1 The EIC Accelerator Project

The EIC Accelerator program is a key component of the European Innovation Council (EIC) aimed at supporting small and medium-sized enterprises (SMEs) and startups in developing and scaling innovative technologies. Focused on high-risk, high-potential innovations, the program provides blended finance, which combines grants and equity investments, thereby enabling participants to overcome financial barriers and accelerate their growth.

Funding Structure

Under the EIC Accelerator, companies can receive significant funding to foster their innovations. The grant component allows for funding of up to €2.5 million, which is designed to assist in the development and market introduction of groundbreaking products or services. This grant is particularly useful for covering early-stage expenses such as research and development, prototyping, and initial marketing efforts.

In addition to the grant, the program offers equity funding, which is particularly crucial for scaling operations and attracting further investments. Until 2024, companies can access up to €15 million in equity financing, which significantly boosts their capacity to scale. From 2025, this figure will be adjusted to up to €10 million. This blended approach is structured to facilitate the transition from an innovative idea to a sustainable business model, ensuring that companies have the necessary resources to attract private sector funding.

Purpose and Role

The EIC Accelerator plays a vital role in the European DeepTech and startup ecosystem by providing essential support to innovative companies that may struggle to secure funding through traditional means. By bridging the funding gap, the program empowers entrepreneurs to bring their revolutionary ideas to market, thereby enhancing Europe's competitiveness in the global innovation landscape.

The program not only offers financial support but also provides mentorship, coaching, and networking opportunities. This holistic approach helps companies refine their business models, identify market opportunities, and connect with potential investors, thereby increasing their chances of success in the private sector.

Case Study: Acorai AB and the AHM Project

Acorai AB, a Swedish company, is a recent winner of the EIC Accelerator grant for its innovative project known as the Acorai Heart Monitor (AHM). The project was submitted as part of the Step 2 proposal on June 21, 2023, and subsequently secured funding through the Step 3 interview process.

Project Overview

The Acorai Heart Monitor is a non-invasive multi-sensor device specifically designed for continuous heart failure monitoring. This innovative technology aims to provide real-time data on patients' heart health, enabling healthcare providers to make informed decisions about treatment and care.

Technology Basics and Background

The AHM leverages advanced sensor technology to monitor critical cardiovascular parameters without the need for invasive procedures. The device integrates multiple sensors that measure various biomarkers related to heart function. This non-invasive approach minimizes discomfort for patients while providing accurate and timely data.

The technology behind the Acorai Heart Monitor is grounded in the growing need for proactive management of heart failure, a condition that affects millions worldwide. Traditional monitoring methods often require hospital visits or invasive procedures, which can be burdensome for patients and healthcare providers alike. The AHM addresses this gap by offering a convenient and user-friendly solution that can be utilized in both clinical and home settings.

Moreover, the device is designed to facilitate remote monitoring, thereby allowing healthcare professionals to track patients' conditions in real-time. This capability not only enhances patient care but also reduces the strain on healthcare systems by minimizing unnecessary hospital visits.

Conclusion

The EIC Accelerator program represents a significant opportunity for innovative companies like Acorai AB to secure funding and resources essential for scaling their groundbreaking technologies. By combining grants with equity investments, the program effectively supports the transition from concept to market, contributing to the growth of the European DeepTech ecosystem. The Acorai Heart Monitor exemplifies the potential of such innovations to revolutionize healthcare monitoring and improve the quality of life for patients suffering from heart failure.

2 The Funding Rounds

# Acorai AB: Funding Journey and Growth Since EIC Accelerator Funding

Acorai AB, a Swedish medical device manufacturer specializing in heart failure management technology, has made significant strides since receiving EIC Accelerator funding in June 2023. The company is developing innovative non-invasive intracardiac pressure monitoring (ICPM) technology with the potential to impact over 60 million heart failure patients worldwide.

EIC Accelerator Funding

Acorai was among 47 European startups selected in the June 2023 EIC Accelerator call, which awarded a total of €349 million to bring game-changing innovations to market. The company received a €2.3 million grant from the European Commission through this program in November 2023.

Funding Rounds and Financial Growth

Seed Round (January 2024)

In January 2024, Acorai closed an oversubscribed seed funding round, raising over $4 million (approximately €4.1 million). This early-stage funding helped the company advance its clinical and regulatory efforts.

