Archives

Scandinavian Real Heart AB Announces Outcome of the Exercise of Series TO 2 Warrants

NOT FOR RELEASE, DISTRIBUTION, OR PUBLICATION, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, OR ANY OTHER JURISDICTION WHERE SUCH ACTION WOULD BE UNLAWFUL OR REQUIRE ADDITIONAL REGISTRATION OR OTHER MEASURES.

Scandinavian Real Heart AB (publ) ("Realheart" or the "Company") today announces the outcome of the subscription period for the series TO 2 warrants ("Warrants"), which were issued in connection with the rights issue of units carried out by the Company between June 20, 2023, and July 7, 2023. A total of 17,035,600 Warrants were exercised for the subscription of 85,178 shares, corresponding to a subscription rate of approximately 51 percent of the total 33,495,885 issued Warrants. Through this exercise, Realheart will receive approximately SEK 721,000 before issuance costs.

Overview of Final Outcome

The exercise period for the Warrants ran from January 2, 2025, to January 31, 2025. The final outcome shows that 85,178 shares were subscribed through the exercise of Warrants, corresponding to an exercise rate of approximately 51 percent. The subscription price per share subscribed via the exercise of Warrants was SEK 8.47, which, in accordance with the terms of the Warrants, corresponds to 70 percent of the volume-weighted average price (VWAP) of the Company's shares on Nasdaq First North Growth Market during the measurement period. Through this exercise, Realheart will receive approximately SEK 721,000 before issuance costs.

Shares and Share Capital

As a result of the exercise of Warrants, the total number of shares in Realheart increases by 85,178, bringing the total number of outstanding shares in the Company from 2,068,152 to 2,153,330. The number of votes increases accordingly. The share capital of the Company increases by SEK 426,741.78 from SEK 10,361,441.52 to SEK 10,788,183.30, in accordance with the terms of the issuance. For existing shareholders who did not exercise any Warrants, the dilution amounts to approximately 4 percent of the total number of shares and votes in the Company after the exercise of Warrants.

Exercised Warrants will be replaced with interim shares until registration with the Swedish Companies Registration Office is completed, after which the interim shares will automatically be converted into ordinary shares. The interim shares are expected to be converted into ordinary shares approximately two banking days after registration with the Swedish Companies Registration Office.

IMPORTANT INFORMATION

The information in this press release may not be disclosed, published, or distributed, directly or indirectly, within or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea, or any other jurisdiction where such action would be unlawful, subject to legal restrictions, or require actions beyond those required under Swedish law. Any actions in violation of this directive may constitute a breach of applicable securities laws. This press release does not constitute an offer to acquire or subscribe for securities in Realheart in any jurisdiction, either from Realheart or from any other party.

This press release is not a prospectus under the meaning of Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction.

This press release does not identify or purport to identify risks (direct or indirect) associated with an investment in the Company. The information in this press release is solely intended to describe the background to the exercise of the Warrants and does not claim to be comprehensive or exhaustive. No representations are made regarding the accuracy or completeness of the information in this press release.

This press release does not constitute an offer to sell or an invitation to purchase securities in the United States. The securities mentioned herein may not be sold in the United States without registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States without registration, an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities mentioned herein in the United States or to conduct a public offering of such securities in the United States.

In the United Kingdom, this document and other materials relating to the securities referred to herein are being distributed only to, and are directed only at, "qualified investors" who are (i) persons with professional experience in investment-related matters falling within the definition of "investment professionals" in Article 19(5) of the U.K. Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) high net worth entities as referred to in Article 49(2)(a)-(d) of the Order (all such persons collectively referred to as "relevant persons"). Any investment or investment activity to which this announcement relates is available only to, and will only be engaged in with, relevant persons in the United Kingdom. Persons who are not relevant persons should not take any action based on this press release and should not rely on it.

Realheart Presents Successful Results From a Preclinical Implantation Using Its Total Artificial Heart

Västerås, Sweden, January 30, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has successfully completed a 7-day animal study with its total artificial heart Realheart® TAH. The results show that the device provided adequate cardiac function, automatically adapted to rest and movement and maintained good blood biochemistry.

“We are very pleased to share this positive update. Results from the implantation test show that Realheart® TAH achieved the targeted cardiac output, resulting in adequate perfusion of the body with low mechanical stress and damage to red blood cells” says Ina Laura Perkins, CEO of Realheart.

Throughout the study the device functioned as intended. At one week the study was terminated as there had been some signs of bleeding which is a common complication of large cardiac surgery.

“A 7-day chronic implantation is a meaningful milestone for our development as this duration affords the assessment of the device performance in an animal that is awake and ambulatory and under various cardiac loads and allows for the elimination of many post-surgical effects”, says CEO Ina Laura Perkins.

The company is currently conducting a preclinical program to evaluate the safety and function of Realheart® TAH prior to conducting clinical studies in heart failure patients. The results from this test will guide further preclinical testing of Realheart® TAH and serve as an integral part of the data set used in dialogue with regulatory agencies.

Realheart® TAH Receives Humanitarian Use Device Designation by the U.S. Food and Drug Administration (FDA)

Västerås, Sweden, January 29, 2025 – Scandinavian Real Heart AB (publ) today announces that its total artificial heart, Realheart® TAH, has been granted Humanitarian Use Device (HUD) designation by 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 limited marketing rights.

Realheart® TAH is a total artificial heart that mimics the structure and physiological function of the human heart. Following multiple rounds of communication with the FDA, the device has been granted Humanitarian Use Device status which paves the way for Realheart® TAH to treat patients with advanced biventricular heart failure who have few other options and need to be supported by a total artificial heart.

HDE is approved if the sponsor can demonstrate data indicating probable safety and benefit to the intended patient group.

Realheart will continue communications with the FDA to develop a clinical investigation strategy to support a Humanitarian Device Exemption premarket approval.

“We are extremely pleased that Realheart® TAH has been granted Humanitarian Use Device designation by the FDA. It is gratifying to look forward to our efforts culminating in such humanitarian benefit. We look forward to updating the market on further clinical and regulatory activities and meanwhile continue our preclinical development which will be important for a potential future full market approval,” says Ina Laura Perkins, CEO of Realheart.

Last Day for Exercise of Warrants TO 2 in Scandinavian Real Heart AB

Scandinavian Real Heart AB (“Realheart” or the “Company”) reminds holders of warrants of series TO 2 (the “warrants”) that the last day for exercise is January 31, 2025. Holders who do not exercise their warrants risk that they expire without value.

Upon full exercise of all warrants, the Company will receive approximately SEK 1.4 million before issue costs. To avoid the warrants expiring without value, the holder must either trade or subscribe.

Important Dates

  • Last day of trading: January 29, 2025
  • Last day to exercise: January 31, 2025

Summarized Terms and Conditions

  • Subscription price: SEK 8.47 per share (corresponding to 70 percent of the volume weighted average price during the measurement period).
  • Exercise ratio: 200 warrants entitle the holder to subscribe for one (1) new share in the Company.
  • ISIN code for the warrants: SE0020358166.
  • Total number of warrants: 33,495,885 warrants series TO 2. Upon full exercise, 167,479 new shares will be issued.
  • Dilution effect at full exercise: Approximately 7.5 percent.
  • Trading venue: The warrants are admitted to trading on Nasdaq First North under the ticker “HEART TO2”.

Instructions for use

Nominee-Registered Holdings
Holders with warrants in a share depository account, ISK account or endowment insurance should contact their bank or nominee well in advance of January 31, 2025, to ensure that the application is processed correctly.

