PUBLIC ALERT REGARDING THE PRODUCT KNOWN AS RENEW CELL®

In view of the marketing of a product known as RENEW CELL®, publicly presented as a treatment for ageing, it is essential to inform doctors, patients, clinics, distributors and health authorities of a series of serious inconsistencies that require immediate clarification by our entity, LABOVital GmbH & Co. KG.

We have received and continue to handle calls and emails from people demanding documentation about this product, which we neither manufacture nor distribute.

The reports to be highlighted concern five people who are hospitalised in Mexico following the alleged use of this product, as well as several reports of other people who have experienced adverse reactions with serious health problems in Colombia, and two people in the Dominican Republic who had to go to hospital following the alleged administration of this product.

LABOVital GmbH & Co. KG is a German company that distributes products mainly for veterinary use. It currently appears in falsified documents as the supposed manufacturer of the aforementioned medicine, with the address of our actual headquarters changed to a non-existent location that is not ours. We are not the manufacturer of RENEW CELL®, nor is our company the holder of a registered RENEW CELL trademark covering this medicine or injectable product. Our lawyers have confirmed that no documentation has been presented for this product demonstrating an existing contractual relationship or authorisation between RENEW CELL and LABOVital GmbH & Co. KG.

The situation to which we are unlawfully exposed is particularly serious because RENEW CELL® is not promoted merely as a cosmetic.

RENEW CELL cannot be verified through official sources. It is therefore reasonable to question the origin, authenticity, traceability and regulatory status of a product intended for intramuscular administration, which would be introduced directly into the human body, as well as the identity of its manufacturer, its health authorisation, manufacturing conditions, sterility, actual composition, microbiological controls and the identity of the importer and/or responsible health authorisation holder in each country where it is marketed. No current registration or health authorisation has been found in Germany or in any other country of the European Community either.

Healthcare professionals have the right to know with absolute certainty what product they are administering, who manufactures it, under what health authorisation it is marketed, and which entity is responsible for its quality and safety.

Likewise, patients have the right to receive truthful and verifiable information.

We therefore formally request that Invima in Colombia, Cofepris in Mexico, DIGEMAPS in the Dominican Republic and other health authorities in the countries concerned, where RENEW CELL® is offered, investigate those responsible for its manufacture and marketing.

This communication is not intended to replace the investigation by the authorities or to attribute criminal responsibility to any person in advance, pending actual verification of this product, after which legal allegations against those responsible may be pursued if appropriate.

In light of the foregoing, through this reasonable clarification Labovital is exempt from any accusation seeking to implicate it in this product and to call its good name and reputation into question.