# Scandinavian Real Heart > Clarifo company profile — qualitative business description generated from > the company's filings. Financial statements, charts and ratios are > available on Clarifo (https://www.clarifo.com/en/companies/scandinavianrealheart). ## Overview 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. ## Products & services • Realheart® TAH total artificial heart • External control unit for the heart system • Preclinical device testing and validation • Patent and IP development for circulatory support technology - **Total artificial heart systems** (70%) — Implantable cardiac replacement systems designed to support or replace the failing heart. - **External control units** (15%) — Wearable control hardware used to operate and monitor the heart system. - **Preclinical development services** (10%) — Testing, validation, and study work supporting device advancement toward clinical use. - **Intellectual property and licensing-related assets** (5%) — Patents and related technology rights that protect the platform and future commercialization. - Realheart® TAH total artificial heart - External control unit for the heart system - Preclinical device testing and validation - Patent and IP development for circulatory support technology ## 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. - **Hospital research partners** (primary) — They collaborate on acute and chronic implantation studies to generate safety and performance evidence. - **Regulators and notified bodies** (primary) — They review the device, testing data, and clinical pathway before human use. - **Future cardiac centers** (secondary) — They would evaluate and purchase the system for advanced heart failure treatment once approved. - **Patients with severe heart failure** (secondary) — They are the eventual beneficiaries of the device, though not direct purchasers. - Academic and hospital research partners running preclinical studies - Regulatory bodies and notified bodies reviewing device evidence - Future transplant centers and cardiac surgery hospitals - Patients with end-stage heart failure as the eventual end user - Healthcare payers and providers that would fund adoption ## 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. - Headquartered in Västerås, Sweden - Preclinical collaboration with Sahlgrenska University Hospital near Gothenburg - Regulatory pathway includes the EU and the United States - Patent coverage extends across Europe, the US, China, Japan, and India ## 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. - **Complete preclinical validation** (short-term) — The device must demonstrate safety, handling, and physiologic stability before clinical studies can begin. - **Advance regulatory readiness** (medium-term) — Parallel engagement with EU and US regulators shortens the path to first-in-human use. - **Strengthen intellectual property** (medium-term) — Patent protection supports future commercialization and reduces competitive imitation risk. - **Maintain funding capacity** (short-term) — Long development cycles require ongoing capital to fund testing and regulatory work. - Complete acute implantation series and analyze device performance - Advance from preclinical testing to chronic in vivo studies - Prepare ethics and regulatory submissions for human evaluation - Protect the platform with patents across major medical markets - Secure financing to support a long development timeline ## 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. - **Preclinical development risk** [high] — The company must complete hemolysis, endurance, and implantation studies before human trials. - **Regulatory approval risk** [high] — EU and US pathways can require additional evidence, redesign, or longer review cycles. - **Financing risk** [critical] — The company does not yet generate operating cash flow and depends on external capital. - **Technical performance risk** [high] — The device must prove surgical usability, physiologic stability, and durability in testing. - **IP and competitive risk** [medium] — Protection must be broad enough to defend future commercialization in multiple markets. - Preclinical failure could delay or stop clinical entry - Regulatory review may require additional studies or design changes - Funding needs are ongoing until commercialization - Device performance and surgical handling remain technical risks - Patent and IP protection must be maintained across key markets ## Accounting As a development-stage company, the most important accounting issues are the treatment of grants, capitalization of development costs, and impairment testing of intangible assets. The company also changed the presentation of received grants in the cash flow statement, which affects classification but not total cash flow or profit. - **Government and other grants** — Affects operating income, intangible asset carrying values, and cash flow presentation - **Capitalized development costs** — Can materially affect balance sheet and future expense recognition - **Impairment of intangible assets** — Could reduce reported assets and earnings - **Foreign currency translation** — Can create translation differences in equity and reported results - **Cash flow presentation of grants** — Changes cash flow line items without changing total cash flow - Grant accounting affects whether support is shown as income or a reduction of development costs - Capitalized development costs and intangibles require impairment judgment - Cash flow classification of grants can change investing vs financing presentation - Foreign currency translation matters because reporting is in SEK - Going-concern and financing assumptions are important for valuation --- *Last updated: 2026-08-11T04:04:55.672423+00:00*