Today Realheart publishes the annual report for 2023.
The annual report, including the auditor's report can be found at www.realheart.se and as attachment to this press release.
An English version/translation of the annual report will be released later.
Archives
Realheart Receives Grant From Vinnova for Assembly Processes of Its Artificial Heart
Västerås, 25 April 2024 – Scandinavian Real Heart AB (publ) today announces that the company has received a grant from Vinnova of approximately 100,000 SEK within the framework of a competence strengthening grant. The grant is funded by Medtech4Health, a strategic innovation program aimed at strengthening the medical device industry. The grant will be used to support the development of assembly processes for the company's artificial heart, Realheart® TAH.
As Realheart takes steps forward in the preclinical development of Realheart® TAH, the assembly process. Therefore, a project is now underway to develop a high-quality and scalable manufacturing method that will eventually enable a continuous production flow. The grant from Vinnova will finance a part-time consultancy position for a mechanical engineer with specialist expertise in process and production development of implantable medical devices. The person in this position has previous experience in leading and supporting this type of development project.
The grant is awarded in the framework of the ‘Strengthening Competence in Small Business 2024’ and ‘Collaborative Projects for Better Health’ programs funded by the Medtech4Health public innovation program. The program aims to enable the clinical implementation of medical technology ideas and solutions in consultation with healthcare, academia and industry.
‘As the company's preclinical projects progress, new development needs arise. To be able to meet the clinical demand for our artificial heart, Realheart® TAH, a high-quality, scalable and validated production capacity is required. We are therefore very grateful for the Vinnova grant, which makes it possible to bring in additional external expertise as we now establish assembly processes’, says Ina Laura Perkins, CEO of Realheart.
About Medtech4Health
Medtech4Health strive to increase the number and quality of new innovative products and services within MedTech. In collaboration with patients, healthcare, academia, and business, we contribute to increasing value for people affected by disease in their everyday lives. Medtech4Health is funded by the Swedish government through the Swedish innovation authority Vinnova, Swedish Energy Agency and Swedish Research Council for Sustainable Development Formas, and by the programme’s partners.
www.medtech4health.se
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 characteristics 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 preclinical trial models for 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, please visit www.realheart.se
Correction/Update of Q1 – 2024
Scandinavian Real Heart publishes an updated version of the Q1 report.
The new details in the update are:
Information on change in equity.
Calculated number of shares considering the future dilution from existing warrant programs.
Information on existing warrant program/incentive program for employees.
The above is information that has been communicated earlier, but has now been added to the report.
Interim Report Q1 2024
Summary of Interim Report January – March 2024
| (SEK) | ||||
| Group Overview | 2024-01-01 | 2023-01-01 | 2023-01-01 | |
| 2024-03-31 | 2023-03-31 | 2023-12-31 | ||
| 3 mon | 3 mon | 12 mon | ||
| Operating income | 10 058 | 24 181 | 902 882 | |
| Earnings after financial items | -7 784 687 | -4 100 639 | -67 977 292 | |
| Balance Sheet total | 93 733 581 | 119 484 206 | 102 638 279 | |
| Equity / Assets ratio | 79% | 82% | 80% | |
| Earnings per share | -0.08 | -0.12 | -0.70 | |
| Number of shares | 96 994 446 | 34 979 248 | 96 994 446 | |
| Parent Company Overview | 2024-01-01 | 2023-01-01 | 2023-01-01 | |
| 2024-03-31 | 2023-03-31 | 2023-12-31 | ||
| 3 mon | 3 mon | 12 mon | ||
| Operating income | 10 058 | 24 181 | 902 882 | |
| Earnings after financial items | -7 763 990 | -3 919 738 | -67 678 901 | |
| Balance Sheet total | 93 934 536 | 113 420 143 | 103 221 678 | |
| Equity / Assets ratio | 88% | 86% | 88% | |
| Earnings per share | -0.08 | -0.11 | -0.70 | |
| Number of shares | 96 994 446 | 34 979 248 | 96 994 446 |
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 Q1 with 4.7 MSEK. 1.7 for purchased services and other external costs and 3.0 for personnel. In line with the valuation model for impairment testing of intangible assets adopted at year and, the company has chosen to write down the asset capitalized in the period with 4.7 MSEK.
Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees and 4 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
With a cash balance of 34.3 MSEK at the end of the period the company has funding that will last until the first quarter of 2025.
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
The preclinical development of our artificial heart is progressing and we recently announced successful results from another implantation. Realheart® TAH produced good cardiac function and was gentle on the blood, while the survival time of the implanted animal exceeded previous trials. In March, Magnus Öhman took over as the new Chairman of the Board of Realheart. Magnus has extensive experience from leading positions in the medical device industry and will have an operational role in the development of Realheart® TAH. Earlier in the quarter, we were named Innovator of the Year in the Almi Guldstänk entrepreneurship competition – a definite confirmation of the increasing external interest in our unique concept.
Significant Events During the First Quarter of the Year
In the beginning of March, the Company announces that Magnus Öhman will take over as Executive Chairman of Realheart's Board of Directors. Magnus will thus take an active role in the company's operational work to develop and commercialise Realheart® TAH. Christer Norström, outgoing chairman, will remain on the board as a member.
In the middle of March, Realheart is awarded Almi Guldstänk as the innovator of the year 2023. Realheart was nominated based on the jury's motivation that highlights the company's development of the groundbreaking artificial heart Realheart® TAH.
During the first quarter, the Company announces the appointment of Andreas Hultdin as successor to Jonas Caspari Bark as Interim CFO. Andreas will act as interim CFO until a permanent successor has been appointed. Between 2019 and 2022, Andreas was CFO at Realheart where he among other things helped secure funding from the European Investment Council (EIC).
Significant Events After the End of the Period
In early April, the Company announces that positive haematological data will be presented at the American Society for Artificial Internal Organs 70th Annual Conference in Baltimore. During the conference, new study data will be presented that strengthens the company's previous results, which show that the company's artificial heart, Realheart® TAH, has a low damaging effect on red blood cells (hemolysis) compared to today's market-dominant heart pump system. The new results are based on in-depth analyses that include several blood components and further confirm that Realheart® TAH causes a significantly lower degree of blood damage.
In mid-April, more positive results from another successful preclinical trial with the Realheart® TAH artificial heart will be communicated. The implantation has been done within the framework of the preclinical programme that will form the basis for the first clinical study in humans. The results show that Realheart® TAH gives rise to good cardiac function and low levels of adverse blood effects, while the survival time of the implanted animal exceeded previous attempts. Overall, the results support that the Realheart® TAH has the potential to replace the human heart in the future.
On May 7, the board decided to propose a rights issue. The details and conditions are communicated on the company's website.
NOTICE TO ATTEND THE ANNUAL GENERAL MEETING IN SCANDINAVIAN REAL HEART AB
The shareholders in Scandinavian Real Heart AB, reg. no. 556729–5588 (the "Company"), are hereby invited to the Annual General Meeting on Friday, 7 June 2024 at 15.00 at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, 722 13 Västerås. Registration for the Meeting begins at 14:30.
Right to participate in the Meeting, etc.
Shareholders who wish to participate in the Meeting shall
• be recorded in the share register kept by Euroclear Sweden AB no later than Wednesday 29 May 2024, and
• notify the Company their intention to participate no later than Friday, 31 May 2024 by post to Scandinavian Real Heart AB, Kopparbergsvägen 10, 722 13 Västerås, by phone +46 (0) 70 219 45 99 or by e-mail andreas.hultdin@realheart.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 Wednesday, 29 May 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 Friday, 31 May 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/Integritypolicy-bolagsstammor-svenska.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. Presentation of the annual report and the auditor’s report
7. Resolution on
a) adoption of the profit and loss statement and the balance sheet;
b) appropriation of the Company’s profit or loss as set forth in the adopted balance sheet;
c) discharge of the Board members and the CEO from liability
8. Determination of number of Board members and auditors
9. Determination of fees for Board members and auditor
10. Election of Board members, Chairman of the Board and auditor
11. Election of Nomination Committee
12. Resolution on amendment of the Articles of Association
13. Resolution regarding reduction of the share capital without redemption of shares
14. Approval of the resolution by the Board of Directors to issue new units consisting of shares and warrants with preferential rights for the shareholders
15. Resolution regarding bonus issue
16. Resolution regarding reduction of the share capital without redemption of shares
17. Resolution on authorisation for the Board of Directors to resolve on a new share issue
18. Closing of meeting
The Nomination Committee’s proposals
The Nomination Committee's proposals regarding the election of Chairman of the Meeting (item 1), determination of number of Board members and auditors (item 8), determination of fees for Board members and auditor (item 9), election of Board members, Chairman of the Board and auditor (item 10) as well as the election of the Nomination Committee (item 11) will be presented on the Company's website www.realheart.se well in advance of the Meeting.
The Board of Directors’ proposals
Item 7 b – Resolution on appropriation of the Company’s profit or loss as set forth in the adopted balance sheet (item 8 b)
The Board of Directors proposes that the Annual General Meeting shall resolve that distributable profits are carried forward and not to distribute any dividends for the financial year 2023.
