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Vita 34 AG / Key word(s): Legal Matter Internal investigation by Vita 34 AG reveals irregularities related to a limited number of biological samples at one of its subsidiaries regarding compliance with medical law requirements 10-Nov-2023 / 14:57 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. Internal investigation by Vita 34 AG reveals irregularities related to a limited number of biological samples at one of its subsidiaries regarding compliance with medical law requirements Leipzig, 10 November 2023 – Based on an internal notice, Vita 34 AG has conducted an investigation at one of its small subsidiaries. This revealed potential irregularities in a total of not more than 1,700 umbilical cord blood samples regarding compliance with medical law requirements, which could lead to these samples being not acceptable for medical treatment or requiring an additional permit for use. The number of affected samples corresponds to approximately 0.2 percent of all biological samples stored by Vita Group. Customer samples at Vita 34 AG and all other subsidiaries are not impacted. The possible irregularities identified relate to the required qualifications of a responsible medical person and formal inaccuracies in the documentation of some of the samples, which could have an impact on the subsidiary’s manufacturing authorization. However, the Management Board of Vita 34 believes that the biological quality of the samples is not affected by these regulatory issues. Whether there is a financial impact and the exact extent of a possible financial impact cannot be assessed conclusively at this time. Should the risks described above fully materialize, Vita 34 estimates a possible financial burden for the subsidiary of low single digit million euros in the coming years. Vita 34 will work closely and transparently with the responsible authorities to clarify the facts. Person required to report: Jakub Baran (Chief Executive Officer) — End of inside information according to Art. 17 MAR — End of Inside Information Information and Explanation of the Issuer to this announcement: Contact: Company profile Vita 34 was founded in Leipzig in 1997 and is today by far the leading cell bank in Europe and the third largest worldwide. As Europe’s first private cord blood bank and a pioneer in cell banking, the company has since offered collection logistics, processing and storage of stem cells from umbilical cord blood, umbilical cord tissue and other postnatal tissues as a full-service cryopreservation provider. Due to the expansion of its business model following the merger with PBKM, the company plans to invest in cell and gene therapies and CDMO. The body’s own cells are a valuable starting material for medical cell therapy and are kept alive in the vapor of liquid nitrogen. Customers from around 50 countries have already ensured the health of their families with more than 930,000 units of stored biological material at Vita 34. 10-Nov-2023 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
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