KALLELSE TILL EXTRA BOLAGSSTÄMMA I SCANDINAVIAN REAL HEART AB

Aktieägarna i Scandinavian Real Heart AB, org.nr. 556729-5588 (”Bolaget”), kallas härmed till extra bolagsstämma tisdagen den 24 november 2025 kl. 17.30 på Best Western Plus Hotel Plaza, Kopparbergsvägen 10, 722 13 Västerås. Inregistrering till stämman börjar kl. 17.00.

Rätt att delta vid stämman m.m.

Aktieägare som önskar delta vid stämman ska:

dels vara införd i den av Euroclear Sweden AB förda aktieboken senast måndagen den 17 november 2025, och
dels anmäla sig till Bolaget senast onsdagen den 19 november 2025 per post till Scandinavian Real Heart AB, att: Jimmy Nybom, Kopparbergsvägen 6, 722 13 Västerås eller per e-post till jimmy.nybom@realheart.se. I anmälan ska uppges fullständigt namn, person- eller organisationsnummer, aktieinnehav, adress, telefonnummer dagtid samt, i förekommande fall, uppgift om ställföreträdare eller biträden (högst två).

För att ha rätt att delta i stämman måste en aktieägare som låtit förvaltarregistrera sina aktier, förutom att anmäla sig till stämman, låta registrera aktierna i eget namn så att aktieägaren blir upptagen i framställningen av aktieboken per avstämningsdagen måndagen den 17 november 2025. Sådan omregistrering kan vara tillfällig (s.k. rösträttsregistrering) och begärs hos förvaltaren enligt förvaltarens rutiner i sådan tid i förväg som förvaltaren bestämmer. Rösträttsregistrering som gjorts av förvaltaren senast onsdagen den 19 november 2025 kommer att beaktas vid framställningen av bolagsstämmoaktieboken.

Ombud m.m.

Om aktieägare ska företrädas av ombud måste ombudet ha med skriftlig, daterad och av aktieägaren undertecknad fullmakt till stämman. Fullmakten får inte vara äldre än ett år om den inte anger att den är giltig under en längre tid, dock längst fem år. Om fullmakten utfärdats av juridisk person ska ombudet också ha med aktuellt registreringsbevis eller motsvarande behörighetshandling för den juridiska personen. För att underlätta inpasseringen bör kopia av fullmakt och andra behörighetshandlingar bifogas anmälan till stämman. Fullmaktsformulär hålls tillgängligt på Bolagets hemsida www.realheart.se och skickas med post till aktieägare som kontaktar Bolaget och uppger sin adress.

Behandling av personuppgifter

För information om hur personuppgifter behandlas i samband med bolagsstämman hänvisas till den integritetspolicy som finns tillgänglig på Euroclear Sweden AB:s hemsida: https://www.euroclear.com/dam/ESw/Legal/Integritetspolicy-bolagsstammor-svenska.pdf.

Förslag till dagordning

Val av ordförande vid stämman
Val av protokollförare vid stämman
Val av en eller två justeringspersoner
Upprättande och godkännande av röstlängd
Godkännande av dagordning
Prövning av om stämman blivit behörigen sammankallad
Beslut om nyemission av aktier
Beslut om ändring av bolagsordningen
Stämmans avslutande

Punkt 1 – Val av ordförande vid stämman

Styrelsen föreslår att Jimmy Nybom väljs till ordförande på stämman.

Punkt 7 – Beslut om nyemission av aktier

Styrelsens förslag till beslut om nyemission av aktier, bilaga 1

Punkt 8 – Beslut om ändring av bolagsordningen

Styrelsens förslag till beslut om ändring av bolagsordningen, bilaga 2

Den föreslagna bolagsordningen i sin helhet, bilaga 3

Beslutet är villkorat av att stämman fattar beslut i enlighet med punkten 7 i kallelsen.

Majoritetskrav

För giltigt beslut enligt beslutspunkten 8 krävs att förslagen biträds av aktieägare med minst två tredjedelar av såväl de avgivna rösterna som de aktier som är företrädda vid stämman.

Uppgifter om antalet aktier och röster

Vid tidpunkten för utfärdandet av denna kallelse uppgår det totala antalet aktier och röster i Bolaget till 4 998 704 stycken.

Aktieägares rätt att erhålla upplysningar

Aktieägarna erinras om rätten att vid stämman begära upplysningar från styrelsen och verkställande direktören i enlighet med 7 kap. 32 § aktiebolagslagen (2005:551).

Tillhandahållande av handlingar

Handlingar enligt aktiebolagslagen kommer att hållas tillgängliga på Bolagets kontor senast två veckor före stämman och tillsändes utan kostnad den aktieägare som begär det och uppger sin postadress. Handlingarna kommer senast från denna tidpunkt även att finnas tillgängliga på Bolagets hemsida www.realheart.se. Samtliga ovanstående handlingar kommer även att framläggas på stämman.

Västerås i oktober 2025

Scandinavian Real Heart AB

STYRELSEN

Om oss
Scandinavian Real Heart AB (publ) utvecklar det första konstgjorda hjärtat som efterliknar det mänskliga hjärtats form, funktion och blodflödesmönster. Dessa unika produktegenskaper ger helt nya möjligheter att rädda liv och ge patienter en god livskvalitet i väntan på en hjärttransplantation. I framtiden kan konstgjorda hjärtan också bli ett alternativ till transplantation för bredare grupper av patienter med svår hjärtsvikt. Realheart® TAH (Total Artificial Heart) utvärderas nu i omfattande prekliniska studier inför en första klinisk studie på patienter. Bolagets aktier är upptagna till handel på Nasdaq Stockholm First North Growth Market. För mer information, besök https://realheart.se/sv/

KALLELSE TILL EXTRA BOLAGSSTÄMMA I SCANDINAVIAN REAL HEART AB

Styrelsens förslag till beslut om nyemission av aktier

Styrelsens förslag till beslut om ändring av bolagsordningen

Bolagsordning

NOTICE OF EXTRAORDINARY GENERAL MEETING OF SCANDINAVIAN REAL HEART AB

The shareholders of Scandinavian Real Heart AB, org.nr. 556729-5588 (the "Company"), are hereby invited to attend the Extraordinary General Meeting to be held on Tuesday, November 24, 2025 at 5:30 p.m. at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, 722 13 Västerås, Sweden. Registration for the meeting will commence at 5:00 p.m.

Right to participate in the meeting, etc.

Shareholders who wish to participate in the Meeting must:

be entered in the share register maintained by Euroclear Sweden AB no later than Monday 17 November 2025, and
notify the Company of their intention to participate no later than Wednesday 19 November 2025 by mail to Scandinavian Real Heart AB, attn: Jimmy Nybom, Kopparbergsvägen 6, 722 13 Västerås or by e-mail to jimmy.nybom@realheart.se. The notification must state the full name, personal identity number or corporate registration number, shareholding, address, daytime telephone number and, where applicable, information about the deputies or assistants (maximum two).