Item 12 – Resolution on amendment of the Articles of Association
The Board of Directors proposes that the Meeting resolves to amend the Articles of Association in accordance with the following:
| Current wording: | Proposed wording: |
| § 4 Share Capital The share capital of the company shall amount to not less than SEK 7,000,000 and not more than SEK 28,000,000. |
§ 4 Share Capital The share capital of the company shall amount to not less than SEK 3,840,000 and not more than SEK 15,360,000. |
| § 5 Number of shares The number of shares in the company shall be not less than 70,000,000 and not more than 280,000,000 shares. |
§ 5 Number of shares The number of shares in the company shall be not less than 96,000,000 and not more than 384,000,000 shares. |
The resolution to amend the Articles of Association shall be conditional upon the Meeting approving item 13, 14 and 15 below.
The Board of Directors or a person appointed by the Board of Directors shall be authorised to make such minor adjustments to the resolution that may prove necessary for registration of the decision with the Swedish Companies Registration Office. For a valid resolution in accordance with the Board’s proposal, it is required that the resolution is supported by shareholders who represent at least two-thirds of both the votes cast and the shares represented at the Meeting.
Item 13 – Resolution regarding reduction of the share capital without redemption of shares
The Board of Directors proposes that the Meeting resolves upon reducing the Company’s share capital with SEK 5,819,666.76. The reduction of the share capital will be made without redemption of shares by changing the share quota value from SEK 0.10 to SEK 0.04 per share. The reduction amount shall be allocated to the unrestricted premium reserve.
The reduction of share capital by changing the quota value is made in order to adjust the share capital in relation to the rights issue suggested for approval in items 14 below. After the reduction, the share capital will amount to SEK 3,879,777.84 divided into 96,994,446 shares (prior to the rights issue), each share with a quota value of SEK 0.04. The resolution to reduce the share capital is conditioned on that the rights issue under item 14 and that the bonus issue under item 15, entailing an increase of the share capital with at least as much as the reduction amount, are registered at the Swedish Companies Registration Office and that the reduction of the share capital, the rights issue and the bonus issue together do not result in a decrease in the Company’s share capital. The resolution to reduce the share capital is conditioned by a change of the Articles of Association as set out in item 12 above.
Item 14 – Approval of the resolution by the Board of Directors to issue new units consisting of shares and warrants with preferential rights for the shareholders
The Board of Directors proposes that the Meeting resolves to approve the Board of Directors’ resolution of 7 May 2024, on issuance of so called units, in the form of new shares and warrants giving right to subscribe for new shares, with preferential rights for the shareholders in accordance with below.
Number of units and share capital increase
The issue comprises no more than 193,988,892 new shares and no more than 106 454 446 warrants of series TO3, which may be subscribed for and allotted together in the form of so called units where each unit consists of two (2) shares and one (1) warrant of series TO3. After the issue, the shares and the warrants will be separated. Two (2) warrants entitles to subscription of one (1) new share in the Company.
The Company’s share capital may be increased through subscription of the new shares and through exercise of the warrants for subscription of new shares. The Company’s share capital may be increased by no more than SEK 9 888 644,60, out of which no more than SEK 7,759,555.68 is from the new shares and no more than SEK 2 129 088,92 is from the new shares that may be subscribed for through exercise of the warrants. The share capital increases have been calculated based on a quotient value of SEK 0.04 per share.
Right to subscribe for units
The shareholders of the Company shall have preferential rights to subscribe for units. For each share held on the record date, the shareholder receives one unit right, whereby one unit right entitles to subscribe for one unit. The record date for determining which shareholders shall be entitled to subscribe for units on a preferential basis shall be 10 June 2024.
In case not all units have been subscribed for, the Board of Directors shall decide that allotment of units subscribed for without unit rights shall take place up to the maximum amount of the issue, whereby the Board of Directors primarily will allot units to those who also subscribed for units based on unit rights, and in the event of over subscription, pro rata to their subscription based on unit rights. Secondly, the Board of Directors will allot units to those who subscribed for units without unit rights, and if full allotment cannot be made, pro rata to their subscription. To the extent not possible, allotment shall be made through drawing of lots, and finally, subject to such allocation being required in order for the issue to be fully subscribed, to the guarantors of the issue.
Warrants may also, with deviation from the shareholders’ preferential rights, be subscribed for by underwriters in the rights issue that have chosen to receive compensation in the form of newly issued units.
Subscription price of units
The subscription price is SEK 0.50 per unit, corresponding to SEK 0.25 per share. The warrants are issued free of charge. In the case of full subscription, this provides issuing proceeds of approximately MSEK 48.5.
The share premium shall be transferred to the unrestricted premium reserve.
Subscription and payments of units
Subscription for units based on unit rights shall be made through payment in cash during the period from 12 June 2024 until, and including 5 July 2024. The Board of Directors shall be entitled to extend the subscription period.
Subscription without unit rights shall be made through notice on special application form during the period from 12 June 2024 until, and including 5 July 2024. The Board of Directors shall be entitled to extend the subscription period. Payment for units shall be made at the latest three business days following the date of the dispatch of a contract note to the subscriber, specifying allocation of units, or such later date as the Board of Directors may decide.
Trading with unit rights is expected to take place during the period from 12 June 2024 until, and including 2 July 2024. Trading in BTU (Paid Subscribed Units) is expected to take place from 12 June 2024 until, around week 30 2024.
Subscription and subscription price of new shares subscribed for through exercise of warrants
Subscription of new shares through exercise of warrants may be made during the period from and including 3 March 2025 up to and including 31 March 2025.
Two (2) warrants entitle the holder to subscribe for one (1) new share in the Company at a subscription price per share (the “Exercise Price”) corresponding to the higher of (i) 70 percent of the volume weighted average trading price of the Company’s share on Nasdaq First North Growth Market during a period of 10 trading days immediately preceding the subscription period, however no more than SEK 2 per share, and (ii) the quotient value of the share at the time of exercise of warrants. The part of the Exercise Price exceeding the quota value of the Company’s shares shall be allocated to the unrestricted share premium fund. If no trading price is recorded for a particular trading day within the specified period, such day shall not be taken into account, but the period shall instead be extended backwards in time with the number of previous trading days required for the period to comprise a total of 10 trading days with a recorded trading price. The Exercise Price calculated in accordance with above shall be rounded off to two decimals, where SEK 0.005 shall be rounded upwards.
The terms and conditions set out in Appendix 1 shall otherwise apply to the warrants.
Right to dividends of new shares
The new shares shall entitle to dividends as from the first record date for dividends following registration of the new shares with the Swedish Companies Registration Office.
Miscellaneous
It was noted that the documents in accordance with Chapter 13, sections 6 of the Swedish Companies Act were duly presented.
The Board of Directors, or a person appointed by the Board of Directors, shall be authorised to make any minor adjustments required to register the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.
The resolution is conditioned by the Meeting resolving on the proposals set out in items 12, 13, 15 and 16.
Item 15 – Resolution regarding bonus issue
The board of directors proposes that the shareholders decide to carry out a bonus issue thereby increasing the share capital with SEK 5,819,666.76 by making use of the Company’s non-restricted equity. The bonus issue is carried out without issuing new shares.
The resolution is conditioned by the Meeting resolving on the proposals set out in items 12 – 14 above.
Item 16 – Resolution regarding reduction of the share capital without redemption of shares
The board of directors proposes that the Meeting resolves upon reducing the Company’s share capital by an amount in SEK corresponding to the increase in the share capital pursuant to the resolution on the rights issue under item 14 above minus the minimum amount required for the share's quotient value after the reduction to correspond to a whole number of öre. The reduction of the share capital will be made without redemption of shares by changing the share quota value. The reduction amount shall be allocated to the unrestricted premium reserve.
The reduction of share capital by changing the quota value is made in order to ensure that the resolution to reduce the share capital in item 13, the resolution on the rights issue in item 14, and the resolution on a bonus issue in item 15 together do not result in a decrease in the Company’s share capital.
The resolution to reduce the share capital is conditioned by the Meeting resolving on the proposals set out in items 12 – 15 above.
Item 17 – Resolution on authorisation for the Board of Directors to resolve on a new share issue
The Board of Directors proposes that the Annual General Meeting resolve on authorisation for the Board of Directors to, within the limits of the applicable Articles of Association, with or without deviating from the shareholders' preferential rights, on one or more occasions during the period until the next Annual General Meeting, resolve on an increase in the Company's share capital through a new issue of shares in the Company. The purpose of the authorisation and the reasons for any deviation from the shareholders' preferential rights is that new issues should be able to take place in order to increase the Company's financial flexibility and the Board's capacity for action, to be able to broaden the shareholder base in the Company and to be able to finance any business mergers and acquisitions of operations or businesses that the Company may carry out.
The total number of shares to be issued by in accordance with the authorisation shall not be limited in any other way than by the limits of the share capital and the number of shares included in the Company's Articles of Association registered at any time. The issues shall be carried out at a market-based subscription price, subject to a market-based issue discount where applicable, and payment shall be made through cash payment, with property in kind or by set-off, or with other conditions.