EIC Fund Investment (November 2024)

On November 27, 2024, Acorai announced the closing of a $4.5 million investment from the European Innovation Council (EIC) Fund, Taiwan Medical University, and private investors. This capital was earmarked to complete Acorai's clinical studies and prepare for regulatory submissions in the US and Europe.

Additionally, the EIC Fund has provisioned an additional $6 million for future equity financing, positioning Acorai to raise more capital in 2025 to fund further clinical validation, regulatory approvals, and early commercialization efforts.

Total Funding

According to available information, Acorai has secured approximately $6.9 million in total funding across multiple rounds, with their most recent funding amount being under $5 million.

Clinical Progress and Regulatory Status

Acorai has made significant clinical progress since receiving the EIC Accelerator funding:

• The company has completed patient enrollment for its flagship CAPTURE-HF clinical study, involving over 1,600 patients across 20 hospitals in 6 countries.
• Acorai has obtained FDA Breakthrough Device Designation for its non-invasive intracardiac pressure monitor.
• The company is working closely with the FDA through the TAP Pilot program.
• Acorai is targeting regulatory submissions and commercial launch by 2026.

Company Information

Acorai AB is headquartered in Helsingborg, Sweden, at 48 Redaregatan. The company was incorporated in Sweden with registration number 5592153794 and is registered as an overseas company in the UK (company number FC041639).

The company is developing the Acorai Heart Monitor, which can monitor intracardiac pressures non-invasively through machine learning analysis of pressure dynamics in acoustics, vibratory, and waveform data. This technology aims to help reduce hospitalizations and readmissions for heart failure patients.

Acorai is led by CEO Filip Peters, who has expressed that the company "has built a solid foundation to become a world leader in non-invasive cardiac care."

Future Outlook

With its recent funding secured and clinical trials progressing well, Acorai is positioned to continue its development trajectory. The company is preparing to raise additional capital in 2025 to support:

The company's technology shows promising precision, with what they describe as a low-risk clinical and regulatory pathway, low dependence on reimbursement, and a fast track to commercialization.

Sources: - Acorai closes $4.5M investment from the EIC Fund

• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission
• EIC Accelerator winners and statistics June 2023: 47 European deeptech startups awarded 349€ million
• Sweden's Acorai bags €4.2M to advance heart failure management technology
• Acorai company information on ZoomInfo

3 The Press Releases

Acorai AB: Recent Developments and EIC Accelerator Funding

Acorai AB, a Swedish medical device manufacturer based in Helsingborg, has made significant strides in developing innovative solutions for heart failure management. The company received substantial funding from the European Innovation Council (EIC) Accelerator in June 2023, marking a pivotal moment in its growth and development.

EIC Accelerator Funding

Acorai secured a €2.3 million grant with a follow-on €10 million investment offer from the EIC. This funding is part of the EIC Accelerator's blended finance model, which supports start-ups and SMEs with groundbreaking technologies. The grant will primarily be used to accelerate clinical validation and regulatory submissions, enabling the commercialization of Acorai's devices.

Technology Advancements

Acorai is pioneering a first-of-its-kind device for non-invasive intracardiac pressure monitoring. This technology aims to improve heart failure management by providing essential data without invasive procedures. The company has demonstrated promising results in a 350-patient pilot study conducted in Sweden.

Regulatory Progress

In August 2023, Acorai received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation allows the company to interact closely with FDA experts, facilitating expedited reviews during the premarket review phase.

Clinical Studies

Acorai has successfully completed patient enrollment for its flagship clinical study, the CAPTURE-HF study, with over 1,600 patients across 20 hospitals in six countries. This study is crucial for gathering clinical evidence necessary for regulatory submissions in both the U.S. and Europe.

Investment and Partnerships

In November 2024, Acorai closed a $4.5 million investment from the EIC Fund, Taiwan Medical University, and private investors. This investment will be used to complete clinical studies and prepare for regulatory submissions. Additionally, the EIC Fund has provisioned an additional $6 million for future equity financing rounds, indicating strong support for Acorai's growth plans.

Press Releases and Updates on acorai.com

Recent press releases on Acorai's website highlight the company's achievements, including securing EIC funding and completing significant clinical milestones. These updates reflect Acorai's progress toward becoming a leader in non-invasive cardiac care, with a focus on improving heart failure management globally.

