Formalin, a water solution of formaldehyde, is extensively used in laboratories of histopathology, so that each one of them currently employs approximately 5,000 liters of formalin each year. Despite its definite advantages in the preservation of the structural and molecular details, allowing diagnostic precision, the reagent is notoriously toxic.
Indeed, the formaldehyde has been considered irritant and allergenic, as it may induce eczema and respiratory asthma for long time. Moreover, over the past decade, the scientific community has highlighted that inhalation of the highly volatile formaldehyde may lead to cancer. In the European Union, its eradication from workplaces has been mandated, by EU n. 1907/2006 and 1272/2008, starting from August 2017.
At present, however, there is no valid alternative accepted by the scientific community. Therefore, the reagent is still ordinarily used worldwide, as its substitution should be demanded to a non-toxic reagent with similar efficacy as fixative.
To fully resolve this social and scientific conundrum, the spin-off proposes a revolution in the fixative market by the introduction of an innovative reagent that will allow the optimal tissue fixation at structural and molecular level combined with the absence of toxicity and carcinogenic activity, at variance of the fixative in use. Glyoxal (a di-aldehyde similar to Formaldehyde) is not volatile and therefore not toxic. When deprived of troublesome acids, the product represents a safe histological fixative providing results as good or even better than Formalin, as proved by histological, immuno-histochemical and molecular analyses.
The company researchers firmly believe that it is possible and necessary to guarantee the highest standard of accuracy and reliability of the examinations carried out on biological samples, to preserve the health of the patients. At the same time, they aim to safeguard the health of the operators, who are currently forced to use a material like Formalin, which exposes them to the risk of inhalation of carcinogenic substances, as well as to contact with material that is harmful to health. The mission of the start-up is thus to create a "Formalin-free" hospital.
The company is particularly interested in finding partners from France and the Netherlands, but as formaldehyde has been forbidden by EU regulations in 2017, all European countries can be interested.
As the spin-off is currently producing small quantities of products at its premises, the scaling up will require establishing partnerships with partners having chemical production facilities, under manufacturing agreement for outsourcing or under licensing agreement, to be discussed. Moreover, the start up is also looking for distributors with expertise in the field of medical devices and introduction into hospitals markets.