Directly Registered Holdings
Holders with warrants in a securities account must complete and submit the application form for exercise, so that it is received by the issuing institution Nordic Issuing no later than January 31, 2025. The application form is available on the Company's and Nordic Issuing's respective websites.

Subscribed and paid shares may be registered in the subscriber's securities depository account as interim shares (IA) until the issue has been registered with the Swedish Companies Registration Office, whereupon interim shares are automatically converted into shares in Realheart.

Full Terms and Conditions of the Warrants
Full terms and conditions of the warrants are available on the Company's website, https://realheart.se/

Advisors
Skills Corporate Finance AB is the financial advisor to the Company and Setterwalls Advokatbyrå AB is the legal advisor. Nordic Issuing acts as issuing agent in connection with the exercise of the warrants.

Subscription Price Set for the Exercise of Series TO 2 Warrants in Scandinavian Real Heart AB

Scandinavian Real Heart AB ("Realheart" or the "Company") hereby announces that the subscription price for series TO 2 warrants (the "warrants") has been set at SEK 8.47. The exercise period for the warrants begins on January 2, 2025, and runs until January 31, 2025. The last day for trading the warrants is January 29, 2025.

Realheart conducted a rights issue of units (the "Rights Issue") during the period June 20, 2023 – July 7, 2023. Each unit issued in the Rights Issue consisted of two (2) shares and one (1) series TO 2 warrant. Two (2) series TO 2 warrants entitle the holder to subscribe for one (1) new share in the Company.

At an extraordinary general meeting on November 5, 2024, a consolidation of shares in the ratio of 1:100 was resolved, meaning that one hundred (100) existing shares were consolidated into one (1) share. In connection herewith, the subscription price and the number of shares that each series TO 2 warrant entitles to were adjusted, in accordance with the terms, to neutralize the effect of the consolidation. After the adjustment, two hundred (200) warrants are required to subscribe for one (1) new share in the Company. The Rights Issue announced on May 7, 2024, resulted in the cap for the subscription price upon exercising TO 2 being adjusted from SEK 200 after the consolidation to SEK 134 per share.

The consolidation does not affect the total number of outstanding warrants or their ISIN code (SE0020358166). Other terms for the warrants, such as the subscription period, remain unchanged.

After the recalculation, one (1) series TO 2 warrant entitles the holder to subscribe for 0.005 shares (previously 0.5 shares). Since it is not possible to subscribe for a fraction of a share, two hundred (200) warrants are now required to subscribe for one (1) new share in the Company. A corresponding recalculation has been made regarding series TO 3 warrants.

Upon full exercise of all series TO 2 warrants, Realheart will receive approximately SEK 1.4 million before issuance costs.

The subscription price for the series TO 2 warrants is set at 70 percent of the volume-weighted average price of the Company's shares on Nasdaq First North Growth Market during the period December 12 – 30, 2024, i.e., during the 10 trading days immediately preceding the start of the subscription period. 70 percent of the volume-weighted average price during the measurement period amounted to SEK 8.47.

Summary Instructions and Important Dates
Holders of warrants who wish to exercise them to subscribe for shares must notify this no later than January 31, 2025. Warrants that are not exercised before then will expire without value. Holders who do not wish to exercise their warrants have the opportunity to sell them. Trading in the warrants will continue until January 29, 2025.

Detailed Information and Instructions for Subscription
Exercise of Custodian-Registered Warrants
Holders who have their warrants custodian-registered (held in a securities account, ISK account, or capital insurance) should notify the exercise of the warrants by contacting their custodian and following the custodian's instructions regarding subscription and payment. This should be done well in advance of January 31, 2025, as different custodians have different processing times.

Exercise of Directly Registered Warrants
Holders who have their warrants directly registered (held in a VP account) should notify the exercise of the warrants by filling in and sending in the subscription form for the exercise, so that the subscription form is received by the issuing agent Nordic Issuing no later than January 31, 2025.

The subscription form is available on the Company's and Nordic Issuing's respective websites. Note that payment for the new shares must be received by Nordic Issuing no later than January 31, 2025, in accordance with the instructions on the subscription form.

Trading with TO 2
Holders who do not wish to exercise their warrants have the opportunity to sell them on Nasdaq Stockholm. The warrants are traded until January 29, 2025, under the ticker HEART TO2 and with ISIN code SE0020358166. Warrants that are not exercised by January 31, 2025, will expire without value.

Outcome and Delivery of New Shares
The outcome of the exercise of the warrants will be announced via a press release around February 3, 2025. Subscribed and paid shares may be registered in the subscriber's securities account as interim shares (IA) until the registration of the issue is completed with the Swedish Companies Registration Office, whereupon the interim shares will automatically be converted into shares in Realheart.

Number of Warrants and Potential Proceeds from Exercise
Upon full exercise of all 33,495,885 series TO 2 warrants, the share capital will increase by a maximum of SEK 839,069.79 to SEK 11,200,511.31 through the issuance of a maximum of 167,479 new shares, resulting in the total number of outstanding shares in the Company increasing from 2,068,152 to 2,235,631.

Dilution Effect
Upon full exercise of all series TO 2 warrants, the dilution of the shares will amount to approximately 7.5 percent. Upon full exercise of all warrants, Realheart will receive approximately SEK 1.4 million before issuance costs.

Complete Terms for the Warrants
Complete terms for the warrants are available on the Company's website, https://realheart.se/

Advisors
Skills Corporate Finance AB is the financial advisor to the Company, and Setterwalls Advokatbyrå AB is the legal advisor. Nordic Issuing acts as the issuing agent in connection with the exercise of the warrants.

New Preclinical Simulation Data Shows Superior Effect of Realheart® TAH in Regulating Cardiovascular Function During Sleep

Västerås, Sweden, November 21, 2024 – Scandinavian Real Heart AB (publ) announces today that the company presented updated safety data from a preclinical study with Realheart® TAH at the 30th Annual Meeting of ISMCS 2024. At the meeting, the company’s R&D engineer Faisal Zaman was nominated for the Helmut Reul Young Investigator Award, a prestigious award that recognizes ground-breaking innovation.

Besides presenting positive results from two preclinical studies, earlier communicated in a press release on September 5, Realheart now presented promising results concerning cardiac output during sleep and exercise.

In the current studies, the performance of Realheart® TAH was compared to a market-leading product. Simulation results show that Realheart TAH's automatically regulated cardiac output is superior to the market-leading product in adapting to patient needs, both during sleep and exercise.

“This is very promising data as it is likely that patients will have a better quality of life if the artificial heart can automatically adapt to the body's activity level. We are committed to developing an artificial heart that mimics the physiological heart as closely as possible, and the research results presented at the ISMCS meeting reveal yet another aspect in which we are successful in this ambition,” said Ina Laura Perkins, CEO of Realheart.

During ISMCS, Realheart R&D engineer Faisal Zaman was nominated for the Helmut Reul Young Investigator Award for his contributions to the research and development of Realheart® TAH. The nomination meant that the research results were presented in the opening session of the conference and thus to a packed auditorium.

Realheart Is Granted Patent Approval in India for Its Device Used in the Surgical Implantation of Realheart® TAH

Västerås, Sweden, November 20, 2024 – Scandinavian Real Heart AB (publ) announces today that the company has been granted an approval by Intellectual Property India for its patent application (no. 202117045813) concerning a technical application related to the clinical use of Realheart® TAH.

