The panorama of companies operating in the biomedical field in Europe, and consequently in Italy too, is composed by two completely different business realities.
On one hand, there are multinational companies, certainly attentive to technological innovation, but often, due to slow and stratified decision-making processes, not very reactive in translating this innovation into marketable products.
On the other hand, there is a myriad of small businesses usually less inclined to innovation, often because of a short-sighted managerial attitude that considers an economic exposure as an immediate risk rather than a competitive advantage for the future.
We at UBGEN have a totally different vision, we strongly believe in technological innovation and we consider investing in it a fundamental element to anticipate the future. Therefore, we conceived a lean structure that is able to adapt to a changing market.
From an analysis that we conducted internally, we realized that the solutions offered in the biomedical field by other commercial entities are incomplete, generic and undifferentiated.
For this reason, the clinician needs to address to different suppliers to get everything he needs to operate in bone surgery in the dental field. This involves a sort of “do-it-yourself” in the procurement of equipment and materials that can also lead to unwanted results caused by unavoidable incompatibility between different products.
That's why at UBGEN we created OTiGEN SYSTEM: while our competitors only provide some of the components, often not even specifically designed for dental surgery, we have created the first complete system of products and services specifically designed to meet the needs of those who work in tissue engineering, with a specific focus in the dental field.
OTiGEN SYSTEM is therefore the linking ring that allows the clinician to have a single commercial partner able to serve her/him at 360°: from the initial phases with the blood-derived concentrates until the suturing of the wound through our Bone & Tissue Management instruments.
For our partners it means having the first and only integrated system in which each component has been designed to interact with the others, ensuring full compatibility and predictability of results.
The RE-BONE bone graft is a highly purified material, produced from the epiphyses of bovine femurs from selected Italian slaughterhouses UNI EN ISO 9001: 2015 certified. In accordance with the guidelines of the EU Directive 93/42 EEC, the raw material, i.e. bone tissue, is classified as prion-free and therefore safe, as it comes from animals born and raised in Italy, killed under 24 months in agreement with REGULATION (EC) N.357 / 2008.
The manufacturing process, strict control procedures and clinical documentation are controlled by the responsible regulatory authorities. CE certifications confirm that the product fully meets the necessary requirements.
The production of RE-BONE is subject to the quality certification system in accordance with the international guidelines ISO 13485. This control system is evaluated at least once a year by independent experts and international supervisory authorities.
RE-BONE has been tested in experimental animal and clinical studies. Professionals and researchers from various universities continuously carry out clinical and scientific research with RE-BONE.
SHELTER Fast and SHELTER Slow are membranes produced from decellularized bovine pericardium. The raw material, obtained from certified and controlled cattle, is processed according to a tested and certified cleaning process called Pericross.
This process involves a series of steps to eliminate the protein and lipid cellular component, while preserving the natural structure of the pericardium.
SHELTER complies with the ISO 10993-1 standard which ensures the legal requirements for biocompatibility as a medical device.
After packaging, the SHELTER Fast and SHELTER Slow membrane is sterilized with γ rays for the inactivation of viruses and bacteria.
CE certifications confirm that the product fully meets the required requirements.
SHELTER has been tested in experimental animal and clinical studies. Researchers in various universities continuously carry out clinical and scientific research.
UBGEN Srl Viale del Lavoro 14, 35010, Vigonza (PD), Italy - Phone: +39 049 628 630