Periodic Reporting for period 1 - GAF (The First non-cancerogenic Glyoxal Acid-Free fixative for a Formalin-free hospital)
Berichtszeitraum: 2020-01-01 bis 2020-08-31
ADDAX Biosciences is an academic spin-off of the University of Torino, born after long time research activity of its founders on the fixation of pathological tissues.
Our main corporate goal responds to the need to replace the use of Formalin with an innovative histological fixative (GAF, Glyoxal Acid-Free) that guarantees the same diagnostic precision but is non-toxic. Formalin is a product widely used in histopathology to fix and preserve the pathological tissues to be analyzed for diagnostic purposes. However, Formalin is known to be toxic and carcinogenic. It is thus highly dangerous for the health of operators in the health-sector who come into contact with it. Furthermore, it can cause damage to the environment during its disposal process.
Specifically, Formalin is the aqueous and highly volatile solution of Formaldehyde, whose carcinogenicity is confirmed by scientific studies and has been progressively recognized by European and extra-European legislation. The use, production, and commerce of Formaldehyde are prohibited within the European Union starting from August 2017 (Directive 2004/37/EC, Regulation 2006/1907/EC and Regulation 2008/1272/EC ). Member States were also recommended to minimize exposure to the substance (European Parliament resolution of 27 March 2019). However, a system of authorization to the use of Formalin has been envisaged within specific sectors: this is related to the current absence of an alternative product recognized to be as valid as Formalin by the scientific community.
The innovative reagent proposed by ADDAX Biosciences for the fixation of tissues is the solution to this problem. It permits a perfect fixation of the tissue (results are analogous or better than Formalin, s.c. “non-inferiority”). At the same time, it is non-toxic nor carcinogenic. Therefore, it would allow for safeguarding the health of workers in the health sector who, managing Formalin, are exposed to the risk of developing tumours, diseases of the respiratory system, as well as to eczema and eye irritation. Furthermore, it would allow avoiding the environmental impact of the carcinogenic vapors of Formalin, absorbed by the hoods in the laboratory and partially released into the air. All this, without compromising the diagnostic precision, which is guaranteed by an optimal fixation of the tissues at the structural and molecular level.
The goal that Addax intends to achieve, therefore, is represented by the progressive replacement of Formalin with the innovative fixative proposed, to generate substantial benefits for the health of workers, patients, and the environment.
Our main corporate goal responds to the need to replace the use of Formalin with an innovative histological fixative (GAF, Glyoxal Acid-Free) that guarantees the same diagnostic precision but is non-toxic. Formalin is a product widely used in histopathology to fix and preserve the pathological tissues to be analyzed for diagnostic purposes. However, Formalin is known to be toxic and carcinogenic. It is thus highly dangerous for the health of operators in the health-sector who come into contact with it. Furthermore, it can cause damage to the environment during its disposal process.
Specifically, Formalin is the aqueous and highly volatile solution of Formaldehyde, whose carcinogenicity is confirmed by scientific studies and has been progressively recognized by European and extra-European legislation. The use, production, and commerce of Formaldehyde are prohibited within the European Union starting from August 2017 (Directive 2004/37/EC, Regulation 2006/1907/EC and Regulation 2008/1272/EC ). Member States were also recommended to minimize exposure to the substance (European Parliament resolution of 27 March 2019). However, a system of authorization to the use of Formalin has been envisaged within specific sectors: this is related to the current absence of an alternative product recognized to be as valid as Formalin by the scientific community.
The innovative reagent proposed by ADDAX Biosciences for the fixation of tissues is the solution to this problem. It permits a perfect fixation of the tissue (results are analogous or better than Formalin, s.c. “non-inferiority”). At the same time, it is non-toxic nor carcinogenic. Therefore, it would allow for safeguarding the health of workers in the health sector who, managing Formalin, are exposed to the risk of developing tumours, diseases of the respiratory system, as well as to eczema and eye irritation. Furthermore, it would allow avoiding the environmental impact of the carcinogenic vapors of Formalin, absorbed by the hoods in the laboratory and partially released into the air. All this, without compromising the diagnostic precision, which is guaranteed by an optimal fixation of the tissues at the structural and molecular level.
The goal that Addax intends to achieve, therefore, is represented by the progressive replacement of Formalin with the innovative fixative proposed, to generate substantial benefits for the health of workers, patients, and the environment.
The work performed during the present Feasibility Study cover the pursue of the technical feasibility and the economic viability of our project.
To validate our fixative at the European level we defined and initiated an open-label, comparative non-inferiority study. called: ADDAX-GAF-2019: Performance evaluation of Glyoxal Acid-Free (GAF) used as histological fixative in comparison with Formalin. The trial will work as the scientific validation of GAF’s efficacy and confirmation of its fixative capacity (equal to or greater than that of Formalin). The Trial is in an advanced stage of development. Tests were therefore carried out in 3 pathology laboratories located in 3 different countries (Italy, Spain, UK) on a large number of oncological biopsies. Starting the trial involved a series of necessary preliminary activities such as: identifying the research centers, requesting and subsequently acquiring the opinion of the Ethics Committee, training the personnel involved in each centre (also through the creation of a video that illustrates the procedure to be followed) and preparing an online platform of Digital Pathology necessary for data collection. At present, 61 samples have been collected and processed in duplicate (GAF and Formalin for a total of 610 tests), and currently evaluated by a blind central reviewer. After reaching 65 cases an interim analysis will be performed. The results of the interim analysis will be presented at congresses and in a publication and will be diffused to increase the consensus on the product. This will represent a focal point of our marketing campaign.
