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Beskrivning

LandSverige
ListaMid Cap Stockholm
SektorHälsovård
IndustriMedicinteknik
Xvivo Perfusion är verksamt inom medicinteknik. Bolaget tillhandahåller lösningar för transplantation av lungor. Exempel på produkter som bolaget levererar innefattar kanyler, organförvaring samt kyllösningar. Produkterna vidaresäljs till kliniker och forskningsinstitut runtom den globala marknaden, med störst närvaro inom Norden och Europa. Bolaget kom till via en avknoppning från Vitrolife under 2012 och har sitt huvudkontor i Göteborg.
2023-09-13 18:00:00

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR TO THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. ADDITIONAL RESTRICTIONS APPLY, PLEASE REFER TO “IMPORTANT INFORMATION” AT THE END OF THE PRESS RELEASE.

XVIVO Perfusion AB (publ) (“XVIVO” or the “Company”) intends to carry out a directed share issue corresponding to approximately SEK 440 million in the Company through an accelerated bookbuilding procedure directed to Swedish and international institutional investors (the “Directed Issue”), starting immediately. XVIVO has engaged Carnegie Investment Bank AB (publ) (“Carnegie”) and DNB Markets, a part of DNB Bank ASA, Sweden branch (“DNB Markets”) to act as Joint Bookrunners (together the “Joint Bookrunners”) in connection with the Directed Issue.

The Directed Issue
The subscription price and the number of new shares in the Directed Issue will be determined through an accelerated bookbuilding procedure, which will commence immediately following the publication of this press release and will be led by the Joint Bookrunners. Closing of the accelerated bookbuilding procedure, pricing and allocation of the new shares are expected to take place before the commencement of trading on Nasdaq Stockholm at 09:00 CEST on 14 September 2023. The timing of closing, pricing and allocation in the bookbuilding procedure are determined at the discretion of the Company and may be shortened, extended or cancelled at any time, meaning the Company may refrain, in part or in full, from carrying out the Directed Issue. The Company will announce the outcome of the Directed Issue in a press release after the bookbuilding procedure has been completed.

The interest from US clinics for XVIVO’s upcoming US heart preservation trial has been significant. On July 25, 2023 the FDA granted XVIVO approval to include Donation after Circulatory Death (“DCD”) hearts in its Investigational Device Exemption (“IDE”) clinical trial. Expanding the clinical trial to include DCD hearts means that the Company’s technology is additionally made available to approximately one third of the US donor pool.

Today, XVIVO is the European market leader within liver machine perfusion, supported by strong clinical data published in leading scientific journals. In 2022, 9,528 liver transplants were performed in the US (UNOS data). In order to become the the global market leader within abdominal machine perfusion, the Company has identified an opportunity to shorten the time to market in the US for the Liver Assist technology. This can be achieved by conducting a clinical trial to support the FDA PMA approval process for the Liver Assist in addition to the Company’s heart preservation trial, meaning that the Company aims to conduct regulatory processes for both heart and liver in the US.

The net proceeds from the Directed Issue are intended to be used for:
· Increased investment in US clinical trial infrastructure and support to create an efficient FDA PMA regulatory approval process for the heart preservation technology;
· Fast-track the preparation and start of the clinical trial and FDA PMA regulatory approval process for Liver Assist; and
· Scale-up of disposable production to ensure delivery capacity and decrease in cost of goods sold.

Prior to the Directed Issue, the Company's board of directors has made an overall assessment and carefully considered the possibility to raise capital through a rights issue with preferential right for the Company's existing shareholders. The board of directors considers that the reasons for deviating from the shareholders’ preferential right are (i) that a rights issue would take a significantly longer time to complete and entail a higher risk for a adverse effect on the share price, particularly in light of the current market volatility and the challenging market conditions, (ii) to diversify and strengthen the Company's shareholder base with international institutional investors, (iii) to carry out a directed share issue can be made at lower costs and with less complexity than a rights issue and in light of the current market conditions, the board of directors has assessed that a rights issue would also require external underwriting from a guarantor syndicate that would entail additional significant costs. Considering the above, the board of directors has made the assessment that a directed share issue with deviation from the shareholders’ preferential right is the most favourable alternative for XVIVO, creates value for the Company and is in the best interest of the Company’s shareholders. The board of directors thus considers that the reasons outweigh the main rule that new share issues are to be carried out with preferential rights for the shareholders.

Since the subscription price in the Directed Issue will been determined through an accelerated bookbuilding procedure, the board of directors assesses that the subscription price will reflect market terms and conditions.

Lock-up undertakings
In connection with the Directed Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 180 calendar days after the settlement date of the Directed Issue. In addition, XVIVO’s board members and shareholding members of the senior management have undertaken not to, subject to customary exceptions, divest any shares in XVIVO for a period of 180 days from the settlement date of the Directed Issue.

Advisors
Carnegie and DNB Markets have been appointed Joint Bookrunners in connection with the Directed Issue. Advokatfirman Vinge acts as legal counsel to the Company and Baker McKenzie acts as legal counsel to the Joint Bookrunners.

September 13, 2023
Gothenburg
XVIVO Perfusion AB (publ)