The Board of Directors or a person appointed by the Board of Directors shall authorised to make the minor adjustments required for the registration of the resolution at the Swedish Companies Registration Office. For a valid resolution in accordance with the Board's proposal, the resolution must be supported by shareholders with 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 96,994,446.
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 Directors and the CEO at the Meeting.
Provision of documents
The Company's annual report and audit report for the financial year 2022, the Board of Directors' complete proposals for resolutions as set out above as well as other documents according to the Swedish Companies Act will be kept available to the shareholders at the Company's head office; Kopparbergsvägen 10, 722 13 Västerås and on the Company's website www.realheart.se no later than Friday 24 May 2024. Copies of the documents will also be sent to shareholders who so request and who provide their postal address.
Västerås in May 2024
Scandinavian Real Heart AB
THE BOARD OF DIRECTORS
Realheart Decides on a Rights Issue of SEK 48.5 Million
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.
The board of directors of Scandinavian Real Heart AB (publ) (“Realheart” or the “Company”) has, subject to the approval of the annual general meeting, resolved to carry out a rights issue of a maximum of 193,988,892 shares with preferential rights for existing shareholders (the “Rights Issue”). The date of the Annual General Meeting has been moved to June 7, 2024. The subscription period will take place from June 12 until and including July 5, 2024. In the event the Rights Issue is fully subscribed, the Company will receive approximately SEK 48.5 million before transaction costs. The Rights Issue is covered to approximately 50 percent through underwriting commitments and subscription commitments from current shareholders and external investors.
Summary of the Rights Issue
- In the event the Rights Issue is fully subscribed, Realheart will receive approximately SEK 48.5 million before issue costs.
- Approximately 50 percent of the Rights Issue is covered by underwriting commitments.
- The subscription period for the Rights Issue is planned to run from June 12, 2024 to July 5, 2024.
- Shareholders on the record date of June 10, 2024 will receive one (1) unit right for each share in the Company. One (1) unit right entitles the holder to subscribe for one (1) unit in the Rights Issue. One (1) unit consists of two (2) newly issued shares and one (1) free warrant of series TO3. The subscription price is SEK 0.5 per unit, corresponding to SEK 0.25 per share. The warrants are issued free of charge.
Background and reasons for the Rights Issue
Realheart is developing a Total Artificial Heart (TAH) for implantation in patients with life-threatening heart failure. The company's TAH has a patented design that incorporates a four-chamber system (two atria, two chambers) to generate a physiologically adapted blood flow that mimics the body's natural circulation.
Realheart has conducted several animal studies as part of the preclinical program that will form the basis of the first human clinical trial, the last animal trial was in April 2024. The results show that Realheart TAH gives rise to good heart function and low levels of harmful blood effects, 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 addition, parallel blood studies show that Realheart TAH induces 80 percent less blood damage (hemolysis) compared to the market leader's artificial heart.
In 2024, Realheart will continue to optimize the surgical methodology to further improve survival times. In parallel, durability tests and blood analyses are being conducted as part of the preclinical studies. The goal is to initiate human clinical trials in 2025/2026. Realheart has an ongoing dialog with both the FDA in the US and the Notified Body in the EU to ensure regulatory compliance and approval for clinical studies.
Realheart is also focusing on strengthening the collaboration with strategic national and international suppliers and partners to ensure the development and production of TAH. To finance the preclinical studies and ensure successful results for clinical trials in 2025/2026, the company is now conducting a rights issue.
The proceeds from the Rights Issue of a maximum of approximately SEK 48.5 million are planned to be distributed according to the following order of priority and scope:
1. preclinical studies: approximately 78 percent
a. Blood tests and durability tests: 8 percent
b. Animal studies: 70 percent
2. regulatory work: approximately 4%
3. corporate costs: around 18%
Terms and conditions for the Rights Issue
- In the event of full subscription in the Rights Issue, the Company will receive proceeds of approximately SEK 48.5 million before transaction costs.
- Shareholders on the record date June 10, 2024 will receive one (1) unit right for each share in the Company. One (1) unit right entitles to subscribe for one (1) unit. One (1) unit consists of two (2) newly issued shares and one (1) warrant of series TO3.
- The subscription price is SEK 0.5 per unit, corresponding to SEK 0.25 per share. The warrants are issued free of charge.
- The rights issue entails an issue of a maximum of 96,994,446 units, corresponding to 193,988,892 shares and 96,994,446 warrants of series TO3.
- The rights issue is conditional upon the Annual General Meeting on June 7, 2024 resolving on the necessary amendments to the Articles of Association. For more information, please refer to the notice to the Annual General Meeting, which will be published in a separate press release.
Terms for the warrants of series TO3
- Two (2) warrants of series TO3 entitle the holder to subscribe for one (1) new share in the Company. The subscription price when subscribing for shares with the support of the warrants amounts to seventy (70) percent of the volume-weighted average price of the Company's share ten (10) days before the subscription period.
- The warrants may be exercised for subscription of new shares during the period from March 3, 2025 up to and including March 31, 2025.
- Subscription of shares through warrants of series TO3 entails an increase at full subscription of a maximum of 48,497,223 shares.
- The warrants of series TO3 are expected to be admitted to trading on Nasdaq First North Growth Market in close connection with the registration with the Swedish Companies Registration Office and Euroclear and the conversion of BTUs into shares and warrants.
Change in number of shares and share capital and dilution
- In the event of full subscription in the Rights Issue, the number of shares in the Company will increase by a maximum of 193,988,892 shares, from 96,994,446 shares to a maximum of 290,983,338 shares.
- The share capital will increase by a maximum of SEK 7,759,555.68, from SEK 3,879,777.84 to a maximum of SEK 11,639,333.52, calculated based on the proposed new quota value of SEK 0.04 per share after the reduction of the share capital, for more information please refer to the notice to the Annual General Meeting, which will be published in a separate press release.
- The dilution effect amounts to a maximum of 66.7 percent of the total number of shares and votes in the Company.
- In the event of full exercise of warrants of series TO3, the number of shares in the Company will increase by a maximum of 48,497,223 shares, which means that the share capital can increase by an additional SEK 1,939,888.92. The share capital is calculated based on the proposed new quota value of SEK 0.04 per share after reduction of share capital, for more information please refer to the notice to the Annual General Meeting, which will be published in a separate press release.
- The dilution effect amounts to a maximum of 14.3 percent.
EU Growth Prospectus
Full terms and conditions of the Rights Issue and other information about the Company will be set out in the EU Growth Prospectus expected to be published by the Company on or about June 11, 2024 (the “Prospectus”).
Subscription commitments and underwriting commitments
The Company has received subscription commitments of approximately SEK 602,905, corresponding to approximately 1.2 percent of the Rights Issue, and underwriting commitments of approximately SEK 23.7 million, corresponding to approximately 48.8 percent of the Rights Issue. The Rights Issue is thus covered to approximately 50 percent by subscription commitments and underwriting commitments. EIC (European Innovation Council) is positive towards participating in the transaction. However, under its regulations, the EIC is not able to enter into underwring or subscription commitments. They must also take into account that their final shareholding in the Company may not exceed 20 percent. Underwriting compensation is paid at fifteen (15) percent of the underwritten amount if the underwriters choose cash compensation or at twenty (20) percent of the underwritten amount if the underwriters choose compensation in the form of newly issued units. If the underwriters choose to receive compensation in newly issued units, the Board of Directors will decide on a directed issue of such units based on the authorization from the Annual General Meeting on 7 June 2024. In the event of compensation in the form of units, the subscription price is SEK 0.50 per unit, corresponding to SEK 0.25 per share, as per the terms of the Rights Issue. The warrants are issued free of charge.
No compensation is paid for the subscription commitments. Neither the subscription nor the underwriting commitments are secured by bank guarantee, blocked funds, pledge or similar arrangements.
Preliminary timetable for the Rights Issue
| Annual General Meeting | June 7, 2024 |
| Last day of trading in the Company's shares including the right to receive unit rights | June 5, 2024 |
| First day of trading in the Company's shares excluding the right to receive unit rights | June 7, 2024 |
| Record date for participation in the Rights Issue | June 10, 2024 |
| Estimated date for publication of EU Growth Prospectus | June 11, 2024 |
| Subscription period in the Rights Issue | June 12 – July 5, 2024 |
| Trading in unit rights (UR) | June 12 – July 2, 2024 |
| Preliminary date for publication of outcome in the Rights Issue | July 9, 2024 |
| Trading in paid subscribed units (BTU) | From 12 June until around week 30, 2024 |
Advisors
Skills Corporate Finance Nordic AB is acting as financial advisor and Setterwalls Advokatbyrå AB is acting as legal advisor to Realheart in connection with the Rights Issue.
For further information please contact:
Ina Laura Perkins, CEO
Tel: +46 (0) 70 406 49 21
E-mail: inalaura.perkins@realheart.se
About Scandinavian Real Heart AB
Scandinavian Real Heart AB is developing a Total Artificial Heart (TAH) for implantation in patients with life-threatening heart failure. The company's TAH has a patented design that includes a copy of the natural human heart. The Realheart® TAH incorporates a four-chamber system (two atria, two chambers) which provides the ability to generate a physiologically adapted blood flow that mimics the body's natural circulation. A concept that is unique in the medical device world.