In order to be entitled to participate in the meeting, a shareholder whose shares are registered in the name of a nominee must, in addition to giving notice of participation in the meeting, register the shares in their own name so that the shareholder is included in the presentation of the share register as of the record date of Monday, November 17, 2025. Such re-registration may be temporary (so-called voting rights registration) and is requested from the nominee in accordance with the nominee's procedures at such time in advance as determined by the nominee. Voting rights registration made by the nominee no later than Wednesday, November 19, 2025 will be taken into account in the preparation of the general meeting share register.

Agents, etc.

If a shareholder is to be represented by a proxy, the proxy must bring a written, dated and signed power of attorney to the meeting. The power of attorney may not be older than one year unless it specifies that it is valid for a longer period of time, but not more than five years. If the power of attorney has been issued by a legal entity, the representative must also bring the current certificate of registration or equivalent authorization document for the legal entity. To facilitate entry, a copy of the power of attorney and other authorization documents should be attached to the notification to the meeting. Proxy forms are available on the Company's website www.realheart.se and will be sent by mail to shareholders who contact the Company and state their address.

Processing of personal data

For information on how personal data is processed in connection with the Annual General Meeting, please refer to the privacy policy available on Euroclear Sweden AB's website: https://www.euroclear.com/dam/ESw/Legal/Integritetspolicy-bolagsstammor-svenska.pdf.

Draft agenda

Election of Chairman of the Meeting
Election of minutes of the meeting
Election of one or two persons to verify the minutes
Preparation and approval of the voting list
Approval of the agenda
Determination of whether the meeting has been duly convened
Resolution on new issue of shares
Resolution to amend the Articles of Association
Closing of the meeting

Item 1 – Election of Chairman of the Meeting

The Board of Directors proposes that Jimmy Nybom be elected Chairman of the Meeting.

Item 7 – Resolution on new issue of shares

The Board of Directors' proposal for a resolution on a new issue of shares, appendix 1

Item 8 – Resolution to amend the Articles of Association

The Board of Directors' proposal for a resolution to amend the Articles of Association, appendix 2

The proposed Articles of Association in its entirety, appendix 3

The resolution is conditional upon the Annual General Meeting resolving in accordance with item 7 of the notice.

Majority requirements

A valid resolution under resolution item 8 requires that the proposals are supported by shareholders representing at least two-thirds of both the votes cast and the shares represented at the meeting.

Information on the number of shares and votes

At the time of issuing this notice, the total number of shares and votes in the Company amounts to 4,998,704.

Shareholders' right to receive information

Shareholders are reminded of the right to request information from the Board of Directors and the CEO at the Annual General Meeting in accordance with Chapter 7. Section 32 of the Swedish Companies Act (2005:551).

Provision of documents

Documents in accordance with the Swedish Companies Act will be available at the Company's office no later than two weeks prior to the Annual General Meeting and will be sent free of charge to the shareholder who so requests and states their postal address. The documents will also be available on the Company's website www.realheart.se at the latest from this date. All of the above documents will also be presented at the Annual General Meeting.

Västerås in October 2025

Scandinavian Real Heart

The Board of Directors

About Us
Scandinavian Real Heart AB (publ) is developing the first artificial heart that mimics the shape, function, and blood flow pattern of the human heart. These unique product features provide completely new opportunities to save lives and give patients a good quality of life while waiting for a heart transplant. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with severe heart failure. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive preclinical trials ahead of a first clinical study in patients. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se

NOTICE OF EXTRAORDINARY GENERAL MEETING OF SCANDINAVIAN REAL HEART AB

Board Resolution On Rights Issue

Board Resolution On Change Of Articles Of Association

Articles Of Association

Realheart Receives Patent Approval in Japan

Västerås, Sweden, September 26, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has been granted patent approval by the Japan Patent Office (JPO) concerning the automatic control of Realheart® TAH. While this is the first jurisdiction to approve the patent, the company has pending applications of the same patent in Europe, the US, India, China and Australia.

Realheart is developing Realheart® TAH, the first total artificial heart that mimics the structure and function of the native human heart. The recently approved patent (JP patent no. 7731894) covers a key technology of Realheart® TAH, entailing the automated control function of the device. The feature is an important part of the product’s value proposition, designed to provide a meaningful treatment alternative for patients awaiting a heart transplant, while providing benefits that may increase the quality of life. The structural design of Realheart® TAH aims to decrease risk factors commonly associated with currently approved artificial heart treatment devices, e.g., stroke, internal bleeding, and anemia.

The patent approval confers market protection for the device in Japan until 2041.

Realheart Receives Patent Approval in Japan

Realheart Publishes Positive Blood Flow Data Using a Groundbreaking 4D Medical Imaging Method

Västerås, Sweden, September 17, 2025 – Scandinavian Real Heart AB (publ) announces today that the company and its academic partner at Linköping University has published results from a scientific study evaluating a 3D-printed MRI-compatible artificial heart with advanced medical imaging that shows three-dimensional blood flow changes in real time (4D). The resultsshow that Realheart® TAH produces blood flow patterns comparable to those of the natural human heart, underscoring its potential as a safe and effective treatment for severe heart disease.

In the study, researchers used four dimensional (4D) flow MRI – an imaging approach that can capture three‑dimensional flow patterns in a human heart – combined with a physical, 3D‑printed model of Realheart® TAH to study its blood flow profile. This is the first time a 3D-printed pulsatile MRI-compatible artificial heart has been built and successfully evaluated with 4D flow MRI. Results from the study show that Realheart® TAH produces a blood flow profile comparable to the native human heart, further highlighting its potential as an effective treatment in cardiac disease.

“Our study demonstrates that the combination of 4D flow MRI with 3D printing is a powerful way to evaluate blood flow in artificial hearts. The levels of stagnant blood, energy loss, and turbulence that were found when evaluating Realheart® TAH were comparable to those observed in the native human heart. Further, by pairing 4D flow MRI with 3D printing, we add a valuable tool to complement computer simulations and blood testing in the design process of medical cardiac devices,” says Tino Ebbers, Professor in physiological measurements at Linköping University, Sweden.

In summary, the study results match earlier computer simulations, confirming low friction forces and little stagnant blood flow in Realheart® TAH. Overall, the blood flow showed a healthy profile – showing no greater risk of clots or other complications than in the human heart. Areas of slow flow, which can trigger clots, were similar to those in healthy human hearts, and turbulence levels – another clot and hemolysis risk – were even lower than in patients with valve disease.

“By combining cutting-edge imaging with precision engineering, we highlight, yet again, the great potential in our technology to address severe heart disease. The study results provide further validation of Realheart® TAH’s performance and its capability to generate an adequate blood health profile. Collectively, these data strengthen our position and provide further support toward clinical studies,” says Ina Laura Perkins, CEO, Realheart.