The approved patent pertains to a vascular coupling device, which is used to connect Realheart® TAH to the major vessels of the circulatory system. The duration of the patent (no. 552361) is 20 years, which will thus expire in April 2042.

“We are very happy that the patent authority in India has granted us a patent approval that complements and further strengthens our IP portfolio in India, which is a valuable as fast-growing market. While the U.S. remains our most prioritized market in the short term, we see great potential in the Indian market to realize the company’s long term growth potential,” says Ina Laura Perkins, CEO of Realheart.

Interim Report Q3 2024

Summary of Interim Report July – September 2024

(SEK)
Group Overview 2024-07-01 2023-07-01 2024-01-01 2023-01-01
2024-09-30 2023-09-30 2024-09-30 2023-09-30
3 month 3 month 9 month 9 month
Operating income 4 650 878 45 030 104 835
Profit/loss after financial items -9 914 833 -8 016 849 -24 021 221 -15 081 319
Balance Sheet total assets 92 709 939 150 142 414 92 709 939 150 142 414
Equity / Assets ratio 84% 90% 84% 90%
Earnings per share -0,05 -0.08 -0,12 -0.16
Number of shares 206 815 258 96 994 446 206 815 258 96 994 446
Earnings per share after dilution* -0.04  -0.06  -0.10  -0.11 
Parent Company Overview 2024-07-01 2023-07-01 2024-01-01 2023-01-01
2024-09-30 2023-09-30 2024-09-30 2023-09-30
3 month 3 month 9 month 9 month
Operating income 4 650 878 45 030 104 835
Profit/loss after financial items -5 903 757 -8 064 889 -19 826 199 -14 813 578
Balance Sheet total assets 96 750 454 148 435 929 96 750 454 148 435 929
Equity / Assets ratio 85% 92% 85% 92%
Earnings per share -0,03 -0.08 -0,10 -0.15
Number of shares 206 815 258 96 994 446 206 815 258 96 994 446
Earnings per share after dilution* -0.02  -0.06  -0.08  -0.11 

* Upon full exercise of all options in TO2, TO3 and Option Program 2022/2027.

Revenue and Result
Scandinavian Real Heart AB is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of received de minimis grants. Research and development costs of Realheart® TAH were capitalized during Q4 with 5.7 MSEK. During the period, capitalized research and development costs were written down by 6.3 MSEK.

Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees.

Related Party Transactions
No significant related party transactions have taken place during the period.

Significant Risks and Uncertainties
Realheart's focus is on getting through the pre-clinical phase (Hemolysis, GLP studies on 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 that will be included in these tests. Realheart must also conduct parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route to market for the product. The company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the company can solve its financing. The board is continuously working with 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 31.7  MSEK. 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
During the third quarter, we have taken further steps in the preclinical validation of Realheart® TAH. As a result of the high innovation standard in our device, we have successfully established new important collaborations with the University of Gothenburg and the Hannover Medical School. These collaborations aim to accelerate the preclinical testing of Realheart® TAH, as well as familiarize leading transplantation surgeons with the device ahead of clinical studies. Further, we have proudly announced positive results from three separate studies reaffirming the promising hematological profile as well as the physiological control functions of Realheart® TAH. In parallel, our ongoing activities to optimize the preclinical safety study protocol are moving ahead. Collectively, our step-wise successes reflect the company’s work in moving toward the clinical evaluation of our artificial heart. 

Significant Events During the Third Quarter of the Year
At the beginning of the period, the outcome of the Company's rights issue is published. The outcome shows that 38,083,456 units were subscribed for with unit rights, corresponding to approximately 39.3 percent of the Rights Issue. In addition, the Company has received subscription applications for 5,527,237 units, corresponding to approximately 5.7 percent of the Rights Issue, for subscription without unit rights. Through the Rights Issue, the Company will initially receive approximately SEK 24.3 million before issue costs.

Halfway into July, Realheat carries out a directed issue of units to guarantors in connection with the completed rights issue. The Company's Board of Directors, based on the authorization from the Annual General Meeting on June 7, 2024, has decided to issue 6,300,000 units as guarantee compensation directed to a number of the guarantors who provided guarantee commitments in the rights issue of units carried out by the Company during the period June 12 through July 5, 2024, in accordance with the guarantee agreements entered into. Through the directed issue to the underwriters, 6,300,000 warrants of series TO3 are also issued, which entitle to subscribe for a maximum of 3,150,000 shares in the Company. Upon full exercise of the Warrants, the share capital will increase by a maximum of SEK 126,000.00.

July ends with Realheart announcing the last day of trading in BTUs and the first day of trading in warrants of series TO3. The number of warrants of series TO3 amounts to 54,910,406. Upon full exercise of all warrants of series TO3, the Company can be provided with a maximum of 27,455,203 new shares, which corresponds to a dilution of 11.7 percent.

During the first half of August, the Company announces the appointment of Jimmy Nybom as new interim CFO, during the ongoing recruitment process of a permanent CFO. Jimmy has had extensive contacts with Realheart as the company's auditor during the years 2019-2022 and is therefore well versed in the company's finances and operations.

In the second half of August, Realheart announces that it has entered into a collaboration with a leading veterinary large animal unit at the University of Gothenburg in Sweden for the continued preclinical safety evaluation of the Realheart® TAH artificial heart. The purpose is to conduct high-quality animal experimental large animal experiments required to ultimately conduct a clinical study. This will also facilitate the preparation of the clinical trial planned to be conducted in Sweden.

The final event of the period is an announcement that the company will present new data from two successful preclinical studies evaluating the treatment safety of the company's total artificial heart Realheart® TAH, at the 30th Annual Meeting of the International Society for Mechanical Circulatory Support (ISMCS) 2024, on November 13-15 in Utsunomiya, Japan.

Significant Events After the End of the Period
The first event after the end of the period is an announcement that the Company has published a preclinical study describing a new method to simulate hemolysis in artificial hearts using pumping mechanisms. This unique method will be important in the further development of Realheart® TAH. Based on its innovative approach, the study was awarded the ESAO-SAGE research prize at the 50th Congress of the European Society for Artificial Organs 2024.

Closer to mid-October, the company announces a collaboration with Professors Arjang Ruhparwar and Jan Schmitto, at the Department of Cardiothoracic, Transplantation and Vascular Surgery at Hannover Medical School, Hannover, Germany. The collaboration aims to familiarize leading transplant surgeons with Realheart® TAH and gain valuable professional input for the clinical trials. Realheart® TAH is intended for use in patients awaiting heart transplantation or as an alternative to transplantation.

November begins with the publication of the communiqué from Realheart's extraordinary general meeting. At the same time, the record date for the reverse share split in the Company is announced as November 22. The reverse share split will take place according to the ratio 1:100, whereby one hundred (100) existing shares will be consolidated into one (1) share.

Record Date for Reverse Share Split in Scandinavian Real Heart AB

At the Extraordinary General Meeting in Scandinavian Real Heart AB (“Realheart” or the “Company”) held on 5 November 2024 a reverse share split of 1:100 was resolved upon, whereby one hundred (100) existing shares become one (1) share. Further, the Extraordinary General Meeting resolved to authorize the Board of Directors to determine the record date for the reverse share split. The Board of Directors of Realheart has today resolved that the record date for the reverse split shall be 22 November 2024.

Reverse share split

At the Extraordinary General Meeting in Realheart held on 5 November 2024 a reverse share split of 1:100 was resolved upon, whereby one hundred (100) existing shares become one (1) share. Further, the Extraordinary General Meeting resolved to authorize the Board of Directors to determine the record date for the reverse share split. The Board of Directors of Realheart has today resolved that the record date for the reverse split shall be 22 November 2024.

