower environmental impact. However, the environmental impact of ATMOS will go beyond, since the data about personal exposure to air pollutants will serve as evidence to increase awareness about air pollutant emissions and to influence future environmental policies. Improvement of diagnoses and therapies: The device and tools developed here, aim to cover the gap between air quality and chronic respiratory diseases exacerbations. First, the microsensor will be a continuous and immediate readout of the personal air quality alerting the user of conditions that might trigger exacerbations enabling the user to take actions in this respect. Second, the chemical characterisation of the air pollutant profiles by the sorbent tubes not only will help to increase our current knowledge on the role of specific organic air pollutants on chronic diseases progression, but also will provide evidence of their toxicity to influence future atmospheric emission policies. Finally, we will be able to train AI microsensors to distinguish the air quality conditions that might trigger exacerbations to each chronic respiratory disease patient, decreasing the possibilities of exacerbations and improving their quality of life and health status, not only of the chronic respiratory disease, but also of the associated comorbidities.

Air pollution is a major environmental health threat. However, there is a lack of information on personal air pollution exposure which is essential to prevent health outcomes. Air monitoring studies have been largely based on the estimation of personal exposure from unspecific data such as survey-based data, or environmental air pollution measurements—i.e. airborne particulate matter, NOx or total volatile organic compounds— in combination with mathematical prediction models, assuming the misconception that all residents living in an area undergo the same degree of exposure to air pollutants. The analysis of exposure biomarkers concentrations in biological samples is commonly used to determine personal exposure, but this approach is restricted to the assessment of few selected compounds, limited by the half-life of the biomarkers in the body, therefore just reflecting recent exposure, and often limited to one spot sample per participant, not representative of larger periods of time. Our solution is a novel product called ATMOS, an innovative passive air sampler designed as a wearable wristband. ATMOS innovation relies on three pillars: i.the accurate chemical characterization of both volatile and semivolatile organic air pollutants by using different type of sorbents in combination with gas chromatography-mass spectrometry; ii.the immediate readout of air quality provided by an in-built microsensor. This signal will help patients with respiratory illnesses to make actions and prevent exacerbations linked to indoor and outdoor air pollution. Also, the integration of a CO2 sensor will indicate the need of ventilation to reduce the transmission of infectious microorganisms spread via aerosols (i.e. covid-19). iii.and the versatility of the device: sorbents and sensors can be personalised depending on the final user. ATMOS and the undelaying developed technology will be a service for environmental health studies and occupational health surveillance.

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After the development and patent of ATMOS, technology transfer can follow three different exploitation models: -License agreement to a company in the field of surveillance chronic disease with clinical and occupational. -Third-party service to certified environmental analytical laboratories recognized by the quality accreditation ISO 9001. -Establishment of a spin-off company to manage the developed device and services. We believe that this strategy is the most suitable for technology valorization.

Specific solutions available on the market have been analysed to detect possible unmet needs that could be addressed by a technology like Atmos. None of the current solutions provide simultaneously an immediate readout of the quality of the inhaled air in addition to the chemical composition of the air like ATMOS. Specifically, the three of them are based on polydimethylsiloxane as sorbent to monitor air pollutants, which is a sorbent not able to capture the more volatile air pollutants. Also, none of these solutions incorporates electronical microsensors able to provide immediate air quality readout. Since there are no similar solutions in Europe and our device is unique, we believe that it will be well accepted by the market.

Considering the capabilities of these devices, a possible application can target the occupational market. Companies can easily monitor toxic gases in their warehouses and work areas by implementing an intelligent control system. With the help of smart portable detection technology that minimizes human errors, employees can work in a safe environment where gas exposures can be successfully detected, preventing hazards for employers. In terms of clinical applicability, ATMOS is considered a detection tool for exposomes in at-risk patients and may become a standard in public health research. ATMOS in public health should become a standard for measuring individual exposure to customizable health-hazardous compounds, particularly for patients with respiratory conditions that necessitate this solution. The global chronic respiratory diseases treatment market size was worth around USD 143 billion in 2021 and is predicted to grow to around USD 300 billion by 2028 with a compound annual growth rate of roughly 17.5% between 2022 and 2028. The use of the technology developed here, will prevent exacerbations thus reducing the need of pharmacological and other clinical approaches to treat these crises increasing the health status of the patients and the improvement of the associated comorbidities.