Link to the paper: https://rdcu.be/eGpzl

Realheart Publishes Positive Blood Flow Data Using a Groundbreaking 4D Medical Imaging Method

Interim Report April – June 2025

Summary of Interim Report April – June 2025

Group Overview	2025-04-01	2024-04-01	2025-01-01	2024-01-01	2024-01-01
	2025-06-30	2024-06-30	2025-06-30	2024-06-30	2024-12-31
	3 mon	3 mon	6 mon	6 mon	12 mon
Operating income	20 592	30 322	90 586	40 380	50 054
Earnings after financial items	-8 729 586	-6 321 701	-18 627 956	-14 106 388	-34 350 238
Balance sheet total	87 939 144	86 640 481	87 939 144	86 640 481	83 279 673
Equity / assets ratio	85%	74%	85%	74%	81%
Earnings per share	-1,98	-0,07	-4,23	0,15	-16,61
Number of shares*	4 398 704	96 994 446	4 398 704	96 994 446	2 068 152

Parent Company Overview	2025-04-01	2024-04-01	2025-01-01	2024-01-01	2024-01-01
	2025-06-30	2024-06-30	2025-06-30	2024-06-30	2024-12-31
	3 mon	3 mon	6 mon	6 mon	12 mon
Operating income	20 592	30 322	90 586	40 380	50 054
Earnings after financial items	-8 618 743	-6 158 452	-18 458 587	-13 922 442	-32 409 725
Balance sheet total	90 551 912	87 141 085	90 551 912	87 141 085	85 837 128
Equity / assets ratio	86%	74%	86%	74%	82%
Earnings per share	-1,96	-0,06	-4,20	-0,14	-15,67
Number of shares*	4 398 704	96 994 446	4 398 704	96 994 446	2 068 152

* In November 2024, a reverse share split was carried out whereby 100 shares were combined into 1 share.

Revenue and Result
Scandinavian Real Heart AB is currently engaged in research and development and currently has no sales of its own products. Research and development costs incurred for Realheart® TAH were capitalized during the period April 1 – June 30, 2025, in the amount of SEK 6.7 million.

Employees
The number of employees in the Group at the end of the quarter was 12 full-time employees and 2 hourly employees.

Transactions With Related Parties
No significant transactions with related parties have taken place during the period.

The Company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the Company can secure funding in both the short and long term. The board is continuously working on different scenarios to ensure the Company’s future operations.

Financial Position
At the end of the period, the Group’s cash and cash equivalents amounted to SEK 27.9 million. At present, the Group does not generate its own positive cash flow and is thus dependent on external financing. In order to solve the longer-term financing needs, the Board of Directors is continuously evaluating options for further capitalization of the Company.

CEO Comment
Over the last quarter, Realheart has been visible in several different forums. In a recently aired public service documentary in Germany and France, Realheart® TAH was showcased, putting the spotlight on artificial hearts as a future treatment option for heart failure patients. Shortly thereafter, our state-of-the-art system was described in a research article in the prestigious journal Artificial Organs. Together with strategic events, including the election of Oskar Mellgren as new chairman of the board, we remain topical while making essential strides forward in the development of Realheart® TAH.

Significant Events During the Second Quarter of the Year
During April, the company received a total of SEK 25.7 million before direct issue costs, which partly stems from payment for shares subscribed for in the directed issue that the board decided on in March 2025 and partly from payment for shares subscribed for through warrents of series TO3.

On April 29, Realheart announces that the company has been granted a patent approval by the Japan Patent Office (JPO) concerning a pressure sensor device for artificial hearts and circulatory support systems such as Realheart® TAH. The patent is a supportive measure to ensure market protection of the company’s device on the Japanese market and is valid until 2041.

On May 2, Realheart announces that EIC has Subscribed for 600,000 Shares in the Directed Share Issue Resolved by the Board of Directors of Realheart on 27 April 2025.

At the general meeting in June, two new board members were elected: Mia Tomczak and Oskar Mellgren, who was also elected chairman of the board.

On June 10, Realheart announces that the company’s technology is presented and showcased in a public service documentary broadcasted by ARTE TV, targeted at the German and French general public. The documentary features a visit to Realheart and showcases one of the company’s preclinical implantation procedures. Additionally, Realheart® TAH is demonstrated in the lab, highlighting its unique adaptive pressure system and the patient-friendly controller that is under development.

On June 17, Realheart announces that the company has been granted patent approval by the United States Patent and Trademark Office (USPTO) concerning the core technology of Realheart® TAH. The same patent has previously been approved in the European Patent Office (EPO). The patent approval confers market protection for the device in the US until 2037.

On June 18, Realheart announces that the company’s scientific collaborator at the Royal School of Technology (KTH) has published new results in the scientific journal Artificial Organs, validating the function of Realheart® TAH to produce systemic hemodynamic balance, as well as adaptively adjust the system’s cardiac output based on pressure sensor data. The new data are based on simulations from a state-of-the-art semi-virtual system financed through a joint strategic initiative between Vinnova, Formas and the Swedish Energy Agency (Energimyndigheten).

On June 27, Realheart announces that the company is shifting from issuing financial reports once per quarter to semi-annual reporting. The change is made as a strategic decision intended to free up time for the company’s management to be dedicated to the development of Realheart® TAH and increase cost efficiency. Consequently, the financial reporting will comprise three reports: one for the first half-year, one for the second half-year/full year, and an annual report.

Significant Events After the End of the Period
On July 7, Realheart announces that the company has received an outstanding payment of approximately SEK 6.8 million from the European Innovation Council (EIC) following the company’s directed share issue communicated on May 2, 2025, wherein it was announced that EIC has subscribed 600,000 shares to the subscription price of SEK 11.31 per share.

On August 11, Realheart announces that the company has received its third disbursement from the European Innovation Council (EIC) grant, initially awarded in December 2021. The grant aims to support the development of the artificial heart Realheart® TAH. The payment of EUR 250,000 equals 10% of the total grant sum of EUR 2.5 million.

Realheart Interim Report Q2 2025

Realheart Receives EUR 250,000 in Third Grant Payment From the European Innovation Council

Västerås, Sweden, August 11, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has received its third disbursement from the European Innovation Council (EIC) grant, initially awarded in December 2021. The grant aims to support the development of the artificial heart Realheart® TAH. The payment of EUR 250,000 equals 10% of the total grant sum of EUR 2.5 million.

The company was awarded a EUR 2.5 million grant within the framework of the European Innovation Council Accelerator program, aimed at supporting European innovations that have the potential to create new markets or disrupt existing ones. The grant continues to serve as a valuable mark of excellence that has enhanced the company's international standing among distinguished clinics and industry experts.

“We’re glad to receive the third disbursement from the European Innovation Council as part of its support for the development of Realheart® TAH. The funds will be used as part of our current efforts to further improve our quality workflows and accelerate production capabilities,” says Ina Laura Perkins, CEO, Realheart.

Realheart Receives EUR 250,000 in Third Grant Payment From the European Innovation Council

Realheart Receives SEK 6.8 Million Following Directed Share Issue to the European Innovation Council

Västerås, Sweden, July 7, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has received an outstanding payment of approximately SEK 6.8 million from the European Innovation Council (EIC) following the company’s directed share issue communicated on May 2, 2025, wherein it was announced that EIC has subscribed 600,000 shares to the subscription price of SEK 11.31 per share.

The European Innovation Council (EIC) has hitherto subscribed in two separate share issues resolved by the company. Due to the size of the investment and that Realheart acts within a sector of interest to the Swedish state, the transaction has been reviewed according to the Foreign Direct Investment Act, causing a delay in the payment.

