01 | Strategic Report | ANGLE plc Annual Report and Financial Statements 2023 |
CORPORATE RESPONSIBILITY REPORT
Sustainability and Environment, Social and Governance (ESG) overview
ANGLE's mission is to change the way that cancer is diagnosed, treated and monitored
ANGLE continues to measure and monitor its social, economic and environmental impact, benchmarking against key policies, standards and frameworks that map directly to the United Nations Sustainable Development Goals (SDGs).
The 17 SDGs were set in 2015, as agreed by all United Nation Member states, and underline the commitment of the members to "peace and prosperity for people and the planet, now and into the future"1. This agreement put into place ambitious sustainability targets to be achieved by 2030.
ANGLE has targeted 10 of the total 17 SDGs which are of high materiality to both the industry within which ANGLE operates, and ANGLE as an individual business entity. ANGLE also continues to track, meet and monitor Sustainability Accounting Standards Board (SASB) standards.
ANGLE ESG Priorities | |
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Encourage diversity, inclusion and equality
1. www.concern.org.uk/news/explained-sustainable-development-goals
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Liquid biopsy
Towards a sustainable future of cancer care
Good Health and Wellbeing, Goal 3 of the United Nations 17 Sustainable Development Goals. This goal sets out to "ensure healthy lives and promote well-being for all at all ages" and includes a target to reduce mortality by one-third
from all non-communicable diseases, including cancer, by 2030. This goal also aims to increase accessibility to affordable healthcare by all, while also supporting research and improving health financing to reduce deaths from both communicable and non- communicable diseases.
ANGLE's stated mission is to change the way that cancer is diagnosed, treated and monitored. The Parsortix system enables the capture and harvest of circulating tumour cells (CTCs), which are cells shed from a tumour into the peripheral blood, for analysis. This is known as a liquid biopsy.
Liquid biopsy is a minimally-invasive diagnostic technique that involves the analysis of various biomarkers in a patient's bodily fluids, such as blood or urine, to detect and monitor diseases, particularly cancer, and ANGLE believes its Parsortix liquid biopsy system has the potential to significantly improve care for cancer patients while also reducing the significant costs and resources involved in cancer care.
ANGLE's Parsortix liquid biopsy system has the potential to contribute to the health and wellbeing of millions of people worldwide by:
- reducing or eliminating many of the risks associated with current standard of care cancer diagnosis;
- providing complementary and additional diagnostic and prognostic information for clinical decision making;
- providing complementary information on suitable treatment, and the early detection of response or resistance to treatment;
- enabling the monitoring of tumour evolution and metastasis; and
- detecting minimal residual disease (MRD) prior to current standard of care.
As the Parsortix system relies on a blood rather than a tissue sample, the technology has the potential to significantly reduce patient travel and the consumption of healthcare resources, as blood can be drawn locally and shipped (with other laboratory specimens) reducing the higher travel and healthcare costs associated with an individual travelling to a hospital or clinic for a tissue biopsy.
The Parsortix system and the analysis of the CTCs isolated using this liquid biopsy technology has the potential to revolutionise the future of cancer care, both by improving the health and wellbeing of millions of cancer sufferers worldwide, while also helping to reduce the impact of healthcare provision on the environment.
The role of liquid biopsy in improving healthcare
The targets of the Good Health and Wellbeing SDG goal are reflected in the UK's NHS Long-Term Plan which sets out ambitions for cancer care.
These include that:
- by 2028, the NHS aims to improve diagnosis of stage 1 and 2 cancers from 50% to 75%. This translates to 55,000 more patients surviving cancer per year for at least five years after diagnosis;
- faster cancer diagnosis will enable those patients who are diagnosed with cancer to receive treatment sooner;
- genomic testing will be offered to all cancer patients;
- in line with the NHS Comprehensive Model for Personalised Care, all cancer patients will have access to personalised care and targeted treatment; and
- after treatment, patients will have rapid access to clinical support when they are worried that their cancer may have recurred.
The socio-economic impact of cancer is vast. An estimated one in two men, and one in three women will be diagnosed with cancer during their lifetime. This equates to almost 18 million new cases globally per year, of which ~50% will be fatal1. The incidence of cancer is also rising, and it is estimated that the cost to the global economy could be in the region of $25.2 trillion international dollars between 2020 and 20502. Each patient's cancer is unique, highly complex and changes over time. Effective treatment requires personalised care that evolves as the cancer progresses. As such, there is a desperate need for more accurate, cost-effective and less invasive means to enable cancer diagnosis and monitoring.
The existing standard of care for obtaining tumour material for evaluation and diagnosis is a solid tissue biopsy. Tissue biopsy is invasive, time-consuming, potentially harmful and unsuitable for longitudinal monitoring. Furthermore, it is well established that tumours are highly heterogeneous and single, or even multiple biopsies, may be insufficient to accurately determine the expression of biomarkers which may facilitate patient candidacy for targeted therapies.