Important information
The publication, release or distribution of this press release may be restricted by law in certain jurisdictions and persons in the jurisdictions where this press release has been published or distributed should inform themselves about and observe any such legal restrictions. The recipient of this press release is responsible for using this press release and the information contained herein in accordance with the applicable rules in each jurisdiction. This press release does not constitute an offer to sell or the solicitation of an offer to buy or subscribe for any securities issued by the Company in any jurisdiction in which such offer or solicitation would be unlawful. In any Member State of the European Economic Area (“EEA”), securities referred to in this announcement may only be offered pursuant to applicable exemptions in the Prospectus Regulation.
This press release does not constitute an offer or invitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an applicable 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 absent registration or 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 referred to herein in the United States or to make a public offering of such securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into the United States, Canada, Japan, South Africa or Australia or any other jurisdiction where such announcement, publication or distribution of this information would be unlawful or where such action is subject to legal restrictions or would require additional registration or other measures than those required by Swedish law. Actions in violation of this instruction may constitute a violation of applicable securities legislation.
In the United Kingdom, this document and any other materials in relation to the securities referred to 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” (as defined in section 86(7) of the Financial Services and Markets Act 2000) who are (i) persons who have professional experience in matters relating to investments and 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 referred to in Article 49(2)(a) to (d) of the Regulations (all such persons together being referred to as “relevant persons”). Any investment or investment activity to which this communication relates is available in the United Kingdom only to relevant persons and will be engaged in only with relevant persons. Persons who are not relevant persons should not take any action based on this document or act or rely on it.
A prospectus relating to the Rights Issue described in this press release will be published by the Company on or around June 11, 2024. However, this press release is not a prospectus within the meaning of the Prospectus Regulation. This press release constitutes advertising within the meaning of Article 2(k) of the Prospectus Regulation. Full information regarding the Rights Issue can only be obtained through the Prospectus. Realheart has not authorized any offer to the public of shares or rights in any other member state of the EEA other than Sweden. This press release does not identify or purport to identify any risks (direct or indirect) that may be associated with an investment in new shares. An investment decision to acquire or subscribe for new shares in the Rights Issue may only be made on the basis of publicly available information, which has not been verified by the Company's financial advisor. The financial advisor is acting on behalf of the Company in connection with the transaction and not on behalf of anyone else. The Financial Adviser is not responsible to anyone else for providing the protection afforded to their clients or for providing advice in connection with the transaction or in respect of anything else referred to herein.
Information for distributors
For the purpose of complying with the product governance requirements contained in: (a) Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments, as consolidated, (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593, which complements MiFID II; and (c) national implementing measures (together, the “MiFID II Product Governance Requirements”) and in order to discharge itself from any non-contractual, regulatory or other liability to which any “manufacturer” (within the meaning of the MiFID II Product Governance Requirements) might otherwise be subject, Realheart's shares have been subject to a product approval process, which has determined that such shares are: (i) suitable for a target market of retail investors and investors meeting the criteria of professional clients and eligible counterparties, as defined in MiFID II; and (ii) suitable for distribution through all distribution channels permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of Realheart's shares may decline and investors may lose all or part of their investment; Realheart's shares do not carry any guarantee of return or capital protection; and an investment in Realheart's shares is suitable only for investors who do not need a guaranteed return or capital protection and who (alone or with the assistance of an appropriate financial or other adviser) are capable of evaluating the merits and risks of such investment and who have sufficient resources to bear the losses that such investment may result in. The Target Market Assessment is without prejudice to any other requirements relating to contractual, legal or regulatory selling restrictions in connection with the Rights Issue.
For the avoidance of doubt, the Target Market Assessment does not constitute (a) an assessment of suitability or appropriateness for the purposes of MiFID II or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares of Realheart.
Each distributor is responsible for conducting its own target market assessment in respect of Realheart's shares and for determining appropriate distribution channels.
Realheart Reports Results From Another Successful Preclinical Trial With the Artificial Heart Realheart® TAH
Västerås, 15 April 2024 – Scandinavian Real Heart AB (publ) today announces that the company has successfully completed another implantation of the Realheart® TAH artificial heart within the framework of the preclinical programme that will form the basis for the first clinical study in humans. The results show that Realheart® TAH gives rise to good cardiac function and low levels of adverse blood effects, while the survival time of the implanted animal exceeded previous attempts. Overall, the results support that the Realheart® TAH has the potential to replace the human heart in the future.
Realheart is developing the world's first artificial heart that, like the human heart, consists of two atria and two ventricles and can thus imitate the function and blood flow pattern of the human heart. Before the first clinical study of Realheart® TAH, the authorities require a comprehensive preclinical data package based on safety studies, blood tests and reliability studies.
An important part of the preclinical programme is the trials where the artificial heart is implanted and evaluated in animals. Realheart has conducted a series of such trials since 2022 and can now report the results from the latest trial.
After the implantation, several positive results regarding the performance of the artificial heart were measured, including good cardiac output, proper blood pressure control and balance between the oxygen-rich and oxygen-poor side of the circulatory system. In accordance with the previously presented data, the hemolysis level was below the reference value, i.e. little harmful effect on red blood cells. Being able to document hemolysis below the reference value is an important regulatory requirement for conducting clinical studies in patients. Survival time was improved compared to previous trials and now exceeds well over four days. The surgical team included Realheart's medical partner, cardiac surgeon Dr Göran Dellgren, senior physician and professor at the Thorax Clinic and Transplantation Centre at Sahlgrenska University Hospital in Gothenburg.
Based on the results, Realheart continues to further optimise the surgical protocol for future trials. The latest trial used an updated version of Realheart® TAH with an improved anatomical design. This version follows an evaluation of in-depth anatomy studies by Dr Göran Dellgren and Dr Jan Schmitto, Professor of Cardiac Surgery at the Department of Cardiac, Thoracic, Transplantation and Vascular Surgery at Hannover Medical School in Germany. The updated design proved favorable and will be included in further implantation trials.
"We are very pleased with the results showing that Realheart® TAH has the ability to restore good systemic circulation without serious side effects. These types of complex trials are conducted under the strict ethical guidelines that surround animal experimentation, and each successful surgery provides invaluable new insights that will help us move forward. The surgeons in charge describe Realheart® TAH as very easy and efficient to work with and the results meet their and our high expectations. We are now working to further improve the surgical protocol and look forward to presenting new results as soon as possible", says cardiac surgeon Ulf Kjellman, Chief Medical Officer 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 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 Presents Positive Hematological Data at the American Society for Artificial Internal Organs 70th Annual Conference in Baltimore
Västerås, 10 April 2024 – Scandinavian Real Heart AB (publ) announces today that the company will participate in the annual conference organised by the American Society for Artificial Internal Organs (ASAIO). The conference brings together the world's leading scientists, clinicians, engineers and entrepreneurs in the development of artificial organs. Representatives from Realheart will attend the conference, which takes place in Baltimore, Maryland, USA between 29 May and 1 June.
During the conference, new study data will be presented that strengthens the company's previous results, which show that the company's artificial heart, Realheart® TAH, has a low damaging effect on red blood cells (hemolysis) compared to today's market-dominant heart pump system. The new results are based on in-depth analyses that include several blood components and further confirm that Realheart® TAH causes a significantly lower degree of blood damage.
ASAIO is an annual conference that brings together clinicians, scientists, engineers and companies involved in the research and development of artificial organs. The conference is also attended by representatives from the US Food and Drug Administration (FDA) and other public institutions.
Realheart will participate in the Bioengineering1 session, Thursday 30 June at 15.20, to present the scientific abstract "In Vitro Human Blood Damage Profile of the SynCardia TAH and the Realheart® TAH in a Full Body Circulation Test Rig".
Click on the link to read the abstract: www.asaio.org/conference/program/2024/BIO9.cgi.
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 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 Awarded Almi Guldstänk as Innovator of the Year
Västerås, 14 March 2024 – Scandinavian Real Heart AB (publ) announces today that the company has been awarded Innovator of the Year 2023 in the Almi Guldstänk competition. Realheart was nominated based on the jury's motivation that highlights the company's development of the groundbreaking artificial heart Realheart TAH. After an open vote during the period 8-25 February, Realheart has been selected as the winner in the Innovation category. Representatives of Realheart were present at the ceremony on 14 March in Västerås Concert Hall to receive the award.
Guldstänk is a networking event and competition organised by Almi Mälardalen, Företagarna Västerås, Handelskammaren Mälardalen, Marknadsföreningen i Västerås and the City of Västerås to celebrate local entrepreneurs. The awards are given to reward entrepreneurs and organisations based in the region and are awarded to nominees selected by public vote.
"We are honoured to have been awarded Almi Guldstänk's Innovator of the Year award. We see this award as proof of the confidence in our hard work to fundamentally change the care for people living with heart failure", says Realheart's CEO, Ina Laura Perkins.
In Europe and the US, there are currently more than 8,300 patients with severe heart failure waiting for a heart transplant, and many unfortunately die during their time on the waiting list. Realheart is developing Realheart TAH, an artificial heart that resembles the human heart in structure and function, whose unique product characteristics provide completely new opportunities to save lives and give patients a good quality of life while waiting for a heart transplant.