No action is required by shareholders to participate in the reverse split.

As a consequence of the reverse split, the ISIN Code for the Realheart share will be changed. As from 21 November 2024, the shares will be traded with the new ISIN Code SE0023286836.

The reverse split means that the total number of shares in the Company will be reduced from 206,815,200 shares to 2,068,152 shares, each with a quota value of approximately SEK 5.01. The reverse split will result in a corresponding re-calculation of the outstanding warrants and incentive scheme in Realheart. Shareholders, whose number of shares on the record date is not evenly divided by 100, will for no consideration receive shares from Najar Medical and Invention AB, so that their respective shareholding will be evenly divided by 100. The transfer of these rounding shares will be administrated by Euroclear Sweden AB and without shareholders being required to take any further actions.

Time table for the reverse split

  • The last trading date in Realheart’s share before the reverse split shall be 20 November 2024.
  • The first trading date in Realheart’s share after the reverse split shall be 21 November 2024, which means that the share price as from this date will reflect the effects of the reverse split.
  • The record date for the reverse split shall be Friday 22 November 2024.

Bulletin From the Extraordinary General Meeting in Scandinavian Real Heart AB on 5 November 2024

An Extraordinary General Meeting in Scandinavian Real Heart AB (the “Company”) has been held on 5 November 2024 and in particular the following resolutions were made.

Reduction of the Company’s share capital through redemption of shares

The Meeting resolved to reduce the Company’s share capital by SEK 2.9 through a redemption of shares. The reduction is carried out in order to achieve a number of shares in the Company evenly divisible by 100, for the purpose of enabling the reverse share split in accordance with the below. The reduction of the share capital shall be effected through the redemption of all own shares that the Company will hold by the Board member Azad Najar, through Najar Medical and Invention AB, returning a total of 58 shares without consideration, whereby the number of shares will be evenly divisible by 100. The reduction of the share capital is made for allocation to the Company’s unrestricted equity.

Bonus issue without the issue of new shares

The Meeting resolved to restore the Company's share capital by increasing the share capital by SEK 20,681.52 through a bonus issue without issuance of new shares. The bonus issue is carried out in order to achieve a time-efficient procedure with the redemption of shares in accordance with the above, without requiring permission from the Swedish Companies Registration Office or a general court. The bonus issue is carried out through a transfer from the Company's non-restricted equity to the Company's share capital.

After completion of the bonus issue and reduction of the share capital in accordance with the above, the Company's share capital will amount to SEK 10,361,441.52 divided into 206,815,200 shares, each with a quota value of SEK 0.0501.

Amendment of the Articles of Association

The Meeting resolved on an amendment of the Articles of Association, whereby the limits for the number of shares in the Articles of Association (§ 5) is changed to not less than 2,000,000 and not more than 8,000,000, and the limits for the share capital (§ 4) is changed to not less than SEK 10,020,000 and not more than SEK 40,080,000.

The amendment is made in order to enable the reverse share split in accordance with the below.

Reverse share split

In order to achieve an appropriate number of shares for the Company, the Meeting resolved on a reverse share split of the Company's shares (1:100), whereby the number of shares in the Company is reduced by combining one hundred (100) shares into one (1) share. It was resolved to authorize the Board of Directors to determine the record date for the reverse share split (to occur after the resolution has been registered with the Swedish Companies Registration Office) and to otherwise take the measures required for the implementation of the reverse share split.

If a shareholder’s holding of shares does not correspond to a full number of new shares, i.e. is not evenly divisible by one hundred (100), this shareholder will, free of charge, receive such number of shares from Najar Medical and Invention AB so that his/her holding, after addition of the provided shares, is evenly divisible by one hundred (100). Further information on the procedure for the reverse share split will be announced when the Board of Directors resolves on the record date.

Complete resolutions as above are available on the Company's website, www.realheart.se/sv/investerare/agarinformation/bolagsstammor/

Realheart Initiates Collaboration With Hannover Medical School Ahead of Clinical Studies and Potential Launch of Realheart® TAH

Västerås, Sweden, October 10, 2024 – Scandinavian Real Heart AB (publ) announces today that the company has entered a collaboration with Professors Arjang Ruhparwar and Jan Schmitto, at the Department of Cardiothoracic, Transplantation and Vascular Surgery at the Hannover Medical School, Hannover, Germany. The collaboration aims to familiarize leading transplantation surgeons with Realheart® TAH and gain valuable professional input ahead of clinical studies. Realheart® TAH is intended for use in patients awaiting heart transplant treatment or as an alternative to transplantation.

Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG) at Hannover Medical School is considered one of the leading medical centers in the world, specializing in the treatment of complex cardiac indications and diseases. Within the framework of the agreement, HTTG will function as an advisor and, in due time, potentially take part in the company’s clinical evaluation of Realheart® TAH.

“We are delighted to enter this partnership with Hannover Medical School, through which we will be able to gain further valuable input from leading cardiac surgeons on the therapeutic use of Realheart® TAH. Further, it provides an opportunity for Prof. Dr. Jan Schmitto and his team to get familiarized with our artificial heart ahead of its potential implementation in clinical practice,” says Ina Laura Perkins, CEO of Realheart.

Realheart’s partners at HTTG are Dr. Arjang Ruhparwar, professor in Cardiac Surgery and director of the Department of Cardiothoracic, Transplantation and Vascular Surgery, and Dr. Jan Schmitto, Professor in Cardiac Surgery, and director of the Mechanical Circulatory Support (MCS) program, Surgical Head of the Interdisciplinary Heart Failure Unit, and the director of the newly implemented Innovation-Division “Cardiac Device Technologies” at Hannover Medical School. As academic surgeons with long-standing experience in the development of novel medical devices, innovative cardiac surgery and experimental research, Professors Ruhparwar and Schmitto are recognized as global key opinion leaders in the mechanical circulatory support field.

“Total artificial hearts constitute a new and important class of devices that will help to fulfill the large unmet medical need for patients awaiting a heart transplant. My team and I look forward to getting familiarized with the Realheart® TAH in detail, with the aim to provide new insights to its development and, hopefully, evaluate the device in an upcoming clinical study,” comments Jan Schmitto, Professor, Department of Cardiothoracic, Transplantation and Vascular Surgery, at the Hannover Medical School.

Realheart’s Preclinical Study Presenting a Unique Computational Model Recognized With the ESAO-SAGE Research Award

Västerås, October 1, 2024 – Scandinavian Real Heart AB (publ) announces today that the company has published a preclinical study describing a novel method to simulate hemolysis in artificial heart devices that utilize pumping mechanisms. This unique method will be important in the further development of Realheart® TAH. Based on its innovative height, the study was recognized with the ESAO-SAGE Research Award at the 50th European Society for Artificial Organs Congress 2024.

The breakdown of red blood cells (hemolysis) in mechanical devices that circulate blood (MCS) is still a safety issue due to consequential side effects, e.g., thrombosis. It is therefore important to reduce the risk of hemolysis from devices that seek regulatory approval for clinical use. In a recent study, Realheart, and its academic partner University of Bath, describe a newly-developed simulation model for MCSs that utilize back-and-forth (positive-displacement) pumping mechanisms. Such simulations have historically been based on devices that spin to pump blood, thus limiting the applicability to Realheart® TAH. This novel method, and the study results, will be important in further improving the hemolytic profile of Realheart® TAH and in providing essential safety information to regulatory agencies.

