Periodic Reporting for period 1 - OZONELASER (Cost and time-effective universal medical device for treatment of onychomycosis by combining several technologies)
Reporting period: 2016-05-01 to 2016-10-31
Onychomycosis - OM - is a contagious fungal nail infection caused by dermatophytes. OM prevalence has increased significantly over the last few decades, being a rare disease in Europe during the first half of the 20th Century, it has become the most common pathology affecting nails. According to different authors , it is estimated that between 5% and 10% of the world’s population suffer from this disease, this means that 800 million people worldwide are affected by nail fungus.
Despite these figures, conventional treatments for this condition such as topical antifungal treatments (lacquers and enamels), oral antifungal drugs (terbinafine, itraconazole, fluconazole etc.), and laser treatment have important weaknesses related to secondary effects, low efficiency, long treatment periods, high prices and pain.
In this context, TERMOSALUD, a company involved in the development of medical devices for dermatology, has developed pioneering equipment for the treatment of OM, which has demonstrated effectiveness in the treatment of the infection at the in-vitro and ex-vivo tissue assay levels, overcoming the limitations and contraindications of the current treatments.
The main innovative feature of the device is that it combines the action of two active technologies in the treatment of fungal diseases, which are able to stimulate an immune response in the body and have bactericidal, fungicidal, virucidal, antiinflammatory, analgesic and detoxifying effects. The result is a non-invasive, painless treatment without side effects, which is universal and suitable for all kinds of people.
Despite these figures, conventional treatments for this condition such as topical antifungal treatments (lacquers and enamels), oral antifungal drugs (terbinafine, itraconazole, fluconazole etc.), and laser treatment have important weaknesses related to secondary effects, low efficiency, long treatment periods, high prices and pain.
In this context, TERMOSALUD, a company involved in the development of medical devices for dermatology, has developed pioneering equipment for the treatment of OM, which has demonstrated effectiveness in the treatment of the infection at the in-vitro and ex-vivo tissue assay levels, overcoming the limitations and contraindications of the current treatments.
The main innovative feature of the device is that it combines the action of two active technologies in the treatment of fungal diseases, which are able to stimulate an immune response in the body and have bactericidal, fungicidal, virucidal, antiinflammatory, analgesic and detoxifying effects. The result is a non-invasive, painless treatment without side effects, which is universal and suitable for all kinds of people.
The objective addressed by TERMOSALUD during this preparatory phase was to carry out a feasibility study on a novel medical device to cure fungal nail infections, in order to reduce the time to market it.
For this TERMOSALUD has carried out an in-depth analysis about the following elements: market, competitors, IPRs, commercialisation strategy; technical and economic issues for TRL9, medical constraints, strategic partner selection, financial, investment, etc.
The market analysis revealed opportunities in a market dominated thus far by solutions that do not meet most of the affected population and with a high rate of therapeutic failure that oscillates, according to some authors, between 20-50% .
A highly-regulated market, the health market, which requires scientific evidence for new solutions to be admitted, and where the conclusions of the in-vitro study represent an important first step.
The study demonstrated that TERMOSALUD is a developer with the technical and human capacity to manufacture this equipment, certified under medical standards, and experienced in obtaining CE marking.
Finally, financial forecasts which show high rates of return on investment.
Based on this study, TERMOSALUD is determined to move forward with the project.
For this TERMOSALUD has carried out an in-depth analysis about the following elements: market, competitors, IPRs, commercialisation strategy; technical and economic issues for TRL9, medical constraints, strategic partner selection, financial, investment, etc.
The market analysis revealed opportunities in a market dominated thus far by solutions that do not meet most of the affected population and with a high rate of therapeutic failure that oscillates, according to some authors, between 20-50% .
A highly-regulated market, the health market, which requires scientific evidence for new solutions to be admitted, and where the conclusions of the in-vitro study represent an important first step.
The study demonstrated that TERMOSALUD is a developer with the technical and human capacity to manufacture this equipment, certified under medical standards, and experienced in obtaining CE marking.
Finally, financial forecasts which show high rates of return on investment.
Based on this study, TERMOSALUD is determined to move forward with the project.
"The clinical trial demonstrated the effectiveness of the treatment by firstly identifying fungicidal activity of the protocol on pure in-vitro cultures of species of representative fungi from each of the three main subgroups that cause OM in humans and, secondly, on ex-vivo animal tissue cultures obtained from porcine hooves.
Bearing in mind the numbers that surround this fungal disease, in terms of number of affected people and health expenditure, this discovery will have a substantial impact on the society and also from the economic point of view.
Regarding the affected population, a non-invasive, painless and without side effects treatment will be accessible and universal, which will reduce the time needed to achieve a fungal cure and the clinical improvement of the affected members.
For some patients, a fungal desease is only an aesthetical inconvenience and not a medical problem. However, the impact of the onychomycosis varies and can significantly reduce the patients quality of life, cause pain, permanent nail damage and even physical disability, as well as the contagion to other people and emotional problems. Thus, an effective treatment of this nature will motivate the patients, contrary to the current lines of treatment, which easily discourage them, causing that many patients simply get used to living with this condition.
In this sense, an increased awareness about the illness has been noticed, specially in the elderly people sector, encouraged by the sensibilisation about the ""healthy longevity"" concept.
From the point of view of economy, the ageing population and public awareness, increases of per capita health expenditure on current treatments. Only taking into account the topical and oral treatments dispensed under medical prescription, it is estimated that OM moves around 3 billion euros, 70% of which is in topical treatments (lacquers), and other therapies are not included.
On the other hand, fungal nail infections can become a persistent reservoir for more significant infectious disease problems. In diabetic patients for example, OM increases the risk of other foot ailments such as bacterial infections, ulcers and gangrene. Diabetic patients with foot ulcers are four times more likely to suffer foot amputation if they have OM.
Therefore, the successful implementation of our strategy could alter the way they treat fungal nail infections and significantly reduce the morbidity caused by these infections, as well as improve the quality of life of millions of affected people.
"
Bearing in mind the numbers that surround this fungal disease, in terms of number of affected people and health expenditure, this discovery will have a substantial impact on the society and also from the economic point of view.
Regarding the affected population, a non-invasive, painless and without side effects treatment will be accessible and universal, which will reduce the time needed to achieve a fungal cure and the clinical improvement of the affected members.
For some patients, a fungal desease is only an aesthetical inconvenience and not a medical problem. However, the impact of the onychomycosis varies and can significantly reduce the patients quality of life, cause pain, permanent nail damage and even physical disability, as well as the contagion to other people and emotional problems. Thus, an effective treatment of this nature will motivate the patients, contrary to the current lines of treatment, which easily discourage them, causing that many patients simply get used to living with this condition.
In this sense, an increased awareness about the illness has been noticed, specially in the elderly people sector, encouraged by the sensibilisation about the ""healthy longevity"" concept.
From the point of view of economy, the ageing population and public awareness, increases of per capita health expenditure on current treatments. Only taking into account the topical and oral treatments dispensed under medical prescription, it is estimated that OM moves around 3 billion euros, 70% of which is in topical treatments (lacquers), and other therapies are not included.
On the other hand, fungal nail infections can become a persistent reservoir for more significant infectious disease problems. In diabetic patients for example, OM increases the risk of other foot ailments such as bacterial infections, ulcers and gangrene. Diabetic patients with foot ulcers are four times more likely to suffer foot amputation if they have OM.
Therefore, the successful implementation of our strategy could alter the way they treat fungal nail infections and significantly reduce the morbidity caused by these infections, as well as improve the quality of life of millions of affected people.
"