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Hundreds of tissue regeneration medical devices seized for alleged  potential health risks

The Ordinary Court of Turin has ordered the seizure of hundreds of allegedly counterfeit products marketed as „equivalent“ to the Rigenera® technology patented by Rigenera HBW, a leading Italian company in the field of regenerative medicine. This step has been taken in the midst of legal proceedings for the alleged violations of intellectual property rights and for the potential risk to the health of users due to the use of materials for non-medical use.

The investigation began in 2021 following a complaint to the Italian authorities by Rigenera HBW. This warned of an international network of manufacturing and distribution of counterfeit devices, led by former partners and collaborators of the company, operating through companies in Italy, Ireland and Turkey mainly. The distribution network is spread across many countries of the GCC, including UAE and KSA, as well as Russia, Turkey, and Jordan, and was overseen by an Irish company.

These devices lacked essential medical certifications, representing a risk to public health and patient safety. This may result in adverse effects, allergic reactions and rejection of the treated tissues, among other possible health effects.

The main charges include Criminal Association (Art. 416) for being part of a stable organization to commit continuous crimes related to the counterfeiting and commercialization of medical devices; and Counterfeiting and Alteration of Industrial Patents (Arts. 473 and 517-ter), for imitating the patented Rigenera® technology for the regeneration of tissue such as hair or cartilage and being produced and commercialized without medical certifications


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