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Biomedical company developing new formalin-free fixative is looking for manufacturing partners

Country of origin:
Country: 
ITALY
Opportunity:
External Id: 
TOIT20200324001
Published
01/04/2020
Last update
06/04/2020
Expiration date
04/04/2021

Keywords

Partner keyword: 
Cytology, Cancerology, Oncology
Diagnostics, Diagnosis
Environmental Medicine, Social Medicine, Sports Medicine
Cellular and Molecular Biology
Diagnostic services
In-vitro diagnostics
Forensic science
Molecular diagnosis
Anatomy, Pathology, Immunology, Physiology
Hospital activities
Residential nursing care activities
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Summary

Summary: 
A university spin-off in Northern Italy has developed a non toxic and non-cancerogenic fixative alternative to the use of formaline, that is a forbidden substance, to create Formalin-free hospitals, where thousands of health workers are now exposed to its effects. In order to scale up, partners for outsourcing production abroad or for licensing agreements are sought.

Description

Description: 

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.

Advantages & innovations

Cooperation plus value: 
The company introduced into the market a histological fixative as alternative to Formalin, a toxic and carcinogenic agent, based on an innovative glyoxal solution. The proposed reagent is the most safe and reliable fixative to be used in Clinics, Surgeries, Hospitals, Research Centres, Forensic and Veterinary laboratories. It is the first real alternative to carcinogenic Formalin, overtaking all other ineffective fixatives. It combines the optimal tissue fixation at structural and molecular level with the absence of toxic and carcinogenic activity and it fully complies with EU regulation and preserves the health of medical sector workers.

Stage of development

Cooperation stage dev stage: 
Field tested/evaluated

Partner sought

Cooperation area: 
The spin-off is currently producing small quantities of products at its premises, but aims to scale up: thus it is looking for partners having chemical production facilities, under manufacturing agreement for outsourcing or under licensing agreement, to be discussed. They should be producers of chemical reagents/IVD for an outsourcing production of the fixative. GLP production is required. Moreover, the start up is also looking for distributors/companies with expertise in the field of medical devices and introduction into hospitals markets, via commercial agreements with technical assistance.