- https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
- Chen, S. et al. JAMA Oncol. 9, 465 (2023).
03 | Strategic Report | ANGLE plc Annual Report and Financial Statements 2023 |
CORPORATE RESPONSIBILITY REPORT CONTINUED
Social (community)
The importance of our employees
An open and inclusive work environment
ANGLE actively strives to foster an environment of inclusivity and equality. ANGLE does not tolerate, and will take strong action against discrimination or harassment of any kind and specifically on the grounds of race, colour, nationality, ethnic or national origin, religion, gender, marital status, sexual orientation or medical condition including progressive illness, age and disability.
Mental health
ANGLE recognises the importance of the mental health of our employees and the relationship between physical health and mental health. ANGLE promotes a cycle to work scheme and encourages the use of Surrey Research Park's extensive grounds and facilities.
Managers and HR are proactive in encouraging staff to take annual leave regularly throughout the year, offer flexible working to staff and provide Employee Assistance Plans and the option to enrol for private health insurance. ANGLE's offices provide wellness rooms and breakout spaces for use by all employees, as well as providing access to trained mental health first aiders throughout the organisation.
As well as supporting and promoting World Mental Health Day, ANGLE piloted a Mental Health Awareness Training Course on 11 October 2023. This face-to-faceworkshop was designed to help the team learn more about mental health including spotting the warning signs, starting conversations, and supporting each other.
Communication is key
ANGLE recognises the importance and impact of clear and timely communication throughout all levels of the organisation. To this end, ANGLE makes use of multiple platforms, including the appropriate use of information technology, to ensure the dissemination of relevant, accurate and prompt organisational and operational information.
ANGLE uses various platforms to increase communication and feedback including the performance management platform Clear Review, PeopleHR for management of employee data, MS Teams for communications, and monday.com to assist with project management. These technologies are used to increase transparency and ownership and to streamline workflow processes, improving the overall employee experience and improving efficiencies. Companywide meetings are scheduled regularly to include a CEO business update, project spotlights from across the organisation and a social/team building element.
ANGLE offers
Competitive & comprehensive salary and benefits
Flexible & part- time working arrangements
Ongoing training & development
Seeks to promote staff internally
Our core values
Adaptability
We embrace change with resilience and innovation, we believe in the power of flexibility, continuously evolving to meet challenges and seize opportunities
Resilience
Our determination helps us navigate adversity, learn from setbacks and emerge stronger
Getting it done
Our go-getting attitude empowers us to achieve success with an optimistic, can-do spirit
Loyalty
The glue that keeps us together, we are honest and committed to our mission and each other
Togetherness
We embrace unity and collaboration; we foster a culture of togetherness that empowers every individual to contribute their unique strengths towards our shared success
120
permanent staff at year end
56%
female staff at year end
30
nationalities represented
82%
of staff have higher education qualifications including Degrees, Masters and Doctorates
ADAPTABILITY
RESILIENCE
GETTING IT DONE
LOYALTY
TOGETHERNESS
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Health and Safety: a shared responsibility
ANGLE takes ultimate responsibility for employee health and safety and takes every reasonable precaution for the protection of workers in the workplace, including providing employees with information, training and competent supervision for their specific work tasks. However, Health and Safety is a shared responsibility, and ANGLE requires that every employee must also strive to protect their own health and safety by working in compliance with the law, and with safe work practices and procedures established by the employer to reduce the risk of injury and occupational disease. ANGLE makes every effort to provide a safe, healthy work environment and commitment to health and safety forms an integral part of this organisation from the executives to the employees.
Quality runs through all we do
ANGLE is committed to fulfilling market and regulatory requirements to meet both the needs of the customer and for the benefit of the patient. This ensures that ANGLE produces quality in vitro diagnostic devices and accessories for the capture, harvest and analysis of cells present in blood based on their larger size and deformability. The quality of medical devices produced by ANGLE will conform, as a minimum, to the In Vitro Diagnostic Directive 98/79/EC (transitioning to In Vitro Diagnostic Regulation EU 2017/746), FDA GMP 21 CFR 820 and other requirements
as applicable to the countries in which the device or service is intended to be offered for sale.
Staff are encouraged to identify non-conformities and inefficiencies with the intent of creating and operating systems which cause zero harm to the patient. It is the policy of the Group to have a commitment to quality, with all quality procedures being maintained to ISO 13485:2016 +A11:2021 reflecting the current state of the art and post market surveillance findings. This policy is regularly reviewed and notified to all employees to ensure that it is understood, implemented and maintained.