Sources

• EIC Accelerator winners and statistics June 2023
• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission
• Acorai closes $4.5M investment from the EIC Fund
• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission
• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission

4 The Technology Advancements

Acorai AB: Advancements and Developments Since EIC Accelerator Funding

Acorai AB, a Swedish company, has been at the forefront of developing innovative non-invasive intracardiac pressure monitoring systems for heart failure management. Since receiving the EIC Accelerator funding in June 2023, Acorai has made significant advancements in its technology and clinical trials.

Current Capabilities

Acorai's flagship device, the Acorai Heart Monitor, utilizes a patented SAVE Sensor System, combining seismic, acoustic, visual, and electric sensors to estimate intracardiac pressures non-invasively. This technology is supported by state-of-the-art machine learning models, which have demonstrated accuracy comparable to invasive methods. The device is designed to be handheld and portable, making it easily integrable into daily clinical practice.

Advancements and Improvements

Following the EIC funding, Acorai has continued to refine its technology through ongoing clinical studies. The CAPTURE-HF study, which enrolled over 1,600 patients across six countries, concluded its patient enrollment phase. This study aims to confirm whether the Acorai Heart Monitor can provide actionable information equivalent to invasive methods.

Acorai also secured additional funding, including a $4.5 million investment from the EIC Fund, Taiwan Medical University, and private investors in November 2024. This investment will be used to finalize clinical studies and prepare for regulatory submissions in the U.S. and Europe. Furthermore, Acorai received a €2.3 million grant from the European Innovation Council, with a potential follow-on investment of €10 million.

Demonstrations and Clinical Trials

Acorai has been actively involved in demonstrating its technology through extensive clinical trials. The CAPTURE-HF study is a major milestone, showcasing the device's potential in real-world settings. Additionally, Acorai completed a 400-patient feasibility study, which showed promising results comparable to the invasive gold standard.

New Features and Technologies

Acorai continues to enhance its machine learning algorithms through ongoing studies. The company aims to finalize these algorithms in preparation for regulatory submissions and commercial launch by 2026. There have been no specific announcements about new features beyond the refinement of existing technology.

Patents, Scientific Studies, and Publications

While there are no recent announcements on new patents filed, Acorai has been focused on generating robust clinical data to support regulatory approvals. The company's Breakthrough Device Designation from the FDA in August 2023 underscores its technological advancements.

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Sources: - Acorai: Home

• Acorai closes $4.5M investment from the EIC Fund
• Acorai's Study of Noninvasive Pressure Monitoring Device in Heart Failure Begins Enrollment
• Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval
• Acorai enrols first patient in global clinical trial of heart monitor
• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission
• Intracardiac pressure monitoring device startup Acorai raises €2.3M
• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission
• Acorai - preparatory project for international application: EIC Accelerator

5 The Partnerships and Customers

Acorai AB: Partnerships and Collaborations

Acorai AB, a Swedish company, has been actively engaging in strategic partnerships and collaborations since receiving funding from the EIC Accelerator in June 2023. This support has facilitated Acorai's growth and development in the healthcare industry, particularly in heart failure management.

Partnerships and Collaborations

• Royal Brompton and Harefield Hospitals: Acorai has collaborated with these hospitals for clinical trials of its heart monitor. The first patient was enrolled at these hospitals, marking a significant step in Acorai's clinical validation process.
• MIM Solutions: This company is participating in the software development for Acorai's projects, specifically focusing on non-invasive intracardiac pressure monitoring and AI methods.
• European Innovation Council (EIC) Fund: Acorai received substantial funding from the EIC Fund, which includes an additional provision for future equity financing. This financial support is crucial for completing clinical studies and preparing for regulatory submissions in the US and Europe.

New Partners and Customers

As of the latest information, specific details about new partners or customers are not explicitly mentioned. However, Acorai's partnerships with entities like the Royal Brompton and Harefield Hospitals and the EIC Fund indicate a strong network within the healthcare and innovation sectors.

Nature and Purpose of Relationships

Acorai's relationships are primarily focused on advancing its non-invasive heart monitoring technology and expanding its market presence. Collaborations with clinical partners help in generating robust clinical data, while financial support from the EIC Fund aids in scaling up clinical and regulatory efforts.

Market Positioning

These partnerships and collaborations position Acorai as a leader in non-invasive cardiac care, enhancing its ability to impact the global market. Acorai aims to positively affect over 60 million heart failure patients worldwide.

Technology Advancements and Scaling

The partnerships with MIM Solutions and the funding from the EIC Fund facilitate advancements in machine learning technologies and device development. This support enables Acorai to refine its heart monitor's software and hardware capabilities, making it more effective and scalable for global markets.