“This settlement marks the completion of EIC’s participation in yet another financing round for the continued development of our unique technology. In this highly competitive arena, where only one in twenty applying companies receive any form of EIC support, we see this investment as an important external validation of the company’s innovation and potential. We look forward to continuing our constructive dialogue with the agency,” says Ina Laura Perkins, CEO, Realheart.

Realheart Receives SEK 6.8 Million Following Directed Share Issue to the European Innovation Council

Realheart Changes From Quarterly to Biannual Financial Reporting

Västerås, Sweden, June 27, 2025 – Scandinavian Real Heart AB (publ) announces today that the company is shifting from issuing financial reports once per quarter to semi-annual reporting. The change is made as a strategic decision intended to free up time for the company’s management to be dedicated to the development of Realheart® TAH and increase cost efficiency. Consequently, the financial reporting will comprise three reports: one for the first half-year, one for the second half-year/full year, and an annual report.

The decision to shift from quarterly to biannual reporting follows the company’s internal overview and is an initiative to increase product development efficiency and decrease company costs. The transition is made in accordance with marketplace rules (First North Growth Market Rulebook, chapter 4.4). The company will continue to update the market via its official channels, including press releases and social media, on notable events connected to the company’s activities. As previously communicated, all future communications from Realheart will be in English.

Realheart Changes From Quarterly to Biannual Financial Reporting

Realheart publicerar validerande data som visar hemodynamisk balans och automatiserad kontroll av hjärtminutvolymen

Västerås, Sverige, 18 juni 2025 – Scandinavian Real Heart AB (publ) meddelar idag att bolagets vetenskapliga samarbetspartner vid Kungliga Tekniska Högskolan (KTH) har publicerat nya resultat i den vetenskapliga tidskriften Artificial Organs, som validerar Realheart® TAH:s funktion att skapa systemisk hemodynamisk balans, samt adaptivt justera systemets hjärtminutvolym baserat på data från trycksensorer. De nya resultaten är baserade på simuleringar från den senaste tekniken av ett semi-virtuellt system som finansierats genom ett gemensamt strategiskt initiativ mellan Vinnova, Formas och Energimyndigheten.

De publicerade resultaten visar att Realheart® TAHs automatiska kontrollalgoritm upprätthåller en korrekt vänster-högerbalans, vilket balanserar blodtrycket mellan systemisk cirkulation och lungcirkulation i hjärt-kärlsystemet. Vidare visar data att Realheart® TAH automatiskt ökade hjärtminutvolymen med upp till 2,1 gånger under träning från vila och minskade hjärtminutvolymen med 25 % under sömn samtidigt som trycket i förmaken hölls stabilt. Detta visades i simuleringar som utvärderade ett friskt tillstånd, samt i varierande nivåer av pulmonell hypertension. Sammantaget visar dessa resultat på enhetens förmåga att anpassa sig till snabba övergångar mellan fysiologiska tillstånd.

"Våra data visar att Realheart® TAH utmärker sig genom sin förmåga att möjliggöra olika nivåer av fysisk aktivitet för patienter som vill fortsätta att vara aktiva. Kombinationen av trycksensorbaserad återkopplingskontroll och pumpmekanismens förmåga att tillhandahålla ett träningsflöde gör den unik. Vi ser fram emot att genomföra ytterligare studier och utvärdera den mot de produkter som för närvarande är godkända", säger Dr. Seraina Dual, biträdande professor i biomedicinsk signalbehandling vid institutionen för biomedicinsk teknik och hälsosystem, Kungliga Tekniska Högskolan, Sverige.

Studien bygger på ett gemensamt projekt mellan Realheart och KTH, som har byggt en toppmodern kardiovaskulär ”hybridsimulator”, som inkluderar en digital modell av hjärta, lungor och kärl som kan kopplas fysiskt till Realheart® TAH. Uppsättningen möjliggör simuleringar av patientspecifika scenarier och förfining av pumpens styralgoritmer. Projektet möjliggörs av två bidrag på totalt 8 miljoner kronor, finansierade av Vinnovas program Smart Elektronik, ett samarbete med Formas och Energimyndigheten.

"Objektiva studier av vår enhets fysiologiska kontroll, utförda av experter inom forskningsområdet, är av avgörande betydelse för att öka vår innovations övergripande trovärdighet och förtroende, visa dess prestanda och potential samt lära oss om områden där vi kan fortsätta att förbättra oss. Genom att använda hybridsystemet kan vi genomföra snabba iterativa utvecklingscykler för att justera mjukvaran och snabbt testa ett stort antal olika fysiologiska scenarier", säger Ina Laura Perkins, VD, Realheart.

Artikeln ”Physiological Control of Realheart® Total Artificial Heart” är publicerad i Artificial Organs vol. 17 juni, 2025.
https://onlinelibrary.wiley.com/doi/10.1111/aor.15036

Realheart publicerar validerande data som visar hemodynamisk balans och automatiserad kontroll av hjärtminutvolymen

Realheart Publishes Validating Data Showing Hemodynamic Balance and Automated Cardiac Output Control

Västerås, Sweden, June 18, 2025 – Scandinavian Real Heart AB (publ) announces today that the company’s scientific collaborator at the Royal School of Technology (KTH) has published new results in the scientific journal Artificial Organs, validating the function of Realheart® TAH to produce systemic hemodynamic balance, as well as adaptively adjust the system’s cardiac output based on pressure sensor data. The new data are based on simulations from a state-of-the-art semi-virtual system financed through a joint strategic initiative between Vinnova, Formas and the Swedish Energy Agency (Energimyndigheten).

The published results demonstrate that Realheart® TAH automatic control algorithm maintains proper left-right balance, balancing blood pressure between the systemic and pulmonary circulation in the cardiovascular system. Further, data show that Realheart® TAH automatically increased cardiac output by up to 2.1 times during exercise from rest and decreased cardiac output by 25% during sleep whilst maintaining stable pressure in the atria. This was shown in simulations evaluating a healthy state, as well as in varying levels of pulmonary hypertension. Collectively, these results demonstrate the device’s ability to adapt to rapid transitions between physiological states.

“Our data show that Realheart® TAH stands out in its ability to enable different levels of physical activity for patients who want to remain active. The combination of pressure-sensor based feedback control and the power of the pump mechanism to provide exercise flow makes it unique. We look forward to pursuing further studies and evaluating it against currently approved devices,” says Dr. Seraina Dual, Assistant Professor in Biomedical Signal Processing at the Department of Biomedical Engineering and Health Systems, Royal School of Technology, Sweden.

The study builds upon a joint project between Realheart and KTH, which has built a state-of-the-art cardiovascular “hybrid simulator”, including a digital model of the heart, lungs, and vessels that can be physically coupled to Realheart® TAH. The setup allows simulations of patient-specific scenarios and refinement of the pump’s control algorithms. The project is enabled by two back-to-back grants, totalling SEK 8 million, funded by Vinnova’s Smart Electronics program, a joint effort with Formas and the Swedish Energy Agency (Energimyndigheten).