ANGLE's Quality Management System falls within the scope of ISO 13485:2016 +A11:2021 and covers the design, development, manufacture, testing, storage, distribution, service and sale of in vitro diagnostic devices, associated equipment and consumables for the capture and harvest of cells present in blood. There are no exclusions within the Quality Management System. Customer requirements, national standards, directives, external documents and regulatory and statutory requirements are all considered as inputs to our Quality Management System. To ensure that ANGLE's Quality Management System remains effective Key Performance Indicators (KPIs) are established and performance data is analysed. Issues arising are investigated in accordance with
ISO 13485:2016 Corrective and Preventative Action (CAPA) and Defect Reporting Procedures. The CAPA process requires evidence of effective completion and all information is captured in our Quality Management System records and confirmed through internal and external audits.
ANGLE's Quality Management System is subject to inspection audits by an external Notified Body (British Standards Institution, BSI). A complete annual programme of internal audits is also established. ANGLE recently committed to a re-certification audit by BSI which resulted in a positive recommendation and valuable feedback. The audit focused on all critical areas of the standard requirements and ANGLE's Quality Management System. Based on the samples assessed, we were commended for our robust practices, which effectively meet the requirements of the ISO/EN/ BSI 13485:2016 standards.
The BSI auditors were particularly impressed with several aspects of our organisation, including our state-of-the-art facilities and the exemplary condition of our laboratories. Additionally, they commended the effectiveness of our robust risk management and analysis frameworks, alongside the effectiveness of
our automations, internal audit procedures, and document management systems, noting their significant contribution to the effectiveness of our Quality Management System.
Offered
Six science placements
- Four in Engineering
- Two in R&D
Two apprenticeships
- Successfully completed in 2023
Several work experience placements
ANGLE plc
Works with
Cancer Research UK
Local universities
ANGLE has donated products and funded medical research in pursuit of our mission to transform the way cancer is diagnosed and treated
Promotes
World Cancer Day
World Cancer Research Days
World Mental Health Day
Mental Health Awareness Week
Our staff fundraise on behalf of
05 | Strategic Report | ANGLE plc Annual Report and Financial Statements 2023 |
CORPORATE RESPONSIBILITY REPORT CONTINUED
Governance
Ethical and responsible management
Leadership from the Board of Directors
The Board is committed to high standards of corporate governance and adheres to the Quoted Companies Alliance (QCA) Corporate Governance Code for small and mid-size quoted companies (the "QCA Code").
Section 172 statement
The Corporate Governance Report on pages 50 to 57 and this Corporate Responsibility Report set out how the Board has approached its duty under Section 172 of the Companies Act, which is summarised below, in order to meet these requirements. Specifically, it refers the reader to QCA Principle 1 (Strategy and business model), Principle 2 (Meeting shareholder needs), Principle 3 (Manage our responsibilities to wider stakeholders) and, in particular within this report, the sections headed 'The importance of our employees' and 'Health and safety: a shared responsibility' and the section headed 'Environment: a core priority' for the impact of the Group's operations on the community and environment. The Corporate Governance Report can also be found on the Company's website www.angleplc.com.
In accordance with Section 172 of the Companies Act 2006, the Directors recognise the importance of our wider stakeholders to the sustainability of our business. The Directors behave and carry out their activities to promote the long-term success of the Group for the benefit of the Company's shareholders, employees, partners, customers, suppliers and other stakeholders such as regulatory authorities.
The Group engages with stakeholders to reflect their insights and views when making decisions on strategy, delivering operational effectiveness, driving initiatives and delivering outcomes.
The culture and values promoted by the Directors create a focus across the Group on observing and maintaining high standards of regulatory compliance, quality control and business conduct whilst promoting the long-term success of the Group.
Employee share schemes are used as a means of encouraging ownership and aligning the interests of employees and external shareholders. Awards are generally made annually to all qualifying staff. This facilitates an inclusive environment, one where all staff benefit from ANGLE's success.
Marketing ANGLE products and services
ANGLE is required to have systems in place to ensure it meets medical device regulatory standards for the accurate marketing of function and performance of in vitro diagnostic (IVD) and research use only (RUO) products in the territories in which ANGLE operates. ANGLE is in the process of transitioning from IVDD to IVDR in Europe, while maintaining MDR 2002 status in the UK.
On 25 May 2022, the US regulator, FDA, granted a De Novo Class II classification request for the Parsortix PC1 system for the capture and harvest of CTCs from metastatic breast cancer (MBC) patient blood for subsequent, user validated, downstream analysis. This was closely followed by an IVD CE mark in Europe for the same indication and registration of the system with the UK Medical and Healthcare Regulatory Agency (MHRA), in October 2022 and 21CFR 801, 809, 820, 830 and 1010 in the USA.