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 entirely 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 currently being evaluated in extensive preclinical models ahead of its first clinical study in patients expected to commence in 2025. Realheart TAH addresses a significant and urgent medical need – currently many people worldwide are on waiting lists for a heart transplant, and unfortunately, many patients die while waiting. In the future, artificial hearts may become an alternative to transplantation for broader groups of patients with severe heart failure. The company's stock is traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se
Magnus Öhman Appointed Executive Chairman at Realheart
Västerås, Sweden, March 11, 2024 – Scandinavian Real Heart AB (publ.) today announces that the board of directors has appointed Magnus Öhman as executive chairman. He will thereby assume an active role in the company's day-to-day operations to develop and commercialize Realheart TAH. Christer Norström, former chairman, will remain as a member of the board.
"As we approach the clinical phase in the development of Realheart's artificial heart, we take a step closer to commercialization and therefore see a need to strengthen our operational capacity in these areas. Magnus Öhman's extensive experience in leading and developing medical technology companies is invaluable, and in his new role, he will be able to contribute further to the ongoing transformation of Realheart," says former chairman of the board of Realheart, Christer Norström.
Magnus Öhman has extensive experience in the medical technology industry. He has, among other roles, been the CEO of St. Jude Medical's Swedish subsidiary in Cardiac Rhythm Management, with over 600 employees and a turnover of approximately SEK 5 billion.
"Realheart's artificial heart has tremendous potential to address complex and extensive medical needs in today's cardiac care. In my view, Realheart is ready to take the next step forward, and I very much look forward to becoming part of the daily activities and at the same time leading the overall strategic work in my new role as executive chairman," says Realheart's newly appointed chairman, Magnus Öhman.
For more information, please contact:
Magnus Öhman, Chairman of the board
Phone: +46 (0) 73-973 7840
E-mail: magnus@ohman.eu
Certified Adviser: Svensk Kapitalmarknadsgranskning AB, www.skmg.se
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 entirely 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 currently being evaluated in extensive preclinical models ahead of its first clinical study in patients expected to commence in 2025. Realheart TAH addresses a significant and urgent medical need – currently many people worldwide are on waiting lists for a heart transplant, and unfortunately, many patients die while waiting. In the future, artificial hearts may become an alternative to transplantation for broader groups of patients with severe heart failure. The company's stock is traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se
Year-End Report 2023
Summary of Year-End Report 2023
| (SEK) | ||||
| Group Overview | 2023-10-01 | 2022-10-01 | 2023-01-01 | 2022-01-01 |
| 2023-12-31 | 2022-12-31 | 2023-12-31 | 2022-12-31 | |
| 3 mon | 3 mon | 12 mon | 12 mon | |
| Operating income | 798 047 | 31 468 | 902 882 | 667 589 |
| Earnings after financial items | -52 895 973 | -2 914 829 | -67 977 292 | -13 987 911 |
| Balance sheet total | 119 816 255 | 102 638 279 | 119 816 255 | 102 638 279 |
| Equity/Assets ratio | 80% | 81% | 80% | 81% |
| Earnings per share | -0.55 | -0.09 | -0.70 | -0.42 |
| Number of shares | 96 994 446 | 33 183 461 | 96 994 446 | 33 183 461 |
| Parent Company Overview | 2023-10-01 | 2022-10-01 | 2023-01-01 | 2022-01-01 |
| 2023-12-31 | 2022-12-31 | 2023-12-31 | 2022-12-31 | |
| 3 mon | 3 mon | 12 mon | 12 mon | |
| Operating income | 798 047 | 31 468 | 902 882 | 667 589 |
| Earnings after financial items | -52 865 323 | -2 824 786 | -67 678 901 | -13 810 029 |
| Balance sheet total | 103 221 678 | 111 229 225 | 103 221 678 | 111 229 225 |
| Equity/Assets ratio | 80% | 88% | 80% | 88% |
| Earnings per share | -0.55 | -0.09 | -0.70 | -0.42 |
| Number of shares | 96 994 446 | 33 183 461 | 96 994 446 | 33 183 461 |
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 Q3 with 5.4 MSEK. 2.8 MSEK for purchased services and other external costs and 2.6 MSEK for personnel. During the period, write-downs of capitalized costs for research and development for the years 2016-2020 were made by 50,1 MSEK.
Financial Position
During the period, the company has received Grant payments from EIC, Vinnova and Eurostars of 10.3 MSEK, and interest income of 0.5 MSEK. With a cash balance of 43.3 MSEK at the end of the period the company has funding that will last to the and of 2024. In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.
Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees and 4 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.
CEO Comment
In the autumn, we presented a clarified strategy that initially focuses the commercialisation of Realheart TAH on patients on the waiting list for a heart transplant – a well-defined sub-market with high potential to generate significant revenues and lay the foundation for our long-term value creation. Shortly after Christmas, the European Innovation Council (EIC) announced its decision to pay the second part of its development grant to Realheart under its accelerator programme. During the spring, a number of important milestones are expected in the preclinical development of Realheart TAH – with the goal of reaching the clinical development phase in 2025.
Significant Events During the Fourth Quarter of the Year
In October, Realheart communicates that Giovanni Lauricella has been adjuncted to the board of directors. Giovanni Lauricella is a managing partner at Lifeblood Inc., specializing in recruitment and fund raising for medtech companies.
The very first day in November, The Company announces Its successfully establishment a novel test system to evaluate hemolysis of its total artificial heart. The preclinical test system replicates the body's circulatory system and enables more precise evaluations of hemolytic events.
In the middle of November, Realheart provides a strategy update on the development and commercialization of its artificial heart, the Realheart® TAH, which in initial testing has been shown to induce 80% lower levels of hemolysis compared to today's market-dominant artificial heart.
The last event of the year is a press release about Realheart has received its second payment from the European Innovation Council (EIC) grant that was awarded in December 2021, aimed at supporting the development of the artificial heart Realheart TAH. The payment of 750,000 EUR equals 30% of the total grant sum of 2.5 MEUR.
Significant Events After the End of the Period
WRITE-DOWN OF INTANGIBLE ASSETS
The Board of Directors of Scandinavian Real Heart AB decided February 12 on a write-down of the book value of intangible fixed assets in the parent company of a total of -50.1 MSEK, mainly due to increased WACC and current market conditions. The write-down has no impact on Cash-Flow but will impact net income in the fourth quarter of 2023.
The value of the Group's intangible assets is tested annually or when indications of significant changes in assumptions are identified. In connection with the work on the 2023 financial statements, a thorough analysis of the book values of the Group's intangible assets has been carried out in relation to current WACC requirements.
Due to the sharply increased interest rate level in 2023, which increases WACC requirements, and previously communicated delays in the commercialization process, the Board of Directors has decided to write down the value of intangible assets by -50.1 MSEK. The write-down does not impact cash flows.
A write-down of the value of intangible assets means that the requirement for future amortization decreases, which gives a better future result.
Realheart appoints Andreas Hultdin as interim CFO following the resignation of Jonas Caspari Bark
Västerås, February 6, 2024 – Scandinavian Real Heart AB (publ.) today announces that Jonas Caspari Bark will be leaving the position of Chief Financial Officer on March 4th to take up a senior role at another company. Andreas Hultdin will be acting as interim CFO until a permanent successor has been appointed.
Andreas Hultdin holds an MBA from Umeå University, Sweden, and has held several senior financial roles, including as Group Accounting Manager at ABB and Financial Manager at ABB Norden Holding, before taking up his current position as CEO of the consultancy firm Nogap. Between 2019 and 2022, he served as the CFO of Realheart where he contributed to securing financing from the European Investment Council.
“We wish to thank Jonas Bark for his significant contributions to the well-structured financial control environment at Realheart. The appointment of Andreas Hultdin as interim CFO will secure a smooth transition, not least as he has extensive knowledge of Realheart since his time as permanent CFO during the period 2019–2022,” comments Ina Laura Perkins, CEO of Realheart.
The process of recruiting a permanent CFO will be initiated immediately.
Report from the extraordinary general meeting in Scandinavian Real Heart AB on November 24, 2023
Press release November 24th, 2023
Scandinavian Real Heart AB (the "Company") has on November 24, 2023, held an extraordinary general meeting where mainly the following decisions were made.
Determination of the number of board members.
The meeting resolved to approve the nomination committee's proposal that the number of members of the board of directors shall consist of eight ordinary board members without deputies.
Election of board members.
The meeting resolved to approve the nomination committee's proposal to elect Magnus Öhman, Stuart McConchie and Giovanni Lauricella to the board of directors. The other members remain on the Board of Directors as proposed by the Nomination Committee.
Determination of fees for the Board of Directors
The Meeting resolved, in accordance with the Nomination Committee's proposal, that fees to the Board of Directors shall be paid with SEK 72,500 to each of the new members.
Interim Report 230701-230930
Press Release November 16, 2023
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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 foreign currency exchange gains. Research and development costs of Realheart® TAH were capitalized during Q3 with 4.2 MSEK. 1.9 MSEK for purchased services and other external costs and 2.3 MSEK for personnel. During the period, write-downs of capitalized costs for research and development were made by 0 MSEK.
