1 The EIC Accelerator Project

EIC Accelerator Program Overview

The EIC Accelerator program is a pivotal initiative under the European Innovation Council (EIC) designed to support small and medium-sized enterprises (SMEs) and startups in Europe, especially those in the deep tech sector. The program aims to bridge the funding gap between early-stage innovations and the commercialization phase, providing substantial financial resources alongside strategic support.

Funding Structure

The EIC Accelerator offers a unique funding structure that includes both grants and equity investments.

Purpose and Impact

The primary purpose of the EIC Accelerator is to foster innovation and promote entrepreneurship across Europe, particularly in sectors characterized by high technological complexity, such as biotechnology, artificial intelligence, and advanced manufacturing. By facilitating access to funding, the program plays a crucial role in helping companies overcome financial barriers, enabling them to innovate and grow.

Furthermore, the EIC Accelerator enhances the European deep tech ecosystem by connecting startups with investors and industry partners, ultimately driving economic growth and job creation. The program's emphasis on funding high-risk, high-reward projects encourages a culture of innovation and experimentation, crucial for maintaining Europe's competitive edge in global markets.

Role in Scaling and Funding

The EIC Accelerator is instrumental in helping companies scale by providing not only financial resources but also mentorship, networking opportunities, and access to a broader ecosystem of advisors and investors. Successful candidates receive tailored support, which can include business coaching and access to potential partners, facilitating their journey from concept to commercial viability.

By proving the viability of their innovations through the EIC Accelerator’s funding, companies can leverage this success to attract additional private investments, further enhancing their growth prospects and market presence.

Case Study: Scandinavian Real Heart AB and ArtOfHeart

Company Overview: Scandinavian Real Heart AB, based in Sweden, is the winner of the EIC Accelerator grant and equity funding for their groundbreaking project, ArtOfHeart. Their mission is to develop the first Total Artificial Heart (TAH) that truly mimics the human heart's functionality, with the potential to revolutionize cardiac care.

Project Overview: ArtOfHeart aims to create a TAH that not only replaces the biological heart but also replicates its natural mechanics and dynamics, addressing the limitations of existing artificial hearts. This innovative technology has the potential to transform treatment options for patients with severe heart failure, bridging the gap between mechanical support and biological function.

Technology Basics and Background

The technology behind the ArtOfHeart project is rooted in advanced biomaterials and engineering principles. Unlike conventional artificial hearts, which often face challenges such as thrombosis, infection risk, and limited patient adaptability, the ArtOfHeart is designed to integrate seamlessly with the human body.

The ArtOfHeart project exemplifies the potential of the EIC Accelerator to support transformative innovations that can significantly impact healthcare and patient outcomes, further solidifying Europe's position as a leader in deep tech and medical advancements.

2 The Funding Rounds

Scandinavian Real Heart AB: Funding and Development

Scandinavian Real Heart AB, a Swedish company, is pioneering the development of a total artificial heart that mimics the shape and function of the human heart. The company has received significant funding and recognition, including an investment from the European Innovation Council (EIC) Accelerator.

Financing Raised

• EIC Accelerator Investment: In May 2023, Realheart secured an initial investment of up to 3.5 MEUR (approximately 39 MSEK) from the EIC Accelerator, with the potential for a follow-on investment of up to 15 MEUR based on future milestones.
• Vinnova Grant: In May 2024, Realheart received a grant of SEK 4 million from Vinnova to further develop its transplantation system and compare its artificial heart with a competitor's product.
• Private Funding: The company has also raised funds through private investments, such as $1.7 million for the development of its artificial heart.

Funding Rounds

• EIC Accelerator Funding: The investment from the EIC is conditional on co-investment with new and existing shareholders, ensuring that EIC's ownership does not exceed 20% of the company.
• Rights Issue: In 2021, Realheart conducted a rights issue that raised approximately SEK 61.5 million to support strategic goals, including optimizing the heart pump and conducting blood tests.
• Extended Loans: Realheart has received cash from extended loans, such as 3.7 MSEK from ALMI and 4.1 MSEK from TO1.

Timing and Amount of Funding Rounds

• EIC Accelerator (2023): Up to 3.5 MEUR (initial investment).
• Vinnova Grant (2024): SEK 4 million.
• Private Funding (Recent): $1.7 million.
• Rights Issue (2021): Approximately SEK 61.5 million.