“Objective studies of our device’s physiological control, performed by research field experts, are of pivotal importance to increase our innovation's overall credibility and confidence, demonstrate its performance and potential, and teach us about areas where we can continue to improve. By using the hybrid system, we can conduct rapid iterative development cycles to adjust the software and rapidly test a large number of different physiological scenarios,” says Ina Laura Perkins, CEO, Realheart.

The article, "Physiological Control of Realheart® Total Artificial Heart”, is featured in Artificial Organs vol. June 17, 2025. https://onlinelibrary.wiley.com/doi/10.1111/aor.15036

Realheart Publishes Validating Data Showing Hemodynamic Balance and Automated Cardiac Output Control

Realheart erhåller patentgodkännande i USA

Västerås, Sverige, 17 juni 2025 – Scandinavian Real Heart AB (publ) meddelar idag att bolaget har beviljats patentgodkännande av United States Patent and Trademark Office (USPTO) avseende kärnteknologin i Realheart® TAH. Samma patent har tidigare godkänts av det europeiska patentverket (EPO).

Det nyligen godkända patentet (US patent no. 12318603 B2) omfattar nyckelteknologin i Realheart® TAH, det enda artificiella hjärtat med fyra kammare som efterliknar fysiologin i det naturliga mänskliga hjärtat. Dessa unika produktegenskaper ger helt nya möjligheter att rädda liv och ge patienterna en god livskvalitet i väntan på en hjärttransplantation. Den strukturella utformningen kan ge viktiga fördelar, t.ex. minskad risk för stroke, blödning och blodbrist – vanliga biverkningar vid behandling med idag godkända konstgjorda hjärtan.

Patentgodkännandet ger marknadsskydd för enheten i USA fram till 2037.

Realheart erhåller patentgodkännande i USA

Realheart Receives Patent Approval in the US

Västerås, Sweden, June 17, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has been granted patent approval by the United States Patent and Trademark Office (USPTO) concerning the core technology of Realheart® TAH. The same patent has previously been approved in the European Patent Office (EPO).

The newly approved patent (US patent no. 12318603 B2) covers the key technology of Realheart® TAH, the only artificial four-chamber heart that mimics the physiology of the natural human heart. These unique product features provide completely new opportunities to save lives and give patients a good quality of life while waiting for a heart transplant. The structural design may provide important benefits, e.g., a reduced risk of stroke, bleeding, and anemia – common side effects seen with treatments using currently approved artificial heart devices.

The patent approval confers market protection for the device in the US until 2037.

Realheart Receives Patent Approval in the US

Kommuniké från årsstämman i Scandinavian Real Heart AB den 12 juni 2025

Scandinavian Real Heart AB (”Bolaget”) har idag den 12 juni 2025 hållit årsstämma där i huvudsak följande beslut fattades.

Fastställande av resultat- och balansräkning, resultatdisposition och ansvarsfrihet
Stämman beslutade att fastställa den framlagda resultat- och balansräkningen för räkenskapsåret 2024. Vidare beslutade stämman att ingen utdelning lämnas för räkenskapsåret 2024 och att resultatet ska balanseras i ny räkning. Stämman beviljade styrelsens ledamöter och den verkställande direktöreren som varit verksam under räkenskapsåret 2024 ansvarsfrihet gentemot Bolaget.

Fastställande av arvoden åt styrelse och revisor
Stämman beslutade att styrelsearvode ska utgå till styrelseordförande med 160 000 kronor och med 77 500 kronor till var och en av de övriga ledamöter vilka ej är anställda av Bolaget. Arvode till revisorn beslutades utgå enligt godkänd räkning.

Val av styrelse och revisor
Det beslutades, för tiden intill slutet av nästa årsstämma, omval av Magnus Öhman, Azad Najar, Oliver Voigt, Giovanni Lauricella och Stuart McConchie samt nyval av Oskar Mellgren* och Mia Tomczak** som styrelseledamöter. Oskar Mellgren valdes som styrelseordförande.

Till revisor omvaldes revisionsbolaget Grant Thornton Sweden AB för tiden intill årsstämman 2026. Bolaget har blivit informerade om att Joakim Söderin kommer att utses till huvudansvarig revisor.

Valberedning
Stämman beslutade att valberedningen inför årsstämman 2026 ska bestå av Claes Mellgren.

Bemyndigande för styrelsen att emittera aktier
Stämman beslutade om bemyndigande för styrelsen att inom ramen för gällande bolagsordning, med eller utan avvikelse från aktieägarnas företrädesrätt, vid ett eller flera tillfällen under tiden fram till nästa årsstämma fatta beslut om ökning av Bolagets aktiekapital genom nyemission av aktier i Bolaget.

Fullständiga beslut enligt ovan finns tillgängliga på Bolagets webbplats, www.realheart.se/sv

*Oskar Mellgren
Utbildning
Civilingenjör, Uppsala Universitet
Certifierad styrelseledamot Styrelseakademien

Erfarenhet
Oskar har över 10 år erfarenhet från industriell produktion främst inom AQ Group. Bland annat medicinteknisk utrustning till läkemedelskunder. Haft ledande befattningar som kvalitetschef, inköpschef, produktionschef, vice VD samt VD. Även ansvarat för globala projekt som projektledare. Idag driver Oskar eget företag inom affärsutveckling och ledarskapsutbildning.

**Mia Tomczak
Utbildning
Civilekonom, Mälardalens Universitet
Exekutive MBA, Handelshögskolan i Stockholm

Styrelseuppdrag
För närvarande är Mia ledamot i flera interna styrelser inom Kamic/Amplex/Mindelon-koncernerna, ledamot i Nodica Group AB där hon även är ordförande i revisionsutskottet, samt ledamot i Cascade Drives AB.

Erfarenhet
Mia är idag verksam som Group CFO för Kamic Group/Amplex/Mindelon Group. Hon har tidigare varit CFO i AQ Group AB, Ekonomichef/ Controller inom Sandvik, Outokumpu, samt drivit reklambyrå B2B.

Kommuniké från årsstämman i Scandinavian Real Heart AB den 12 juni 2025

Bulletin From the Annual General Meeting of Scandinavian Real Heart AB on June 12, 2025

Scandinavian Real Heart AB (the “Company”) has today, June 12, 2025, held its annual general meeting where the following resolutions were made.

Adoption of the Income Statement and Balance Sheet, Appropriation of Earnings and Discharge from Liability
The Meeting resolved to adopt the presented Income Statement and Balance Sheet for the financial year 2024. Furthermore, the Meeting resolved that no dividend shall be paid for the financial year 2024 and that the result shall be carried forward. The Meeting discharged the members of the Board of Directors and the Managing Director who have been active during the financial year 2024 from liability towards the Company.

Determination of Fees for the Board of Directors and Auditor
The Meeting resolved that fees of SEK 160,000 shall be paid to the Chairman of the Board of Directors and SEK 77,500 to each of the other members who are not employed by the Company. Fees to the auditor were decided to be paid according to approved invoices.

Election of Board of Directors and Auditor
It was resolved, for the period until the end of the next Annual General Meeting, to re-elect Magnus Öhman, Azad Najar, Oliver Voigt, Giovanni Lauricella and Stuart McConchie and to elect Oskar Mellgren* and Mia Tomczak** as new Board members. Oskar Mellgren was elected as Chairman of the Board.