Other external costs of 8.9 MSEK includes cost for guarantors of 3.4 MSEK and issuing costs of 2.3 MSEK.
Financial Position
During the period, the company has received cash of 42.2 MSEK after issuing costs from a preferred and directed share issue, 7.2 MSEK from R&D Tax credit in Australia and 0.5 MSEK from received Grants. With a cash balance of 44 MSEK at the end of the period the company has funding that will last into the third quarter of 2024.
In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.
Significant Events During the Second Quarter of the Year
The period begins with Realheart initiating a collaboration with Chief Physician and Professor Göran Dellgren at the Transplantation Centre and Thorax Clinic at Sahlgrenska University Hospital in Gothenburg. The collaboration is part of the preparations for the clinical studies with the company's artificial heart.
During the first week of July, it was announced that Realheart, after Almi's evaluation, has received business development support totalling SEK 0.850 million. Realheart submitted four applications, all of which have now been approved.
Halfway through July, Realheart publishes the outcome of the company's rights issue. A total of 21,214,649 units were subscribed, corresponding to 60.6 per cent of the Rights Issue. The Rights Issue provides the Company with approximately SEK 33.9 million before issue costs.
The last days of July, Realheart communicates that it carries out a directed new issue of units to guarantors in connection with the completed rights issue. The decision means that it issues 642,950 units as guarantee compensation directed to a number of the guarantors who provided guarantee commitments in the rights issue of units that the Company carried out during the period 20 June to 7 July 2023, in accordance with the guarantee agreements entered into.
On the same day, the company also announces that it carries out a directed issue to EIC in connection with the completed rights issue. The Company's Board of Directors, pursuant to the authorisation granted by the Annual General Meeting on 14 June 2023, decided to issue 9,150,000 units to the European Innovation Council ("EIC") Accelerator, in accordance with the investment agreement published on 15 May 2023. Realheart thus receives an additional SEK 14,640,000 before transaction costs.
During the first part of August, Realheart announces that the Nomination Committee of the company proposes that Magnus Öhman be elected to the Board at the next general meeting. Until then, he is co-opted to the board. Magnus Öhman has extensive experience from the medical technology industry, including as CEO of St Jude Medical's Swedish subsidiary within Cardiac Rhythm Management.
In the second half of August, the company announced three upcoming presentations regarding different parts of the achieved research results. The presentations take place at three different scientific conferences in Europe – ESAO in Bergamo, BDW in Rostock and EUMS in Paris – where many future customers and partners participate. Among other things, the company highlights its experience with animal-free methods in its development work and challenges the industry to take the step away from animals.
In a press release at the end of August, Realheart announced that CEO Ina Laura Perkins has been invited to speak about the company's artificial heart at the China Heart Congress in Beijing in September 2023. The conference is one of the largest in cardiovascular diseases in the Asia-Pacific region with over 8,000 participants. Ina Laura Perkins has been invited by one of China's leading heart surgeons, Mr Shenshou Hu, President of Fuwai Hospital in Beijing.
The last thing that happens in August is that Realheart decides to co-opt Stuart McConchie to the board, after the nomination committee informs that it intends to propose him as a new board member at the next general meeting. Stuart McConchie has held top positions in global medical technology companies for more than 25 years, guiding companies from research to product commercialisation.
September begins with the news that Realheart has been selected for Business Sweden's scale-up programme Catalyst, which aims to create international growth. In the programme, which is aimed at Sweden's most innovative and promising companies, participants receive a tailored project plan for market entry valued at SEK 250,000 and opportunities to build networks in the market, among investors and other experts.
Significant Events After the End of the Period
On the penultimate day of October, Realheart announces another addition to the board, Giovanni Lauricella, after the nomination committee announced that it intends to propose him as a new board member at the next general meeting. Giovanni Lauricella is currently Managing Partner at Lifeblood Inc, a company specialising in recruitment and fundraising for medical device companies.
November begins with the press release announcing that Realheart has successfully established a new test model for evaluating the impact of artificial hearts on the blood. Initial test results show that the company's artificial heart, Realheart TAH, induces 80% lower degree of haemolysis compared to today's market-dominant heart pump system. The company will shortly start haemolysis testing with the clinical version of the product.
In mid-November, Realheart provides an update on the development and commercialisation of Realheart TAH based on a thorough analysis conducted under the guidance of the company's Board of Directors, including the new co-opted members. Realheart will focus more clearly on the use of the product as a bridging treatment before organ transplantation and now assesses that the product can receive reimbursement in the US already when used in clinical trials.
CEO Ina Laura Perkins Has the Word
Since last summer, we have been able to attract three new people who will be proposed for election to the Board at an
Extraordinary General Meeting on November 24. They have already contributed significant knowledge and experience from the cardiac medical device industry as adjunct members. After the end of the reporting period, we could announce that initial tests show that Realheart TAH induces 80% less hemolysis than today's market-dominant artificial heart, and a few days ago we presented an updated development and commercialization plan. Although our timetable has been slightly postponed, we now see an opportunity for revenue already during the upcoming clinical trials.
New Specialist Expertise to the Board
In August, Magnus Öhman, former CEO of Cardiac Rhythm Management, and Stuart McConchie, with a background as CEO and COO of three international heart pump companies, were added to the company's board. At the end of October, Giovanni Lauricella, who has a solid network among international specialist investors, was also added.
Updated Development and Commercialization Plan
After thorough work under the leadership of our strengthened board, we were able to present an updated development and commercialization plan earlier this week. We will now focus more clearly on the use of Realheart TAH as a bridging treatment while waiting for organ transplantation – a sub-market where each percentage point of the patients currently on the waiting list for heart transplantation in Europe and the US corresponds to a potential sales revenue of 150 MSEK. At the same time, we have identified an opportunity to obtain reimbursement for Realheart TAH in the US already in the clinical trial phase, which would result in an earlier revenue flow than previously planned. In light of, among other things, delayed deliveries of components, we have updated the schedule for the remaining steps before the first clinical study and we now estimate that a trial application can be submitted at the turn of the year 2024/25.
Additional Puzzle Pieces in Place for the First Clinical Study
We have now succeeded in establishing a preclinical test system that makes it possible to mimic the blood flow throughout the body and more comprehensively evaluate damage to red blood cells (hemolysis). Initial test results show that Realheart TAH induces 80% lower degree of hemolysis compared to today's market-dominant artificial heart. It is also gratifying that for the first clinical study in humans, we have a well-functioning collaboration in place with Professor Göran Dellgren, chief physician at the Transplantation Center and Thoracic Clinic at Sahlgrenska University Hospital.
International Attention for Realheart TAH
In late August, we participated in ESAO in Italy and EUMS in Paris, two important European meetings that bring together experts in interventional cardiology. During the quarter, we were awarded Business Sweden's CATALYST grant of 250,000 SEK to map the addressable market for Realheart TAH in China.
Business Sweden also sponsored our presence at the Chinese International Import Expo (CIIE) in Shanghai where we participated on November 5-10. The visit followed closely on the heels of the China Heart Congress in early September, where the company was invited to present Realheart TAH to China's top cardiologists.
We have also attended scientific meetings and investor conferences in Finland, Malta, USA, China and Turkey and had the opportunity to demonstrate a prototype of the product's controller. In October, I was invited by the Heart Failure Policy Network to attend the launch of the Heart Failure Mission at the European Parliament in Brussels. Today, approximately 15 million individuals in Europe suffer from heart failure, a figure that is expected to increase by 90% by 2040. The Parliament's initiative aims to highlight the clinical need for new heart failure treatments and promote European investment in the field.
Ina Laura Perkins
CEO, Scandinavian Real Heart AB
Scandinavian Real Heart AB
Swedish innovation power has given the world medical technology inventions such as the heart and lung machine, the pacemaker and the dialysis machine. The next big innovation is Realheart's artificial heart. A Swedish patented innovation that will save the lives of heart failure patients. Every year, 3,500 people die of heart failure in Sweden alone. Today, the only rescue is a heart transplant, but the number of donated hearts is only enough for 2% of those in need.
The start-up of the company was initiated by the doctor Azad Najar in 1999 when he started sketching an artificial heart that completely mimics the biological. In 2007, Azad co-founded Scandinavian Real Heart with two partners. The original idea behind Realheart® TAH is based on flow analyzes made at KTH 2002-2005 and is based on constructing an artificial heart that mimics the biological. By imitating its basic principle, a pressure and flow is created that reduces the risk of blood clots and provides an energy-efficient blood flow. These factors are important to give the patient a good quality of life. The development of the product has progressed strongly over the years. Blood circulation, pump function, pressure, and pulse generation have been verified in ethically approved animal experiments. Today, research and development takes place in close collaboration with world-leading heart surgeons, researchers and engineers.
Patent Protection
Realheart has granted patents in Sweden, Germany, the United Kingdom, the United States, China and India that protect the original pump principle in TAH. This patent also provides protection for future products: RealVAD® and PulsePump®.