Sources

• Acorai: Home
• Predicting heart failure using non-invasive intracardiac pressure monitoring and artificial intelligence methods
• Heart Failure start-up, Acorai, secures €2.3m grant funding from the European Commission
• Acorai enrols first patient in global clinical trial of heart monitor
• Acorai closes $4.5M investment from the EIC Fund

6 The Hiring and Company Growth

Acorai AB's Team Growth and Hiring Strategy Post-EIC Accelerator Funding Since securing EIC Accelerator funding in mid-2023, Acorai has focused on clinical development and regulatory scaling. While specific headcount figures remain undisclosed, the company has emphasized team-driven milestones, including the completion of its CAPTURE-HF study (1,600+ patients across 20 hospitals) and preparations for 2026 commercialization.

Key Developments:

• Funding Growth: Closed $4.5M in November 2024 from the EIC Fund, Taiwan Medical University, and private investors, following an oversubscribed $4M seed round earlier that year. An additional $6M is provisioned for future rounds.
• Hiring Focus: Current hiring likely targets clinical operations, regulatory affairs, and machine learning engineering roles to support FDA/CE submissions and product development. The team includes CEO Filip Peters and co-founders Jakob Gelberg, Kasper Bourdette, and Matthew Mace, with no reported management changes since 2024.
• Scaling Impact: New hires would accelerate data analysis for its multimodal sensor system (combining seismic, acoustic, visual, and electric sensors) to refine non-invasive cardiac pressure monitoring.

The absence of direct headcount disclosures suggests strategic hiring aligned with regulatory milestones rather than rapid team expansion. Acorai’s growth trajectory hinges on clinical validation outcomes ahead of its planned 2026 launch.

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Sources
Acorai closes $4.5M investment from the EIC Fund
Sweden's Acorai bags €4.2M to advance heart failure management
Acorai Heart Monitor at MedTech Strategist Summit
Acorai's oversubscribed $4m funding round

7 The Media Features and Publications

Acorai AB: A Swedish EIC Accelerator Winner

Acorai AB, a Swedish start-up focused on heart failure management, has been actively advancing its innovative medical device technology since receiving support from the European Innovation Council (EIC) Accelerator funding in June 2023. The company is developing a first-of-its-kind non-invasive intracardiac pressure monitoring device, aimed at improving heart failure treatment for millions worldwide.

Media Features and Publications

Acorai has been featured in several publications due to its groundbreaking technology and significant achievements. Notably, the company received Breakthrough Device Designation from the U.S. FDA in August 2023, highlighting its potential to transform heart failure management. Publications such as Biospace and Medical Design & Development have covered Acorai's clinical trials and technological advancements.

Content from Publications

Publications have highlighted Acorai's clinical trials, including the CAPTURE-HF study, which successfully enrolled over 1600 patients across multiple countries. The company's device has shown promise by providing accurate, non-invasive intracardiac pressure monitoring, comparable to invasive methods.

Podcasts and Interviews

While specific podcasts or interviews featuring Acorai's team are not readily available, the company's achievements and progress are frequently discussed in industry news and updates.

Conference and Fair Visits

Acorai has participated in prestigious events such as being accepted into the Medtech Innovator American Heart Association program and winning the EIT Health Catapult award. These participations reflect the company's commitment to showcasing its technology and engaging with the medical community.

Events and Involvement

Acorai is actively involved in conferences and events related to heart failure management and medical technology innovation. For instance, the company presented pilot study data at the Heart Failure Association (HFA) conference, demonstrating the device's potential to accurately estimate intracardiac pressures.

Since receiving the EIC Accelerator funding, Acorai has continued to advance its clinical studies and regulatory submissions, aiming for a commercial launch by 2026. The company's innovative approach to non-invasive heart failure management positions it as a leader in the field.

Sources:

• Acorai News Archives
• Acorai Closes $4.5M Investment from the EIC Fund
• Acorai's Study of Noninvasive Pressure Monitoring Device in Heart Failure Begins Enrollment
• Heart Failure Start-Up, Acorai, Embarks on the Next Vital Stage Towards Regulatory Approval
• Heart Failure Start-Up, Acorai, Starts Clinical Trials
• Acorai H1 News: CAPTURE-HF Study, MedTech Innovator, EIT Health Catapult Winner
• Acorai