The auditing firm Grant Thornton Sweden AB was re-elected as auditor for the period until the 2026 Annual General Meeting. The company has been informed that Joakim Söderin will be appointed auditor in charge.

Election Committee
The Meeting decided that the Election Committee for the 2026 AGM shall consist of Claes Mellgren.

Authorization for the Board of Directors to Issue Shares
The Meeting resolved to authorize the Board of Directors, within the framework of the current Articles of Association, with or without deviation from the shareholders' preferential rights, on one or more occasions during the period until the next Annual General Meeting, to decide on an increase of the Company's share capital by issuing new shares in the Company.

The full text of the above decisions is available on the Company's website, www.realheart.se

*Oskar Mellgren
Education
Master of Engineering, Uppsala University
Certified Board Member Styrelseakademien

Experience
Oskar has over 10 years of experience from industrial production mainly within AQ Group. Among other things, medical equipment for pharmaceutical customers. Has held senior positions as quality manager, purchasing manager, production manager, vice president and CEO. Also responsible for global projects as project manager. Today Oskar runs his own company in business development and leadership training.

**Mia Tomczak
Education
MBA, Mälardalen University
Executive MBA, Stockholm School of Economics

Board Assignments
Mia is currently a member of several internal boards within the Kamic/Amplex/Mindelon groups, a member of Nodica Group AB where she is also chairman of the audit committee, and a member of Cascade Drives AB.

Experience
Mia is currently active as Group CFO for Kamic Group/Amplex/Mindelon Group. She has previously been CFO of AQ Group AB, CFO / Controller at Sandvik, Outokumpu, and ran an advertising agency B2B.

Bulletin From the Annual General Meeting of Scandinavian Real Heart AB on June 12, 2025

Realheart® TAH lyfts fram i public service-dokumentär

Västerås, Sverige, 10 juni 2025 – Scandinavian Real Heart AB (publ) meddelar idag att bolagets teknologi presenteras och visas upp i en public service-dokumentär som sänds av ARTE TV, riktad till den tyska och franska allmänheten. Dokumentären är tillgänglig via nätverkets onlinevisning.

Miljontals människor världen över lider av hjärtsvikt – men på grund av organbrist får endast 8 000 patienter per år en hjärttransplantation. För att ta itu med och beskriva det pågående teknikskiftet inom behandling av hjärtsvikt har det fransk-tyska public service-nätverket ARTE TV producerat en dokumentär som illustrerar den potentiella rollen för konstgjorda hjärtan i framtidens behandling av hjärtsvikt. Dokumentären innehåller ett besök på Realheart och visar även en av bolagets prekliniska implantationsprocedurer. Dessutom demonstreras Realheart^® TAH i labbet, där den unika adaptiva automatiska styrningen och den patientvänliga kontrollenheten som är under utveckling lyfts fram.

Vidare innehåller dokumentären en intervju med den första kvinnliga patienten som fått det enda godkända TAH-systemet i EU implanterat. Intervjun belyser möjligheterna att förbättra ljudnivån och den externa strömförsörjningen för de artificiella hjärtan som för närvarande är godkända. Bland de yrkesverksamma som demonstrerar och kommenterar Realheart-systemet finns Dr. Thomas Finocchiaro, CTO på Realheart, samt Dr. Dilek Gürsoy, M.D. och certifierad hjärtkirurg vid de privata hjärtkirurgiska klinikerna Mönchengladbach och Clinic Bel Etage, som har direkta erfarenheter av att implantera Realheart^® TAH.

"Realheart^® TAH är det enda totala artificiella hjärtat i världen som efterliknar det naturliga mänskliga hjärtats struktur och fysiologi. Den mekaniska konstruktionen gör det tyst, och som ett resultat av samarbeten med patienter och vårdpersonal utvecklar vi utvecklat en patientvänlig monitorlösning som ger en enkel överblick för användarna. Vi är mycket glada över att ha fått möjlighet att visa upp vårt unika system för tittare runt om i Europa", säger Ina Laura Perkins, VD, Realheart.

Dokumentären är tillgänglig för allmänheten: https://www.arte.tv/de/videos/117722-000-A/ein-herz-auf-bestellung/

Realheart® TAH lyfts fram i public service-dokumentär

Realheart® TAH Showcased in Public Service Documentary

Västerås, Sweden, June 10, 2025 – Scandinavian Real Heart AB (publ) announces today that the company’s technology is presented and showcased in a public service documentary broadcasted by ARTE TV, targeted at the German and French general public. The documentary is available via the network’s online viewer.

Millions globally suffer from heart failure – but worldwide only 8,000 patients annually receive a heart transplant due to organ shortage. To address and describe the current technological shift in treating heart failure, the French-German public service network ARTE TV has produced a documentary illustrating the potential role of total artificial hearts in the future of heart failure treatment. The documentary features a visit to Realheart and showcases one of the company’s preclinical implantation procedures. Additionally, Realheart^® TAH is demonstrated in the lab, highlighting its unique adaptive pressure system and the patient-friendly controller that is under development.

Further, the documentary includes an interview with the first female patient implanted with the only approved system in the EU. This interview highlights the possibilities of improving the sound level and external powering of currently approved artificial heart devices. Among the professionals who demonstrate and comment on the Realheart system are Dr. Thomas Finocchiaro, CTO of Realheart, and Dr. Dilek Gürsoy, M.D. and board-certified heart surgeon at the private cardiac surgery clinics Mönchengladbach and Clinic Bel Etage, who has first-hand experience of implanting Realheart^® TAH.

“Realheart^® TAH is the only total artificial heart device in the world that mimics the structure and physiology of the natural human heart. Its mechanical construction makes it silent, and as a result of collaborations with patients and healthcare personnel, we have developed a patient-friendly monitoring unit that provides an easy overview for its users. We are very happy to have been given the opportunity to showcase our unique system to viewers around Europe,” says Ina Laura Perkins, CEO, Realheart.

The documentary is available for public viewing: https://www.arte.tv/de/videos/117722-000-A/ein-herz-auf-bestellung/

Realheart® TAH Showcased in Public Service Documentary

Realheart publicerar årsredovisning för 2024

Västerås, 23 maj 2025. Idag publicerar Realheart årsredovisningen för 2024.

Årsredovisningen inklusive revisionsberättelse (Eng) återfinns på www.realheart.se samt som bilaga i detta pressmeddelande.

Den engelska versionen är en översättning från den svenska.

Realheart Annual Report 2024 ENG Incl Auditor's Report Final

Realheart Releases Annual Report for 2024

Västerås, May 23, 2025. Today, Realheart releases the annual report for 2024.

The annual report including the auditor's report (Eng) can be found at www.realheart.se and as an attachment to this press release.

The English version is a translation from the Swedish version.