Patent protection is also available on the latest version of Realheart® TAH in Sweden, USA, UK, Australia and Japan. The patent application for it has also been filed for Germany and Canada. The patents provide protection in the markets that are largest and most important for artificial hearts right now, with the exception of China and India which are considered important emerging markets. In addition to the patent protection described above, Realheart has also approved patents in Sweden, the USA and the United Kingdom for the future Sternal prosthesis product.
The application is also submitted in Germany and France. In 2018, a new connection was designed for a simple and secure connection between Realheart® TAH and the body's circulatory system. The patent application for this has also been filed.
Finally, the patent application has been filed in two parts for the use of pressure sensors for the automatic control. Given the existing patents together with the new patent applications, the Board believes that the company has a strong patent situation and strong intellectual property protection.
Mission and Goal
Realheart's mission is to use medical technology solutions to save as many heart failure patients as possible and to create the best conditions for a life-affirming continuation of life. The company's overall goal is for the artificial heart to be commercialized and become a full-fledged treatment alternative for patients with heart failure. The heart should have a better function than the solutions that are on the market today. It should be possible to use both as a bridge to transplantation and as final therapy.
The Stock
Scandinavian Real Heart AB was listed on the Nasdaq First North Growth Market in December 2021. Nasdaq First North GM is a registered SME marketplace for growth companies that enables Nordic and international entrepreneurs to gain access to growth capital to develop and expand their operations. As of September 30, 2023, the number of shares in Scandinavian Real Heart was 96 994 446.
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Principles for the Preparation of the Interim Report
The interim report has been prepared in accordance with the Annual Accounts Act and with the application of general advice, recommendations and statements from the Swedish Accounting Standards Board.
Audit Review
The interim report has not been reviewed by the Company's auditor.
Upcoming Financial Reports
Year-end Report 2023 2024-02-15
Interim Report Q1 2024 2024-05-11
Annual Report 2023 2024-05-23
Annual General Meeting
The company's annual general meeting is planned to be held Thursday, June13th, 2024.
Submission of Interim Report
Västerås, November 16, 2023
The Board
Scandinavian Real Heart AB
For Further Information, Please Contact
Ina Laura Perkins
CEO Scandinavian Real Heart
Phone: +46 70 406 49 21
E-mail: inalaura.perkins@realheart.se
Jonas Caspari Bark
CFO Scandinavian Real Heart
Phone: +46 70 643 88 61
E-mail: jonas.bark@realheart.se
This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB's news distributor Cision upon publication of this press release.
Link to archive for financial reports: https://realheart.se/sv/investerare/arkiv/
Realheart provides an update on the development and commercialization of its artificial heart
Västerås, Sweden, November 13, 2023 – Scandinavian Real Heart AB (publ) today provides a strategy update on the development and commercialization of its artificial heart, the Realheart TAH, which in initial testing has been shown to induce 80% lower levels of hemolysis compared to today's market-dominant artificial heart. This update is based on a thorough analysis conducted under the guidance of the company's Board of Directors, including the new adjunct board members. Realheart will increase its focus on the use of the product as a bridging treatment ahead of organ transplantation and now deems that the product is eligible for reimbursement in the US already when used in upcoming clinical trials. Because of significant supply chain issues and delays with development partners, the scheduled start of the first clinical study has been postponed from 2024 to 2025. This is in turn likely to impact the timing of a future market introduction.
"The Board and management, in consultation with external experts, have conducted a thorough review of the plans for the development and commercialization of the Realheart TAH. The updated plan includes a sharper focus on the use of the Realheart TAH as a bridging treatment for patients awaiting organ transplantation. Further, we have identified an opportunity to get the product reimbursed already for use in upcoming clinical trials in the US, which has the potential to generate early revenues for the company. The use of our artificial heart ahead of organ transplantation is the first important step towards our long-term vision – that no one should have to die from heart failure," says Realheart's CEO, Ina Laura Perkins.
A more precisely defined commercialization strategy
In total, more than 8,300 patients with severe heart failure are currently listed for a heart transplant in Europe and the US. Many of these unfortunately die during their time on the waiting list. Realheart aims to significantly reduce this mortality and increase the quality of life for those waiting for a donor organ. The company aims to provide the first artificial heart that mimics the human heart, and thus, has the potential to minimize the risk of side effects.
Following decades of research and development, the Realheart TAH is now undergoing functional and safety testing ahead of the first clinical study in humans. Realheart deems that the product is eligible for reimbursement in the US already for use in the upcoming clinical trials, which has the potential to generate early revenue streams for the company.
Future market approvals will create significant commercial potential – each one percent of the patients currently on waiting lists in Europe and the US for heart transplantation corresponds to a potential sales revenue of SEK 150 million. The use of the Realheart TAH in this setting is an important first step towards the company's long-term vision – that broader patient groups will have access to the product so that no one must die of heart failure.
Since the global number of transplant centers is limited, it will be possible to market Realheart TAH with relatively limited resources. The company's business model is based on direct sales of the product in the US and Europe, with the addition of necessary services and support for clinical staff and patients.
Updated timeline
Preparatory activities ahead of clinical studies
An application to initiate the first clinical study of Realheart TAH is expected to be submitted to the relevant authorities at the turn of 2024/2025. This requires a comprehensive preclinical data package based on safety studies, blood tests and reliability studies.
Safety studies are being conducted in preclinical models to meet regulatory requirements for the first study in patients. This work is progressing with very positive results to date.
The blood tests are carried out in a laboratory setting and the company has recently established a preclinical test system that mimics the natural blood flow throughout the body, thereby enabling a more reliable evaluation of red blood cell damage (hemolysis). Initial test results show that the Realheart TAH induces 80% lower levels of hemolysis compared to today's market-dominant heart pump systems.
Reliability studies of the individual components of the Realheart TAH have already been carried out with good results, and corresponding tests of the artificial heart as a complete system will start shortly.
First in human study
As part of the preparations for the first clinical study of the Realheart TAH, the company has established a collaboration with Professor Göran Dellgren, Chief Physician at the Transplantation Center and Thorax Clinic at Sahlgrenska University Hospital in Gothenburg, Sweden. Several experimental and clinical preparatory studies are conducted within the framework of this collaboration, including further evaluation of alternative surgical methods, and definition of the suitable patient pool for the clinical study.
The initial clinical study, which is expected to be initiated in 2025, will be conducted in 2 to 4 patients awaiting heart transplantation. Assuming positive results, an additional study in 10-20 patients will follow to confirm the performance and safety of the Realheart TAH in clinical use, prior to market authorization applications.
The process towards market authorization
A process has been initiated in Europe with a Notified Body (an independent organization that ensures that manufacturers comply with EU regulations), to establish the requirements for Market Approval in the EU.
In parallel, Realheart has had meetings with the US regulatory authority (the FDA) to determine what documentation will be required for Market Approval, and further meetings are anticipated to establish the specific application process that is most appropriate in the US.
This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB's news distributor Cision upon publication of this press release.
Notice to Attend the Extraordinary General Meeting in Scandinavian Real Heart AB
Press Release November 8, 2023
The shareholders in Scandinavian Real Heart AB, reg. no. 556729-5588 (the "Company"), are hereby invited to the Annual General Meeting on Friday, 24 November 2023 at 10.00 at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, 722 13 Västerås. Registration for the Meeting begins at 09:30.
Right to participate in the Meeting, etc.
Shareholders who wish to participate in the Meeting shall
- be recorded in the share register kept by Euroclear Sweden AB no later than Thursday, 16 November 2023, and
- notify the Company their intention to participate no later than Monday, 20 November 2023 by post to Scandinavian Real Heart AB, Kopparbergsvägen 6, 722 13 Västerås, by phone +46 (0)70-643 88 61 or by e-mail jonas.bark@realheart.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 Thursday, 16 November 2023. 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 Monday, 20 November 2023, 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/Integritypolicy-bolagsstammor-svenska.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.
Determination of number of Board members
7.
Election of Board members
8.
Determination of fees for Board members
9.
Closing of meeting
The Nomination Committee's proposals
Item 1 – Election of Chairman of the Meeting
The Nomination Committee consists, until the Annual General Meeting 2024, of Kim Norström and Azad Najar as decided by the Annual General Meeting 2023. The Nomination Committee proposes that Christer Norström, or the person appointed by the Nomination Committee if he is prevented from attending, is appointed as Chairman of the Extraordinary General Meeting.
Item 6 – Determination of number of Board members
The Nomination Committee proposes that the Board of Directors should consist of eight
ordinary Board members without deputies.
Item 7 -Election of Board members
The Nomination Committee proposes, for the period until the end of the next Annual General Meeting, that the current Board of Directors be supplemented with the following new members: Magnus Öhman, Stuart McConchie and Giovanni Lauricella. The board of directors otherwise consists of the members Christer Norström, also chairman of the board, Azad Najar, Ulf Grape, Oliver Voigt and Solveig Bergström as board members.
Magnus Öhman
Born: 1961
Education: MSc in Mechanical Engineering
Board of Director assignments: Magnus is currently Chairman of the board of Neosense Technologies, a Swedish medtech start-up company that develops invasive sensor based products where the first product significantly improves continuous oxygen monitoring for neonatal children to improve survival rate and Quality of Life. He has been a board member at Stockholms Tekniska Institut, an engineering school founded in 1924.
