SFDR Article 9

PwC certifies KELES as first VC-firm to achieve SFDR Article 9 for digital health investment

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Paris & London – March 24, 2025: PwC and KELES, the pioneering digital health venture capital (VC) firm, are setting a new standard in digital health investment, leveraging ESG and innovation. With its novel, forward-thinking Sustainable Finance Disclosure Regulation (SFDR) Article 9 ESG framework, certified by PwC, KELES is leading the charge in shaping the future of healthcare investment with a strategy that aligns transformative technology and social impact to drive superior financial returns.

KELES is the first digital health VC firm to implement a robust ESG framework that integrates groundbreaking innovation with social impact, improving healthcare accessibility and availability, and ultimately, patient outcomes. By embedding ESG principles into its investment thesis, KELES ensures sustainable value creation and enables cutting-edge technologies to be utilised ethically to improve healthcare for all.

With a targeted fund size of €250 million, KELES is focusing its investments on European growth-stage companies at the forefront of AI-powered drug discovery, precision diagnostics, and next-generation digital health solutions. The firm expects to close its first funding round in the first half of 2025, channeling capital into breakthrough technologies that will define the future of life science and healthcare.

Geoffroy Marcassoli, Sustainability Assurance leader at PwC Luxembourg, said: “Complying with the provisions of Article 9 of the SFDR can be particularly challenging for venture capital investments, as the level and granularity of the data required can be overwhelming and difficult to obtain. The framework developed by KELES not only complies with current requirements but also proactively anticipates future regulatory requirements, such as the revision of the principal adverse impact indicators. With this framework, KELES is demonstrating how European sustainability regulations such as the SFDR can be instrumentalised to meaningfully advance sustainability objectives and invest in the digital transformation of key sectors of the European economy while ensuring a high degree of transparency and investor protection.”

Driving Fund Performance Through ESG

KELES’s SFDR Article 9 ESG framework will shape its investment strategy through:

Positive Social Impact – Healthcare impact assessment ensuring portfolio companies contribute to improved healthcare availability and accessibility, ethical usage of healthcare data and AI, and improved patient outcomes.
Do No Significant Harm – Criteria to assess and minimise potential adverse ESG impacts of investments.
Good Governance – Including diversity and inclusion mandates, requiring transparent gender pay gap reporting and board diversity metrics to attract top talent and reflect the needs of diverse patient populations.

Laurent van Lerberghe, Founder and Managing Partner at KELES, said: “This certification from PwC is an exciting step for digital health investment. Our approach to investing will enable large-scale access to new AI solutions and generate stronger financial returns.”

“KELES’s new ESG principles are structured to generate both immediate measurable outcomes and societal benefits, with the emphasis on sustainable value creation over time and returns that contribute to a healthier and more profitable European ecosystem.”

Supporting Digital Innovation for Sustainable Healthcare

The huge financial opportunity presented by the rapid progression of AI and technology in the healthcare industry also brings an opportunity to deliver significant social impact; lowering the cost of healthcare, bringing drugs to market faster and ensuring more patients can benefit from earlier diagnosis and access better treatments.

David Buller, Managing Partner at KELES, said: “Embedding ESG standards early on in digital health investing supports our shared vision for a healthy, equitable and sustainable future. All our portfolio companies will deliver social impact and we will support them to effectively adhere to our Article 9 ESG principles.”

“As the digital health sector evolves rapidly, KELES will be a key player; funding entrepreneurs and companies that are creating breakthrough technologies to solve health challenges and helping them achieve the highest ESG standards. The PwC SFDR Article 9 certification is a milestone in KELES’s journey to accelerate digital health growth in Europe, fuelling a new era of sustainable, high-performance healthcare innovation.”

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About KELES

Named after the ancient Greek word for “racehorse” or “fast sailing ship,” KELES symbolises the firm’s commitment to speed, agility, and leadership in driving forward healthcare innovation. It aims to accelerate digital health growth across Europe and build global champions.

The founders are committed to investing in transformative healthcare innovations that tackle global challenges while delivering strong financial returns, focusing on new R&D models, and AI and data-enabled diagnostics and patient care.

KELES will back the companies leading the revolution in technology and biotechnology, reshaping the future of healthcare.

For media enquiries or more information, please contact Amy Thomas at SomX: amy@somx.health

About PwC

PwC Luxembourg (www.pwc.lu) is the largest professional services firm in Luxembourg with over 3,800 people employed from 90 different countries. PwC Luxembourg provides audit, tax and advisory services including management consulting, transaction, financing and regulatory advice. The firm provides advice to a wide variety of clients from local and middle market entrepreneurs to large multinational companies operating from Luxembourg and the Greater Region. The firm helps its clients create the value they are looking for by contributing to the smooth operation of the capital markets and providing advice through an industry-focused approach.

At PwC, our purpose is to build trust in society and solve important problems. We’re a network of firms in 149 countries with more than 370,000 people who are committed to delivering quality in assurance, advisory and tax services. Find out more and tell us what matters to you by visiting us at http://www.pwc.com and http://www.pwc.lu.