Realheart Annual Report 2024 ENG Incl Auditor's Report Final

Interim Report January – March 2025

Summary of Interim Report January – March 2025

Group Overview	2025-01-01	2024-01-01	2024-01-01
	2025-03-31	2024-03-31	2024-12-31
	3 mon	3 mon	12 mon
Operating income	69 994	10 058	50 054
Earnings after financial items	-9 898 370	-7 784 687	-34 350 238
Balance sheet total	71 568 884	93 733 581	83 279 673
Equity / assets ratio	81%	79%	81%
Earnings per share	-4.60	-0.08	-16.61
Number of shares*	2 153 330	96 994 446	2 068 152

Parent Company Overview	2025-01-01	2024-01-01	2024-01-01
	2025-03-31	2024-03-31	2024-12-31
	3 mon	3 mon	12 mon
Operating income	69 994	10 058	50 054
Earnings after financial items	-9 839 844	-7 763 990	-32 409 725
Balance sheet total	74 151 494	93 934 536	85 837 128
Equity / assets ratio	82%	88%	82%
Earnings per share	-4.57	-0.08	-15.67
Number of shares*	2 153 330	96 994 446	2 068 152

* In November 2024, a reverse share split was carried out whereby 100 shares were combined into 1 share.

Revenue and Result
Scandinavian Real Heart AB is currently engaged in research and development and currently has no sales of its own products. Research and development costs incurred for Realheart® TAH were capitalized during the period January 1 – March 31, 2025, in the amount of SEK 7 million.

Employees
The number of employees in the Group at the end of the quarter was 12 full-time employees and 2 hourly employees.

Transactions With Related Parties
No significant transactions with related parties have taken place during the period.

Significant Risks and Uncertainties
Realheart’s focus is on getting through the preclinical phase (hemolysis, GLP studies in animals and endurance tests) to be able to start clinical studies. This means that the Company must finalize the version of both the controller and the heart pump to be included in these tests. Realheart must also hold parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route for the product to market. The Company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the Company can secure funding in both the short and long term. The board is continuously working on different scenarios to ensure the Company’s future operations.

Financial Position
At the end of the period, the Group’s cash and cash equivalents amounted to SEK 11.5 million. At present, the Group does not generate its own positive cash flow and is thus dependent on external financing. In order to solve the longer-term financing needs, the Board of Directors is continuously evaluating options for further capitalization of the Company.

CEO Comment
Realheart develops Realheart® TAH, the world’s first completely artificial heart that mimics the structure and physiology of the natural human heart. Through the Company’s pioneering engineering, we have led the product through extensive preclinical evaluations, and recently the product was awarded HUD status by the FDA. This progress is made possible by great engineers and medical professionals, and individuals who see the potential in Realheart’s technology and support our vision. In the past quarter we were happy to have welcomed new, experienced long-term investors, providing further support toward entering our first-in-human clinical trial.

Significant Events During the First Quarter 2025
On January 29, Realheart announced via a press release that Realheart® TAH has received Humanitarian Use Device (HUD) designation from the U.S. Food and Drug Administration (FDA). The HUD designation makes Realheart® TAH eligible to apply for Humanitarian Device Exemption (HDE), an expedited regulatory pathway that can grant the product special market rights.

On January 30, Realheart issues a press release announcing successful results from a preclinical implantation of the Realheart® TAH total artificial heart. The successful results are from a 7-day animal study of the Realheart® TAH and show that the device provides adequate cardiac function, automatically adapts to rest and exercise, and maintains good blood biochemistry.

On February 4, Realheart announces the outcome of the exercise of warrants of series TO 2 issued in connection with the rights issue of units carried out by the Company during the period June 20, 2023 – July 7, 2023. In total, 17,035,600 Warrants were exercised for subscription of 85,178 shares, corresponding to a subscription rate of approximately 51 percent of the total 33,495,885 issued Warrants. Through the exercise, Realheart will receive approximately SEK 721 thousand before issue costs.

On March 3, the Company communicates via a press release that the subscription price for warrants of series TO3 (the “warrants”) has been set at SEK 12.98. The exercise period for the warrants begins on March 3, 2025 and runs until March 31, 2025. The last day of trading in the warrants is March 27, 2025.

On March 27, the Company publishes two press releases, one with the intention to carry out a directed share issue and one with the decision on a directed share issue of a maximum of 2,881,115 shares, which at full subscription will provide the Company with approximately SEK 32.6 million. The investors in the Directed Share Issue consist of a limited number of qualified and other professional investors, including both new and existing shareholders, including Claes Mellgren and Per Olof Andersson. The Company has received subscriptions for 2,085,382 shares, which means that the Company will receive approximately SEK 23.6 million before deduction of transaction costs. In addition, the existing shareholder European Investment Council (“EIC”) has, in accordance with the Board of Directors’ issue resolution, the opportunity to decide on participation in the Directed New Share Issue with subscription of a maximum of 795,733 shares which, upon full subscription, will provide the Company with approximately SEK 9.0 million.

Significant Events After the End of the First Quarter
On April 2, Realheart announces, via a press release, the outcome of the exercise of warrants of series TO 3. The exercise period for the Warrants ran during the period March 3 through March 31, 2025. The final outcome shows that 159,992 shares were subscribed for through the exercise of Warrants, which corresponds to a utilization rate of approximately 58 percent. The subscription price for one share subscribed for through the exercise of the Warrants was SEK 12.98 and the Company received SEK 2.1 million before issue costs.

On April 29, it was announced via a press release that the Company has been granted a patent approval by the Japan Patent Office (JPO) for a pressure sensor for artificial hearts and circulatory support systems such as Realheart® TAH. The patent is a support measure to ensure market protection for the Company’s device in the Japanese market and is valid until 2041.

On May 2, the Company communicates via a press release that EIC has subscribed for 600,000 shares in the directed share issue decided by the Board of Directors of Realheart on April 27, 2025. The subscription price in the directed share issue amounts to SEK 11.13 per share. The Company thereby receives SEK 6,678,000 and its share capital increases by SEK 3,006,000, from SEK 22,037,507.04 to SEK 25,043,507.04. The total number of shares increases from 4,398,704 to 4,998,704. EIC’s subscription of shares entails a dilution of approximately 12.0 percent of the capital and votes for existing shareholders, based on the total number of shares and votes in the Company after the Directed New Share Issue.

Realheart Interim Report Q1 2025

Delårsrapport januari – mars 2025

Sammanfattning av delårsrapport januari – mars 2025

Översikt koncernen	2025-01-01	2024-01-01	2024-01-01
	2025-03-31	2024-03-31	2024-12-31
	3 mån	3 mån	12 mån
Rörelseintäkter	69 994	10 058	50 054
Resultat efter finansiella poster	-9 898 370	-7 784 687	-34 350 238
Balansomslutning	71 568 884	93 733 581	83 279 673
Soliditet	81%	79%	81%
Resultat per aktie	-4,60	-0,08	-16,61
Antal aktier*	2 153 330	96 994 446	2 068 152

Översikt moderbolaget	2025-01-01	2024-01-01	2024-01-01
	2025-03-31	2024-03-31	2024-12-31
	3 mån	3 mån	12 mån
Rörelseintäkter	69 994	10 058	50 054
Resultat efter finansiella poster	-9 839 844	-7 763 990	-32 409 725
Balansomslutning	74 151 494	93 934 536	85 837 128
Soliditet	82%	88%	82%
Resultat per aktie	-4,57	-0,08	-15,67
Antal aktier*	2 153 330	96 994 446	2 068 152

* I november 2024 genomfördes en sammanläggning av aktier varvid 100 aktier lades samman till 1 aktie.