ANGLE currently holds ISO/EN/BSI 13485:2016 certification for ANGLE Europe Limited, while ANGLE's clinical laboratory is working towards securing ISO 15189:2022 registration in the UK. MHRA registration is in place for the Parsortix PC1 system and ANGLE retains membership of the British In Vitro Diagnostics Association (BIVDA) and Regulatory Affairs Professionals Society (RAPS) in the UK.
To retain CE IVD status of the Parsortix PC1 system in the European market, ANGLE is required to produce a Post-Market Performance Follow-up (PMPF) Report and a Periodic Safety Update Report (PSUR) annually as part of ongoing post-market surveillance (PMS) and vigilance activities. The primary goal of PMPF activities is to continuously review the performance of the device to ensure that it reflects the current state of the art. PMPF also confirms the safety and scientific validity throughout the expected lifetime of the device, identifying previously unknown or emergent risks and any events of misuses. The PSUR summarises all the PMS activities including PMPF, device usage, vigilance and quality assurance, as well as describing the safety profile of the product based on the analysis of both internal and external data from those who use the device. The PSUR is designed to assess and confirm that the benefit-risk profile of the product has not been (or has been) adversely impacted and remains unchanged.
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ANGLE clinical studies
It is essential that ANGLE engages in clinical studies to evaluate new medical applications.
To engage in clinical studies ANGLE must comply with applicable national and international ethics, medical device and IVD regulations and requirements, which includes conforming to:
- Food and Drug Administration (FDA) Rules and Regulations
- Code of Federal Regulations (CFR)
- European Union Medical Device and IVD Regulations
- Institutional Review Boards (IRB) / Ethics Committees (EC)
- International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
ANGLE sponsored study investigators are responsible for ensuring that the study is performed in accordance with the study protocol, current ICH guidance E6(R2) on Good Clinical Practice (GCP), and in-line with applicable regulatory and institution-specific requirements.
Voluntary informed consent from patients involved in clinical studies is obtained prior to the commencement of any study-related activity. Informed consent is gathered in accordance with principles that originated in the Declaration of Helsinki, current ICH and GCP guidelines, applicable regulatory and/or country specific requirements, and institutional policies.
Our pharma services clients must provide assurances that any samples have been ethically provided in line with ICH GCP and other applicable regulations prior to the commencement of processing.
ANGLE is committed to ensuring the highest standards of health and safety for employees, visitors, the general public and those involved in our clinical studies. ANGLE complies with all applicable laws and regulations wherever it operates and holds all the licences necessary to operate its business and studies.
Our governance values
Integrity
- Meeting commitments and earning trust
Customer focus
- The ability to identify, assess, understand and meet customer/ stakeholder needs
- Passionate about meeting or exceeding customer/stakeholder needs
Collaboration and inclusion
- Building effective, beneficial and enduring relationships, internally and externally
- Engaging positively with diverse views and cultures
Shared excellence
- Driving to do things better, striving for and setting new standards of performance
- Being constantly curious, fostering and rewarding innovation
07 | Strategic Report | ANGLE plc Annual Report and Financial Statements 2023 |
CORPORATE RESPONSIBILITY REPORT CONTINUED
Environment
A core priority
Waste management
ANGLE aims to recycle as much as is feasibly possible, both through our landlords, Surrey Research Park and via specialist recycling. We recycle:
- Electrical equipment
- Coffee pods
- Shipment materials
We use plumbed water coolers and reusable bottles to reduce our consumption of plastic bottles.
ANGLE participates in Surrey Research Park's Food Waste scheme launched in March 2023. Food waste collected from participating buildings is collected and processed to produce biogas and digestate. Gas engines then convert the biogas to renewable energy while the digestate is used as fertiliser on local farmland.
Energy management
100% of our energy comes from renewable sources.
Office lighting and heating are sensor-controlled to reduce consumption.
Plumbed boiling water taps are used in our offices which are more energy efficient than kettles.
Travel
ANGLE aims to reduce fossil fuel use by:
- Encouraging the use of technology to reduce business- related travel
- Carpooling
- Encouraging hybrid and flexible working
- Promoting a cycle-to-work scheme
ANGLE's technology, the Parsortix system, has the potential to significantly reduce patient travel and the consumption of healthcare resources.
Blood can be drawn locally by a phlebotomist and shipped (with other laboratory specimens) rather than an individual having to drive to a clinic for a tissue biopsy.
Parsortix technology uses pressure to harvest cells rather than a chemical approach thereby reducing/negating the need for antibody reagents and other chemicals and their resultant impact on the environment.
ANGLE strives to find new ways to reduce our waste and energy footprint.
ANGLE plc Annual Report and Financial Statements 2023 | 08 | ||||||||||
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ANGLE plc published this content on 05 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 July 2024 09:33:05 UTC.