Investor Information

• EIC Fund: The European Innovation Council's (EIC) dedicated investment arm, which supports innovative companies with high growth potential.
• Private Investors: Individuals and companies like Lars Forslund and his company LF Invest have invested in Realheart.

Company Valuations

As of the latest available data, Realheart's financial position is primarily focused on research and development, with no product sales reported. The company's shares are traded on the Nasdaq Stockholm First North Growth Market.

Funding or Exit Events

There are no reported exit events for Realheart. However, the company continues to secure funding through various channels, including grants and private investments, to advance its artificial heart technology.

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Realheart Receives EIC Funding EIC Fund Invests in Realheart Realheart Receives Vinnova Grant Realheart TAH Receives HUD Designation Realheart Raises $1.7 Million Realheart Interim Report Annual Report 2021 Financial Statements

3 The Press Releases

Scandinavian Real Heart AB, a Swedish medical technology company developing the Realheart® Total Artificial Heart (TAH), has issued multiple press releases and updates since winning the EIC Accelerator funding in October 2021. Their communications highlight significant advancements, partnerships, team expansions, and ongoing preclinical progress.

Key Press Releases and Updates

Preclinical Study Successes:

• In April 2024, Scandinavian Real Heart announced the successful completion of a 7-day animal trial demonstrating promising survival times with their total artificial heart.
• In September 2024, they reported positive results from two preclinical studies evaluating the treatment safety of Realheart® TAH. These studies assessed mechanical stress effects on human blood and the device’s ability to meet varying cardiovascular demands. The data showed a high safety profile compared to market-leading devices and was presented at ISMCS 2024 in Japan.

Technological Advancements:

• Early in 2023, they announced achieving increased survival time for implanted animals from one day to four days while meeting critical performance criteria such as no hemolysis or thromboembolic events and good pumping capacity balance between right-left chambers.
• Collaboration with KTH Royal Institute of Technology led to Sweden’s first patient simulator (digital twin) for testing their TAH algorithm. This hybrid simulator enhances R&D efficiency by allowing virtual testing of heart functions before clinical trials. This project received funding from Smart Elektronik Systems – a joint innovation program by Vinnova, Formas, and the Swedish Energy Agency.

Team Expansion:

The Medical Advisory Board was strengthened by adding Dr. Ulf Kjellman in early 2023. Kjellman brings over 35 years of cardiothoracic surgery experience supporting clinical development efforts.

Financial Developments:

• Scandinavian Real Heart has actively managed its capital structure through warrant exercises that expanded share capital recently in April 2025. This supports ongoing development activities without immediate dilution exceeding approximately four percent for existing shareholders post-exercise.
• They conducted a rights issue targeting about SEK 48.5 million during mid-2024 aimed at fueling further research and clinical trial preparations.

Partnerships

The collaboration with KTH Royal Institute of Technology is central to their innovation strategy by integrating digital twin technology for enhanced product validation before human trials start. They also benefit from governmental funding programs like Smartare Elektroniksystem that support strategic innovation projects within Sweden's tech ecosystem.

Upcoming Milestones

Realheart is progressing toward initiating its first clinical study following robust preclinical validations showing extended animal survival times and device safety profiles comparable or superior to existing solutions on the market.

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Summary Table: Scandinavian Real Heart Recent Highlights

Area	Details
Preclinical Studies	Successful large animal trials; positive blood compatibility & flow response data
Technology	Developed Sweden’s first patient simulator/digital twin; improved surgical protocols
Team Updates	Added Dr. Ulf Kjellman (cardiothoracic surgeon)
Financial Actions	Exercised warrants increasing shares; completed SEK ~48.5 million rights issue
Partnerships	Collaboration with KTH Royal Institute of Technology; funded partly by Swedish innovation grants
Upcoming Plans	Preparing for human clinical trials after extensive preclinical success

Scandinavian Real Heart continues positioning itself as an innovative leader developing artificial hearts that mimic natural cardiac function more closely than current options—aiming both to improve quality of life for transplant candidates now and potentially become an alternative therapy option in future decades.