Intäkter och resultat
Scandinavian Real Heart AB bedriver för närvarande forskning och utveckling och har för närvarande ingen försäljning av egna produkter. Forsknings- och utvecklingskostnader för Realheart® TAH har aktiverats under perioden 1 januari – 31 mars 2025 med 7 MKR.

Anställda
Antalet anställda i koncernen vid kvartalets slut var 12 heltidsanställda och 2 timanställda.

Transaktioner med närstående
Inga väsentliga transaktioner med närstående har ägt rum under perioden.

Väsentliga risker och osäkerhetsfaktorer
Realhearts fokus ligger på att ta sig igenom den prekliniska fasen (hemolys, GLP-studier i djur och uthållighetstester) för att kunna starta kliniska studier. Detta innebär att Bolaget måste färdigställa den version av både styrenheten och hjärtpumpen som ska ingå i dessa tester. Realheart måste också föra parallella diskussioner med det anmälda organet i EU och med FDA i USA för att säkerställa den snabbaste och säkraste vägen för produkten till marknaden. Bolaget arbetar kontinuerligt med åtgärder för att minimera förseningarna. Vidare kräver den fortsatta produktutvecklingen att bolaget kan säkra finansiering på både kort och lång sikt. Styrelsen arbetar kontinuerligt med olika scenarier för att säkerställa Bolagets framtida verksamhet.

Finansiell ställning
Vid periodens slut uppgick koncernens likvida medel till 11,5 MKR. Koncernen genererar i dagsläget inte något eget positivt kassaflöde och är därmed beroende av extern finansiering. För att lösa de mer långsiktiga finansieringsbehoven utvärderar styrelsen kontinuerligt möjligheterna till ytterligare kapitalisering av Bolaget.

VD-kommentar
Realheart utvecklar Realheart® TAH, världens första helt konstgjorda hjärta som efterliknar det naturliga mänskliga hjärtats struktur och fysiologi. Genom Bolagets banbrytande ingenjörskonst har vi lett produkten genom omfattande prekliniska utvärderingar, och nyligen tilldelades produkten HUD-status av FDA. Dessa framsteg möjliggörs av fantastiska ingenjörer och medicinsk personal, och av individer som ser potentialen i Realhearts teknologi och stödjer vår vision. Under det senaste kvartalet var vi glada över att ha välkomnat nya, erfarna långsiktiga investerare, vilket ger ytterligare stöd för att inleda vår första kliniska studie på patienter.

Väsentliga händelser under första kvartalet 2025
Den 29 januari meddelar Realheart via ett pressmeddelande att Realheart® TAH har erhållit Humanitarian Use Device (HUD) designation från den amerikanska läkemedelsmyndigheten FDA. HUD-beteckningen gör Realheart® TAH berättigad att ansöka om Humanitarian Device Exemption (HDE), en påskyndad regulatorisk väg som kan ge produkten särskilda marknadsrättigheter.

Den 30 januari publicerar Realheart ett pressmeddelande med framgångsrika resultat från en preklinisk implantation av det totala konstgjorda hjärtat Realheart® TAH. De framgångsrika resultaten kommer från en 7-dagars djurstudie av Realheart® TAH och visar att enheten ger adekvat hjärtfunktion, automatiskt anpassar sig till vila och träning samt upprätthåller god blodbiokemi.

Den 4 februari meddelar Realheart utfallet av utnyttjandet av teckningsoptioner av serie TO 2 utgivna i samband med den företrädesemission av units som Bolaget genomför under perioden 20 juni 2023 – 7 juli 2023. Totalt utnyttjades 17 035 600 teckningsoptioner för teckning av 85 178 aktier, vilket motsvarar en teckningsgrad om cirka 51 procent av de totalt 33 495 885 utgivna teckningsoptionerna. Genom utnyttjandet kommer Realheart att tillföras cirka 721 TKR före emissionskostnader.

Den 3 mars meddelar Bolaget via ett pressmeddelande att teckningskursen för teckningsoptioner av serie TO3 (”teckningsoptionerna”) har fastställts till 12,98 kronor. Nyttjandeperioden för teckningsoptionerna inleds den 3 mars 2025 och löper till och med den 31 mars 2025. Sista dag för handel med teckningsoptionerna är den 27 mars 2025.

Den 27 mars offentliggör Bolaget två pressmeddelanden, ett med avsikt att genomföra en riktad nyemission och ett med beslut om en riktad nyemission om högst 2 881 115 aktier, som vid full teckning tillför Bolaget cirka 32,6 miljoner kronor. Investerarna i den Riktade Nyemissionen består av ett begränsat antal kvalificerade och andra professionella investerare, inklusive både nya och befintliga aktieägare, däribland Claes Mellgren och Per Olof Andersson. Bolaget har erhållit teckningar för 2 085 382 aktier, vilket innebär att Bolaget tillförs cirka 23,6 miljoner kronor före avdrag för transaktionskostnader. Därutöver har den befintliga aktieägaren European Investment Council (”EIC”), i enlighet med styrelsens emissionsbeslut, möjlighet att besluta om deltagande i den Riktade Nyemissionen med teckning av högst 795 733 aktier som vid full teckning kommer att tillföra Bolaget cirka 9,0 miljoner kronor.

Väsentliga händelser efter första kvartalets utgång
Den 2 april meddelar Realheart, via ett pressmeddelande, utfallet av utnyttjandet av teckningsoptioner av serie TO 3. Utnyttjandeperioden för teckningsoptionerna löpte under perioden 3 mars till och med 31 mars 2025. Det slutliga utfallet visar att 159 992 aktier tecknades genom utnyttjande av Teckningsoptioner, vilket motsvarar en nyttjandegrad om cirka 58 procent. Teckningskursen för en aktie som tecknades med stöd av teckningsoptionerna var 12,98 kronor och Bolaget tillfördes 2,1 miljoner kronor före emissionskostnader.

Den 29 april meddelas via ett pressmeddelande att Bolaget har erhållit ett patentgodkännande från Japan Patent Office (JPO) för en trycksensor för konstgjorda hjärtan och cirkulationsstödjande system såsom Realheart® TAH. Patentet är en stödåtgärd för att säkerställa marknadsskydd för Bolagets enhet på den japanska marknaden och är giltigt till 2041.

Den 2 maj meddelar Bolaget via ett pressmeddelande att EIC har tecknat 600 000 aktier i den riktade nyemission som beslutades av styrelsen i Realheart den 27 april 2025. Teckningskursen i den riktade nyemissionen uppgår till 11,13 kronor per aktie. Bolaget tillförs härigenom 6 678 000 kronor och dess aktiekapital ökar med 3 006 000 kronor, från 22 037 507,04 kronor till 25 043 507,04 kronor. Det totala antalet aktier ökar från 4 398 704 till 4 998 704. EIC:s teckning av aktier medför en utspädning om cirka 12,0 procent av kapitalet och rösterna för befintliga aktieägare, baserat på det totala antalet aktier och röster i Bolaget efter den Riktade Nyemissionen.

Realheart Interim Report Q1 2025

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