The study was recognized with the ESAO-SAGE Research Award at the 50th European Society for Artificial Organs Congress, earlier in September. The awardee is selected by a Special Committee based on a manuscript published in the International Journal for Artificial Organs, which is presented at the Annual ESAO Congress.

“The insight from this study is unique as it is the first time an artificial heart with four valves, of which two are also moving, has been simulated. It has been a challenging study that our academic partner University of Bath have taken on and excelled at. The results provide an excellent basis for further understanding of functional valve movements in Realheart® TAH to further optimize the control of the heart and the scale of the product components when developing new devices of varying sizes, such as MINIheart,” says Ina Laura Perkins, CEO of Realheart.

Read the full article: www.journals.sagepub.com/doi/pdf/10.1177/03913988241267797

NOTICE TO ATTEND THE EXTRAORDINARY GENERAL MEETING IN SCANDINAVIAN REAL HEART AB

The shareholders of Scandinavian Real Heart AB, reg. no. 556729–5588 (the "Company"), are hereby invited to an Extraordinary General Meeting on Tuesday, 5 November 2024 at 10.00 at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, SE-722 13 Västerås, Sweden. Registration for the Meeting begins at 09.30.

Right to participate in the Meeting, etc.

Shareholders who wish to participate in the Meeting must:

  • be recorded in the share register kept by Euroclear Sweden AB no later than Monday, 28 October 2024; and
  • notify the Company of their intention to participate no later than Wednesday, 30 October 2024 by post to Setterwalls Advokatbyrå AB, attn: Anna af Petersens, P.O. Box 1050, 101 39 Stockholm or by e-mail to anna.afpetersens@setterwalls.se. The notification shall state full name, personal identification number/company registration number, shareholding, address, daytime telephone number and, if applicable, information about proxies or assistants (maximum two).

To be entitled to participate in the Meeting, shareholders whose shares are held in the name of a nominee must, in addition to providing notification of their participation in the Meeting, re-register the shares in their own name so that the shareholders are registered in the share register on the record date on Monday, 28 October 2024. This re-registration may be temporary (so-called “voting right registration”) and is carried out through the nominee according to their procedures at a time predetermined by the nominee. Voting rights registration that has been completed by the nominee no later than Wednesday, 30 October 2024, are considered when preparing the share register.

Proxies etc.

If a Shareholders shall be represented by proxy, the proxy shall bring a written, dated and by the shareholder signed, power of attorney to the Meeting. The power of attorney may not be older than one year unless indicated that it is valid for a longer period, not exceeding five years. If the proxy is issued by a legal person, the proxy shall bring a current copy of the registration certificate and similar papers of authorisation. In order to facilitate entry to the Meeting, a copy of the power of attorney and other authorisation documents should be attached to the notification to the Meeting. Proxy forms will be available on the Company's website www.realheart.se and will be sent by post 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 Meeting, please refer to the privacy policy available on Euroclear Sweden AB's website: https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.

Proposal for agenda

  1. Election of chairman of the Meeting
  2. Election of one or two persons to verify the minutes
  3. Preparation and approval of the voting list
  4. Approval of the agenda
  5. Determination as to whether the Meeting has been duly convened
  6. Resolution regarding reduction of the Company’s share capital through redemption of shares
  7. Resolution regarding bonus issue without the issue of new shares
  8. Resolution on amendment of the Articles of Association
  9. Resolution on a reverse share split
  10. Closing of Meeting

Item 1 – Election of chairman of the Meeting

The Board of Directors proposes that Magnus Öhman is elected chairman of the Meeting.

Item 6 – Resolution regarding reduction of the Company’s share capital through redemption of shares

In order to achieve a number of shares in the Company evenly divisible by 100, for the purpose of enabling the reverse share split pursuant to item 9 below, the Board of Directors proposes that the Meeting resolves to reduce the share capital of the Company through a redemption of shares. As of the date of this notice, there are 206,815,258 shares in the Company. Through a redemption of 58 shares, the number of shares will be evenly divisible by 100. The Board member Azad Najar, through Najar Medical and Invention AB, who currently holds 3,487,905 shares in the Company, has undertaken to, without consideration, return 58 shares to the Company.

In light of the above, the Board of Directors has decided that the shares so returned shall be redeemed. The Board of Directors therefore proposes that the General Meeting resolves to reduce the share capital by SEK 2.9, without repayment to Najar Medical and Invention AB. The reduction of the share capital shall be effected through the redemption of all own shares that the Company will hold by Najar Medical and Invention AB returning a total of 58 shares without consideration. The reduction of the share capital is made for allocation to the Company’s unrestricted equity.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 7–9 of the notice.

Item 7 – Resolution regarding bonus issue without the issue of new shares

In order to achieve a time-efficient procedure with the redemption of shares in accordance with item 6 above and without requiring permission from the Swedish Companies Registration Office or a general court, the Board of Directors proposes that the General Meeting resolves to restore the Company's share capital by increasing the share capital by SEK 20,681.52 through a bonus issue without issuance of new shares. The bonus issue is carried out through a transfer from the Company's non-restricted equity to the Company's share capital.

After completion of the bonus issue and reduction of the share capital in accordance with item 6 above, the Company's share capital will amount to SEK 10,361,441.52 divided into 206,815,200 shares, each with a quota value of SEK 0.0501.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 6 and 8–9 of the notice.

Item 8 – Resolution on amendment of the Articles of Association

In order to resolve on the reverse share split as proposed under item 9 below, the Board of Directors proposes that the General Meeting resolves to change the limits for the number of shares in the Articles of Association (§ 5) from “not less than 96,000,000 and not more than 384,000,000 shares” to “not less than 2,000,000 and not more than 8,000,000 shares”.

The Board of Directors furthermore proposes that the General Meeting resolves to change the limits for the share capital in the Articles of Association (§ 4) from “not less than SEK 3,840,000 and not more than SEK 15,360,000” to “not less than SEK 10,020,000 and not more than SEK 40,080,000”.

The Board of Directors furthermore proposes that the General Meeting resolves to amend the Articles of Association to be bilingual and thus be written both in Swedish and in English.

The proposed Articles of Association in its entirety will be set out in the Board of Directors’ compete proposal.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 6–7 and 9 of the notice.

Item 9 – Resolution on a reverse share split

In order to achieve an appropriate number of shares for the Company, the Board of Directors proposes that the General Meeting resolves on a reverse share split of the Company’s shares (1:100), whereby the number of shares in the Company is reduced by combining one hundred (100) shares into one (1) share. The Board of Directors shall be authorized to determine the record date for the reverse share split (to occur after the resolution has been registered with the Swedish Companies Registration Office) and to otherwise take the measures required for the implementation of the reverse share split.

If a shareholder’s holding of shares does not correspond to a full number of new shares, i.e. is not evenly divisible by one hundred (100), this shareholder will, free of charge, receive such number of shares from Najar Medical and Invention AB so that his/her holding, after addition of the provided shares, is evenly divisible by one hundred (100). Further information on the procedure for the reverse share split will be announced when the Board of Directors resolves on the record date.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 6–8 of the notice.

Majority requirements

For resolutions according to items 6–9 to be valid, it is required that the resolutions are supported by shareholders who represent 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 issue of this notice, the total number of shares and votes in the Company amounts to 206,815,258.

Shareholders’ right to request information

The shareholders are reminded of their right, in accordance with Chapter 7 Section 32 of the Swedish Companies Act (2005:551), to request information from the Board of Directors and the CEO.