Our current need for funding is for personnel that helps with the project management and with the laboratory and field validation.

We are seeking funding to develop a minimum viable product/service (MVP/MVS).

The OnBREATHE project has been awarded the R2B (Research 2 Business) grant by the FURV (Fundación URV) to help in the Laboratory and Field Validations with a grant for a master's/doctorate student and to attendance at fairs or congresses for results’ dissemination or for clinical purposes.

The main objective of ATMOS is to develop and validate a disruptive wearable digital solution to monitor personal exposure to organic air pollutants and health status of chronic respiratory disease adult and paediatric patients. This main objective is divided into two secondary objectives: First: the development of the device from the design of the PCB, sorbent tubes and the initial prototype and the VOCs and SVOCs analytical methods.

Financial: The development and validation of the prototype requires efforts in terms of personnel, supplies, analytical measurements, programming, etc. We aim to develop the prototype and associated technologies and assess their viability on clinical applications (TRL5). Once validated, we will apply to further transference calls to advance on the TRL stage chain.

A clear roadmap is established to achieve a functional Proof-of-Concept (POC) in an operational environment. The roadmap details crucial work packages, including: Research & Conceptualization: Analyzing microsensor technology and existing air quality solutions, collaborating with industry experts to define essential features and adapt the microsensor to the project needs. Software Development: Developing the OnBREATHE app to enable real-time data acquisition and offline data visualization. Sensor Integration & Validation: Collaborating with microsensor manufacturers to ensure compatibility and reliability. Conducting rigorous testing in different environments to validate consistent performance. These steps are being assessed by the project team and the engineering design company. Customization & User Interface: Designing an intuitive interface for flexible customization based on specific needs. Incorporating adjustable settings for personalized assessments. These steps are being assessed by the project team and the ONLEAN company. Pilot Testing & Refinement: Deploying the technology in diverse environments to assess functionality and gather user feedback for iterative improvements will be assessed when the WP3, WP4 and WP5 will begin. Data Security & Privacy: Implementing stringent data security protocols to safeguard sensitive information and ensure compliance with privacy regulations remains a critical focus. Protocols will be implemented to safeguard sensitive information collected during clinical validations. These strategies will be meticulously developed once the validation stages reach their final phase. User Training & Support: The project team will provide comprehensive instructional materials and offer on-site training during app and device installation for clinical users. This ensures a smooth onboarding process and effective software utilization. Partnerships & Collaborations: Forging strategic alliances with public health entities, environmental agencies, and industry stakeholders to expand research initiatives and broaden software capabilities is part of the dissemination plan for the OnBREATHE project.

Patentability study and market study. We are in the process of submitting the patent.

Dr. Noelia Ramírez González is Miguel Servet researcher at the URPNDH of the Institut of Health Research Pere Virgili and the Universitat Rovira i Virgili, where she leads a research line on the effects of early exposure to environmental pollutants in close collaboration with the Metabolomics Interdisciplinary Lab research group. She has authored 30 publications in peerreviewed scientific journals in the fields of analytical chemistry, environmental sciences and metabolomics, 19 of them as main author, and presented communications in 30 international congresses, 7 invited talks and 8 invited scientific workshops. Her research has been granted with prestigious international grants including a MSCA individual fellowship by the European Commission (MSCA-2014- IF-ST-660034). She is currently the principal investigator of 2 competitive projects and a transference contract, and she has participated in a total of 19 research, transference and development projects and contracts.

We are submitting a patent for the device with UNGRIA PATENTES Y MARCAS, S.A and registering the trade name with ELZABURU S.L.P.

We will assess whether the product requires environmental and other appropriate quality certifications, as well as the regulatory process for CE marking.

Personal passive air samplers are an innovative approach to determine individual exposure, since they are easy to use, minimally invasive and less expensive than active samplers. Silicone (polydimethylsiloxane) wristbands have emerged as attractive, simple, inexpensive and unobtrusive personal sampler. Despite their multiple uses, silicone-based wristbands have two main drawbacks: first, they can only absorb semivolatile organic compounds, not being able to monitor the most volatile air pollutants (those present on the gas phase and able to straight pass through the lung tissue into the blood stream); and second, they do not provide an immediate readout hindering of taking preventive measures in case of acute exposure to air pollutants.