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Sources

• Press Releases - realheart.se
• Outcome Exercise Warrants - Inderes
• Positive Preclinical Results Announcement - realheart.se
• Interim Report Q1/23 - realheart.se
• Rights Issue Announcement - realheart.se

4 The Technology Advancements

Scandinavian Real Heart AB: Current Capabilities and Advancements

Scandinavian Real Heart AB, based in Sweden, is a leading developer of the Realheart TAH, a total artificial heart designed to mimic the structure, function, and blood flow pattern of the human heart. The company has made significant advancements since receiving funding from the European Innovation Council (EIC) Accelerator in October 2021.

Current Capabilities

Realheart TAH is currently undergoing extensive preclinical trials to evaluate its safety and effectiveness. The device has shown promising results in animal studies, demonstrating adequate cardiac function and adapting to rest and movement, maintaining good blood biochemistry. The company aims to use this technology not only as a bridge to heart transplantation but potentially as a long-term alternative for patients with severe heart failure.

Advancements Since EIC Funding

Since receiving the EIC funding, Scandinavian Real Heart AB has continued to enhance its technology and expand its development program. Key advancements include:

• Preclinical Studies: The company has successfully completed a 7-day animal study with Realheart TAH, showing positive outcomes in terms of cardiac function and adaptability.
• Regulatory Progress: Realheart TAH was granted the FDA's Humanitarian Use Device (HUD) designation, allowing it to be used in certain U.S. patients with advanced biventricular heart failure while they await a transplant.
• Investment and Funding: Besides the EIC funding, the company received confirmation of an initial investment of up to €3.5 million from the EIC Accelerator, with potential follow-on investments.

Technology Improvements and Market Demos

The company has been working on refining the design of Realheart TAH to make it more user-friendly for surgeons. This includes simplifying certain aspects of the surgical procedure. While there are no reports of specific market demonstrations or customer trials, the focus remains on preclinical development ahead of clinical trials.

Patents, Scientific Studies, and Clinical Trials

Scandinavian Real Heart AB has been active in presenting data from preclinical studies. In 2024, the company presented positive results from two preclinical studies evaluating the treatment safety and performance of Realheart TAH at the International Society for Mechanical Circulatory Support (ISMCS) conference. There are no recent reports of new patents filed or published whitepapers since the EIC funding. However, the company continues to build its case for clinical trials and potential market approval.

Future Plans

The company is preparing for clinical studies, which are expected to begin after completing the current preclinical program. Realheart aims to secure additional funding to reach the market, with an estimated need of approximately €40 million.

Citations and Sources:

• Realheart TAH
• Press Releases - Realheart
• Scandianvian Real Heart AB Announces Outcome of Exercise of Warrants of Series TO 3
• Realheart TAH Receives Humanitarian Use Device Designation
• Scandinavian Real Heart AB Completes 7-Day Animal Study with Its Total Artificial Heart Realheart TAH
• ANNUAL REPORT 2021
• Realheart to Present Positive Results From Two Preclinical Studies
• EIC Fund to Invest in Scandinavian Real Heart AB
• Swedish total artificial heart tech granted FDA’s humanitarian use designation

5 The Partnerships and Customers

Scandinavian Real Heart AB, a Swedish company and EIC Accelerator winner since October 6, 2021, has actively developed partnerships and customer relationships to advance its pioneering total artificial heart (TAH) technology.

Key Partnerships and Collaborations

Sahlgrenska University Hospital (Sweden):

In July 2023, Scandinavian Real Heart AB entered into a significant partnership with Sahlgrenska University Hospital to conduct clinical trials of its artificial heart. This collaboration includes working closely with the hospital’s Transplantation Center and Thorax Clinic chief physician Professor Göran Dellgren. The partnership aims at conducting experimental and pre-clinical studies focused on patient selection criteria, surgical methods, and performance evaluation of the TAH in a clinical environment. This relationship is crucial for preparing the company to initiate clinical trials in Sweden.

Royal Institute of Technology (KTH), Sweden:

In May 2024, Scandinavian Real Heart received a SEK 4 million grant from Vinnova together with KTH for further development of its transplantation system through advanced simulation technology. The collaboration focuses on using a hybrid simulator — a digital model of human heart-lung-blood vessel systems — to generate comparative data between their TAH product and competitors’ devices. This project supports product miniaturization efforts (MINIheart model) targeted at smaller patients and enhances marketing efforts toward clinical researchers and investors.