Provision of documents

Required documents according to the Swedish Companies Act, including the Articles of Association in their complete proposed new wording, will be available at the Company’s office no later than two weeks before the Meeting and will be sent free of charge to shareholders who request it and state their postal address. The documents will also be available on the Company’s website www.realheart.se from this date at the latest. All the above documents will also be presented at the Meeting.

Västerås in September 2024

Scandinavian Real Heart AB

THE BOARD OF DIRECTORS

Realheart to Present Positive Results From Two Preclinical Studies Evaluating Treatment Safety of Its Total Artificial Heart at ISMCS 2024

Västerås, September 5, 2024 – Scandinavian Real Heart AB (publ) announces today that the company will present new data from two successful preclinical studies evaluating the treatment safety of its total artificial heart Realheart® TAH at the 30th Annual Meeting of the International Society for Mechanical Circulatory Support (ISMCS) 2024, November 13–15th, in Utsunomiya, Japan.

As part of the preclinical development program of Realheart® TAH, the company has evaluated the mechanical stress effects of its total artificial heart on human blood, as well as its capability to respond adequately to varying blood flow demands in the cardiovascular system. In the current studies, the performance of Realheart® TAH was compared to a market-leading product.

Results from the first study show that Realheart® TAH preserves von Willebrand factor (vWF) – a protein that is essential for blood clotting and prevention of internal bleeding. Internal bleeding is a common and challenging side effect of currently available heart pumps. Therefore, protection of blood clotting proteins is essential. Additionally, the study reaffirms previously reported data that Realheart® TAH has a low shear stress effect on red blood cells, resulting in low levels of blood damage (hemolysis) compared to the competitive system.

The second study utilized Scandinavia’s first simulated patient (hybrid simulator) connected to a virtual model of the human cardiovascular system to evaluate the capability of Realheart® TAH to adapt to the varying physiological demand of the patient, e. g., responding to higher blood flow needs during moderate exercise. The collaborators (Prof. Seraina Dual) at KTH Royal Institute of Technology evaluated the TAH performance by measuring cardiac output (CO), the amount of blood pumped through the TAH per minute, and the mean arterial pressure (MAP), the average blood pressure in the arteries. The results show that Realheart TAH produces a higher CO, similar to that of the natural heart, as well as a more stable MAP, compared to the competitive system during moderate exercise.

“We are very happy to present continued positive results from our preclinical program, showing the high treatment safety profile of our total artificial heart. The data provides an important addition to our documentation and puts us one step further toward the clinical evaluation of Realheart® TAH. We look forward to presenting and discussing the new data at the ISMCS 2024 in November,” says Ina Laura Perkins, CEO of Realheart.

Read more about ISMCS 2024: www.ismcs.org/ismcs-2024

This study was partly funded by the Strategic Innovation Program Smartare Elektroniksystem – a collaborative initiative by Vinnova, Formas and Energimyndigheten.

Interim Report Q2 2024

Summary of Interim Report April – June 2024

(SEK)
Group Overview 2024-04-01 2023-04-01 2024-01-01 2023-01-01
2024-06-30 2023-06-30 2024-06-30 2023-06-30
3 mon 3 mon 6 mon 6 mon
Operating income 30 322 103 897 40 380 128 078
Earnings after financial items -6 321 701 -2 963 831 -14 106 388 -7 064 470
Balance Sheet total assets 86 640 481 117 598 027 86 640 481 117 598 027
Equity / Assets ratio 74% 81% 74% 81%
Earnings per share -0,07 -0,08 -0,15 -0.20
Number of shares 96 994 446 34 979 248 96 994 446 34 979 248
Diluted earnings per share for the period* -0.03 -0.08 -0.06 -0.20
Parent Company Overview 2024-04-01 2023-04-01 2024-01-01 2023-01-01
2024-06-30 2023-06-30 2024-06-30 2023-06-30
3 mon 3 mon 6 mon 6 mon
Operating income 30 322 103 897 40 380 128 078
Earnings after financial items -6 158 452 -2 211 630 -13 922 442 -6 748 689
Balance Sheet total assets 87 141 085 111 626 572 87 141 085 111 626 572
Equity / Assets ratio 74% 85% 74% 85%
Earnings per share -0,06 -0,08 -0,14 -0.19
Number of shares 96 994 445 33 183 461 96 994 445 34 979 248
Diluted earnings per share for the period* -0.03 -0.06 -0.06 -0.19

*Rights issue July 2024, and Series TO02, at full exercise January 31, 2025.

Revenue and Result
Scandinavian Real Heart is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of received de minimis grants. Research and development costs of Realheart® TAH were capitalized during Q4 with 4.9 MSEK. 1.9 MSEK for purchased services and other external costs and 3.0 MSEK for personnel.

Employees
The number of employees in the Group at the end of the quarter was 12 full-time employees and 3 hourly employees.

Related Party Transactions
No significant related party transactions have taken place during the period.

Significant Risks and Uncertainties
Realheart's focus is on getting through the pre-clinical phase (Hemolysis, GLP studies on 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 that will be included in these tests. Realheart must also conduct parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route to market for the product.

The company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the company can solve its financing. The board is continuously working with different scenarios to ensure the company's future operations.

Financial Position
At the end of the period the cash balance was 22.8 MSEK. In July the rights issues was finalized and the company will receive 24.3 MSEK before issue costs. This means that cash will last to Q4, 2025. In order to solve the Company's longer-term financing need, Realheart works continously to evaluate alternatives for further capitalization of the Company.

In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.

CEO Comment
During the last quarter, we have noted several important events related to the pre-clinical development of our total artificial heart, Realheart® TAH, as well as to the company's financial status. In April, we announced excellent results, in several parameters, from a pre-clinical implantation test. Our ability to continue this important work has been strengthened by an injection of mixed funds. For the second time, we have been awarded a grant of SEK 4 million from Vinnova and a grant from Medtech4Health. Finally, in early July, we announced the outcome of our latest rights issue, which amounted to SEK 24.3 million. With this funding, we aim to complete our preclinical program.

Significant Events During the First Quarter of the Year
The period begins with a press release announcing that Realheart intends to present positive hematology data at the American Society for Artificial Internal Organs 70th Annual Conference in Baltimore. The new study data presented reinforces the company's previous results, which show that the company's artificial heart, Realheart® TAH, has a low harmful impact on red blood cells (hemolysis) compared to today's market-dominant heart pump systems. The new results are based on in-depth analyses including several blood components and further confirm that Realheart® TAH causes a significantly lower degree of blood damage.

In mid-April, Realheart reports results from another successful preclinical trial with Realheart® TAH, showing that Realheart® TAH results in good cardiac function and low levels of blood damage, while the survival time of the implanted animal exceeded previous trials. Overall, the results support that Realheart® TAH has good potential to replace the human heart in the future.

In early May, Realheart decides on a rights issue of SEK 48.5 million. The rights issue, which runs between June 12 and July 5, is approximately 50 percent covered by guarantee commitments and subscription commitments from existing shareholders and external investors.

In mid-May, the company announced that it had received a grant from Vinnova of approximately SEK 100,000 as part of a competence-enhancing grant. The grant, which will be used to develop production processes for Realheart® TAH, is funded by Medtech4Health, a strategic innovation program aimed at strengthening the medical device industry.

May ends with an announcement that the company has received SEK 4 million in a grant from Vinnova together with its partner at the Royal Institute of Technology (KTH) with the aim of further developing the company's transplantation system. The project runs for two years.

The last event of the period is that Realheart publishes a prospectus for a rights issue of units of approximately SEK 48.5 million.