Experience: Magnus has over 30 years of experience from medtech including R&D leadership in both site and global responsibilities and as Managing Director for the St Jude Medical CRM subsidiary with R&D, manufacturing and distribution operations with over 600 employees and a revenue of 5.3 billion SEK. Magnus has managed or supervised 40+ product developments projects from start to regulatory approved and launched globally. Magnus previously served as CEO of Stockholms Tekniska Institut, an engineering school with 350+ students managing a turnaround operationally and strategically.
Stuart McConchie
Born: 1952
Education: Pharmacology – Monash University, Melbourne, Australia.
Board of Director assignments: Stuart has no current board positions.
Experience: Stuart has held senior positions in global medical device companies for more than 25 years, guiding companies from research to product commercialisation. Stuart has worked with several heart pump companies, most recently as CEO of UK-based Calon Cardio Technology, and previously with US-based Jarvik Heart and Australian HeartWare Inc where he also gained experience in a publicly traded environment before the company was acquired by Medtronic. Stuart has extensive regulatory experience, including FDA interaction with multiple products.
Giovanni Lauricella
Born: 1987
Education: Bachelor of Science (BSc) in Finance, a Master of Science (MSc) in Regulatory Affairs in Medical Devices, a Harvard University Certificate in Advanced Negotiation Strategy and a Universita Bocconi Certificate in Private Equity and Venture Capital.
Board of Director assignments: Managing partner at Lifeblood Inc., specializing in recruitment and fund raising for medtech companies.
Experience Giovanni has worked with over 500 startups worldwide and is currently member of several boards. He also organizes the conference Med-Tech World, which gathers around 3,000 participants, bringing together companies with investors, industry, and the media. He runs the podcast MedTech Money which focuses on demystifying raising and investing capital for Medtech startups.
Item 8 – Determination of fees for Board members
The Nomination Committee proposes that board fees for each of the new members according to item 7 above shall be paid with SEK 72,500.
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 96,994,446.
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 Directors and the CEO at the Meeting.
Provision of documents
Proxy forms as well as other documents required by the Companies Act will be kept available to the shareholders at the Company's head office; Kopparbergsvägen 6, 722 13 Västerås and on the Company's website www.realheart.se.
Copies of the documents will also be sent to shareholders who so request and who provide their postal address.
Västerås in November 2023
Scandinavian Real Heart AB
THE BOARD OF DIRECTORS
Realheart has successfully established a novel test system to evaluate hemolysis of its total artificial heart
Västerås, November 1, 2023 – Scandinavian Real Heart AB (publ.) today announces that the company has successfully established a closed-loop preclinical test system that replicates the body's circulatory system and enables more precise evaluations of hemolytic events. Initial test results show that the company's artificial heart, Realheart TAH, induces 80% less hemolysis compared to the current market leader. The company will shortly start the evaluation of hemolytic events using a clinical version of the product.
Measurements of hemoglobin released from red blood cells (plasma free hemoglobin; pfHb) are performed to determine the risk of ruptured blood cells (hemolysis) during the use of total artificial hearts (TAH). Such analyses compose a cornerstone in the preclinical documentation required to obtain approval from regulatory authorities before conducting clinical trials. During the fall, Realheart successfully completed the construction of an exhaustive test system, which surpasses the regulatory standards of hemolysis testing in pulsating artificial hearts. The model has thereafter been used in initial tests to evaluate the impact of a Realheart TAH prototype on human blood.
The human circulatory system is composed of two halves. One that pumps blood from the heart to the lungs with low pressure, and the other that distributes blood to the organs using high pressure. To the company's knowledge, there are no similar test systems that combine both halves of the human circulatory system for pulsatile pump testing. Initial test results using the preclinical version of Realheart TAH in the test system show that it induces 80% less damage to red blood cells (hemolysis), compared to the current market-leading artificial heart. Furthermore, the tests have been performed using human blood, enabling the company to generate more clinically relevant data and optimize the product design, with the aim of avoiding side effects in future patients who receive treatment with Realheart TAH.
The new and more technically demanding test system was developed following a request from the U.S. Food and Drug Administration (FDA). The development has been time and resource consuming, but has created a positive setting for future regulatory interactions. The CEO of Realheart, Ina Laura Perkins, PhD, has been an active participant in the committee meetings arranged by the agency to develop the new standards for hemolysis testing.
Next, the company will evaluate its clinical product version of Realheart TAH in combination with the clinical control unit in development, to generate the preclinical documentation required in an application to initiate clinical studies in heart failure patients.
"We have succeeded in establishing a test system that opens completely new ways to replicating the function of the human circulatory system, thereby allowing us to compare the properties of our proprietary artificial heart with other cardiac pumps. The model strengthens us in our dialogues with heart specialists and investors who recognize its value in generating comparative performance data. Our initial results point toward a low grade of hemolysis originating from the use of Realheart TAH and we are now eager to test the clinical version of our unique artificial heart," comments Ina Laura Perkins, CEO of Realheart.
Giovanni Lauricella is adjuncted to Realheart’s board of directors
Västerås, October 30 2023 – Scandinavian Real Heart AB (publ.) has today decided to adjunct Giovanni Lauricella to the board of directors, after being informed that the nomination committee intends to propose him as a new member of the board of directors at the next general meeting. Giovanni Lauricella is a managing partner at Lifeblood Inc., specializing in recruitment and fund raising for medtech companies.
Giovanni Lauricella has worked with over 500 startups worldwide and is currently member of several boards. He also organizes the conference Med-Tech World, which gathers around 3,000 participants, bringing together companies with investors, industry, and the media. He runs the podcast MedTech Money which focuses on demystifying raising and investing capital for Medtech startups.
Giovanni Lauricella holds a Bachelor of Science (BSc) in Finance, a Master of Science (MSc) in Regulatory Affairs in Medical Devices, a Harvard University Certificate in Advanced Negotiation Strategy and a Universita Bocconi Certificate in Private Equity and Venture Capital.
"We are happy to welcome Giovanni Lauricella to the board. He has a vast network in the industry and among specialist investors and has worked with a number of companies that have taken the step from innovation to the commercial market. He will make a strong contribution to the board's work," says Christer Norström, Chairman of the Board, Realheart.
Realheart selected for Business Sweden’s Catalyst programme
Press release 2023-09-01
Scandinavian Real Heart AB has been selected for Business Sweden's scale-up programme Catalyst, which aims to create international growth. In the program targeting Sweden’s most innovative and promising companies, participants receive a customized project plan for market entry valued at 250,000 SEK and opportunities to build network in the market, among investors and other experts.
– Scandinavian Real Heart is one of Sweden’s most exciting and innovative medtech companies. With Scandinavian Real Heart, Sweden has the opportunity to develop into a leading Life Science nation. We are proud that Scandinavian Real Heart chooses to work with Business Sweden and look forward to supporting the company in their global growth, says Jonas Thulin, program manager at Business Sweden.
Through the program, Realheart receives for three months hands-on support in a selected market, as well as a customized market visit to increase understanding and to create networks.
– The program gives us a springboard towards international growth with tailored commercialization support, advice and coaching in a chosen market. Having been selected also shows that the expert jury sees great potential for our artificial heart. Realheart will take advantage of this opportunity, says CEO Ina Laura Perkins.
Realheart has been selected in the Asia/Pacific program, a region where the company intends to work with partners and distributors for marketing and sales of its artificial heart. Through the program, the company will be able to intensify the work of identifying possible partners in the region and creating initial contacts with key parties. As part of this effort, CEO Ina Laura Perkins speaks at one of the world's largest cardiovascular disease congresses, the China Heart Congress at the turn of August/September.
The market in the Asia Pacific region is of size. The number of patients with heart failure is estimated in China to be around 12 million and in Southeast Asia to 9 million, which can be compared with 15 million in Europe and 6 million in the USA.
Stuart McConchie Appointed Adjunct Board Member to Realheart
Press release 2023-08-30
Scandinavian Real Heart AB has decided to adjunct Stuart McConchie to the board of directors, after the nomination committee informed that it intends to propose him as new board member at the next general meeting. Stuart McConchie has held top positions at global medical technology companies for 25 years, guiding companies from research phase to commercialization of products.
McConchie has worked with several mechanical circulatory assist device companies, most recently as CEO of UK based Calon Cardio Technology, and previously U.S. Jarvik Heart and Australian HeartWare Inc, where he gained public company experience before the company’s acquisition by Medtronic. Moreover, Stuart McConchie has extensive experience of clinical evaluation and regulatory affairs, including FDA interaction with numerous cardiac products.
– We are excited to welcome Stuart McConchie to the board of directors. His strong track record from successfully guiding MedTech companies from research stage through approval and commercialization, especially with his strong experience in regulatory matters will be very valuable to Realheart in the period ahead, says Chairman of the Board Christer Norström.
“Inevitably the spectrum of mechanical cardiac assist will include effective four chamber support.
The RealHeart® TAH is likely to be that device, and I am delighted to join the Realheart team”.
– says Stuart McConchie