Scandinavian Real Heart reports year-end financial results for 2024

SWEDEN – Scandinavian Real Heart AB has released its financial results for the fourth quarter and full-year 2024, highlighting significant progress in its artificial heart development despite financial challenges.

Financial performance

For the period of October to December 2024, the company reported operating income of SEK 5,024 (USD 473), a sharp decline from SEK 798,047 (US $75,173.42) in the same quarter of 2023.

Full-year operating income stood at SEK 50,054 (approximately US $4714.92), significantly lower than the SEK 902,882 (US $85,048.53) reported for 2023.

The company continues to operate at a loss, with earnings after financial items at SEK -10.3 million (US $ -970,226.30) for Q4 and SEK -34.3 million (US $-3.23 million) for the full year.

This is an improvement from 2023, where losses amounted to SEK -52.9 million (US $-4.98 million) and SEK -67.9 million (US $-6.4 million), respectively.

The balance sheet total for 2024 closed at SEK 83.3 million (US $7.85 million), compared to SEK 102.6 million (US $9.66 million) in 2023.

Meanwhile, the equity-to-assets ratio remained stable at 81%, reflecting the company’s efforts to maintain financial stability.

Earnings per share saw a significant drop to SEK -4.99 (US $-0.45) for Q4 and SEK -16.61 (US $-1.56) for the full year, due to a 1:100 reverse share split carried out in November, reducing the number of outstanding shares but increasing earnings per share (EPS) on paper.

However, EPS remains negative (-4.99 in Q4 2024 vs. -0.55 in Q4 2023), meaning the company is not yet profitable.

Research and development advances

Real Heart remains focused on advancing its total artificial heart (TAH) through the preclinical phase, which includes hemolysis studies, GLP animal trials, and endurance tests. The company is also working on finalizing the controller and heart pump for regulatory approvals.

In Q4 2024, Real Heart capitalized SEK 10 million (US $941,967.28) in research and development costs for its artificial heart.

A key milestone during the quarter was the announcement of a new method to simulate hemolysis in artificial hearts, which won the ESAO-SAGE research prize at the European Society for Artificial Organs Congress.

Additionally, Real Heart initiated a collaboration with renowned transplant surgeons at Hannover Medical School to refine the artificial heart’s design and prepare for clinical trials.

Regulatory and Patent Achievements

A major breakthrough for the company came at the end of January 2025 when the U.S. Food and Drug Administration (FDA) granted its Realheart TAH the Humanitarian Use Device (HUD) designation.

This designation could accelerate the path toward market approval through the Humanitarian Device Exemption (HDE) process.

During Q4, Real Heart also secured a new patent from the Indian Patent Office for a technical application related to the clinical use of its TAH.

Additionally, updated safety data from preclinical trials was presented at the 30th Annual Meeting of the International Society for Mechanical Circulatory Support, with R&D engineer Faisal Zaman earning a nomination for the prestigious Helmut Reul Young Investigator Award.

Financial position and future outlook

By the end of 2024, Real Heart’s cash and cash equivalents stood at SEK 23.7 million (US $2.23 million).

Given that the company does not yet generate positive cash flow, it remains reliant on external financing.

The board is actively exploring options for securing long-term funding to support continued research and development.

Looking ahead, Real Heart aims to finalize the preclinical phase and begin human clinical trials.

The successful results from a recent 7-day animal study provide strong evidence that the device can maintain stable cardiac function under various conditions.

Additionally, the company announced the subscription price for warrants series TO 2 at SEK 8.47 (US $0.8), with the exercise period running through January 2025.

Real Heart’s CEO expressed optimism about the company’s future, emphasizing recent successes in preclinical safety studies and regulatory advancements.

“Receiving HUD designation from the FDA is a significant step forward in our journey to bring the world’s first truly human-mimicking artificial heart to patients in need,” he stated.

Real Heart’s shares are traded on the Nasdaq Stockholm First North Growth Market.