Significant Events After the End of the Period
On July 9, Realheart announces the outcome of the completed rights issue, where the Company initially raises approximately SEK 24.3 million before issue costs.

In mid-July, it is announced that Realheart carries out a directed issue of units to guarantors in connection with the completed rights issue. In total, guarantors have chosen to receive the guarantee compensation paid in units. The company's board of directors has therefore decided, based on the authorization from the annual general meeting on June 7, 2024, to issue 6,300,000 units, corresponding to 12,600,000 new shares and 6,300,000 warrants of series TO3 as compensation to these guarantors, which will increase the company's share capital by approximately SEK 504,000.00.

In the beginning of August, the Company announces that Jimmy Nybom will succeed Andreas Hultdin as interim Chief Financial Officer (CFO) during the ongoing recruitment process of a permanent CFO. Jimmy Nybom will start his assignment on September 6.

Realheart Expands Preclinical Operations to Swedish Veterinary Center for Further Development of Realheart® TAH

Västerås, Sweden, August 22, 2024 – Scandinavian Real Heart AB (publ) today announces that the company has entered into a collaboration with a leading veterinary large animal unit at the University of Gothenburg in Sweden for the continued pre-clinical safety evaluation of the artificial heart Realheart® TAH. The purpose is to conduct high quality large animal experiments required to eventually conduct a clinical study. This will also facilitate the preparation of the clinical trial planned to be conducted in Sweden.

For the first clinical study of Realheart® TAH, the authorities require a comprehensive pre-clinical data package based on safety studies, blood tests and reliability studies.

The company has so far conducted all implant trials with Realheart® TAH at a veterinary center in Belgium that has long and extensive experience of both pre-clinical surgical procedures and interactions with regulatory authorities in the United States and Europe. The collaboration with this institution will continue during the further pre-clinical development. The expansion of the safety evaluation to a Swedish institution means increased proximity to and strengthened collaboration with the surgical team that will participate in future clinical studies. This has significant benefits for the further development of Realheart® TAH. The next step in the collaboration is to submit an application for ethical approval to conduct the planned implantation trials.

"We are very pleased to have partnered with the University of Gothenburg. The expansion of the pre-clinical implantation trials to Sweden will allow the team from the Thorax Clinic at Sahlgrenska, who will participate in the first patient study, to better understand the technology and contribute to the further development of our treatment protocols," said Ina Laura Perkins, CEO of Realheart.

About Realheart

Scandinavian Real Heart AB (publ) is developing the first artificial heart that mimics the shape, function and blood flow patterns of the human heart. These unique product features provide new opportunities to save lives and provide patients with a good quality of life while waiting for a heart transplant. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive pre-clinical studies in preparation for a first clinical study in patients expected to start in 2025. Realheart® TAH addresses a significant and urgent medical need – today, 8,300 people around the world are waiting for a heart transplant and many patients unfortunately die during their time on the waiting list. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with very severe heart failure. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se

Realheart Appoints New Interim Chief Financial Officer

Västerås, August 9, 2024 – Scandinavian Real Heart AB (publ) announces today that Jimmy Nybom will succeed Andreas Hultdin as interim Chief Financial Officer (CFO) during the ongoing recruitment process of a permanent CFO. Jimmy Nybom will start his assignment on September 6.

Jimmy Nybom holds a Master of Science (MSc) in Business Administration and Economics, with a specialization in Accounting and Finance, from Umeå University. Mr Nybom has previous experience as interim CFO and board member in the public company sphere. He has 18 years of experience as an auditor and advisor at the auditing global firm Grant Thornton, where he has had extensive interaction with Realheart as the company’s auditor during year 2019-2022 and is therefore well-informed about the company’s financials and operations.

Jimmy Nybom will join the company on September 6, succeeding the company’s current interim CFO Andreas Hultdin.

“While the process of recruiting a permanent CFO is progressing according to plan, our interim CFO Andreas Hultdin will be handing over the baton to Jimmy Nybom. Jimmy, who was part of the advisory team that supported the IPO of Realheart, is an acknowledged professional in auditing and financials. We wish to thank Andreas for his valuable contributions and wish him good luck in his future endeavors,” says Ina Laura Perkins, CEO of Realheart.

About Realheart
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. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive preclinical trial models ahead of a first clinical study in patients. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with severe heart failure. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se

Realheart Announces Last Day of Trading With BTU and First Day of Trading With Warrants of Series TO3

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Scandinavian Real Heart AB (publ)’s (“Realheart” or the “Company”) rights issue, in which the subscription period ended on July 5, 2024, has now been registered with the Swedish Companies Registration Office. Trading in BTU will therefore cease, and BTU will be replaced with shares and warrants. Realheart’s warrants of series TO3 will, as a result of the registration of the rights issue with the Swedish Companies Registration Office, be admitted to trading on Nasdaq First North Growth Market on August 1, 2024, and traded under the ticker “HEART TO3”.

The last day for trading in BTU on Nasdaq First North Growth Market is July 26, 2024. Owners of BTU will thereafter receive shares and warrants, which are expected to be in place on each shareholder’s VP account/depositary on August 1, 2024.

Terms for the warrants of series TO3

Two (2) warrants of series TO2 entitles the holder to subscribe for one (1) new share in the Company to a subscription price corresponding to 70 percent of the volume-weighted average price paid for the Company’s shares ten (10) days prior to the subscription period. The exercise period for the warrants of series TO3 will take place during the period March 3, 2025, to March 31, 2025.

The number of warrants of series TO3 amounts to 54 910 406. Upon full exercise of all warrants of series TO3, a maximum of 27,455,203 new shares are issued, which corresponds to a dilution of 11.7 percent.

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the rights Issue.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release neither contains nor constitutes an offer to acquire, subscribe for or otherwise trade shares, warrants or other securities in Realheart. No action has been taken and no action will be taken to allow an offer to the public in any jurisdiction other than Sweden. The Swedish Financial Supervisory Authority's approval of the Prospectus shall not be construed as an approval of the Company's shares, warrants or other securities. However, this press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 ("Prospectus Regulation"), and this press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Realheart. The information in this press release is only intended to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance shall be given with respect to the accuracy or completeness of the information in this press release. Any investment decision should, in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, be based solely on the information in the Prospectus. Therefore, an investor is recommended to read the entire Prospectus. This press release constitutes marketing in accordance with Article 2 (k) of the Prospectus Regulation.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49 (2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart performs a directed issue of units to underwriters in connection with the completed rights issue

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Scandinavian Real Heart AB ("Realheart" or the "Company") announces that the Company's board, with the support of the authorization from the annual general meeting on June 7, 2024, has resolved to issue 6 300 000 units as underwriting compensation directed to a number of the underwriters who provided underwriting commitments in the rights issue that the Company carried out during the period June 12 to July 5, 2024, in accordance with the underwriting agreements entered into.

The underwriters who provided underwriting commitments in the rights issue had the option of having the compensation paid out in cash or in the form of issued units in the Company, which was previously communicated in connection with the rights issue. In total, eight underwriters have chosen to have the underwriting compensation paid out in units. The Company's board has therefore resolved, with the support of the authorization from the annual general meeting on June 7, 2024, to issue 6 300 000 units as compensation to these underwriters, which will increase the company's number of shares by 12 600 000 shares and the company’s share capital by 504 000.00 SEK. The purpose of the directed issue and the reason for the deviation from the shareholders’ preferential rights is thus to fulfill the Company’s commitments to the underwriters in accordance with the underwriting agreements.