Furthermore, to improve the economic sustainability of the project, we have updated our Business Plan. We have carried out new market analyses and made new marketing projections for our business model. As a result of this activity, and to improve the efficiency of a future marketing campaign, we are in the process of establishing commercial relationships with national and international distributors. Furthermore, we have developed a digital marketing strategy for the online sale of GAF. The Addax website has been optimized by introducing e-commerce functionalities. SEM and social media marketing campaigns have been set up to reach potential buyers more easily.
The results achieved in this phase of implementation of the project, therefore, can be identified in: the completed launch of the European trial, through which, in the coming months, we will have useful data to scientifically validate the efficacy of GAF; the updating of the Business Plan, and the establishment of profitable commercial relations with national and international distributors to be finalized by December 2020; the improvement of the website and the imminent launch of digital marketing campaigns and e-commerce sales, to work in parallel with traditional distribution methods.
To validate our fixative at the European level we defined and initiated an open-label, comparative non-inferiority study. called: ADDAX-GAF-2019: Performance evaluation of Glyoxal Acid-Free (GAF) used as histological fixative in comparison with Formalin. The trial will work as the scientific validation of GAF’s efficacy and confirmation of its fixative capacity (equal to or greater than that of Formalin). The Trial is in an advanced stage of development. Tests were therefore carried out in 3 pathology laboratories located in 3 different countries (Italy, Spain, UK) on a large number of oncological biopsies. Starting the trial involved a series of necessary preliminary activities such as: identifying the research centers, requesting and subsequently acquiring the opinion of the Ethics Committee, training the personnel involved in each centre (also through the creation of a video that illustrates the procedure to be followed) and preparing an online platform of Digital Pathology necessary for data collection. At present, 61 samples have been collected and processed in duplicate (GAF and Formalin for a total of 610 tests), and currently evaluated by a blind central reviewer. After reaching 65 cases an interim analysis will be performed. The results of the interim analysis will be presented at congresses and in a publication and will be diffused to increase the consensus on the product. This will represent a focal point of our marketing campaign.
Furthermore, to improve the economic sustainability of the project, we have updated our Business Plan. We have carried out new market analyses and made new marketing projections for our business model. As a result of this activity, and to improve the efficiency of a future marketing campaign, we are in the process of establishing commercial relationships with national and international distributors. Furthermore, we have developed a digital marketing strategy for the online sale of GAF. The Addax website has been optimized by introducing e-commerce functionalities. SEM and social media marketing campaigns have been set up to reach potential buyers more easily.
The results achieved in this phase of implementation of the project, therefore, can be identified in: the completed launch of the European trial, through which, in the coming months, we will have useful data to scientifically validate the efficacy of GAF; the updating of the Business Plan, and the establishment of profitable commercial relations with national and international distributors to be finalized by December 2020; the improvement of the website and the imminent launch of digital marketing campaigns and e-commerce sales, to work in parallel with traditional distribution methods.
We believe that the activity carried out has laid the foundations for the progressive achievement of our general aim of maximum product diffusion, towards the complete replacement of Formalin. Soon we will be able to use the scientific results of the trial to accelerate and optimize this replacement process, increasing the credibility of the product within the scientific community. The digital marketing campaigns will generate greater awareness of the problem relating to the use of toxic substances in the health sector and the related dangers to those who work in contact with Formalin. Furthermore, it will contribute to diffuse knowledge about the existence of valid non-toxic alternatives on the market for histological fixatives: i.e. GAF.
We consider that our strategy will accelerate the diffusion of our product in substitution of Formalin. Our main mission critical priority and aim remain to create formalin-free hospitals around the world, starting from Europe where the legislation is already supporting the eradication of Formalin. The number of workers currently exposed to formalin vapors in the absence of adequate protection disposals such as hoods (necessary to avoid dispersion of carcinogenic vapors) is extremely high outside the pathology service, in the surgical and day-hospital rooms, in private medical centers, as well as in the veterinary sector, where many bioptic samples are taken outside.
As already illustrated, achieving our goal will have a highly positive impact both on the health and safety of those workers and on the environment, without compromising the fundamental diagnostic precision.
We consider that our strategy will accelerate the diffusion of our product in substitution of Formalin. Our main mission critical priority and aim remain to create formalin-free hospitals around the world, starting from Europe where the legislation is already supporting the eradication of Formalin. The number of workers currently exposed to formalin vapors in the absence of adequate protection disposals such as hoods (necessary to avoid dispersion of carcinogenic vapors) is extremely high outside the pathology service, in the surgical and day-hospital rooms, in private medical centers, as well as in the veterinary sector, where many bioptic samples are taken outside.
As already illustrated, achieving our goal will have a highly positive impact both on the health and safety of those workers and on the environment, without compromising the fundamental diagnostic precision.