Hydrix Pty Ltd., Australia:

Scandinavian Real Heart established an Australian subsidiary tasked with collaborating alongside Hydrix Pty Ltd., recognized globally for medical device control unit development. Hydrix is responsible for developing control units (external & implantable) for the artificial heart's motor control system as part of ongoing R&D activities including long animal tests. The Australian operation also benefits from favorable R&D tax incentives.

Nature & Purpose of New Relationships

• These collaborations are primarily focused on advancing clinical validation through rigorous trials (Sahlgrenska), improving technological sophistication via simulation modeling (KTH), and enhancing embedded software/hardware controls through expert partners like Hydrix.
• Clinical partnerships enable real-world evaluation critical to regulatory approvals while academic collaborations foster innovation around device miniaturization and comparative efficacy.
• Partnering with specialized companies like Hydrix accelerates scaling by leveraging existing expertise in medical device electronics.

Market Positioning Impact

These new partnerships position Scandinavian Real Heart AB strongly within the highly competitive artificial heart market by:

• Establishing credibility via collaboration with leading hospitals such as Sahlgrenska that provide access to patients for trials.
• Utilizing cutting-edge simulation technologies developed jointly with KTH to differentiate their product based on physiological functionality compared to competitors.
• Expanding global reach through international subsidiaries facilitating broader R&D capabilities.

Together these alliances elevate the company's profile as an innovator providing wearable permanent total artificial hearts that mimic natural cardiac flow more closely than existing options.

Technology Advancements & Scaling Benefits

The relationships facilitate advancements by:

• Allowing iterative design improvements informed by clinical trial feedback.
• Supporting software innovations such as adaptive motor control enabled by embedded software platforms chosen in partnership deals.
• Enabling miniaturized versions suited for diverse patient anatomies via simulator-based design enhancements supported financially by grants linked to these partnerships.

In terms of scaling, these collaborations offer access points into multiple markets—clinical settings for regulatory progression in Europe/Sweden; technological hubs like KTH driving innovation; operational expansion via Australian subsidiary tapping into global talent pools—all critical factors supporting growth trajectory beyond initial launch stages.

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Sources

Realheart Official Website Real Heart partners with Sahlgrenska University Hospital Vinnova Grant Announcement - Collaboration With KTH Scandinavian Real Heart Annual Report & Partnership Details

6 The Hiring and Company Growth

Scandinavian Real Heart AB, a Swedish medical technology company specializing in the development of artificial heart pumps, has shown focused growth and strategic team expansion since receiving EIC Accelerator funding in October 2021.

Current Headcount and Team Size

As of the latest available information from late 2024 to early 2025, Scandinavian Real Heart AB has approximately 11 employees directly reported at their Västerås headquarters. However, the broader global team supporting product development includes around 50 to 60 people distributed across multiple sites—Västerås for product development, Australia for controller development, and Stockholm for clinical testing activities.

Hiring Status and Recent Growth

• The company has been actively growing its team since at least 2021. Their annual report from that year notes new key hires coinciding with leadership changes such as a new CEO appointment (Ina Laura Perkins) and other critical roles to advance clinical version developments of their artificial heart technology.
• Recent hiring includes a significant addition in finance: Jimmy Nybom was appointed interim Chief Financial Officer (CFO) in August 2024, succeeding Andreas Hultdin. Jimmy brings extensive experience as an auditor familiar with the company’s finances over several years and is expected to strengthen financial operations supporting scale-up efforts.
• Other key recent hires include high-level experts like Thomas Finocchiaro as Chief Technology Officer, who joined from competitor companies with decades of experience developing artificial hearts; Martin Cook as Chief Operations Officer; Oliver Foyt bringing deep market expertise having led Syncardia's European expansion; all highlighting recruitment aimed at accelerating both R&D and commercialization capabilities.

Team Growth Impact on Company Future

• New members bring specialized knowledge essential for scaling production readiness and market penetration. For example:
• CTO Thomas Finocchiaro’s engineering expertise enhances technical refinement.
• COO Martin Cook’s previous success with heart pumps supports operational scaling.
• Former Syncardia CEO Oliver Foyt contributes valuable commercial insights into expanding market reach across Europe and Middle East.
• CFO Jimmy Nybom bolsters financial strategy crucial during capital raising phases.