Units are issued at a price of 0.5 SEK per unit, corresponding to 0.25 SEK per share, which corresponds to the pricing of shares and units in the rights issue. The board's assessment is therefore that the subscription price is on market terms. The board has resolved that payment for units shall be made by offsetting the respective underwriter's claim on the Company. The underwriters’ claim amounts to 3 150 000 SEK. When these 6 300 000 units together with the 48 610 406 units that were issued in the rights issue have been registered with the Swedish Companies Registration Office, the number of shares in the Company will amount to 206 815 258 shares, and the Company's share capital to approximately 8 272 610.32 SEK. The dilution that accrues as a result of the directed issue to the underwriters amounts to approximately 6.1 percent after the rights issue has been registered.

Through the directed issue to the underwriters, 6 300 000 warrants of series TO3 are issued, which entitle the holder to subscribe for a maximum of 3 150 000 shares in the Company. Upon full exercise of the warrants, the share capital will increase by an additional maximum of SEK 126 000.00.

The Company has had no specific costs related to the directed issue as this takes place as part of the work with the rights issue.

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the Rights Issue.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release neither contains nor constitutes an offer to acquire, subscribe for or otherwise trade shares, warrants or other securities in Realheart. No action has been taken and no action will be taken to allow an offer to the public in any jurisdiction other than Sweden. The Swedish Financial Supervisory Authority's approval of the Prospectus shall not be construed as an approval of the Company's shares, warrants or other securities. However, this press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 ("Prospectus Regulation"), and this press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Realheart. The information in this press release is only intended to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance shall be given with respect to the accuracy or completeness of the information in this press release. Any investment decision should, in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, be based solely on the information in the Prospectus. Therefore, an investor is recommended to read the entire Prospectus. This press release constitutes marketing in accordance with Article 2(k) of the Prospectus Regulation.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, www.skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Scandinavian Real Heart AB Announces Outcome in the Company’s Rights Issue

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Scandinavian Real Heart AB (publ) ("Realheart" or the "Company") has completed the rights issue of units, consisting of shares and warrants of series TO3, which the board of directors decided on May 7, 2024, with authorization from the annual general meeting on June 7, 2024 (the “Rights Issue”). The outcome concludes that 38 083 456 units have been subscribed through use of unit rights, corresponding to approximately 39.3 percent of the Rights Issue. Additionally, the Company has received applications for subscription of 5 527 237 units without unit rights, corresponding to approximately 5.7 percent of the Rights Issue. A total of 43 610 693 units were subscribed with the support of unit rights and applications for subscription without unit rights, corresponding to 45.0 percent of the Rights Issue. Hence, underwriting commitments of 4 999 713 units, corresponding to 5.2 percent of the Rights Issue, will be exercised. In total, 48 610 406 units were subscribed, corresponding to 50.1 percent of the Rights Issue. Through the Rights Issue, the Company will receive approximately SEK 24.3 million before issue costs.

On May 7, 2024, Realheart announced that the board of directors of the Company had resolved on a rights issue of approximately SEK 48.5 million. The subscription price in the Rights Issue was SEK 0.5 per unit, consisting of two (2) newly issued shares and one (1) warrant of series TO3. The total number of units offered in the Rights Issue amounted to 96,994,446.

Outcome in the Rights Issue

The subscription period in the Rights Issue ended on July 7, 2023. The final outcome shows that 38 083 456 units has been subscribed for with support of unit rights, corresponding to approximately 39.3 percent of the Rights Issue. Additionally, the Company has received applications for subscription of 5 527 237 units without support of unit rights, corresponding to approximately 5.7 percent of the Rights Issue. Consequently, 43 610 693 units were subscribed with and without unit rights, corresponding to approximately 45.0 percent of the Rights Issue. Underwriting commitments of 4 999 713 units will be exercised by the Company, corresponding to 5.2 percent of the Rights Issue. In total, 48 610 406 units were subscribed, corresponding to 97 220 812 newly issued shares and 48 610 406 warrants of series TO3.

Through the Rights Issue, the Company will initially receive approximately SEK 24.3 million before deduction of issue costs.

Comment from Ina Laura Perkins, CEO

""We are pleased that so many shareholders have subscribed to units in Realheart and we welcome all new shareholders. We will continue the Realheart ® TAH development, which is at a very exciting stage.", commented Ina Laura Perkins, CEO at Realheart.

Allocation of units subscribed for without the support of unit rights

Allocation of units subscribed for without the support of unit rights has taken place in accordance with the principles set out in the prospectus that the Company published on June 11, 2024, due to the Rights Issue (the “Prospectus”). Notification of such allocation is announced separately through settlement notes. Nominee-registered shareholders receive notification of allotment in accordance with instructions from the respective nominee.

Shares, share capital, and dilution

Through the Rights Issue, the total number of shares in the Company increase by 97 220 812 shares, from 96 994 446 shares to 194 215 258 shares, and the share capital increase by SEK 3 888 832.48, from SEK 3 879 777,84 to SEK 7 768 610.32, corresponding to a dilution effect of 50.1 percent of the total number of shares and votes in the Company. If all warrants of series TO3 are fully exercised for subscription of new shares in the Company, the total number of shares in the Company will increase with an additional 24 305 203 shares, from 194 215 258 shares to 218 520 461 shares, and the share capital will increase with an additional SEK 972 208.12, from SEK 7 768 610.32 to SEK 8 740 818.44, corresponding to a dilution effect of 11.1 percent of the total number of shares and votes in the Company.

Trading in paid subscribed units ("BTU”)

Trading in BTU takes place until the conversion of BTU into shares and warrants of series TO3 after the Rights Issue has been registered with the Swedish Companies Registration Office. Registration with the Swedish Companies Registration Office is expected to take place during week 30, 2023.

Warrants of series TO3

Two (2) warrants of series TO3 entitles the holder to subscribe for one (1) new share in the Company at an exercise price corresponding to seventy (70) percent of the volume-weighted average price (VWAP) paid for the Company’s shares ten (10) days prior to the subscription period. Subscription of new shares through warrants of series TO3 shall be carried out in accordance with the terms and conditions of the warrants during the period from and including March 3, 2025, up to and including March 31, 2025. Trading in warrants of series TO3 shall take place from and in conjunction with the conversion of BTU into shares and warrants of series TO3, which is expected to take place during week 30, 2023.

Compensation to underwriters

In connection with the Rights Issue, a number of investors have entered underwriting commitments. For underwriting commitments made, an underwriting compensation of 15 percent of the underwritten amount is paid if the underwriters choose compensation in the form of cash or alternatively 20 percent of the underwritten amount if the underwriters choose compensation in the form of newly issued units. Underwriters who wish to receive underwriting compensation in the form of units must notify Skills no later than two days after having been notified.

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the Rights Issue.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release neither contains nor constitutes an offer to acquire, subscribe for or otherwise trade shares, warrants or other securities in Realheart. No action has been taken and no action will be taken to allow an offer to the public in any jurisdiction other than Sweden. The Swedish Financial Supervisory Authority's approval of the Prospectus shall not be construed as an approval of the Company's shares, warrants or other securities. However, this press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 ("Prospectus Regulation"), and this press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Realheart. The information in this press release is only intended to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance shall be given with respect to the accuracy or completeness of the information in this press release. Any investment decision should, in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, be based solely on the information in the Prospectus. Therefore, an investor is recommended to read the entire Prospectus. This press release constitutes marketing in accordance with Article 2 (k) of the Prospectus Regulation.

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49 (2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.