Scandinavian Real Heart
Scandinavian Real Heart AB is a Swedish medical technology company developing the Realheart® TAH, a total artificial heart intended to replace the native heart in patients with severe heart failure. The company is based in Västerås, Sweden, and its work spans device development, preclinical testing, intellectual property protection, and regulatory preparation.
Fiscal year 2025 · change from previous year
Development 2022–2025
Business
Share of revenueImplantable cardiac replacement systems designed to support or replace the failing heart.
Wearable control hardware used to operate and monitor the heart system.
Testing, validation, and study work supporting device advancement toward clinical use.
Patents and related technology rights that protect the platform and future commercialization.
Customers
The company’s direct customers are not commercial buyers today; its near-term counterparties are hospitals, clinical investigators, regulators, and ethics boards involved in preclinical and future clinical evaluation. Longer term, the end users are patients with advanced heart failure, while the purchasing decision would likely sit with transplant centers, hospital systems, and healthcare payers.
They collaborate on acute and chronic implantation studies to generate safety and performance evidence.
They review the device, testing data, and clinical pathway before human use.
They would evaluate and purchase the system for advanced heart failure treatment once approved.
They are the eventual beneficiaries of the device, though not direct purchasers.
Strategy
The company’s near-term strategy is to complete preclinical work on the controller and heart pump, then use the resulting data to support chronic animal studies and later first-in-human evaluation. It is also building a broad patent position and maintaining access to external funding so the platform can progress through a long regulatory and development cycle.
The device must demonstrate safety, handling, and physiologic stability before clinical studies can begin.
Parallel engagement with EU and US regulators shortens the path to first-in-human use.
Patent protection supports future commercialization and reduces competitive imitation risk.
Long development cycles require ongoing capital to fund testing and regulatory work.
Geography
The company is headquartered in Västerås, Sweden, and its current development work is centered in Sweden, including collaboration with Sahlgrenska University Hospital near Gothenburg. Its patent portfolio and regulatory pathway are international, with protection and planned market access spanning Europe, the United States, China, Japan, and India.
Risks
The business depends on successful completion of demanding preclinical and regulatory milestones, and delays in testing or approvals can push out commercialization. As a development-stage medtech company, it also faces financing risk, technical risk, and the possibility that the device does not perform as intended in animal or human studies.
- Financing riskImpact: CriticalLikelihood: Medium
The company does not yet generate operating cash flow and depends on external capital.
Exposure: Ongoing R&D and study funding
- Preclinical development riskImpact: HighLikelihood: High
The company must complete hemolysis, endurance, and implantation studies before human trials.
Exposure: Realheart® TAH and controller development
- Regulatory approval riskImpact: HighLikelihood: High
EU and US pathways can require additional evidence, redesign, or longer review cycles.
Exposure: Notified Body and FDA interactions
- Technical performance riskImpact: HighLikelihood: Medium
The device must prove surgical usability, physiologic stability, and durability in testing.
Exposure: Heart pump and external control unit
- IP and competitive riskImpact: MediumLikelihood: Low
Protection must be broad enough to defend future commercialization in multiple markets.
Exposure: Patent portfolio across major jurisdictions
Accounting
Judgemental itemsGrants may be recognized as revenue, offset development costs, or shown as liabilities until conditions are met.
Impact: Affects operating income, intangible asset carrying values, and cash flow presentation
Development work may be recorded as intangible assets and later amortized or impaired.
Impact: Can materially affect balance sheet and future expense recognition
If the device program stalls, capitalized costs and patents may need write-downs.
Impact: Could reduce reported assets and earnings
The group reports in SEK while activities and future commercialization are international.
Impact: Can create translation differences in equity and reported results
Received grants were reclassified from investing to financing activities in the cash flow statement.
Impact: Changes cash flow line items without changing total cash flow
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Last updated: 24/09/2026