Periodic Reporting for period 1 - RAM (RAM is a revolutionary magneto-optical technology platform, outperforming current solutions in accuracy, cost, and time to diagnosis, when assessing human blood cells for Malaria presence)
Periodo di rendicontazione: 2016-10-01 al 2016-12-31
Malaria is a deadly disease exposed to over 3.3 billion people worldwide, affecting more than 106 countries and territories. There are more than 500 million infections at any given time, with at least 627,000 deaths in 2012 alone, of which an estimated 482,000 were children under the age of 5
RAM is a medical device that wholly revamps the Malaria diagnostics landscape. Its diagnostics capabilities put it ahead of all current day solutions in terms of sensitivity to identification, and quickness to results. It utilizes its novel and patented method in identifying the hemozoin cell produced in Malaria infection, as well as tracking the exact quantity of parasitemia cells contained in a given individual’s blood sample, through an exact hemozoin count. Considering the sensitive matter of blood cells, parasitic cells, and produced hemozoin cells in an infected individual, DDG still brings about a safe, reliable, and cost-effective RAM screening device that would benefit the millions of lives plagued by the disease, enabling important early stage treatment. The innovation project’s invariable benefits would come in the meeting of strict GMP in development design that would continue on to importantly address safety, regulation, compliance, and ethics issues as an end product medical device to be utilized in Malaria screening. RAM would additionally require going through conclusive clinical trials as part of successful EU commercialisation.
RAM is a medical device that wholly revamps the Malaria diagnostics landscape. Its diagnostics capabilities put it ahead of all current day solutions in terms of sensitivity to identification, and quickness to results. It utilizes its novel and patented method in identifying the hemozoin cell produced in Malaria infection, as well as tracking the exact quantity of parasitemia cells contained in a given individual’s blood sample, through an exact hemozoin count. Considering the sensitive matter of blood cells, parasitic cells, and produced hemozoin cells in an infected individual, DDG still brings about a safe, reliable, and cost-effective RAM screening device that would benefit the millions of lives plagued by the disease, enabling important early stage treatment. The innovation project’s invariable benefits would come in the meeting of strict GMP in development design that would continue on to importantly address safety, regulation, compliance, and ethics issues as an end product medical device to be utilized in Malaria screening. RAM would additionally require going through conclusive clinical trials as part of successful EU commercialisation.
Through our stakeholder interviews, we have understood that the public market involving international and national institutions (e.g. WHO, Global Fund, Governments, Universities) are very focused on scaling up malaria Rapid Diagnostic Tests (RDT’s). Highest on the agenda of the public sector, was rapid screening, accuracy in both symptomatic and asymptomatic populations, as well as portability. RDT’s are the closest solutions that enable these three key requirements. We understand from our contacts at the WHO that the public body acquires malaria testing solutions through its dedicated procurement portal (FIND), of which we will tender a bid upon RAM’s industrial production. Alternatively, the private sector takes a slightly different direction. Having spoken to some of the largest distributors of malaria diagnostics tools (e.g. Bosch Healthcare, GV Meditech, IDEO Healthcare, Harmac Medical etc.), accuracy was also a concern, while cost-price and mark-up margins have been cited to be of primary interest. In particular, the ‘razor-blade’ business model was cited as the method of choice – where private hospitals and clinics are able to invest in a single device, while upselling each ‘razor blade’ which in this case would be the cuvette. Existing RDT’s are once again, the current solution of choice, and provide the closest semblance to enacting this business model. The business model importantly allows more margin to be spread across more channels, such as wholesalers, resellers, and agents etc. When accounting for both the public and private sector, RAM will have to excel on all 6 core metrics defined by the WHO, as well as the added component of portability (which is already pervasive in today’s RDT’s), in order to competitively penetrate the malaria screening market space.
The Phase 1 Feasibility Study was instrumental to investigating the market landscape, strengths, as well as lacking requirements, in order to ensure successful commercialisation of RAM. The Feasibility Study confirmed our initial inklings of choosing the European marketspace as the first spot of commercialisation, ahead of North American expansion. This took into consideration the core of the solution’s value chain being situated in Europe, including subcontractor producers DAS, as well as third-party assistance from the University of Mons and the Royal Tropical Institute of Netherlands. Additionally, it is noted that a mass majority of public institutions such as the WHO, Global Fund, and Bosch Healthcare, choose to hold European headquarter presence, considering its centralised ‘springboard’ ability (both logistical and bilateral trade agreements) to malaria locations throughout the globe, including malaria hotbeds in the Mediterranean and sub-Saharan Africa, as well as Latin America, South Asia, and South-East Asia. Initial European commercialisation also has the advantage of pursuing CE mark approval as the ideal benchmark for first regulatory requirements.
The Phase 1 Feasibility Study was instrumental to investigating the market landscape, strengths, as well as lacking requirements, in order to ensure successful commercialisation of RAM. The Feasibility Study confirmed our initial inklings of choosing the European marketspace as the first spot of commercialisation, ahead of North American expansion. This took into consideration the core of the solution’s value chain being situated in Europe, including subcontractor producers DAS, as well as third-party assistance from the University of Mons and the Royal Tropical Institute of Netherlands. Additionally, it is noted that a mass majority of public institutions such as the WHO, Global Fund, and Bosch Healthcare, choose to hold European headquarter presence, considering its centralised ‘springboard’ ability (both logistical and bilateral trade agreements) to malaria locations throughout the globe, including malaria hotbeds in the Mediterranean and sub-Saharan Africa, as well as Latin America, South Asia, and South-East Asia. Initial European commercialisation also has the advantage of pursuing CE mark approval as the ideal benchmark for first regulatory requirements.
The value proposition is that early detection of this infectious disease is the only method of eradication over the long-term – where asymptomatic populations continue to go undetected acting as host to the one-celled parasite plasmodium, which is then propagated through the vector anopheles mosquito to new contractors of the disease. RAM will enable remote and mass screening program in a quick and systematic manner, identifying all host of the plasmodium parasite. This would then allow hasty treatment and isolation to prevent further propagation through the vector anopheles