ONE Fund Management Sustainability-related disclosures for

KELES S.C.Sp., SICAV – RAIF European Digital Health Growth Fund (hereafter “the Fund”)

Website product disclosure for financial products that have sustainable investments as their objective in accordance with Chapter IV – Section 2 of the the COMMISSION DELEGATED REGULATION (EU) 2022/1288 of 6 April 2022 and Article 10 of the REGULATION (EU) 2019/2088 of 27 November 2019 (hereafter “the SFDR”).

Information in accordance with Article 10(1) (a) and (b) of the SFDR
- Summary
- No significant harm to the sustainable investment objective
- Sustainable investment objective of the financial product
- Investment Strategy
- Proportion of investments
- Monitoring of sustainable investment objective
- Methodologies
- Data sources and processing
- Limitations to methodologies and data
- Due diligence
- Engagement policies
- Attainment of the sustainable investment objective
Information in accordance with Article 10(1) (d) of the SFDR
Information in accordance with Article 10(1) (c) of the SFDR

Information in accordance with Article 10(1) (a) and (b) of the SFDR

A. Summary

KELES has developed a Sustainable Investment framework that meets the SFDR Article 9 framework.

Below is a high-level summary of the framework’s approach and methodology:

The Positive Contribution methodology is tailored to the digital healthcare sector’s needs, offering two different pathways for measurable positive impacts. It outlines strategies and rationales for digital healthcare companies to address critical healthcare challenges while aligning with sustainability goals. This includes guidance on how investments in digital health innovations can enhance health outcomes, improve accessibility, and support ethical technology use. Furthermore, it sets metrics for tracking and evaluating these contributions, ensuring that positive impacts are quantifiable and aligned with broader sustainability objectives. KELES’ innovative and pragmatic framework focuses on three core social objectives:

Ethical Use of AI and Healthcare Data
Healthcare Availability and Enhancement
Healthcare Accessibility

The Do No Significant Harm methodology provides a comprehensive approach for each of the fourteen currently mandatory Principal Adverse Impacts (PAIs) for portfolio companies and incorporates recent updates to the PAI indicators. By integrating multiple factors, the methodology helps ensure a thorough assessment, minimizing potential blind spots.

The Good Governance methodology is addressing all key elements of good governance. Additionally, it leverages insights and synergies from the Do No Significant Harm (DNSH) assessment, enhancing its operability and effectiveness in governance evaluation.

KELES is investing in Europe’s Digital Health Growth. It recognizes that SFDR 9 requirements are key drivers of performance and innovation, as well as key differentiator in the market. The binding elements of the investment strategy are to invest solely in sustainable investments with a social objective, as defined within KELES Sustainability Framework, save that KELES may make cash management investments on a limited and temporary basis. In addition, KELES will ensure that the portfolio adheres to specific investment restrictions as outlined in the Placement Memorandum.

The minimum share of sustainable investments with a social objective is 90%.

The sustainable investment objective and the sustainability indicators are monitored at three key moments: investment, investment holding and growth, and exit.

The methodologies used to measure the attainment of the sustainable investment objective and how the sustainability indicators to measure the attainment of that sustainable investment objective are used are consolidated in a specific KELES document “KELES SFDR Article 9 Sustainable Investments Framework”, with PwC certifying that it meets SFDR Article 9 regulatory requirements. KELES has defined sustainability indicators for each social objective.

Data sources used to assess the achievement of sustainable investment objectives and the selected indicators come from different sources: invested company, public sources, audited suppliers. The data will be reported on a dedicated KELES software app and processed automatically before it is verified by KELES team.

The framework has been developed with a focus on feasibility (the methodologies and data can be executed) and compliance with the social objective and SFDR Article 9 regulatory requirements.

ESG due diligence will be systematically performed as part investment due diligence. Data will be gathered; indicators will be assessed and compliance with the objective and indicators will be confirmed. In addition, a plan is developed to continue strengthening it through the execution of the strategic growth plan.

KELES will engage with target companies on a regular basis to ensure the agreed targets are monitored and achieved as planned.

B. No significant harm to the sustainable investment objective

KELES has developed a framework to gather information on the 14 mandatory indicators for corporates, as the use of PAI indicators is requested to assess DNSH.

The Do No Significant Harm methodology provides a comprehensive approach for each of the fourteen currently mandatory Principal Adverse Impacts (PAIs) for portfolio companies and incorporates recent updates to the PAI indicators. By integrating multiple factors, the methodology helps ensure a thorough assessment, minimizing potential blind spots;

The Good Governance methodology is addressing all key elements of good governance. Additionally, it leverages insights and synergies from the Do No Significant Harm (DNSH) assessment, enhancing its operability and effectiveness in governance evaluation.

C. Sustainable investment objective of the financial product

KELES has developed a Sustainable Investments Framework aligned with requirements applicable to Article 9 Fund. The framework is specifically tailored to the digital healthcare sector, addressing current regulatory requirements while also anticipating future reporting needs.