These additions align with Realheart's ambition to develop "the most user-friendly artificial heart" designed not only for clinical trials but also eventual widespread adoption globally.

Management Changes

• A notable management change was the replacement of CFO Andreas Hultdin by Jimmy Nybom in mid-2024 indicating ongoing executive reshaping aligned with growth needs.
• The CEO Ina Laura Perkins has been leading since around or before EIC funding award time (in position since about 2017 internally but noted prominently by latest reports), overseeing strategic direction including partnerships, patent filings, animal studies progress toward clinical trials.

This stable yet evolving leadership appears focused on preparing Realheart for regulatory milestones such as FDA Humanitarian Use Device designation achieved early January 2025—a step critical towards U.S. market entry—and further fundraising rounds supporting scale-up activities.

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Summary Table: Scandinavian Real Heart AB Team & Growth Highlights

Aspect	Details
Current core employee count	~11 staff at Västerås HQ; ~50–60 total globally across sites
Hiring status	Actively hiring senior roles recently (e.g., interim CFO appointed mid-2024)
Key recent hires	Interim CFO Jimmy Nybom; CTO Thomas Finocchiaro; COO Martin Cook; former Syncardia GM Oliver Foyt
Management changes	Interim CFO appointment replacing prior CFO
Team growth impact	Specialists hired enhance R&D sophistication, operational scale-up & commercial expansion potential
Strategic focus	Preparing product for clinical trials & commercialization post-FDA designation

Through these deliberate expansions in personnel—particularly experienced leadership—the company is positioning itself strongly to progress from innovative research phase into successful large-scale manufacturing and global sales of its four-chamber total artificial heart device.

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Sources:

• Realheart Official Website
• Realheart Interim Report August 2024
• Realheart Annual Report 2021
• Inderes Scandinavian Real Heart Profile
• Realheart Management Page
• DiCardiology FDA Designation Article January 30th, 2025
• YouTube Interview Transcript Summary on Team Size & Roles

7 The Media Features and Publications

Scandinavian Real Heart AB: Media Features and Public Engagements

Media Features

Scandinavian Real Heart AB, a Swedish company known for developing the total artificial heart Realheart TAH, has gained significant media attention. The company's innovative device is designed to mimic the human heart's physiological function, featuring a four-chamber system to provide natural circulation. Realheart TAH has been highlighted in publications for its potential to revolutionize the treatment of heart failure.

In recent news, Realheart TAH received Humanitarian Use Device (HUD) designation from the US FDA, making it eligible for an expedited regulatory pathway. This recognition underscores the device's potential for treating advanced biventricular heart failure.

Publications and Content

Publications have emphasized Realheart's advancements in preclinical studies. For instance, the company presented positive results from two preclinical studies at the International Society for Mechanical Circulatory Support (ISMCS) 2024, focusing on treatment safety and device performance. These studies demonstrated the device's ability to adapt to varying blood flow demands and maintain stable blood pressure during exercise.

Podcasts and Interviews

Ina Laura Perkins, CEO of Realheart, participated in an interview with Aktieportföljen Live, discussing the company's progress and future plans. She highlighted the completion of animal implantations and the establishment of a subsidiary in Australia to leverage research and development incentives.

Conferences and Events

Realheart actively participates in conferences to present its research. The company will present new data at the 30th Annual Meeting of the International Society for Mechanical Circulatory Support (ISMCS) 2024, showcasing the safety and performance of Realheart TAH.

Involvement in Events

Realheart's presence at international events like ISMCS underscores its commitment to advancing the field of mechanical circulatory support. By engaging with global experts and presenting its research, the company reinforces its position as a leader in heart technology innovations.

EIC Accelerator Funding

Scandinavian Real Heart AB received EIC Accelerator funding in October 2021, marking a significant milestone for the company. This support has enabled Realheart to accelerate the development of its total artificial heart technology.

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Sources: - Realheart TAH Receives Humanitarian Use Device Designation ...

• News/Media - Realheart TAH
• Scandinavian Real Heart AB Completes 7-Day Animal Study with Its Total Artificial Heart Realheart TAH
• Realheart to Present Positive Results From Two Preclinical Studies ...
• Scandinavian Real Heart hos Aktieportföljen Live - YouTube