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

• The Italian courts have ordered the seizure of all allegedly fraudulent copies of the Rigenera® technology in the legal proceedings initiated at the request of Rigenera HBW, a leading company in regenerative medicine
• The use of counterfeit devices lacking medical and official certifications, and with materials that are not suitable for medical use, can represent a high risk for patients, with possible health consequences
• With the seizure decreed by the Ordinary Court of Turin, the judiciary is moving forward in the legal proceedings initiated by Rigenera HBW and thus confirms indications of counterfeit medical devices with potential risk for patients

TURIN, Italy, Feb. 25, 2025 /PRNewswire/ -- 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.

With the decision to seize all allegedly counterfeit devices, the Court reinforces the position of Rigenera HBW and its official distributor, Regenera Activa, in defense of public health and technological innovation.

About Rigenera® technology 

Rigenera® was created to democratize regenerative medicine and improve the quality of life of patients. This technology, patented and produced by Rigenera HBW and distributed only by Regenera Activa, provides patients with a unique and innovative minimally invasive solution based on autologous micro-grafts of biological compounds with unmanipulated progenitor cells. This makes it possible to regenerate tissues of the human body and to treat pathologies such as osteoarthritis, chronic wound healing or androgenic alopecia more quickly and effectively. With over 10 years of experience, the technology is used by 10,000 doctors worldwide, more than 450,000 treatments have been performed and it is supported by more than 80 scientific studies.