KELES’ innovative and pragmatic framework focuses on three core social objectives:

Ethical Use of AI and Healthcare Data
Healthcare Availability and Enhancement
Healthcare Accessibility

The Positive Contribution methodology is tailored to the digital healthcare sector’s needs, offering two different pathways for measurable positive impacts. It outlines strategies and rationales for digital healthcare companies to address critical healthcare challenges while aligning with sustainability goals. This includes guidance on how investments in digital health innovations can enhance health outcomes, improve accessibility, and support ethical technology use. Furthermore, it sets metrics for tracking and evaluating these contributions, ensuring that positive impacts are quantifiable and aligned with broader sustainability objectives.

D. Investment Strategy

KELES is investing in Europe’s Digital Health Growth.

KELES is a newly established venture capital firm specializing in growth-stage digital health investments across Europe. The firm focuses on European companies at or approaching the scale-up phase, prioritizing those with demonstrated profitability. Its key investment sectors include Research & Development (R&D), Diagnostics, and Patient Care.

The flagship fund, KELES SCSP SICAV-RAIF, aims to tackle major global healthcare challenges, such as rising burden of chronic disease, aging Healthcare professionals and population, low R&D productivity. By investing in cutting-edge digital health solutions, KELES seeks to improve care efficiency, enhance patient outcomes, and set new standards in healthcare delivery.

Leveraging its extensive industry expertise, KELES is well-equipped to identify promising investment opportunities, support scaling efforts, and optimize exit strategies, driving the growth of digital health across Europe.

KELES recognizes the importance of ESG factors in driving sustainable growth and is dedicated to upholding the highest standards of Sustainable Finance Disclosure Regulation (SFDR) and ESG compliance within its Sustainable Investment Framework, which emphasizes creating significant social impact. .

By aligning with SFDR Article 9, the most stringent level of regulatory requirements, KELES demonstrates its commitment to responsible investing that meets rigorous sustainability criteria. This alignment ensures that the firm’s investments not only fulfill essential regulatory obligations but also contribute positively to societal and environmental outcomes. KELES is also committed to making this approach beneficial for its portfolio companies, ensuring that implementation and monitoring are manageable.

KELES recognizes that SFDR 9 requirements are key drivers of performance and innovation, as well as key differentiator in the market.

Through its Article 9 alignment and ESG framework, KELES aims to lead in the digital health sector, fostering impactful investments that drive positive change in healthcare delivery and patient outcomes across Europe.

The binding elements of the investment strategy are to invest solely in sustainable investments with a social objective, as defined within KELES Sustainability Framework, save that KELES may make cash management investments on a limited and temporary basis.

In addition, KELES will ensure that the portfolio adheres to specific investment restrictions as outlined in the Placement Memorandum.

E. Proportion of sustainable investments

The minimum share of sustainable investments with a social objective is 90%.

F. Monitoring of sustainable investment objective

The sustainable investment objective and the sustainability indicators are monitored at three key moments:

Investment: as part of investment due diligence, compliance with the objective and indicators is confirmed and a plan is developed to continue strengthening it through the execution of the strategic growth plan
Investment holding and growth: a review and reporting is performed every year with a corrective action plan and closer monitoring if needed
Exit: a final assessment is performed and included in the exit package with the intent to use it as an additional argument of quality of the asset and value creation potential for the new owner

G. Methodologies

The methodologies used to measure the attainment of the sustainable investment objective and how the sustainability indicators to measure the attainment of that sustainable investment objective are used are consolidated in a specific KELES document “KELES SFDR Article 9 Sustainable Investments Framework”, with PwC certifying that it meets SFDR Article 9 regulatory requirements.

KELES has defined the following sustainability indicators, classified by social objective:

Ethical use of AI and healthcare data:
- (1)Compliance with Data Protection Regulations
- Audits and Compliance Certifications
- (1.2) Absence of ongoing investigations or (1.3) Prevention measures for data breaches
Healthcare availability and enhancement:
- Number of new targets or drug candidates
- Number of patients involved
- Number of clinical trials that have been digitised
- Number of new drugs manufactured
- Number of acute care patients or hospitals that benefited
- Improvement of health outcome
- Number of patients benefited
- Number of patients or imaging centers / hospitals that benefited
- Number of countries where digital MedTech is approved
Healthcare accessibility:
- Time-to-Market acceleration
- Cost impact
- Reimbursement tracking
- Number of people accessing a new drug
- Number of clinics/professionals impacted
- Clinical trials done remotely
- Increase in diversity
- Increase in efficiency of recruitment
- Capacity increase
- Patients remaining longer at home
- Capacity increase of imaging

H. Data sources and processing

Data sources used to assess the achievement of sustainable investment objectives and the selected indicators come from different sources: invested company, public sources, audited suppliers.

The data will be reported on a dedicated KELES software app and processed automatically before it is verified by KELES team.

Depending on the type of portfolio companies, in cases where certain data is unavailable or unreported, estimations may be made.

I. Limitations to methodologies and data